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    Ganciclovir

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    Mar.19.2024

    Ganciclovir

    Indications/Dosage

    Labeled

    • cytomegalovirus (CMV) disease prophylaxis
    • cytomegalovirus (CMV) retinitis
    • cytomegalovirus (CMV) retinitis prophylaxis
    • herpes simplex virus epithelial keratitis
    • multicentric Castleman disease

    Off-Label

    • acute retinal necrosis (ARN)
    • congenital cytomegalovirus (CMV) disease
    • cytomegalovirus (CMV) pneumonitis
    • cytomegalovirus (CMV)-associated gastrointestinal disease
    • encephalitis
    • herpes simplex virus infection
    • human herpesvirus 6 (HHV-6) infection
    • human herpesvirus 8 (HHV-8) infection
    • neonatal herpes simplex virus infection
    • progressive outer retinal necrosis (PORN)
    • varicella (chickenpox) infection
    † Off-label indication

    For the treatment of viral encephalitis†

    for varicella-zoster (herpes zoster) encephalitis† as an alternative to acyclovir

    Intravenous dosage

    Adults

    5 mg/kg/dose IV every 12 hours is recommended by the Infectious Diseases Society of America (IDSA). Although no duration is given for ganciclovir, 10 to 15 days duration of therapy is recommended for acyclovir.[34213]

    Infants 4 months and older, Children, and Adolescents

    5 mg/kg/dose IV every 12 hours. The American Academy of Pediatrics (AAP) recommends ganciclovir as the first line alternative when IV acyclovir is unavailable for patients with herpes simplex/varicella zoster infections in immunocompromised hosts and patients unable to tolerate oral acyclovir or valacyclovir.[52560]

    Neonates and Infants 1 to 3 months

    6 mg/kg/dose IV every 12 hours. The American Academy of Pediatrics (AAP) recommends ganciclovir as the first line alternative when IV acyclovir is unavailable for patients with suspected or proven neonatal herpes simplex disease and herpes simplex/varicella zoster infections in immunocompromised hosts and patients unable to tolerate oral acyclovir or valacyclovir.[52560]

    for the treatment of cytomegalovirus (CMV) encephalitis† and for the treatment of cytomegalovirus (CMV) neurological disease† (including encephalitis†) in HIV-infected patients

    Intravenous dosage

    Adults and Adolescents

    5 mg/kg/dose IV every 12 hours plus IV foscarnet (to stabilize the disease and maximize response); optimal duration has not been established. Routine maintenance therapy is not recommended unless there is concurrent retinitis, there have already been recurrent infections, or severe disease was present initially.[34213] [34362]

    Infants and Children

    5 mg/kg/dose IV every 12 hours plus IV foscarnet (to stabilize the disease and maximize response). Continue treatment until there is symptomatic improvement, then follow with secondary prophylaxis (chronic maintenance therapy). Acutely, single drug therapy with ganciclovir is not recommended due to therapeutic failures.[34213] [34361]

    Neonates

    6 mg/kg/dose IV every 12 hours for 6 weeks. If during the 6 weeks of therapy an infant is identified as HIV-infected, some experts recommend extending the course of therapy beyond 6 weeks.[34361]

    for encephalitis† due to B virus (cercopithecine herpesvirus) infection† as an alternative to valacyclovir

    Intravenous dosage

    Adults, Adolescents, Children, and Infants

    5 mg/kg/dose IV every 12 hours for a minimum of 14 days or until all CNS symptoms have resolved is recommended by the IDSA.[34213]

    For induction treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including persons with HIV

    Intravenous dosage

    Adults

    5 mg/kg/dose IV every 12 hours for 14 to 21 days as an initial therapy. Systemic therapy may be combined with intravitreal ganciclovir or foscarnet for immediate sight-threatening lesions (i.e., within 1,500 microns of the fovea). Follow with chronic maintenance therapy.[32676] [34362]

    Adolescents†

    5 mg/kg/dose IV every 12 hours for 14 to 21 days as an initial therapy. Systemic therapy may be combined with intravitreal ganciclovir or foscarnet for immediate sight-threatening lesions (i.e., within 1,500 microns of the fovea). Follow with chronic maintenance therapy.[32676] [34362]

    Infants† and Children†

    5 mg/kg/dose IV every 12 hours for 14 to 21 days; may increase dose to 7.5 mg/kg/dose IV every 12 hours if needed. Consider adding IV foscarnet for sight-threatening disease. Follow with chronic maintenance therapy.[34361]

    Intravitreal dosage†

    Adults

    2 mg intravitreally once weekly until lesion inactivity is achieved for patients with immediate sight-threatening lesions (i.e., within 1,500 microns of the fovea). Intravitreal injections are given to achieve rapid high intraocular drug concentrations and should be administered in combination with systemic induction therapy.[34362]

    Adolescents

    2 mg intravitreally once weekly until lesion inactivity is achieved for patients with immediate sight-threatening lesions (i.e., within 1,500 microns of the fovea). Intravitreal injections are given to achieve rapid high intraocular drug concentrations and should be administered in combination with systemic induction therapy.[34362]

    For the treatment of cytomegalovirus (CMV)-associated gastrointestinal disease† (e.g., esophagitis†, gastroenteritis†, or colitis†)

    in HIV-infected patients

    Intravenous dosage

    Adults

    5 mg/kg/dose IV every 12 hours is recommended by the HIV guidelines for 21 to 42 days or until resolution of signs and symptoms; when patient can tolerate PO, switch to oral valganciclovir to complete therapy. Maintenance therapy is usually not necessary, but should be considered after relapse.[34362]

    Adolescents

    5 mg/kg/dose IV every 12 hours is recommended in the HIV guidelines. Therapy may be switched to oral valganciclovir once the patient can tolerate PO therapy. The total duration of therapy should be 21 to 42 days or until resolution of signs and symptoms.[34362]

    Infants and Children

    5 mg/kg/dose IV every 12 hours for 14 to 21 days is recommended in the HIV guidelines for patients with disseminated disease; the dosage may be increased to 7.5 mg/kg/dose IV every 12 hours if needed.[34361]

    in patients who have undergone a bone marrow transplant (BMT)

    Intravenous dosage

    Adults

    In a small randomized, placebo-controlled trial, BMT patients with biopsy-documented CMV infection of the GI tract were treated with ganciclovir 2.5 mg/kg/dose IV every 8 hours for 14 days and did not demonstrate a superior clinical response or endoscopic appearance compared to the placebo group. Cultures were negative more often, however, in the ganciclovir group.[24288]

    For the treatment of cytomegalovirus (CMV) pneumonitis†

    Intravenous dosage

    Adults

    Experience is limited in HIV-infected patients. 5 mg/kg/dose IV every 12 hours is suggested by the HIV guidelines; however, optimal duration has not been established.[34362] In an open trial in BMT patients, ganciclovir 2.5 mg/kg/dose IV every 8 hours for 14 days, in combination with intravenous CMV-IVIG (on days 1, 2, 7, and 14) was studied. In patients who were still symptomatic, a maintenance dose of 5 mg/kg/dose IV once daily was given for an additional 14 days with CMV-IVIG on day 21. Twelve of 25 patients died a median of 12 days after treatment.[24033] In another trial in BMT patients, ganciclovir 2.5 mg/kg/dose IV every 8 hours for 20 days, then 5 mg/kg/dose IV once daily 3 to 5 times per week for 20 additional doses in combination with IV immune globulin was evaluated. Combination therapy was successful in 7 of 10 patients.[24376]

    Adolescents

    5 mg/kg/dose IV every 12 hours. For HIV-infected patients, treatment should be considered in patients with well-documented, histologic evidence of CMV pneumonitis. Data for treating CMV pneumonitis in HIV-infected patients is limited and the optimal duration of therapy has not been established.[34362] In 3 pediatric patients who developed CMV pneumonitis after allogenic stem cell transplant, 5 mg/kg/dose IV every 12 hours for 14 days, then 5 mg/kg/dose IV once daily for 5 to 7 days each week for 3 weeks was used. Intravenous immunoglobulin was given in addition to ganciclovir in all patients for part of the study period. Two of the 3 patients that developed CMV pneumonitis died; 1 of multiorgan failure and 1 of acute graft versus host disease.[52568]

    Infants and Children

    5 mg/kg/dose IV every 12 hours for 14 to 21 days. For HIV-infected patients with disseminated disease, the dose may be increased to 7.5 mg/kg/dose IV every 12 hours if needed.[34361] 5 mg/kg/dose IV every 12 hours for 14 days, then 5 mg/kg/dose IV once daily for 5 to 7 days each week for 3 weeks was used in 3 pediatric patients who developed CMV pneumonitis after allogenic stem cell transplant. Intravenous immunoglobulin was given in addition to ganciclovir in all patients with CMV infection for part of the study period, and then only in patients with subnormal IgG. Two of the 3 patients that developed CMV pneumonitis died; 1 of multiorgan failure and 1 of acute graft versus host disease.[52568]

    For the treatment of symptomatic congenital cytomegalovirus (CMV) disease†

    Intravenous dosage

    Neonates and Infants

    6 mg/kg/dose IV every 12 hours for 6 weeks. Dosage adjustments for the development of neutropenia may be required.[32656] [45501] This regimen is also recommended by the CDC for HIV-infected neonates; if a neonate is confirmed as being HIV-positive during the 6-week treatment course, some experts recommend extending the treatment course beyond 6 weeks.[34361] Clinical practice guidelines recommend antiviral treatment only for symptomatic neonates (first 30 days of life) with severe symptomatic focal organ disease or CNS disease.[34361] [57601]

    For cytomegalovirus (CMV) disease prophylaxis in patients at risk for CMV disease

    for prophylaxis in allogeneic hematopoietic cell transplant (HCT) recipients

    Intravenous dosage

    Adults

    5 mg/kg/dose IV every 12 hours for 7 to 14 days, followed by maintenance therapy of 5 mg/kg/dose IV daily for 7 days per week or 6 mg/kg/dose IV daily for 5 days per week through day 100 to 120 post-transplant.[32676] [51812] Other studies have examined similar doses starting 5 to 7 days prior to transplantation.[24258] [24290] Regimens are transplant center and recipient specific; high dose acyclovir or other co-therapies may be utilized.[24289] [24377] [23964]

    Infants†, Children†, and Adolescents†

    5 mg/kg/dose IV twice daily for 5 to 7 days starting at engraftment, followed by 5 mg/kg/dose IV once daily through day 100 post-transplant. Monitor ANC at least twice weekly during ganciclovir therapy.[51812] Regimens are transplant center and recipient specific; consult local protocols.

    for preemptive therapy in hematopoietic cell transplant (HCT) recipients who are less than 100 days post HCT†

    Intravenous dosage

    Adults

    5 mg/kg/dose IV twice daily for 7 to 14 days for allogeneic transplant recipients or for 7 days for autologous transplant recipients, then 5 mg/kg/dose IV once daily for maintenance. Continue maintenance therapy until CMV detection methods are negative. The minimum length of therapy is 2 weeks for autologous HCT; for allogenic HCT, the minimum is 2 weeks when 14-day induction is used or 3 weeks when a 7-day induction is used. Preemptive therapy is recommended for all allogeneic transplant recipients with evidence of CMV infection in blood by antigenemia, PCR for CMV DNA, or detection of CMV mRNA and for CMV seropositive autologous transplant recipients at high risk when CMV antigenemia is at least 5 cells/slide (or any level for recipients of CD34+ selected grafts).[51812] Regimens are transplant center and recipient specific; consult local protocols.

    Infants, Children, and Adolescents

    5 mg/kg/dose IV twice daily for 7 to 14 days for allogeneic transplant recipients or for 7 days for autologous transplant recipients, then 5 mg/kg/dose IV once daily for maintenance. Continue maintenance therapy until CMV detection methods are negative. The minimum length of therapy is 2 weeks for autologous HCT; for allogenic HCT, the minimum is 2 weeks when 14-day induction is used or 3 weeks when a 7-day induction is used. Preemptive therapy is recommended for all allogeneic transplant recipients with evidence of CMV infection in blood by antigenemia, PCR for CMV DNA, or detection of CMV mRNA and for CMV seropositive autologous transplant recipients at high risk when CMV antigenemia is at least 5 cells/slide (or any level for recipients of CD34+ selected grafts).[51812] Regimens are transplant center and recipient specific; consult local protocols.

    for preemptive therapy in hematopoietic cell transplant (HCT) recipients who are more than 100 days post HCT†

    Intravenous dosage

    Adults

    5 mg/kg/dose IV twice daily for 7 to 14 days, then 5 mg/kg/dose IV once daily for 1 to 2 weeks or until the indicator test is negative. The minimum length of therapy is 2 weeks. Preemptive therapy is recommended when allogeneic transplant recipients, patients receiving steroids for GVHD, or patients who received CMV therapy less than 100 days after HCT have an antigenemia at least 5 cells/slide or at least 2 consecutive positive viremia or PCR tests.[51812] Regimens are transplant center and recipient specific; consult local protocols.

    Infants, Children, and Adolescents

    5 mg/kg/dose IV twice daily for 7 to 14 days, then 5 mg/kg/dose IV once daily for 1 to 2 weeks or until the indicator test is negative. The minimum length of therapy is 2 weeks. Preemptive therapy is recommended when allogeneic transplant recipients, patients receiving steroids for GVHD, or patients who received CMV therapy less than 100 days after HCT have an antigenemia at least 5 cells/slide or at least 2 consecutive positive viremia or PCR tests.[51812] Regimens are transplant center and recipient specific; consult local protocols.

    for solid organ transplant recipients who are CMV-seropositive or CMV-seronegative receiving an organ from a CMV-seropositive donor

    Intravenous dosage

    Adults

    5 mg/kg/dose IV twice daily for 7 to 14 days, followed by 5 mg/kg/dose IV once daily 7 days per week or 6 mg/kg/dose IV once daily 5 days per week is the FDA-approved dosage.[32676] 5 mg/kg/dose IV once daily starting within 10 days post-transplant and continuing for 3 months has been recommended. Studies have been conducted in recipients of kidney, kidney-pancreas, heart, heart-lung, liver, lung, and pancreas transplants.[24375] [24419]

    Children† and Adolescents†

    5 mg/kg/dose IV once daily starting within 10 days post-transplant and continuing for up to 3 months has been recommended. Some protocols may extend therapy up to 6 months in highest risk patients. Regimens vary by transplant center, type of transplant, and recipient characteristics; consult local protocols. CMV hyperimmune globulin may be added to the ganciclovir regimen and/or the duration of IV therapy may vary.[32677]

    for solid organ transplant recipients who are CMV-seropositive and receiving immunosuppressive induction therapy (i.e., transplant rejection treatment) with antithymocyte globulin (ATG)†

    Intravenous dosage

    Adults

    5 mg/kg/day IV for the length of ATG therapy, followed by oral ganciclovir for 3 to 4 months, significantly reduced the incidence of CMV disease in patients who also were treated with ATG.[25495]

    For the treatment of progressive outer retinal necrosis (PORN)† due to varicella zoster virus (VZV)† in persons living with HIV

    Intravenous dosage

    Adults

    5 mg/kg/dose IV every 12 hours plus ganciclovir intravitreal injection and/or foscarnet intravitreal injection. The optimal duration has not been defined; duration should be determined clinically in consultation with an ophthalmologist.[34362]

    Adolescents

    5 mg/kg/dose IV every 12 hours plus ganciclovir intravitreal injection and/or foscarnet intravitreal injection. The optimal duration has not been defined; duration should be determined clinically in consultation with an ophthalmologist.[34362]

    Infants and Children

    5 mg/kg/dose IV every 12 hours plus IV foscarnet plus ganciclovir intravitreal injection and/or foscarnet intravitreal injection. The optimal duration has not been defined; duration should be determined clinically in consultation with an ophthalmologist.[34361]

    Intravitreal dosage

    Adults

    2 mg/0.05 mL intravitreal injection twice weekly, with or without foscarnet intravitreal injection, in combination with systemic therapy (i.e., ganciclovir or acyclovir). The optimal duration has not been defined; duration should be determined clinically in consultation with an ophthalmologist.[34362]

    Adolescents

    2 mg/0.05 mL intravitreal injection twice weekly, with or without foscarnet intravitreal injection, in combination with systemic therapy (i.e., ganciclovir or acyclovir). The optimal duration has not been defined; duration should be determined clinically in consultation with an ophthalmologist.[34362]

    Infants and Children

    2 mg/0.05 mL intravitreal injection twice weekly, with or without foscarnet intravitreal injection, in combination with systemic therapy (i.e., acyclovir or ganciclovir plus foscarnet). The optimal duration has not been defined; duration should be determined clinically in consultation with an ophthalmologist.[34361]

    For the treatment of severe human herpesvirus 8 (HHV-8) infection† and associated diseases in HIV-infected patients, including multicentric Castleman disease† (MCD) and primary effusion lymphoma† (PEL)

    for multicentric Castleman disease (MCD)†

    Intravenous dosage

    Adults, Adolescents, Children, and Infants

    5 mg/kg/dose IV every 12 hours for 3 weeks is recommended by the HIV guidelines.[34361] [34362]

    primary effusion lymphoma† (PEL)

    Intravenous dosage

    Adults, Adolescents, Children, and Infants

    5 mg/kg/dose IV every 12 hours may be useful as an adjunct to chemotherapy and antiretroviral therapy.[34361] [34362]

    For the treatment of herpes simplex virus epithelial keratitis

    NOTE: Ganciclovir ophthalmic gel is an FDA-designated orphan drug for this indication.

    Ophthalmic dosage (0.15% ophthalmic gel)

    Adults

    1 drop in the affected eye(s) 5 times daily, approximately every 3 hours while awake, until corneal ulcer heals, then 1 drop in the affected eye(s) 3 times daily for 7 days.[36875]

    Children and Adolescents 2 to 17 years

    1 drop in the affected eye(s) 5 times daily, approximately every 3 hours while awake, until corneal ulcer heals, then 1 drop in the affected eye(s) 3 times daily for 7 days.[36875]

    For the treatment of acute retinal necrosis (ARN)† due to varicella-zoster virus in patients with HIV

    Intravitreal dosage

    Adults

    2 mg/0.05 mL intravitreal injections given twice weekly until evidence of treatment response. Administer in combination with 10 to 14 days of IV acyclovir, then at least 14 weeks of oral valacyclovir is recommended by the HIV guidelines. Involvement of an experienced ophthalmologist is recommended.[34362]

    Adolescents

    2 mg/0.05 mL intravitreal injections given twice weekly until evidence of treatment response. Administer in combination with 10 to 14 days of IV acyclovir, then at least 14 weeks of oral valacyclovir is recommended by the HIV guidelines. Involvement of an experienced ophthalmologist is recommended.[34362]

    For the treatment of herpes simplex virus infection† or varicella (chickenpox) infection† due to varicella-zoster virus in hospitalized immunocompromised patients unable to take oral therapy

    NOTE: For CNS disease, see encephalitis.

    Intravenous dosage

    Infants 4 months and older, Children, and Adolescents

    5 mg/kg/dose IV every 12 hours. The American Academy of Pediatrics (AAP) recommends ganciclovir as the first line alternative when IV acyclovir is unavailable for herpes simplex/varicella zoster infections in immunocompromised hosts and patients unable to tolerate oral acyclovir or valacyclovir.[52560]

    Neonates and Infants 1 to 3 months

    6 mg/kg/dose IV every 12 hours. The American Academy of Pediatrics (AAP) recommends ganciclovir as the first line alternative when IV acyclovir is unavailable in suspected or proven neonatal herpes simplex disease or herpes simplex/varicella zoster infections in immunocompromised hosts.[52560]

    For the treatment of neonatal herpes simplex virus infection†

    Intravenous dosage

    Neonates and Infants 1 to 3 months

    6 mg/kg/dose IV every 12 hours. The American Academy of Pediatrics (AAP) recommends ganciclovir as the first line alternative when IV acyclovir is unavailable in cases of suspected or proven neonatal herpes simplex disease.[52560]

    For the treatment of encephalitis caused by human herpesvirus 6 (HHV-6) infection† in immunocompromised patients

    Intravenous dosage

    Adults

    5 mg/kg/dose IV every 12 hours for 1 to 3 weeks, followed by a maintenance dose of 5 mg/kg/dose IV once daily to 5 times weekly has been effective in small studies and case reports of immunocompromised adult patients with HHV-6 encephalitis.[57254] [57255] [57297] Ganciclovir alone or in combination with foscarnet is suggested as reasonable by the IDSA due to the lack of other therapeutic options.[34213]

    Infants, Children, and Adolescents

    5 mg/kg/dose IV every 12 hours for 1 to 3 weeks, followed by a maintenance dose of 5 mg/kg/dose IV once daily to 5 times weekly, has been effective in small studies and case reports of pediatric and adult patients with HHV-6 encephalitis.[52562] [57253] [57254] [57255] Higher doses of ganciclovir (18 to 24 mg/kg/day) have also been used in children, without side effects.[57253] [57296] Ganciclovir alone or in combination with foscarnet is suggested as reasonable by the IDSA due to the lack of other therapeutic options.[34213]

    For chronic suppressive therapy of cytomegalovirus (CMV) disease, including CMV retinitis (i.e., secondary cytomegalovirus (CMV) retinitis prophylaxis) in patients with HIV

    NOTE: Ganciclovir intravenous injection has been designated an orphan drug by the FDA for CMV retinitis.

    NOTE: The HIV guidelines generally do not recommend ganciclovir for chronic suppressive therapy following acute CMV disease other than retinitis in adults and adolescents.[34362] In infants and children, chronic suppressive therapy is recommended after disseminated disease, neurologic disease, retinitis, or gastrointestinal disease with relapse.[34361]

    NOTE: For patients who experience progression of CMV retinitis while receiving maintenance therapy, re-induction treatment with the same drug used for maintenance followed by reinstitution of maintenance therapy is recommended.[34361] [34362]

    Intravenous dosage

    Adults

    Following induction therapy for CMV retinitis, give chronic maintenance therapy of 5 mg/kg/dose IV daily for 7 days per week or 6 mg/kg/dose IV daily for 5 days per week; may switch to oral valganciclovir when the patient is clinically improving and there are no concerns about absorption. The duration of maintenance therapy depends on the immune status of the patient. For patients with HIV who have had a sustained immune response to highly active antiretroviral therapy (i.e., CD4 counts greater than 100 cells/mm3 for 3 to 6 months), have been on CMV treatment for at least 3 to 6 months, and have no active lesions, secondary CMV retinitis prophylaxis may be discontinued after consultation with an ophthalmologist. Maintenance therapy should be restarted if subsequent CD4 counts drop to less than 100 cells/mm3, as relapse occurs most frequently in those patients whose counts decrease to less than 50 cells/mm3 after stopping treatment. However, because relapses may occur at any CD4 count, all patients who have had maintenance CMV therapy discontinued should continue to undergo regular ophthalmologic monitoring (every 3 months) for early detection of CMV relapse (as well as for immune reconstitution uveitis).[32676] [34362]

    Adolescents†

    Following induction therapy for CMV retinitis, give chronic maintenance therapy of 5 mg/kg/dose IV daily; may switch to oral valganciclovir when the patient is clinically improving and there are no concerns about absorption. The duration of maintenance therapy depends on the immune status of the patient. For patients with HIV who have had a sustained immune response to highly active antiretroviral therapy (i.e., CD4 counts greater than 100 cells/mm3 for 3 to 6 months), have been on CMV treatment for at least 3 to 6 months, and have no active lesions, secondary CMV retinitis prophylaxis may be discontinued after consultation with an ophthalmologist. Maintenance therapy should be restarted if subsequent CD4 counts drop to less than 100 cells/mm3, as relapse occurs most frequently in those patients whose counts decrease to less than 50 cells/mm3 after stopping treatment. However, because relapses may occur at any CD4 count, all patients who have had maintenance CMV therapy discontinued should continue to undergo regular ophthalmologic monitoring (every 3 months) for early detection of CMV relapse (as well as for immune reconstitution uveitis).[34362]

    Infants† and Children†

    5 mg/kg/dose IV once daily is recommended as the preferred regimen in the HIV guidelines after induction therapy. Treatment duration depends on the immune status of the patient. Discontinuation of secondary prophylaxis may be considered in children who have received at least 6 months of highly active antiretroviral therapy with a sustained increase (more than 6 months) in CD4 percentage of at least 15% (pediatric patients younger than 5 years) or CD4 count more than 100 cells/mm3 (children 6 years and older). For retinitis, the decision to discontinue secondary prophylaxis should be made in consultation with an ophthalmologist. Routine follow-up (every 3 to 6 months) with an ophthalmologist is recommended. Restart maintenance therapy if CD4 percentage is less than 15% in pediatric patients younger than 5 years or if CD4 count is less than 100 cells/mm3 in children 6 years and older.[34361]

    Intravitreal injection dosage†

    Adults

    2 mg intravitreally twice weekly for 3 weeks then weekly thereafter; alternately, 5 mg intravitreal injection once weekly has been studied.[32667] [32668]

    Therapeutic Drug Monitoring

    Maximum Dosage Limits

    • Adults

      10 mg/kg/day IV; 5 drops/day ophthalmic gel in each affected eye.

    • Geriatric

      10 mg/kg/day IV; 5 drops/day ophthalmic gel in each affected eye.

    • Adolescents

      Safety and efficacy have not been established for IV dosing; however, 10 mg/kg/day IV has been used off-label for the treatment of CMV infection. 5 drops/day ophthalmic gel in each affected eye.

    • Children

      2 to 12 years: Safety and efficacy have not been established for IV dosing; however, doses up to 15 mg/kg/day IV have been used off-label for the treatment of CMV infection. 5 drops/day ophthalmic gel in each affected eye.

      1 year: Safety and efficacy have not been established; however, doses up to 15 mg/kg/day IV have been used off-label for the treatment of CMV infection.

    • Infants

      Safety and efficacy have not been established; however, doses up to 15 mg/kg/day IV have been used off-label for the treatment of CMV infection.

    • Neonates

      Safety and efficacy have not been established; however, doses of 12 mg/kg/day IV have been used off-label for the treatment of congenital CMV disease.

    Patients with Hepatic Impairment Dosing

    No dosage adjustment necessary.

    Patients with Renal Impairment Dosing

    Modify dosage for intravenous induction therapy and maintenance therapy based on creatinine clearance (CrCl).

    Adults:

    Intravenous dosage adjustments (induction)

    CrCl 70 mL/minute or more: no dosage adjustment needed.

    CrCl 50 to 69 mL/minute: 2.5 mg/kg/dose IV every 12 hours.

    CrCl 25 to 49 mL/minute: 2.5 mg/kg/dose IV every 24 hours.

    CrCl 10 to 24 mL/minute: 1.25 mg/kg/dose IV every 24 hours.

    CrCl less than 10 mL/minute: 1.25 mg/kg/dose IV 3 times a week after hemodialysis.

     

    Intravenous dosage adjustments (maintenance)

    CrCl 70 mL/minute or more: no dosage adjustment needed.

    CrCl 50 to 69 mL/minute: 2.5 mg/kg/dose IV every 24 hours.

    CrCl 25 to 49 mL/minute: 1.25 mg/kg/dose IV every 24 hours.

    CrCl 10 to 24 mL/minute: 0.625 mg/kg/dose IV every 24 hours.

    CrCl less than 10 mL/minute: 0.625 mg/kg/dose IV 3 times a week after hemodialysis.

     

    Intermittent hemodialysis or Peritoneal dialysis

    1.25 mg/kg/dose IV 3 times per week. Give all doses after dialysis sessions.[32569]

     

    Continuous renal replacement therapy

    Intravenous dosage adjustments (induction): 2.5 mg/kg/dose IV every 24 hours.

    Intravenous dosage adjustments (maintenance): 1.25 mg/kg/dose IV every 24 hours.[32569]

     

    Pediatrics:

    Intravenous dosage adjustments (induction)

    GFR 30 to 50 mL/minute/1.73 m2: 2.5 mg/kg/dose IV every 24 hours.

    GFR 10 to 29 mL/minute/1.73 m2: 1.25 mg/kg/dose IV every 24 hours.

    GFR less than 10 mL/minute/1.73 m2: 1.25 mg/kg/dose IV 3 times a week.[32569]

     

    Intravenous dosage adjustments (maintenance)

    GFR 30 to 50 mL/minute/1.73 m2: 1.25 mg/kg/dose IV every 24 hours.

    GFR 10 to 29 mL/minute/1.73 m2: 0.625 mg/kg/dose IV every 24 hours.

    GFR less than 10 mL/minute/1.73 m2: 0.625 mg/kg/dose IV 3 times a week.[32569]

     

    Intermittent hemodialysis or Peritoneal dialysis

    Give all doses after dialysis sessions.

    Intravenous dosage adjustments (induction): 1.25 mg/kg/dose IV 3 times per week.

    Intravenous dosage adjustments (maintenance): 0.625 mg/kg/dose IV 3 times per week.[32569]

     

    Continuous renal replacement therapy

    Intravenous dosage adjustments (induction): 2.5 mg/kg/dose IV every 24 hours.

    Intravenous dosage adjustments (maintenance): 1.25 mg/kg/dose IV every 24 hours.[32569]

    † Off-label indication
    Revision Date: 03/19/2024, 01:37:00 AM

    References

    23964 - Schmidt GM, Horak DA, Niland JC, et al. A randomized, controlled trial of prophylactic ganciclovir for cytomegalovirus pulmonary infection in recipients of allogeneic bone marrow transplants. N Engl J Med 1991;324:1005-11.24033 - Reed EC, Bowden RA, Dandliker PS, et al. Treatment of cytomegalovirus pneumonia with ganciclovir and intravenous cytomegalovirus immunoglobulin in patients with bone marrow transplants. Ann Intern Med 1988;109:783-8.24258 - Momin F, Chandrasekar PH. Antimicrobial prophylaxis in bone marrow transplantation. Ann Intern Med 1995;123:205-15.24288 - Reed EC, Wolford JL, Kopecky KJ, et al. Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients. Ann Intern Med 1990;112:505-10.24289 - Goodrich JM, Bowden RA, Fisher L, et al. Ganciclovir prophylaxis to prevent cytomegalovirus disease after allogeneic marrow transplant. Ann Intern Med 1993;118:173-8.24290 - Winston DJ, Ho WG, Bartoni K, et al. Ganciclovir prophylaxis of cytomegalovirus infection and disease in allogeneic bone marrow transplant recipients. Ann Intern Med 1993;118:179-84.24375 - Merigan TC, Renlund DG, Keay S, et al. A controlled trial of ganciclovir to prevent cytomegalovirus disease after heart transplantation. N Engl J Med 1992;326:1182-6.24376 - Emanuel D, Cunningham I, Jules-Elysee K, et al. Cytomegalovirus pneumonia after bone marrow transplantation successfully treated with the combination of ganciclovir and high-dose intravenous immune globulin. Ann Intern Med 1988;109:777-82.24377 - Goodrich JM, Mori M, Gleaves CA, et al. Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation. N Engl J Med 1991;325:1601-7.24419 - Hibberd PL, Tolkoff-Rubin NE, Conti D, et al. Preemptive ganciclovir therapy to prevent cytomegalovirus disease in cytomegalovirus antibody-positive renal transplant recipients. Ann Intern Med 1995;123:18-26.25495 - Turgeon N, Fishman JA, Basgoz N, et al. Effect of oral acyclovir or ganciclovir therapy after preemptive intravenous ganciclovir therapy to prevent cytomegalovirus disease in cytomegalovirus seropositive renal and liver transplant recipients receiving antilymphocyte antibody therapy. Transplantation 1998;66:1780-6.32569 - Aronoff GR, Bennett WM, Berns JS, et al. Drug prescribing in renal failure: dosing guidelines for adults and children, 5th ed. Philadelphia: American College of Physicians; 2007.32656 - Kimberlin DW, Lin CY, Sanchez PJ, et al. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: a randomized, controlled trial. J Pediatr 2003;143:16-25.32667 - Young S, Morlet N, Besen G, et al. High-dose (2000-microgram) intravitreous ganciclovir in the treatment of cytomegalovirus retinitis. Ophthalmology 1998;105:1404-10.32668 - Arevalo JF, Garcia RA, Mendoza AJ. High-dose (5000-microg) intravitreal ganciclovir combined with highly active antiretroviral therapy for cytomegalovirus retinitis in HIV-infected patients in Venezula. Eur J Ophthalmol 2005;15:610-8.32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.32677 - American Society of Transplantation. Cytomegalovirus. Amer J Transplant 2004;4 (Suppl 10):51-8.34213 - Tunkel AR, Glaser CA, Bloch KC, et al. The management of encephalitis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2008;47:303-27.34361 - Panel on Opportunistic Infections in Children with and Exposed to HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Children with and Exposed to HIV: Department of Health and Human Services. Accessed Oct 10, 2023. Available at: https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-oi/guidelines-pediatric-oi.pdf.34362 - Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the National Institutes of Health, the Centers for Disease Control and Prevention, the HIV Medicine Association, and the Infectious Diseases Society of America. Accessed Oct 10, 2023. Available at https://clinicalinfo.hiv.gov/en/guidelines/36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.45501 - Oliver SE, Cloud GA, Sanchez PJ, et al. Neurodevelopmental outcomes following ganciclovir therapy in symptomatic congenital cytomegalovirus infections involving the central nervous system. J Clin Virol. 2009;46:S22-651812 - Tomblyn M, Chiller T, Einsele H, et al. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: A global perspective. Biol Blood Marrow Transplant 2009;15:1143-1238.52560 - American Academy of Pediatrics Red Book Online. Intravenous acyclovir shortage recommendations for pediatrics. May 3, 2021. Available on the World Wide Web at https://publications.aap.org/redbook/resources/15648/Intravenous-Acyclovir-Shortage-Recommendations-for?searchresult=152562 - Chik KW, Chan PK, Li CK, et al. Human herpesvirus-6 encephalitis after unrelated umbilical cord blood transplant in children. Bone Marrow Transplant 2002;29:991-4.52568 - Haastrup E, Muller K, Baekgaard H, et al. Cytomegalovirus infection after allogeneic stem cell transplant in children. Pediatr Transplant 2005;9:734-40.57253 - Janoly-Dumenil A, Galambrun C, Basset T, et al. Human herpes virus-6 encephalitis in a paediatric bone marrow recipient: successful treatment with pharmacokinetic monitoring and high doses of ganciclovir. Bone Marrow Transplant 2006;38:769-770.57254 - Fujimaki K, Mori T, Kida A, et al. Human herpesvirus 6 meningoencephalitis in allogeneic hematopoietic stem cell transplant recipients. Int J Hematol 2006;84:432-437.57255 - Zerr DM, Gupta D, Huang ML, et al. Effect of antivirals on human herpesvirus 6 replication in hematopoietic stem cell transplant recipients. Clin Infect Dis 2002;34:309-317.57296 - Olli-Lahdesmaki T, Haataja L, Parkkola R, et al. High-dose ganciclovir in HHV-6 encephalitis of an immunocompetent child. Pediatr Neurol 2010;43:53-56.57297 - Hirabayashi K, Nakazawa Y, Katsuyama Y, et al. Successful ganciclovir therapy in a patient with human herpesvirus-6 encephalitis after unrelated cord blood transplantation: usefulness of longitudinal measurements of viral load in cerebrospinal fluid. Infection 2013;41:219-223.57601 - Kadambari S, Williams EJ, Luck S, et al. Evidence based management guidelines for the detection and treatment of congenital CMV. Early Hum Dev 2011;87:723-728.

    How Supplied

    Ganciclovir Implant tablet

    Vitrasert 4.5mg Ophthalmic Implant (61772-0002) (Bausch Health US, LLC) (off market)

    Ganciclovir Implant tablet

    Vitrasert 4.5mg Ophthalmic Implant (24208-0412) (Bausch Health US, LLC) (off market)

    Ganciclovir Ophthalmic gel

    Zirgan 0.15% Ophthalmic Gel (42826-0605) (Bausch Health US, LLC) (off market)

    Ganciclovir Ophthalmic gel

    Zirgan 0.15% Ophthalmic Gel (24208-0535) (Bausch Health US, LLC) nullZirgan 0.15% Ophthalmic Gel package photo

    Ganciclovir Ophthalmic gel

    Zirgan 0.15% Ophthalmic Gel (42826-0605) (Sirion Therapeutics) (off market)

    Ganciclovir Oral capsule

    Cytovene 250mg Capsule (00004-0269) (Genentech Inc) (off market)

    Ganciclovir Oral capsule

    Ganciclovir 250mg Capsule (63304-0636) (Sun Pharmaceutical Industries, Inc.) (off market)

    Ganciclovir Oral capsule

    Cytovene 500mg Capsule (00004-0278) (Genentech Inc) (off market)

    Ganciclovir Oral capsule

    Ganciclovir 500mg Capsule (63304-0637) (Sun Pharmaceutical Industries, Inc.) (off market)

    Ganciclovir Powder for solution for injection

    Cytovene 500mg Powder for Injection (00004-6940) (Genentech Inc) (off market)Cytovene 500mg Powder for Injection package photo

    Ganciclovir Powder for solution for injection

    Cytovene 500mg Powder for Injection (00004-6940) (Genentech Inc) (off market)

    Ganciclovir Powder for solution for injection

    Cytovene-IV 500mg Powder for Injection (61269-0450) (H2-Pharma, LLC) (off market)

    Ganciclovir Powder for solution for injection

    Ganciclovir 500mg Powder for Injection (63323-0315) (Fresenius Kabi AG) null

    Ganciclovir Powder for solution for injection

    Ganciclovir 500mg Powder for Injection (00143-9299) (Hikma Pharmaceuticals USA inc.) null

    Ganciclovir Powder for solution for injection

    Ganciclovir 500mg Powder for Injection (42023-0173) (Par Pharmaceuticals, an Endo Company) null

    Ganciclovir Powder for solution for injection

    Ganciclovir 500mg Powder for Injection (70436-0089) (Slate Run Pharmaceuticals, LLC.) null

    Ganciclovir Powder for solution for injection

    Ganciclovir 500mg Powder for Injection (PREMIER ProRx) (63323-0315) (Fresenius Kabi AG) null

    Ganciclovir Solution for injection

    Ganciclovir 500mg/250mL Solution for Injection (51754-2500) (EXELA Pharma Sciences) null

    Ganciclovir Solution for injection

    Ganciclovir 500mg/10mL Solution for Injection (25021-0185) (Sagent Pharmaceuticals) null

    Description/Classification

    Description

    Ganciclovir is a synthetic, purine nucleoside analog used for the treatment and prevention of cytomegalovirus (CMV) infections. An ophthalmic gel is used for the treatment of herpetic keratitis.[32676] In addition, ganciclovir has been shown to be active against other viruses, including herpes simplex, varicella zoster, and human herpesvirus 6 and 8.[34362] Hematologic toxicity is common with systemic ganciclovir administration; dosage adjustments for neutropenia or thrombocytopenia may be required. The FDA originally approved intravenous ganciclovir in June 1989. Ganciclovir ophthalmic gel (Virgan) was given an orphan drug designation for acute herpetic keratitis in April 2007 and was granted full approval (Zirgan) in September of 2009.[36875][32676] Ganciclovir oral capsules and intraocular implant were withdrawn from the US market in 2013.

    Classifications

    • General Anti-infectives Systemic
      • Antivirals For Systemic Use
        • Herpes Virus, incl. Cytomegalovirus (CMV), Antivirals
          • Nucleoside and Nucleotide DNA Polymerase Inhibitor Antivirals
    • Sensory Organs
      • Ophthalmologicals
        • Ophthalmological Antiviral Agents
    Revision Date: 03/19/2024, 01:37:00 AM

    References

    32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.34362 - Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the National Institutes of Health, the Centers for Disease Control and Prevention, the HIV Medicine Association, and the Infectious Diseases Society of America. Accessed Oct 10, 2023. Available at https://clinicalinfo.hiv.gov/en/guidelines/36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.

    Administration Information

    General Administration Information

    For storage information, see the specific product information within the How Supplied section.

     

    • Perform frequent hematologic monitoring in patients during treatment and do not administer if the absolute neutrophil count (ANC) is less than 500 cells/mm3, hemoglobin is less than 8 g/dL, or the platelet count is less than 25,000 cells/mm3.Use caution when handling and preparing parenteral solutions.

    Hazardous Drugs Classification

    • NIOSH 2016 List: Group 2 [63664]
    • NIOSH (Draft) 2020 List: Table 1
    • Observe and exercise appropriate precautions for handling, preparation, administration, and disposal of hazardous drugs.
    • INJECTABLE: Use double chemotherapy gloves and a protective gown. Prepare in a biological safety cabinet or compounding aseptic containment isolator with a closed system drug transfer device. Eye/face and respiratory protection may be needed during preparation and administration.
    • ORAL CAPSULES: Use gloves to handle. Cutting, crushing, or otherwise manipulating capsules will increase exposure and require additional protective equipment. Eye/face and respiratory protection may be needed during preparation and administration.
    • TOPICAL: Use double chemotherapy gloves and protective gown. Eye/face and respiratory protection may be needed during preparation and administration.[63664][32676][61771][67506][67507]

    Route-Specific Administration

    Injectable Administration

    • Use caution when preparing and administering the product to avoid direct contact with skin. If contact occurs, wash the area thoroughly with soap and water. Ganciclovir solution for injection is alkaline and may cause irritation.
    • Do NOT administer by rapid infusion or injection; toxicity may be increased.
    • Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit; the solution should be colorless. Discard if discoloration or particulate matter is observed.[32676][61771]

    Intravenous Administration

    Reconstitution

    • Reconstitute 500 mg vials with 10 mL of Sterile Water for Injection. Do NOT use Bacteriostatic Water for Injection containing parabens or precipitation may occur.
    • Gently swirl vial until a clear reconstituted solution is obtained.
    • Storage: Reconstituted vials are stable at room temperature 25 degrees C (77 degrees F) for 12 hours. Do not refrigerate or freeze. Discard any unused portion of the reconstituted solution.[32676]

     

    Dilution

    • Withdraw appropriate dose of reconstituted solution and dilute with 50 to 250 mL of a compatible IV infusion solution including 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Ringer's Solution for Injection, or Lactated Ringer's Injection. Infusion concentrations greater than 10 mg/mL are not recommended.
    • Storage: Once further diluted in an IV solution, use within 24 hours to reduce the risk of bacterial contamination. Refrigerate the diluted infusion solution at 2 to 8 degrees C (36 to 46 degrees F). Do not freeze.[32676]

     

    Premixed IV solution

    • Dilution is not required.
    • Solution does not contain preservatives and is for single use only. Any unused portion must be discarded.[61771]

     

    Intermittent IV Infusion

    • Infuse slowly over 1 hour at a constant rate via a large peripheral or central vein with adequate blood flow to permit rapid dilution and distribution. The infusion should be accompanied by adequate hydration.
    • A controlled-infusion device is recommended for highly concentrated solutions.[32676][61771]

    Other Injectable Administration

    Intravitreal injection†

    NOTE: Ganciclovir is not approved by the FDA for administration via intravitreal injection.

    • Reconstitute and dilute ganciclovir IV powder in 0.9% NaCl Injection to a concentration of 2 mg/0.04 mL to 2 mg/0.1 mL.[34362][61681][61682][61683][61684][61685] Doses of 5 mg/0.1 mL have also been used in adults.[32668]
    • Inject appropriate dose intravitreally using a tuberculin syringe.

    Ophthalmic Administration

    • Ganciclovir ophthalmic gel is for topical ophthalmic use only.
    • To avoid contamination or the spread of infection, do not use dropper for more than 1 person.
    • Do not to touch the tip of the dropper to the eye, fingertips, or other surface to prevent contamination.
    • Instruct patient on proper instillation of eye gel (see Patient Information).
    • Wash hands before and after use. Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch. Close eyes to spread drops.
    • Patients should not wear contact lenses while using ganciclovir ophthalmic gel.[36875]

    Clinical Pharmaceutics Information

    From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database

    Ganciclovir sodium

    pH Range
    Approximately pH 11
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    Sodium Content
    Ganciclovir sodium provides 46 mg of sodium in each 500-mg vial.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    Osmolality/Osmolarity
    Ganciclovir 50 mg/mL as the sodium salt is near isotonicity having an osmolality of 320 mOsm/kg.
    ReferencesTrissel LA. Drug information- osmolalities. Data on file.
    Stability
    Ganciclovir sodium injection in intact containers stored as directed by the manufacturer is stable until the labeled expiration date. The manufacturer indicates that reconstituted ganciclovir sodium is stable for 12 hours at room temperature. Refrigerated storage of the reconstituted solution is not recommended because precipitation may occur. However, Heni reported that reconstituted ganciclovir sodium 50 mg/mL in sterile water for injection is stable for a much longer time period. HPLC analysis found little or no loss of ganciclovir in 60 days stored refrigerated at 4 degree C. A study by Mole et al. also supported an extended stability period for the reconstituted drug. Using HPLC analysis, the authors reported that reconstituted ganciclovir sodium 50 mg/mL in sterile water for injection is stable for at least 10 days with no loss of drug concentration when stored refrigerated at 4 degree C. Infusion Solutions: The manufacturer indicates that ganciclovir sodium is physically and chemically stable in several common infusion solutions including the solutions cited below. Dextrose 5% Lactated Ringer's injection Ringer's injection Sodium chloride 0.9% The manufacturer also indicates that reconstituted ganciclovir sodium admixed in sodium chloride 0.9% is stable for 14 days under refrigeration. Use within 24 hours is recommended nonetheless because of the absence of an antimicrobial preservative. Johnson et al. reported that addition of ganciclovir sodium to parenteral nutrition admixtures might result in precipitation due to its alkaline pH. For simultaneous Y-site administration with parenteral nutrition admixtures, limiting the ganciclovir concentration to 0.83 mg/ml for 1% amino acids and 1.4 mg/ml for 2.5% or higher amino acids was recommended. Even so, the potential for precipitation remains and careful observation is essential. Packaged in Syringes: Mulye et al. reported that ganciclovir sodium 5.8 mg/mL in sodium chloride 0.9% packaged in Health-Tek polypropylene infusion-pump syringes was stable. HPLC analysis found no loss of ganciclovir in 12 hours at room temperature and not more than 3% loss in 10 days under refrigeration. Mole et al. reported the extended stability ganciclovir sodium 5 and 10 mg/mL in dextrose 5% and in sodium chloride 0.9% packaged in ADFuse syringes (Health-Tek). The syringes were stored refrigerated at 4 degree C for 28 days. HPLC analysis found that little or no loss of drug concentration occurred during the study period in either infusion solution. Phaypradith et al. reported that ganciclovir sodium 1.4, 4, and 7 mg/mL in sodium chloride 0.9% in polypropylene syringes frozen at -20 degree C was stable. HPLC analysis found not more than 4% loss of ganciclovir after 364 days of frozen storage. Rapp et al. reported that ganciclovir sodium 8.3 mg/mL in dextrose 5% or in sodium chloride 0.9% packaged in plastic syringes was stable for 24 hours at room temperature. Rapp et al. also reported that ganciclovir sodium 8.3 mg/mL in sodium chloride 0.9% packaged in plastic syringes was stable for 10 days under refrigeration.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesHeni VJ. Rekonstituierte ganciclovirlosung. Untersuchungen zur haltbarkeit. (Reconstituted ganciclovir solutions. Studies on stability.). Krankenhauspharmazie. 1991; 12
    ReferencesJohnson CE, Jacobson PA, Chan E. Stability of ganciclovir sodium and amino acids in parenteral nutrient solutions. Am J Hosp Pharm. 1994; 51
    ReferencesMcEvoy GK (ed). AHFS Drug Information (current edition). Bethesda, MD: American Society of Health-System Pharmacists.
    ReferencesMole L. Oliva C, O'Hanley P. Extended stability of ganciclovir for outpatient parenteral therapy for cytomegalovirus retinitis. J Acquir Immune Defic Syndr. 1992; 5
    ReferencesMulye NV, Turco SJ, Speaker TJ. Stability of ganciclovir sodium in an infusion-pump syringe. Am J Hosp Pharm. 1994; 51
    ReferencesPhaypradith S, Vigneron J, Perrin A, et al. Stabilite des solutions diluees de ganciclovir sodique (Cymevan) en seringues polypropylene et en poches PVC pour perfusions. [Stability of ganciclovir sodium (Cymevan) after dilution in polypropylene syringes and PVC infusions.]. J Pharm Belg. 1992; 47
    ReferencesRapp RP, Hatton J, Record K. Drug stability in plastic syringes. Chester, NY: Repro-Med Systems. 1998;
    pH Effects
    Ganciclovir sodium is a highly alkaline drug and should not be mixed with drugs sensitive to alkaline pH.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    Light Exposure
    No unacceptable adverse effect on drug concentration due to normal fluorescent light exposure was observed in a stability study of ganciclovir sodium in infusion solutions.
    ReferencesVisor GC, Lin LH, Jacson SE, et al. Stability of ganciclovir sodium (DHPG sodium) in 5% dextrose or 0.9% sodium chloride injections. Am J Hosp Pharm. 1986; 43
    Freezing
    The manufacturer indicates that ganciclovir sodium admixed in compatible infusion solutions should not be frozen. However, Phaypradith et al. reported that ganciclovir sodium 0.48 and 1.4 mg/mL in sodium chloride 0.9% in polyvinyl chloride (PVC) bags and 1.4, 4, and 7 mg/mL in sodium chloride 0.9%in polypropylene syringes frozen at -20 degree C was stable. HPLC analysis found not more than 4% loss of ganciclovir after 364 days of frozen storage. Noppawinyoowong et al. evaluated the stability of ganciclovir sodium 10 mg/mL in sodium chloride 0.9% for use as an intravitreal injection. HPLC analysis found no ganciclovir loss after 48 weeks of frozen storage at -8 degree C. In addition, Mole et al. evaluated the stability of ganciclovir sodium 5 and 10 mg/mL in dextrose 5% and in sodium chloride 0.9% packaged in polyvinyl chloride (PVC) plastic bags and stored frozen at -20 degree C for 28 days. HPLC analysis found little or no loss of ganciclovir sodium occurred during 28 days of frozen storage in either infusion solution.
    ReferencesAnon. Manufacturer's information and labeling. (Package insert).
    ReferencesMole L. Oliva C, O'Hanley P. Extended stability of ganciclovir for outpatient parenteral therapy for cytomegalovirus retinitis. J Acquir Immune Defic Syndr. 1992; 5
    ReferencesNoppawinyoowong C, Srisangchun J, Pongjanyakul T, et al. Chemical stability of frozen ganciclovir intravitreal injections. Thai J Hosp Pharm. 2003; 13
    ReferencesPhaypradith S, Vigneron J, Perrin A, et al. Stabilite des solutions diluees de ganciclovir sodique (Cymevan) en seringues polypropylene et en poches PVC pour perfusions. [Stability of ganciclovir sodium (Cymevan) after dilution in polypropylene syringes and PVC infusions.]. J Pharm Belg. 1992; 47
    Filtration
    Pall reported that ganciclovir sodium 5 mg/mL underwent no loss due to filtration through a Supor membrane filter.
    ReferencesAnon. Pall Medical Supor-membrane IV filter device drug-adsorption data. Data on file. 2004; 8
    Sorption Leaching
    Ganciclovir sodium has not been found to undergo substantial sorption to polyvinyl chloride (PVC) containers, polypropylene (in syringes), or glass containers, or to elastomeric pump reservoirs. In addition, Xu et al. reported no sorption occurred to a polyurethane central catheter from Arrow International as well as no leaching of the chlorhexidine antimicrobial in it.
    ReferencesAllen LV Jr, Stiles ML, Prince SJ, et al. Stability of 14 drugs in the latex reservoir of an elastomeric infusion device. Am J Health-Syst Pharm. 1996; 53
    ReferencesParasrampuria J, Li LC, Stelmach AH, et al. Stability of ganciclovir sodium in 5% dextrose injection and in 0.9% sodium chloride injection over 35 days. Am J Hosp Pharm. 1992; 49
    ReferencesMcLaughlin JP, Simpson C. How stable in ganciclovir?. Pharm Pract. 1998; 8
    ReferencesMole L. Oliva C, O'Hanley P. Extended stability of ganciclovir for outpatient parenteral therapy for cytomegalovirus retinitis. J Acquir Immune Defic Syndr. 1992; 5
    ReferencesMulye NV, Turco SJ, Speaker TJ. Stability of ganciclovir sodium in an infusion-pump syringe. Am J Hosp Pharm. 1994; 51
    ReferencesPhaypradith S, Vigneron J, Perrin A, et al. Stabilite des solutions diluees de ganciclovir sodique (Cymevan) en seringues polypropylene et en poches PVC pour perfusions. [Stability of ganciclovir sodium (Cymevan) after dilution in polypropylene syringes and PVC infusions.]. J Pharm Belg. 1992; 47
    ReferencesVisor GC, Lin LH, Jacson SE, et al. Stability of ganciclovir sodium (DHPG sodium) in 5% dextrose or 0.9% sodium chloride injections. Am J Hosp Pharm. 1986; 43
    ReferencesXu QA, Zhang Y, Trissel LA, et al. Adequacy of a new chlorhexidine-bearing polyurethane central catheter for administration of 82 selected parenteral drugs. Ann Pharmacother. 2000; 34
    Other Information
    Ganciclovir sodium is cited by NIOSH as a drug that should be handled as hazardous. Microbial Growth Potential: Kramer reported that Syntex ganciclovir 0.35 mg/mL as the sodium salt in sodium chloride 0.9% did not result in the loss of viability of 4 microbial species. Admixtures should be refrigerated whenever possible, and the potential for inadvertent contamination and microbial growth should be incorporated into decisions regarding beyond use periods. Microparticulates: McLaughlin and Simpson reported that ganciclovir sodium 1 and 5 mg/mL in sodium chloride 0.9% packaged in I-Flow Sidekick polyvinyl chloride (PVC) plastic pump reservoirs and stored refrigerated for 35 days developed a 20-fold increase in microparticulates mostly of 10 microns or smaller. The authors attributed the microparticulate formation to the high pH of the ganciclovir sodium solution interacting with the PVC. When packaged in Intermate elastomeric pump reservoirs a substantial increase in microparticulates did not occur.
    ReferencesAnon. Preventing occupational exposure to antineoplastic and other hazardous drugs in health care settings. NIOSH Publication No. 2004-165. 2004; 165
    ReferencesKramer I. Viability of microorganisms in novel antineoplastic and antiviral drug solutions. J Oncol Pharm Pract. 1998; 4
    ReferencesMcLaughlin JP, Simpson C. How stable in ganciclovir?. Pharm Pract. 1998; 8
    Stability Max
    Maximum reported stability periods: Reconstituted- 60 days refrigerated In D5W- 35 days at room temperature and refrigerated. In NS- 35 days at room temperature and 80 days refrigerated.
    ReferencesHeni VJ. Rekonstituierte ganciclovirlosung. Untersuchungen zur haltbarkeit. (Reconstituted ganciclovir solutions. Studies on stability.). Krankenhauspharmazie. 1991; 12
    ReferencesParasrampuria J, Li LC, Stelmach AH, et al. Stability of ganciclovir sodium in 5% dextrose injection and in 0.9% sodium chloride injection over 35 days. Am J Hosp Pharm. 1992; 49
    ReferencesPhaypradith S, Vigneron J, Perrin A, et al. Stabilite des solutions diluees de ganciclovir sodique (Cymevan) en seringues polypropylene et en poches PVC pour perfusions. [Stability of ganciclovir sodium (Cymevan) after dilution in polypropylene syringes and PVC infusions.]. J Pharm Belg. 1992; 47
    Revision Date: 03/19/2024, 01:37:00 AMCopyright 2004-2024 by Lawrence A. Trissel. All Rights Reserved.

    References

    32668 - Arevalo JF, Garcia RA, Mendoza AJ. High-dose (5000-microg) intravitreal ganciclovir combined with highly active antiretroviral therapy for cytomegalovirus retinitis in HIV-infected patients in Venezula. Eur J Ophthalmol 2005;15:610-8.32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.34362 - Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the National Institutes of Health, the Centers for Disease Control and Prevention, the HIV Medicine Association, and the Infectious Diseases Society of America. Accessed Oct 10, 2023. Available at https://clinicalinfo.hiv.gov/en/guidelines/36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.61681 - Agarwal A, Kumari N, Trehan A, et al. Outcome of cytomegalovirus retinitis in immunocompromised patients without human immunodeficiency virus treated with intravitreal ganciclovir injection. Graefes Arch Clin Exp Ophthalmol 2014;252:1393-1401.61682 - Gore DM, Gore Sk, Visser L. Progressive outer retinal necrosis. Arch Ophthalmol 2012; 130:700-706.61683 - Oschman A, Murthy V, Kollipara R, et al. Intravitreal ganciclovir for neonatal cytomegalovirus-associated retinitis: a case report. J Perinatol 2013;33:329-331.61684 - Hwang YS, Lin KK, Lee JS, et al. Intravitreal loading injection of ganciclovir with or without adjunctive oral valganciclovir for cytomegalovirus anterior uveitis. Graefes Arch Clin Exp Ophthalmol 2010;248:263-269.61685 - Teoh SC, Ou X, Lim TH. Intravitreal ganciclovir maintenance injection for cytomegalovirus retinitis: Efficacy of a low-volume, intermediate-dose regimen. Opthalmology 2012;119:588-595.61771 - Ganzyk-RTU (ganciclovir injection) package insert. Lenoir, NC: Exela Pharma Sciences; 2017 Sept63664 - CDC National Institute for Occupational Safety and Health (NIOSH). NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2016. DHHS (NIOSH) Publication Number 2016-161, September 2016. Available on the World Wide Web at https://www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB201616167506 - American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2018; 75:1996-2031.67507 - NIOSH [2016]. NIOSH Alert: Preventing Occupational Exposures to Antineoplastics and Other Hazardous Drugs in Health Care Settings. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2016-161.

    Adverse Reactions

    Moderate

    • anemia
    • aphasia
    • bleeding
    • blurred vision
    • bone marrow suppression
    • candidiasis
    • cataracts
    • chest pain (unspecified)
    • cholelithiasis
    • cholestasis
    • clastogenesis
    • confusion
    • conjunctival hyperemia
    • conjunctivitis
    • constipation
    • depression
    • dysphagia
    • dyspnea
    • edema
    • elevated hepatic enzymes
    • hallucinations
    • hematuria
    • hepatitis
    • hypercalcemia
    • hypertension
    • hypertriglyceridemia
    • hyponatremia
    • hypotension
    • infertility
    • leukopenia
    • memory impairment
    • metabolic acidosis
    • myasthenia
    • neutropenia
    • peripheral neuropathy
    • peripheral vasodilation
    • phlebitis
    • stomatitis
    • testicular atrophy
    • thrombocytopenia
    • urinary retention

    Mild

    • abdominal pain
    • alopecia
    • anorexia
    • anosmia
    • anxiety
    • arthralgia
    • back pain
    • chills
    • cough
    • diarrhea
    • dizziness
    • drowsiness
    • dysesthesia
    • dysgeusia
    • dyspepsia
    • eructation
    • fatigue
    • fever
    • flatulence
    • headache
    • hyperhidrosis
    • hypoesthesia
    • increased urinary frequency
    • infection
    • influenza
    • injection site reaction
    • insomnia
    • irritability
    • malaise
    • muscle cramps
    • myalgia
    • nausea
    • ocular irritation
    • ocular pain
    • otalgia
    • paresthesias
    • pruritus
    • rash
    • spermatogenesis inhibition
    • tinnitus
    • tremor
    • urticaria
    • vomiting
    • weight loss
    • xerophthalmia
    • xerosis
    • xerostomia

    Severe

    • agranulocytosis
    • anaphylactoid reactions
    • arrhythmia exacerbation
    • bronchospasm
    • cardiac arrest
    • cranial nerve palsies
    • exfoliative dermatitis
    • GI perforation
    • hearing loss
    • hemolytic anemia
    • hemolytic-uremic syndrome
    • hepatic failure
    • increased intracranial pressure
    • keratitis
    • macular edema
    • new primary malignancy
    • pancreatitis
    • pancytopenia
    • pulmonary fibrosis
    • renal failure (unspecified)
    • retinal detachment
    • rhabdomyolysis
    • seizures
    • SIADH
    • Stevens-Johnson syndrome
    • stroke
    • teratogenesis
    • torsade de pointes
    • vasculitis
    • ventricular tachycardia
    • visual impairment

    Ganciclovir can cause significant bone marrow suppression. Anemia (2% to 26%), neutropenia (3% to 29%), pancytopenia, leukopenia (29% to 41%), thrombocytopenia (3% to 57%), and bone marrow failure all can occur. In addition, hemolytic anemia, agranulocytosis, and granulocytopenia have been noted during postmarketing reports.[32676] Related symptoms can include unusual bleeding or bruising. Both granulocytopenia and thrombocytopenia are usually reversible and respond to a dose reduction. Use of the drug is not recommended in patients with neutropenia defined as an absolute neutrophil count (ANC) less than 500 cells/mm3, anemia with hemoglobin less than 8 g/dL, or thrombocytopenia with a platelet count less than 25,000 cells/mm3. In neonates, ganciclovir therapy has been resumed when ANC is 750 cells/mm3 or more; then after treatment re-initiation, the dose reduced to one-half if subsequent ANC is less than 500/mm3, and therapy discontinued if neutropenia persisted while on the reduced dose.[32656] The incidence of hematologic reactions may be higher in bone marrow transplant patients and less in other transplant patients. The hematologic toxicity usually develops within the early weeks of therapy and is generally dose-related and reversible, but occasionally it can be prolonged or irreversible. Blood counts usually begin to recover within 3 to 7 days of discontinuing the drug. Colony-stimulating factors have been shown to increase neutrophil counts in patients receiving ganciclovir.[32676]

    The most common gastrointestinal adverse effects of systemic ganciclovir include abdominal pain, anorexia (14% to 15%), diarrhea (41% to 44%), nausea, vomiting (13%), dysgeusia, and flatulence. Other GI-related adverse events include aphthous stomatitis, constipation, dyspepsia, eructation, GI perforation, pancreatitis, weight loss, and xerostomia (dry mouth). Intestinal ulceration was noted during postmarketing surveillance.[32676]

    Adverse CNS effects are fairly common during systemic ganciclovir therapy and include abnormal dreams, anxiety, confusion, depression, dizziness, headache, insomnia, drowsiness and fatigue, dysphagia, hypoesthesia, abnormal thinking, paresthesias, peripheral neuropathy (8% to 9%), tremor, or more serious reactions such as seizures.[32676] Very few cases of ganciclovir-induced seizures have been reported.[23647] Other adverse events noted during postmarketing surveillance include dysesthesia, dysphasia, aphasia, encephalopathy, extrapyramidal reaction, facial palsies or cranial nerve palsies, hallucinations, increased intracranial pressure, irritability, loss of memory and memory impairment, oculomotor nerve paralysis, and stroke.[32676] Some CNS adverse effects have been caused by opportunistic infection rather than by the drug.

    Systemic ganciclovir is moderately nephrotoxic. Mild to moderate increases in serum creatinine have been reported during therapy. In general, this adverse reaction occurs during the first week of therapy and is reversible. If renal function worsens during therapy, the ganciclovir dosage should be reduced since ganciclovir is extensively eliminated unchanged via glomerular filtration. Patients receiving ganciclovir following transplantation seem to have a higher incidence of nephrotoxicity as compared to patients treated for CMV retinitis. Between 12% to 58% of patients may experience serum creatinine concentrations of 1.5 to 2.4 mg/dL; serum creatinine concentrations of 2.5 mg/dL or more may be seen in up to 20% of patients. Renal failure (unspecified), decreased creatinine clearance, abnormal renal function, hematuria, increased urinary frequency, and urinary retention have also been reported with ganciclovir therapy. Hemolytic-uremic syndrome and renal tubular disorder were noted in postmarketing reports.[32676]

    Dermatologic and allergic adverse effects reported during ganciclovir therapy include alopecia, hyperhidrosis (11% to 12%), pruritus (5% to 6%), dermatitis, rash (unspecified), urticaria, and xerosis (dry skin). Phlebitis or injection site reaction (e.g., local inflammation, pain) can occur with IV ganciclovir. Rash, pruritus, or urticaria may indicate hypersensitivity to ganciclovir. Allergic reaction, anaphylactoid reactions, exfoliative dermatitis, and Stevens-Johnson syndrome have been noted in postmarketing reports.[32676]

    Ganciclovir is considered a potential carcinogen in humans and may cause a new primary malignancy. Ganciclovir has been associated with clastogenesis during in vitro testing at doses 2.8- to 10-times the normal human dose but not at doses comparable to human exposure. Tumors have developed in mice treated with approximately one-tenth to 1.4 times the human dose. Most tumors were of epithelial or vascular origin, although histiocytic sarcoma of the liver was reported. Tumors appeared in some tissues for which there is no human counterpart.[32676]

    Animal and limited human data indicate that ganciclovir may cause temporary or permanent spermatogenesis inhibition and subsequent infertility in males and suppression of fertility in females. Effects on spermatogenesis were reversible at lower doses and irreversible at higher doses. In addition, ganciclovir causes teratogenesis in animals and should not be used during pregnancy. Advise women of childbearing potential about the necessity of using effective contraception during treatment. Females should use effective contraception during and for at least 30 days after treatment with ganciclovir. Males must practice barrier contraception during and for at least 90 days after treatment with ganciclovir.[28463] [32676]

    Infection (9% to 13%), sepsis (4% to 15%), catheter-related infection (4% to 9%), and catheter-related sepsis (1% to 8%) were reported during ganciclovir clinical trials. Other, less frequently reported infections included cellulitis, influenza, upper respiratory tract infections, urinary tract infections, and candida infections including oral candidiasis.[32676]

    General adverse events associated with the use of systemic ganciclovir include fever (38% to 48%), chills (7% to 10%), enlarged abdomen, asthenia, chest pain (unspecified), congenital anomaly, edema, malaise, unspecified pain, testicular hypotrophy/testicular atrophy, and potentially fatal multiple organ failure.[32676]

    Elevated hepatic enzymes were reported with the use of systemic ganciclovir. Hepatic failure, cholelithiasis, cholestasis, and hepatitis were noted during postmarketing reports.[32676]

    Tinnitus, otalgia, and hearing loss (deafness) were reported with the use of systemic ganciclovir. Loss of the sense of smell (anosmia) was noted during postmarketing reports.[32676]

    Increased cough and dyspnea were reported with systemic ganciclovir. Bronchospasm and pulmonary fibrosis were noted during postmarketing reports.[32676]

    Arthralgia, muscle cramps, muscle spasms, back pain, myalgia, and myasthenia have been reported with the use of systemic ganciclovir. Other adverse events noted during postmarketing surveillance include arthritis, myelopathy, and rhabdomyolysis.[32676]

    Hypertension, hypotension, arrhythmia exacerbation, and peripheral vasodilation were reported with the use of systemic ganciclovir. Other cardiovascular adverse events reported during postmarketing surveillance include cardiac arrest, cardiac conduction abnormalities, peripheral ischemia, torsade de pointes, vasculitis, and ventricular tachycardia.[32676]

    Retinal detachment may occur with systemic (8% to 11% of adults) administration of ganciclovir; however, the precise relationship to the drug is not clear. Retinal detachment has occurred in patients with CMV retinitis both before and after initiation of ganciclovir therapy.[32676] Adverse reactions associated with administration of ganciclovir ophthalmic gel include blurred vision (60%), ocular irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).[36875] Other ocular reactions noted with systemic ganciclovir include abnormal vision or visual impairment, ocular pain, conjunctivitis, macular edema, and vitreous disorder. Xerophthalmia and cataracts were noted in postmarketing reports with systemic ganciclovir.[32676]

    Metabolic adverse events noted during postmarketing surveillance with ganciclovir include metabolic acidosis, hypertriglyceridemia, hypercalcemia, hyponatremia, and syndrome of inappropriate antidiuretic hormone secretion (SIADH).[32676]

    Revision Date: 03/19/2024, 01:37:00 AM

    References

    23647 - Barton TL, Roush MK, Dever LL. Seizures associated with ganciclovir therapy. Pharmacother 1992;12:413-5.28463 - Valcyte (valganciclovir hydrochloride) package insert. South San Francisco, CA: Genentech USA, Inc.; 2021 Dec.32656 - Kimberlin DW, Lin CY, Sanchez PJ, et al. Effect of ganciclovir therapy on hearing in symptomatic congenital cytomegalovirus disease involving the central nervous system: a randomized, controlled trial. J Pediatr 2003;143:16-25.32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.

    Contraindications/Precautions

    Absolute contraindications are italicized.

    • acyclovir hypersensitivity
    • ganciclovir hypersensitivity
    • valganciclovir hypersensitivity
    • accidental exposure
    • anemia
    • antimicrobial resistance
    • bone marrow suppression
    • breast-feeding
    • chemotherapy
    • children
    • contact lenses
    • contraception requirements
    • dehydration
    • famciclovir hypersensitivity
    • geriatric
    • infants
    • infertility
    • intramuscular administration
    • leukopenia
    • male-mediated teratogenicity
    • neonates
    • neoplastic disease
    • neutropenia
    • ocular exposure
    • penciclovir hypersensitivity
    • pregnancy
    • pregnancy testing
    • radiation therapy
    • renal failure
    • renal impairment
    • reproductive risk
    • subcutaneous administration
    • thrombocytopenia
    • valacyclovir hypersensitivity

    Ganciclovir is contraindicated in patients with a significant ganciclovir hypersensitivity, valganciclovir hypersensitivity, or acyclovir hypersensitivity.[32676] [61771] Although not specifically contraindicated by the manufacturer, ganciclovir ophthalmic gel should be used with extreme caution in these patients as well. Because of similar chemical structures and possible cross-sensitivity, ganciclovir should not be used in patients with famciclovir hypersensitivity, penciclovir hypersensitivity, or valacyclovir hypersensitivity. Alternative agents such as foscarnet or cidofovir may be suitable since they are not structurally related to these antivirals.

    Use systemic ganciclovir with caution in patients with bone marrow suppression or to those who are receiving other myelosuppressive chemotherapy or radiation therapy. Severe anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia have been reported during ganciclovir therapy. The frequency and severity of these events vary widely in different patient populations. Patients with neutropenia (absolute neutrophil count (ANC) less than 500 cells/mm3), anemia (hemoglobin less than 8 g/dL), or thrombocytopenia (platelet count less than 25,000 cells/mm3) should not receive the drug. Complete blood counts with differential and platelet counts should be performed frequently, especially in patients who have experienced previous drug-induced leukopenia or in patients with a baseline ANC less than 1,000 cells/mm3. The manufacturer notes that ganciclovir should only be used as indicated within the prescribing information; avoid unnecessary use.[32676] [61771]

    Ganciclovir toxicity may be increased with rapid administration which results in excessive plasma levels. Do not administer ganciclovir by rapid or bolus IV, instead administer by slow IV infusion at a constant rate over 1 hour. Do not give ganciclovir by subcutaneous administration or intramuscular administration.[32676] [61771]

    Adjust systemic ganciclovir dosage in patients with renal impairment because it is primarily eliminated unchanged via renal mechanisms. Avoid dehydration in patients on ganciclovir therapy; maintain renal elimination with adequate hydration and fluid intake. The risk of toxic reactions to ganciclovir is greater in patients with renal impairment, especially renal failure. Although clinical studies did not include sufficient numbers of geriatric patients, dose selection for these patients should be cautious, reflecting the greater frequency of decreased cardiac, hepatic, or renal function, and of concomitant disease or drug therapy.[32676]

    Take care to avoid accidental exposure to ganciclovir during preparation, handling or administration, due to the potential mutagenicity and alkaline pH of intravenous ganciclovir. Although human data are not available, the development of neoplastic disease is a potential risk to consider during ganciclovir therapy based on animal carcinogenicity data. The use of protective gowns, gloves and goggles is recommended. Avoid direct contact of ganciclovir solution with skin or mucous membranes. If skin contact occurs, wash thoroughly with soap and water. Following ocular exposure, rinse eyes thoroughly with plain water. Consider handling and disposing of ganciclovir according to guidelines issued for antineoplastic agents. There is no agreement that all the procedures recommended in the guidelines are necessary or appropriate for ganciclovir. The manufacturer notes that ganciclovir should only be used as indicated within the prescribing information; avoid unnecessary use.[32676]

    Because of the potential for long-term carcinogenicity and reproductive toxicity, carefully consider the risks and benefits of using systemic ganciclovir therapy in neonates, infants, children, and adolescents. Carcinogenicity and impaired fertility have occurred in animal models at doses similar to those used in humans; the precise risk in human patients is not known. Although specific human data are not available, it is considered probable in humans that ganciclovir at recommended doses may cause temporary or permanent inhibition of spermatogenesis.[32676]

    Ganciclovir is associated with reproductive risk. The drug can be teratogenic if taken by the father near the time of conception (male-mediated teratogenicity) or by the mother during pregnancy. Discuss contraception requirements with the patient. Females should use effective contraception during and for at least 30 days after treatment with ganciclovir. Males must use a condom during and for at least 90 days after treatment. Females of reproductive potential should undergo pregnancy testing prior to initiation of ganciclovir. In addition, based on animal and limited human data, ganciclovir may cause temporary or permanent inhibition of spermatogenesis and subsequent infertility. Animal studies also indicate that suppression of fertility in females may occur.[32676]

     

    Antimicrobial resistance to ganciclovir may develop following prolonged treatment and has been reported in ganciclovir naive individuals. The possibility of viral resistance should be considered in patients who show poor clinical response or who experience persistent viral excretion during therapy.[32676]

    There are no adequate and well-controlled human studies evaluating use of ganciclovir during pregnancy; however, based on data from animal studies, ganciclovir may be teratogenic or embryotoxic at doses recommended for human use. If considering use of ganciclovir in a pregnant female, consider that most maternal CMV infections are subclinical or may be associated with mononucleosis-like syndrome. However, in immunocompromised patients, CMV infections are often symptomatic and associated with significant morbidity and mortality. Also consider that the risk and severity of congenital CMV infection appear to be higher in infants born to mother with primary CMV infection than in those born to mothers with reactivation of the disease. Of the newborns who are infected with CMV, only 10% are symptomatic at birth and the mortality rate among symptomatic infants is about 10%; however, approximately 50% to 90% of the surviving infants may experience significant problems, including sensorineural hearing loss, mental retardation, and other neurologic defects. It is not known if topically administered ophthalmic ganciclovir could result in significant systemic absorption; therefore, the manufacturer recommends the administration of ophthalmic ganciclovir to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.[32676] [36875] [61771]

    It is not known if ganciclovir is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants, the manufacturer recommends instructing mothers to stop or not to start breast-feeding if they are receiving ganciclovir. Additionally, ganciclovir may be used to treat infections in patients with HIV and the Centers for Disease Control and Prevention (CDC) recommends that in the US, HIV-infected mothers not breast-feed their infants to avoid the risk of postnatal transmission of HIV. It is not known if topically administered ophthalmic ganciclovir could result in sufficient systemic absorption to produce detectable quantities in breast milk; therefore, the manufacturer recommends caution if ophthalmic ganciclovir is administered to breast-feeding women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.[32676] [36875] [46675] 

    Contact lenses should be removed prior to administration of ganciclovir ophthalmic gel. Ganciclovir ophthalmic gel contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Patients should not wear contact lenses if they have signs or symptoms of herpetic keratitis or during the course of therapy with ganciclovir ophthalmic gel. Ganciclovir ophthalmic gel is indicated for topical ophthalmic use only.[36875]

    Revision Date: 03/19/2024, 01:37:00 AM

    References

    32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.46675 - Centers for Disease Control and Prevention: Breastfeeding recommendation for human immunodeficiency virus (HIV), and acquired immunodeficiency virus (AIDS). Retrieved November 9, 2011. Available on the World Wide Web at: http://www.cdc.gov/breastfeeding/disease/hiv.htm.61771 - Ganzyk-RTU (ganciclovir injection) package insert. Lenoir, NC: Exela Pharma Sciences; 2017 Sept

    Mechanism of Action

    Ganciclovir is a synthetic analog of 2'-deoxyguanosine and inhibits the replication of human cytomegalovirus (CMV). In CMV-infected cells, ganciclovir is initially phosphorylated to ganciclovir monophosphate by the viral protein kinase pUL97. Further phosphorylation by protein kinases produces ganciclovir triphosphate. Ganciclovir triphosphate inhibits viral DNA synthesis by competitive inhibition of viral DNA polymerases and incorporation into viral DNA resulting in eventual termination of viral DNA elongation. Since phosphorylation is dependent upon viral protein kinases, ganciclovir is preferentially metabolized in virus-infected cells. Ganciclovir triphosphate concentrations may be 100-fold greater in CMV-infected cells than in uninfected cells. As sensitivity tests vary due to many factors, the concentration of ganciclovir to inhibit the growth of virus in cell culture by 50% (IC50) ranges from 0.02—3.48 mcg/mL. Ganciclovir inhibits mammalian cell proliferation (CIC50) in vitro at higher concentrations ranging from 30—725 mcg/mL; however, bone marrow cells are more sensitive (CIC50 0.028—0.7 mcg/mL).

     

    Resistance to ganciclovir may occur after prolonged treatment with valganciclovir by selection of mutations in either the viral protein kinase (UL97) and/or in the viral polymerase gene (UL54). Virus with mutations in the UL97 gene is resistant to ganciclovir alone, whereas virus with mutations in the UL54 gene may show cross-resistance to other antiviral agents with a similar mechanism of action. The current definition of CMV resistance to ganciclovir in vitro is IC50 >= 1.5 mcg/mL. CMV resistance to ganciclovir has been observed in individuals with AIDS and CMV retinitis who have never received ganciclovir therapy.

    Revision Date: 03/19/2024, 01:37:00 AM

    References

    Pharmacokinetics

    Ganciclovir is administered intravenously, by topical ophthalmic administration, and by intravitreal injection. Ganciclovir crosses the blood-brain barrier, producing CSF concentrations that average about 40% (range 24% to 70%) of plasma concentrations. Ganciclovir crosses the placenta. It is not known if ganciclovir is excreted into breast milk. Protein binding is roughly 1% to 2%. Ganciclovir undergoes little or no metabolism. Ganciclovir is excreted primarily in the urine, with about 90% excreted unchanged by glomerular filtration and active tubular secretion.[32676]

     

    Affected cytochrome P450 isoenzymes: none

    Route-Specific Pharmacokinetics

    Intravenous Route

    Following IV administration of ganciclovir, distribution into body tissues and fluids is extensive including significant intraocular penetration. The half-life in patients with normal renal function is about 3.5 hours following IV administration.[32676]

    Other Route(s)

    Ophthalmic Route

    Minimal systemic exposure is expected with topical ophthalmic administration of ganciclovir gel.[36875]

    Special Populations

    Renal Impairment

    Half-life of ganciclovir increases in patients with impaired renal function. Patients with an estimated creatinine clearance < 25 mL/minute achieved a mean half-life of 10.7 hours. Hemodialysis reduces ganciclovir concentrations by about 50%.[32676]

    Pediatrics

    The pharmacokinetics of IV ganciclovir in pediatric patients are similar to those seen in adults.

    Infants, Children, and Adolescents

    The Cmax, systemic clearance, and half-life of ganciclovir in 10 infants and children (9 months to 12 years of age) after doses of 5 mg/kg IV were 7.9 mcg/mL, 4.7 mL/minute/kg, and 2.4 hours, respectively.[32676]

    Neonates

    The Cmax, systemic clearance, and half-life of ganciclovir in 27 neonates (2 to 49 days postnatal age, gestational age not specified) after doses of 4 to 6 mg/kg IV were 5.5 to 7 mcg/mL, 3.14 to 3.56 mL/minute/kg, and 2.4 hours, respectively.[32676]

    Revision Date: 03/19/2024, 01:37:00 AM

    References

    32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.

    Pregnancy/Breast-feeding

    pregnancy

    There are no adequate and well-controlled human studies evaluating use of ganciclovir during pregnancy; however, based on data from animal studies, ganciclovir may be teratogenic or embryotoxic at doses recommended for human use. If considering use of ganciclovir in a pregnant female, consider that most maternal CMV infections are subclinical or may be associated with mononucleosis-like syndrome. However, in immunocompromised patients, CMV infections are often symptomatic and associated with significant morbidity and mortality. Also consider that the risk and severity of congenital CMV infection appear to be higher in infants born to mother with primary CMV infection than in those born to mothers with reactivation of the disease. Of the newborns who are infected with CMV, only 10% are symptomatic at birth and the mortality rate among symptomatic infants is about 10%; however, approximately 50% to 90% of the surviving infants may experience significant problems, including sensorineural hearing loss, mental retardation, and other neurologic defects. It is not known if topically administered ophthalmic ganciclovir could result in significant systemic absorption; therefore, the manufacturer recommends the administration of ophthalmic ganciclovir to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.[32676] [36875] [61771]

    breast-feeding

    It is not known if ganciclovir is excreted into breast milk. Due to the potential for serious adverse reactions in nursing infants, the manufacturer recommends instructing mothers to stop or not to start breast-feeding if they are receiving ganciclovir. Additionally, ganciclovir may be used to treat infections in patients with HIV and the Centers for Disease Control and Prevention (CDC) recommends that in the US, HIV-infected mothers not breast-feed their infants to avoid the risk of postnatal transmission of HIV. It is not known if topically administered ophthalmic ganciclovir could result in sufficient systemic absorption to produce detectable quantities in breast milk; therefore, the manufacturer recommends caution if ophthalmic ganciclovir is administered to breast-feeding women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.[32676] [36875] [46675] 

    Revision Date: 03/19/2024, 01:37:00 AM

    References

    32676 - Cytovene IV (ganciclovir for injection) package insert. Montgomery, AL: H2-Pharma, LLC.; 2020 Jun.36875 - Zirgan (ganciclovir ophthalmic gel) package insert. Tampa, FL: Bausch & Lomb, Inc.; 2014 Apr.46675 - Centers for Disease Control and Prevention: Breastfeeding recommendation for human immunodeficiency virus (HIV), and acquired immunodeficiency virus (AIDS). Retrieved November 9, 2011. Available on the World Wide Web at: http://www.cdc.gov/breastfeeding/disease/hiv.htm.61771 - Ganzyk-RTU (ganciclovir injection) package insert. Lenoir, NC: Exela Pharma Sciences; 2017 Sept

    Interactions

    Level 1 (Severe)

    • Cidofovir

    Level 2 (Major)

    • Abacavir; Lamivudine, 3TC; Zidovudine, ZDV
    • Aldesleukin, IL-2
    • Amikacin
    • Aminoglycosides
    • Capreomycin
    • Colistimethate, Colistin, Polymyxin E
    • Colistin
    • Dichlorphenamide
    • Gentamicin
    • Imipenem; Cilastatin
    • Imipenem; Cilastatin; Relebactam
    • Lamivudine, 3TC; Zidovudine, ZDV
    • Mannitol
    • Maribavir
    • Paromomycin
    • Plazomicin
    • Streptomycin
    • Talimogene Laherparepvec
    • Tobramycin
    • Zidovudine, ZDV

    Level 3 (Moderate)

    • Amphotericin B
    • Amphotericin B lipid complex (ABLC)
    • Amphotericin B liposomal (LAmB)
    • Aprotinin
    • Bictegravir; Emtricitabine; Tenofovir Alafenamide
    • Cisplatin
    • Clindamycin
    • Clofarabine
    • Cyclosporine
    • Dapsone
    • Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
    • Didanosine, ddI
    • Doravirine; Lamivudine; Tenofovir disoproxil fumarate
    • Doxorubicin
    • Doxorubicin Liposomal
    • Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate
    • Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
    • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
    • Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
    • Emtricitabine
    • Emtricitabine; Rilpivirine; Tenofovir alafenamide
    • Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate
    • Emtricitabine; Tenofovir alafenamide
    • Emtricitabine; Tenofovir Disoproxil Fumarate
    • Entecavir
    • Flucytosine
    • Hyaluronidase, Recombinant; Immune Globulin
    • Hydroxyurea
    • Immune Globulin IV, IVIG, IGIV
    • Inotersen
    • Lamivudine; Tenofovir Disoproxil Fumarate
    • Mycophenolate
    • Nitisinone
    • Pentamidine
    • Probenecid
    • Probenecid; Colchicine
    • Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
    • Tacrolimus
    • Telavancin
    • Tenofovir Alafenamide
    • Tenofovir Alafenamide
    • Tenofovir Disoproxil Fumarate
    • Trimethoprim
    • Vancomycin
    • Vinblastine
    • Vinca alkaloids
    • Vincristine
    • Vincristine Liposomal
    • Vinorelbine
    • Voclosporin

    Level 4 (Minor)

    • Acetaminophen; Ibuprofen
    • Amlodipine; Celecoxib
    • Bacitracin
    • Bupivacaine; Meloxicam
    • Celecoxib
    • Celecoxib; Tramadol
    • Chlorpheniramine; Ibuprofen; Pseudoephedrine
    • Diclofenac
    • Diclofenac; Misoprostol
    • Diflunisal
    • Diphenhydramine; Ibuprofen
    • Diphenhydramine; Naproxen
    • Etodolac
    • Fenoprofen
    • Flurbiprofen
    • Hydrocodone; Ibuprofen
    • Ibuprofen
    • Ibuprofen; Famotidine
    • Ibuprofen; Oxycodone
    • Ibuprofen; Pseudoephedrine
    • Indomethacin
    • Ketoprofen
    • Ketorolac
    • Meclofenamate Sodium
    • Mefenamic Acid
    • Meloxicam
    • Nabumetone
    • Naproxen
    • Naproxen; Esomeprazole
    • Naproxen; Pseudoephedrine
    • Nonsteroidal antiinflammatory drugs
    • Oxaprozin
    • Piroxicam
    • Polymyxin B
    • Sulindac
    • Sumatriptan; Naproxen
    • Tolmetin
    Abacavir; Lamivudine, 3TC; Zidovudine, ZDV: (Major) Coadministration of ganciclovir and zidovudine may increase the hematologic toxicity (e.g., neutropenia, anemia) of zidovudine. Some patients may not tolerate concomitant therapy with these drugs at full dosage. If concomitant use is necessary, monitor hematologic parameters closely. [28305] [32676] Acetaminophen; Ibuprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Aldesleukin, IL-2: (Major) Avoid concomitant use of ganciclovir and aldesleukin; coadministration may result in additive nephrotoxicity. Monitor for renal toxicity if concomitant use is required. [32676] [41853] Amikacin: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Aminoglycosides: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Amlodipine; Celecoxib: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Amphotericin B lipid complex (ABLC): (Moderate) Use caution and monitor renal function when ganciclovir is coadministered with amphotericin B because of the potential increase in serum creatinine. Acute renal failure may occur in patients concomitantly receiving potential nephrotoxic drugs. [32676] Amphotericin B liposomal (LAmB): (Moderate) Use caution and monitor renal function when ganciclovir is coadministered with amphotericin B because of the potential increase in serum creatinine. Acute renal failure may occur in patients concomitantly receiving potential nephrotoxic drugs. [32676] Amphotericin B: (Moderate) Use caution and monitor renal function when ganciclovir is coadministered with amphotericin B because of the potential increase in serum creatinine. Acute renal failure may occur in patients concomitantly receiving potential nephrotoxic drugs. [32676] Aprotinin: (Moderate) The manufacturer recommends using aprotinin cautiously in patients that are receiving drugs that can affect renal function, such as ganciclovir, as the risk of renal impairment may be increased. [5173] [5204] Bacitracin: (Minor) Concurrent use of nephrotoxic agents, including systemic bacitracin, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Bictegravir; Emtricitabine; Tenofovir Alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Bupivacaine; Meloxicam: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Capreomycin: (Major) Since capreomycin is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including ganciclovir, may increase serum concentrations of either drug. Theoretically, the chronic coadministration of these drugs may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function if these drugs are coadministered. [44155] [5173] Celecoxib: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Celecoxib; Tramadol: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Chlorpheniramine; Ibuprofen; Pseudoephedrine: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Cidofovir: (Contraindicated) The administration of cidofovir with another potentially nephrotoxic agent, such as ganciclovir, is contraindicated. Ganciclovir should be discontinued at least 7 days prior to beginning cidofovir. [28388] [32676] Cisplatin: (Moderate) Concomitant use of cisplatin and ganciclovir should be considered only if the potential benefits outweigh the risks of increased treatment-related toxicities. If coadministration is necessary, closely monitor for treatment-related adverse reactions. Ganciclovir is eliminated renally and cisplatin can cause nephrotoxicity, which may result in increased plasma concentrations of ganciclovir. Side effects such as nephrotoxicity and myelosuppression may be additive. [28393] [32676] Clindamycin: (Moderate) Concomitant use of ganciclovir and clindamycin may result in additive nephrotoxicity. Monitor for renal toxicity if concomitant use is required. [29120] [32676] Clofarabine: (Moderate) Concomitant use of clofarabine and ganciclovir may result in altered clofarabine levels because both agents are a substrate of OCT1. Therefore, monitor for signs of clofarabine toxicity such as gastrointestinal toxicity (e.g., nausea, vomiting, diarrhea, mucosal inflammation), hematologic toxicity, and skin toxicity (e.g., hand and foot syndrome, rash, pruritus) in patients also receiving OCT1 substrates. [51834] [54578] Colistimethate, Colistin, Polymyxin E: (Major) Theoretically, chronic coadministration may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function during concurrent use. Since colistimethate sodium is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including ganciclovir, may increase serum concentrations of either drug. [28443] [32676] [33636] Colistin: (Major) Theoretically, chronic coadministration may increase the risk of developing nephrotoxicity, even in patients who have normal renal function. Monitor patients for changes in renal function during concurrent use. Since colistimethate sodium is eliminated by the kidney, coadministration with other potentially nephrotoxic drugs, including ganciclovir, may increase serum concentrations of either drug. [28443] [32676] [33636] Cyclosporine: (Moderate) Use caution and monitor renal function when ganciclovir is coadministered with cyclosporine because of the potential increase in serum creatinine. Acute renal failure may occur in patients concomitantly receiving potential nephrotoxic drugs. [32676] Dapsone: (Moderate) Use ganciclovir and dapsone together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Dichlorphenamide: (Major) Use of dichlorphenamide and ganciclovir is not recommended because of an increased risk of ganciclovir-related adverse effects. Monitor closely for signs of drug toxicity if use together cannot be avoided. For example, the main toxicities of ganciclovir are myelosuppresion or nephrotoxicity. Monitor blood counts and renal function, since increased ganciclovir exposure is possible. Dichlorphenamide inhibits OAT1. Ganciclovir is an OAT1 substrate. Additionally, metabolic acidosis is associated with the use of dichlorphenamide and has been reported with the postmarketing use of ganciclovir. Measure sodium bicarbonate concentrations at baseline and periodically during dichlorphenamide treatment. If metabolic acidosis occurs or persists, consider reducing the dose or discontinuing dichlorphenamide therapy. [32676] [56579] [60122] Diclofenac: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Diclofenac; Misoprostol: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Didanosine, ddI: (Moderate) Ganciclovir can increase the AUC and Cmax of didanosine, ddI when given concurrently. Patients should be monitored closely for didanosine toxicity when receiving ganciclovir concurrently. [5173] [5489] [6321] Diflunisal: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Diphenhydramine; Ibuprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Diphenhydramine; Naproxen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Doravirine; Lamivudine; Tenofovir disoproxil fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] Doxorubicin Liposomal: (Moderate) Use ganciclovir and doxorubicin together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Doxorubicin: (Moderate) Use ganciclovir and doxorubicin together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Emtricitabine: (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Emtricitabine; Tenofovir alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Emtricitabine; Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] (Moderate) Monitor for changes in serum creatinine and adverse reactions, such as lactic acidosis or hepatotoxicity if emtricitabine is administered in combination with nephrotoxic agents, such as ganciclovir. Consider the potential for drug interaction prior to and during concurrent use of these medications. Both emtricitabine and ganciclovir are excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. While no drug interactions due to competition for renal excretion have been observed, coadministration of these medications may increase concentrations of both drugs. [29746] [32676] Entecavir: (Moderate) Entecavir may affect renal function and should be used cautiously in combination with other drugs that may also affect renal function including ganciclovir. [5173] [8007] Etodolac: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Fenoprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Flucytosine: (Moderate) Use ganciclovir and flucytosine together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Flurbiprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Gentamicin: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Hyaluronidase, Recombinant; Immune Globulin: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like ganciclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5173] Hydrocodone; Ibuprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Hydroxyurea: (Moderate) Use ganciclovir and hydroxyurea together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [28463] [32676] Ibuprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Ibuprofen; Famotidine: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Ibuprofen; Oxycodone: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Ibuprofen; Pseudoephedrine: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Imipenem; Cilastatin: (Major) Avoid concomitant use of imipenem; cilastatin and ganciclovir unless the potential benefits outweigh the risks. Generalized seizures have occurred in patients who were receiving imipenem; cilastatin concomitantly with ganciclovir. [29047] [64440] Imipenem; Cilastatin; Relebactam: (Major) Avoid concomitant use of imipenem; cilastatin and ganciclovir unless the potential benefits outweigh the risks. Generalized seizures have occurred in patients who were receiving imipenem; cilastatin concomitantly with ganciclovir. [29047] [64440] Immune Globulin IV, IVIG, IGIV: (Moderate) Immune Globulin (IG) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Patients predisposed to acute renal failure include patients receiving known nephrotoxic drugs like ganciclovir. Coadminister IG products at the minimum concentration available and the minimum rate of infusion practicable. Also, closely monitor renal function. [5173] Indomethacin: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Inotersen: (Moderate) Use caution with concomitant use of inotersen and ganciclovir due to the risk of glomerulonephritis and nephrotoxicity. [63624] Ketoprofen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Ketorolac: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Lamivudine, 3TC; Zidovudine, ZDV: (Major) Coadministration of ganciclovir and zidovudine may increase the hematologic toxicity (e.g., neutropenia, anemia) of zidovudine. Some patients may not tolerate concomitant therapy with these drugs at full dosage. If concomitant use is necessary, monitor hematologic parameters closely. [28305] [32676] Lamivudine; Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] Mannitol: (Major) Avoid use of mannitol and ganciclovir, if possible. Concomitant administration of nephrotoxic drugs, such as ganciclovir, increases the risk of renal failure after administration of mannitol. [33007] Maribavir: (Major) Avoid concomitant use of maribavir and ganciclovir. Maribavir may antagonize the antiviral activity of ganciclovir by inhibiting human CMV pUL97 kinase, which is required for activation of ganciclovir. [67137] Meclofenamate Sodium: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Mefenamic Acid: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Meloxicam: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Mycophenolate: (Moderate) The systemic concentration of ganciclovir and the glucuronide metabolite of mycophenolate are increased in the presence of renal impairment. Concomitant use may result in competition for tubular secretion, which could further increase the systemic exposures. Thus, adverse effects from increased serum concentrations may be anticipated; blood cell count monitoring is recommended. [4702] [4873] Nabumetone: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Naproxen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Naproxen; Esomeprazole: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Naproxen; Pseudoephedrine: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Nitisinone: (Moderate) Monitor for increased ganciclovir-related adverse effects. Coadministration may increase ganciclovir exposure resulting in increased adverse effects. Nitisinone inhibits OAT1. Ganciclovir is an OAT1 substrate. [62200] Nonsteroidal antiinflammatory drugs: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Oxaprozin: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Paromomycin: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Pentamidine: (Moderate) Use ganciclovir with pentamidine only if the potential benefits are judged to outweigh the risks. Concurrent use of agents that inhibit rapidly dividing cell populations (i.e., bone marrow, spermatogonia, germinal layers of the skin, gastrointestinal mucosa) with ganciclovir should be done cautiously, in order to avoid additive toxicity. Additive nephrotoxicity may be seen with the combination of pentamidine and other agents that cause nephrotoxicity, including ganciclovir. [28879] [5173] Piroxicam: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Plazomicin: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Polymyxin B: (Minor) Concurrent use of nephrotoxic agents, such as polymyxin b, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Probenecid: (Moderate) Ganciclovir should be used with probenecid with caution. Probenecid can inhibit renal tubular secretion of ganciclovir, possibly potentiating ganciclovir toxicity. Patients should be monitored for increased ganciclovir toxicity when taking probenecid with ganciclovir. [5173] Probenecid; Colchicine: (Moderate) Ganciclovir should be used with probenecid with caution. Probenecid can inhibit renal tubular secretion of ganciclovir, possibly potentiating ganciclovir toxicity. Patients should be monitored for increased ganciclovir toxicity when taking probenecid with ganciclovir. [5173] Streptomycin: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole: (Moderate) Use ganciclovir and sulfamethoxazole; trimethoprim together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Sulindac: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Sumatriptan; Naproxen: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Tacrolimus: (Moderate) Use ganciclovir and tacrolimus together only if the potential benefits outweigh the risks. Monitor renal function when ganciclovir is coadministered with tacrolimus because of the potential increase in serum creatinine. Acute renal failure may occur in patients concomitantly receiving potential nephrotoxic drugs. [32676] Talimogene Laherparepvec: (Major) Consider the risks and benefits of treatment with talimogene laherparepvec before administering acyclovir or other antivirals to prevent or manage herpetic infection. Talimogene laherparepvec is a live, attenuated herpes simplex virus that is sensitive to acyclovir; coadministration with antiviral agents may cause a decrease in efficacy. [60260] Telavancin: (Moderate) Concurrent or sequential use of telavancin with other potentially nephrotoxic drugs such as ganciclovir may lead to additive nephrotoxicity. Closely monitor renal function and adjust telavancin doses based on calculated creatinine clearance. [36615] [5173] Tenofovir Alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] Tenofovir Alafenamide: (Moderate) Monitor for changes in renal function if tenofovir alafenamide is administered in combination with a nephrotoxic agent, such as ganciclovir. Tenofovir is primarily excreted via the kidneys by a combination of glomerular filtration and active tubular secretion. Coadministration of tenofovir alafenamide with a drug that reduces renal function or competes for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs; thus, increasing the risk of developing renal-related adverse reactions. [60269] [60688] Tenofovir Disoproxil Fumarate: (Moderate) Concurrent use of nephrotoxic agents with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Other nephrotoxic agents include tenofovir. [5173] Tobramycin: (Major) Concurrent use of nephrotoxic agents, such as the aminoglycosides, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. [5173] Tolmetin: (Minor) Concurrent use of nephrotoxic agents, such as NSAIDs, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Monitor renal function carefully if concomitant therapy is required. [32676] Trimethoprim: (Moderate) Use ganciclovir and sulfamethoxazole; trimethoprim together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Vancomycin: (Moderate) Concurrent use of nephrotoxic agents, such as vancomycin, with ganciclovir should be done cautiously to avoid additive nephrotoxicity. Renal function should be monitored closely and vancomycin doses should be adjusted according to vancomycin serum concentrations. [5173] Vinblastine: (Moderate) Use ganciclovir and vinca alkaloids together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Vinca alkaloids: (Moderate) Use ganciclovir and vinca alkaloids together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Vincristine Liposomal: (Moderate) Use ganciclovir and vinca alkaloids together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Vincristine: (Moderate) Use ganciclovir and vinca alkaloids together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Vinorelbine: (Moderate) Use ganciclovir and vinca alkaloids together only if the potential benefits outweigh the risks; bone marrow suppression, spermatogenesis inhibition, skin toxicity, and gastrointestinal toxicity may be additive as both drugs inhibit rapidly dividing cells. [32676] Voclosporin: (Moderate) Concomitant use of voclosporin and ganciclovir may result in additive nephrotoxicity. Monitor for renal toxicity if concomitant use is required. [32676] [66336] Zidovudine, ZDV: (Major) Coadministration of ganciclovir and zidovudine may increase the hematologic toxicity (e.g., neutropenia, anemia) of zidovudine. Some patients may not tolerate concomitant therapy with these drugs at full dosage. If concomitant use is necessary, monitor hematologic parameters closely. [28305] [32676]
    Revision Date: 03/19/2024, 01:37:00 AM

    References

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    Monitoring Parameters

    • CBC with differential
    • LFTs
    • ophthalmologic exam
    • pregnancy testing
    • serum creatinine/BUN

    US Drug Names

    • Cytovene
    • Vitrasert
    • Zirgan
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