English
Smallpox and Monkeypox Vaccine, Live, Nonreplicating
Indications/Dosage
Labeled
- monkeypox virus (mpox) prophylaxis
- variola (smallpox) prophylaxis
General Dosing Information
- Smallpox and monkeypox vaccine, live, nonreplicating is FDA-approved for subcutaneous injection in patients 18 years and older; subcutaneous injection in patients younger than 18 years of age and intradermal injection in patients 18 years and older is covered under an Emergency Use Authorization (EUA).
- Vaccination with the smallpox and monkeypox vaccine is recommended for people at risk for occupational exposure to orthopoxviruses. At-risk people include research laboratory personnel, clinical laboratory personnel performing diagnostic testing for orthopoxviruses, designated response team members at risk for occupational exposure to orthopoxviruses, and health care personnel who administer the smallpox vaccine or care for patients with orthopoxviruses. For laboratory personnel and designated response team members, the use of the smallpox and monkeypox vaccine as an alternative to the smallpox vaccine is recommended for primary vaccination. For healthcare personnel administering the smallpox vaccine or those caring for patients infected with orthopoxviruses, the smallpox and monkeypox vaccine is recommended as an alternative to the smallpox vaccine, based on shared clinical decision-making.
- Administer the second dose as close to the recommended interval as possible; do not schedule the second dose appointment earlier than the recommended dosing interval. Patients receiving a second dose up to 4 days before or any time after the recommended date can be considered fully vaccinated. If the second dose of a vaccine is inadvertently given earlier than the 4-day grace period, the second dose may not need to be repeated. The second dose may be given up to 7 days later than the minimum interval of 28 days (i.e., up to 35 days after the first dose). If there is an extended interval between doses, there is no need to restart or add doses to the series.
- When necessary, patients 18 years and older receiving the first dose with the subcutaneous vaccine may receive the second dose with the intradermal vaccine.
- People who received the 2-dose smallpox and monkeypox primary vaccine series and who are at ongoing risk for occupational exposure to more virulent orthopoxvirus should receive a smallpox and monkeypox vaccine booster dose every 2 years. People who received the 2-dose smallpox and monkeypox primary vaccine series and who are at ongoing risk for occupational exposure to the less virulent orthopoxviruses, should receive booster doses of smallpox and monkeypox vaccine every 10 years.
- A booster dose of smallpox and monkeypox vaccine may be given as an alternative to a booster dose of the smallpox vaccine. People who transition to receiving the smallpox and monkeypox vaccine boosters are expected to continue receiving the smallpox and monkeypox vaccine boosters and should not revert to the smallpox vaccine.
- People with contraindications to vaccination with the smallpox vaccine (e.g., atopic dermatitis, immunocompromising conditions, breastfeeding, or pregnancy) may receive vaccination with the smallpox and monkeypox vaccine.
- Clinical studies have shown maximal antibody titers 2 weeks after administration of the second dose of the 2-dose smallpox and monkeypox primary vaccination series; an immunocompetent person is considered fully immunized at that time.
- The smallpox and monkeypox vaccine may be administered with other vaccines without regard to timing. If multiple vaccines are given at a single visit, administer each injection in a different injection site.
- Due to the documented risk for myocarditis after both the smallpox and mRNA COVID-19 vaccines and unknown risk with smallpox and monkeypox vaccine, patients, in particular adolescents or young adult males, may consider waiting 4 weeks after smallpox and monkeypox vaccination before getting an mRNA COVID-19 vaccine. However, if vaccination with the smallpox and monkeypox vaccine is recommended for prophylaxis during an outbreak, do not delay administration because of recent mRNA COVID-19 vaccination. No minimum interval between mRNA COVID-19 vaccination and smallpox and monkeypox vaccination is necessary.[67654][67763][67840][67847]
Off-Label
For monkeypox virus (mpox) prophylaxis in patients who are at high risk for mpox infection
for pre-exposure prophylaxis
Subcutaneous dosage
Adults
0.5 mL subcutaneously for 2 doses administered 4 weeks apart.[64646]
Infants, Children, and Adolescents†
0.5 mL subcutaneously for 2 doses administered 4 weeks apart.[67840]
Intradermal dosage†
Adults
0.1 mL intradermally for 2 doses administered 4 weeks apart.[67840]
for post-exposure prophylaxis†
Subcutaneous dosage
Adults
0.5 mL subcutaneously for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date to prevent onset of disease. If administered between 4 and 14 days after exposure, vaccination may reduce symptoms of disease, but not prevent disease. If it has been more than 3 years since vaccination, consider revaccinating.[64646] [67650]
Infants, Children, and Adolescents 6 months to 17 years
Prior to dosing, contact jurisdictional health department to assist in consultation with CDC for guidance. 0.5 mL subcutaneously for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date to prevent onset of disease. If administered between 4 and 14 days after exposure, vaccination may reduce symptoms of disease, but not prevent disease.[67654] [67802] [67840]
Infants younger than 6 months
Prior to dosing, contact jurisdictional health department to assist in consultation with CDC for guidance. 0.5 mL subcutaneously for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date to prevent onset of disease. If administered between 4 and 14 days after exposure, vaccination may reduce symptoms of disease, but not prevent disease. Due to an immature immune system and possible decreased vaccine response, immune globulin or antivirals may also be considered.[67802] [67654] [67840]
Intradermal dosage
Adults
0.1 mL intradermally for 2 doses administered 4 weeks apart. Administer within 4 days from exposure date to prevent onset of disease. If administered between 4 and 14 days after exposure, vaccination may reduce symptoms of disease, but not prevent disease. If it has been more than 3 years since vaccination, consider revaccinating.[67650] [67840] [67847]
For variola (smallpox) prophylaxis in patients who are at high risk for smallpox infection
Subcutaneous dosage
Adults
0.5 mL subcutaneously for 2 doses administered 4 weeks apart.[64646]
Therapeutic Drug Monitoring
Maximum Dosage Limits
- Adults
0.5 mL/dose subcutaneous; 0.1 mL/dose intradermal.
- Geriatric
0.5 mL/dose subcutaneous; 0.1 mL/dose intradermal.
- Adolescents
0.5 mL/dose subcutaneous.
- Children
0.5 mL/dose subcutaneous.
- Infants
0.5 mL/dose subcutaneous.
- Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
† Off-label indicationReferences
How Supplied
Modified Vaccinia Ankara Suspension for injection
JYNNEOS Suspension for Injection (50632-0001) (Bavarian Nordic, Inc.) nullDescription/Classification
Description
Smallpox and monkeypox vaccine, live, nonreplicating is used for the prevention of smallpox and monkeypox (mpox) infection in high risk patients. It is FDA-approved for subcutaneous injection in patients 18 years and older; subcutaneous injection in patients younger than 18 years of age and intradermal injection in patients 18 years and older is covered under an Emergency Use Authorization (EUA). Full vaccination requires 2 doses; however, some protection may be gained at least 14 days after the first dose. During sensitivity analysis the average incidence rate ratio (IRR), calculated by dividing the weighted average incidence among unvaccinated patients by that among patients who received 1 dose of vaccine 14 days or more prior, was 14.3 (95% CI = 5 to 41). Although a single dose may provide some protection against monkeypox (mpox) infection, the durability of immunity after a single dose is unknown; it is recommended that eligible patients complete the 2-dose series. Smallpox and monkeypox vaccine, live, nonreplicating does not contain the viruses that cause smallpox or monkeypox (mpox), but instead is made from a vaccinia virus. Vaccinia virus is antigenically similar to the variola virus, which causes smallpox, and to the monkeypox virus (mpox). It contains a modified form of the vaccinia virus called Modified Vaccinia Ankara, which is nonreplicating and does not cause disease in humans. Using a modified form of the vaccinia allows people with pre-existing conditions such as immune system disorders to receive the vaccine; however, they may have a diminished immune response. The smallpox and monkeypox vaccine, live, nonreplicating has several advantages compared to the smallpox vaccine. The smallpox and monkeypox vaccine, live, nonreplicating has fewer contraindications, no risk for inadvertent inoculation and autoinoculation, and is associated with less serious adverse reactions compared to the smallpox vaccine. Additionally, most health care providers have more experience administering a subcutaneous vaccine compared to a percutaneous vaccine. In the United States, routine vaccination of the public against smallpox ended in 1972. The level of immunity, if any, among persons who were vaccinated before 1972 is uncertain, therefore, it is assumed that these persons are susceptible to smallpox. The effectiveness of the smallpox and monkeypox vaccine, live, nonreplicating for the prevention of smallpox was found to be not inferior to the FDA-approved vaccine for the prevention of smallpox in a study of approximately 400 healthy adults. The effectiveness of the smallpox and monkeypox vaccine, live, nonreplicating for the prevention of monkeypox (mpox) infection was inferred from the antibody responses in the smallpox clinical study patients and from studies in nonhuman primates. The vaccine safety was assessed in more than 7,800 patients who received at least 1 dose of the vaccine. Injection site reactions, muscle pain, headache, and fatigue were the most commonly reported adverse reactions. Smallpox and monkeypox vaccine, live, nonreplicating is a 2-dose series administered 4 weeks apart. Full vaccine protection is not present until 2 weeks after administration of the second dose.[64646][64667][67763][67840][68022]
Classifications
- General Anti-infectives Systemic
- Vaccines
- Pure Vaccines
- Smallpox and Monkeypox Vaccines
- Pure Vaccines
- Vaccines
References
Administration Information
General Administration Information
For storage information, see the specific product information within the How Supplied section.
- According to U.S. federal laws, the healthcare provider must record in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.
- Obtain a patient's current health status and immunization history to determine vaccine adverse reactions. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse reactions have been identified. The toll-free number for VAERS is 1-800-822-7967. Depending on the adverse reaction, subsequent vaccination, if needed, may be contraindicated.
- The health care professional should have immediate availability of epinephrine injection and other agents used in the treatment of anaphylaxis in the event of a serious allergic reaction.[64646]
Route-Specific Administration
Injectable Administration
- Administer subcutaneously or intradermally. Do not inject intravenously or intramuscularly.
- Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Smallpox and monkeypox vaccine, live, nonreplicating is a milky, light yellow to pale white colored suspension. Discard if it appears otherwise.
- Due to the documented risk for myocarditis after both the smallpox and mRNA COVID-19 vaccines and unknown risk after smallpox and monkeypox vaccine, patients, in particular adolescents or young adult males, may consider waiting 4 weeks after smallpox and monkeypox vaccination before getting an mRNA COVID-19 vaccine. However, if vaccination with the smallpox and monkeypox vaccine is recommended for prophylaxis during an outbreak, do not delay administration because of recent mRNA COVID-19 vaccination. No minimum interval between mRNA COVID-19 vaccination and smallpox and monkeypox vaccination is necessary.
- There is no data on administering the smallpox and monkeypox vaccine, live, nonreplicating at the same time as the tuberculin skin test (TST). If a patient has any symptoms or signs of active tuberculosis or a delay in the TST would cause a substantial burden (i.e., preventing a person from working due to pre-employment screening policies) then the TST should not be delayed. Otherwise, a delay of at least 4 weeks after smallpox and monkeypox vaccine, live, nonreplicating is preferred. If the vaccine and TST are administered on the same day, administer on different forearms. If both are administered on the same forearm, separate the injection sites by 8 to 10 centimeters (3 to 4 inches) along the length of the forearm to reduce potential reactions. Record the location of each injection site.[64646][67763][67840][67847]
Subcutaneous Administration
- Thaw vaccine to room temperature before use.
- Use caution when removing the cap from the vial. To use, flip off the yellow cap at the arrow with your thumb at a 90-degree angle. Leave the yellow cap on the metal flange. Alternatively, flip the yellow cap all the way off, but ensure the metal flange stays on the stopper/vial. Improperly opening the vial may tear the flange leaving an exposed sharp edge, or if the stopper is removed, it can affect sterility.
- Swirl the vial gently before use for at least 30 seconds. Withdraw a dose of 0.5 mL into a sterile syringe for injection.
- Administer the vaccine by subcutaneous injection, preferably into the anterolateral thigh for infants younger than 1 year of age or into the upper arm for patients 1 year and older.
- Storage: Once thawed, the vaccine may be stored at 2 to 8 degrees C (36 to 46 degrees F) for 4 weeks (per FDA-approved product label) or 8 weeks (per Emergency Use Authorization). Do not refreeze.[64646][67763][67840][68235]
Other Injectable Administration
Intradermal Injection
- Thaw vaccine to room temperature before use.
- Use caution when removing the cap from the vial. To use, flip off the yellow cap at the arrow with your thumb at a 90-degree angle. Leave the yellow cap on the metal flange. Alternatively, flip the yellow cap all the way off, but ensure the metal flange stays on the stopper/vial. Improperly opening the vial may tear the flange leaving an exposed sharp edge, or if the stopper is removed, it can affect sterility.
- Swirl the vial gently before use for at least 30 seconds. Withdraw a dose of 0.1 mL into a sterile syringe for injection.
- Low dead-volume syringes and/or needles can be used to extract 5 doses from a single vial. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.1 mL, discard the vial and content; do not pool excess vaccine from multiple vials.
- Administer the vaccine by intradermal injection, preferably into the volar aspect (inner side) of the forearm.
- Storage: Once thawed, the vaccine may be stored at 2 to 8 degrees C (36 to 46 degrees F) for 8 weeks. Once the vial is punctured and a dose withdrawn, discard if not used within 8 hours of the first puncture. Do not refreeze.[67840][68235]
Clinical Pharmaceutics Information
From Trissel's 2‚Ñ¢ Clinical Pharmaceutics DatabaseReferences
Adverse Reactions
Mild
- chills
- fatigue
- fever
- headache
- injection site reaction
- nausea
- pruritus
Moderate
- erythema
- palpitations
- sinus tachycardia
Injection site reaction is one of the most common adverse reactions associated with smallpox and monkeypox vaccine, live, nonreplicating. Pain (89.4%; grade 3 7.4%), erythema (60.8%; redness of at least 100 mm 1.5%), swelling (51.6%; swelling of at least 100 mm 0.8%), induration (45.4%; induration of at least 100 mm 0.3%), and pruritus (43.1%; grade 3 1.6%) were reported in patients receiving smallpox and monkeypox vaccine, live, nonreplicating during a clinical trial. Most solicited local and systemic adverse reactions reported after vaccination had a median duration of 1 to 6 days. There were similar proportions of patients reporting solicited local or systemic reactions of any severity after Dose 2 compared with Dose 1, with the exception of injection site pain. The incidence of injection site pain was higher with the first dose (79.3%) compared to dose 2 (69.9%). In 3 studies (n = 409) involving patients who had previously been vaccinated with a smallpox vaccine, erythema (80.9%), pain (79.5%), induration (70.4%), swelling (67.2%), and pruritus (32%) were reported. In patients with active or a history of atopic dermatitis (AD), erythema was reported in 61.2% of patients with AD vs. 49.3% without AD and swelling was reported in 52.2% of patients with AD vs. 40.8% without AD.[64646]
Muscle pain (42.8%; grade 3 2.6%), headache (34.8%; grade 3 2.4%), and fatigue (30.4%; grade 3 3%) were reported in patients receiving smallpox and monkeypox vaccine, live, nonreplicating during a clinical trial. In 3 studies (n = 409) involving patients who had previously been vaccinated with a smallpox vaccine, fatigue (33.5%), headache (27.6%), and muscle pain (21.5%) were reported. In patients with active or a history of atopic dermatitis (AD), headache was reported in 47.2% of patients with AD vs. 34.8% without AD.[64646]
Nausea (17.3%; grade 3 1.5%) was reported in patients receiving smallpox and monkeypox vaccine, live, nonreplicating during a clinical trial. In 3 studies (n = 409) involving patients who had previously been vaccinated with a smallpox vaccine, nausea was reported in 9.8% of patients.[64646]
Chills (10.4%; grade 3 1%) and fever (1.7%; grade 3 0.2%) were reported in patients receiving smallpox and monkeypox vaccine, live, nonreplicating during a clinical trial. In 3 studies (n = 409) involving patients who had previously been vaccinated with a smallpox vaccine, chills (0.7%) and fever (0.5%) were reported. In HIV-infected patients with previous smallpox vaccine exposure, fever (1.5%) and chills (8.4%) were reported. The frequency of other solicited local and general adverse reactions in this population were similar to those reported in non-HIV-infected patients who had previously received smallpox vaccination. HIV-infected patients who had not received the smallpox vaccine had solicited local and systemic adverse reactions at similar or lower frequencies as compared to those in non-HIV-infected patients. In patients with active or a history of atopic dermatitis (AD), chills were reported in 15.9% of patients with AD vs. 7.8% without AD.[64646]
Smallpox and monkeypox vaccine, live, nonreplicating recipients were monitored for cardiac-related signs or symptoms through at least 6 months after the last vaccination. Cardiac adverse events were reported in 1.3% (95/7,093) of vaccine recipients and 0.2% (3/1,206) of placebo recipients who were smallpox vaccine-naive. Cardiac adverse events were reported in 2.1% (16/766) of vaccine recipients who were smallpox vaccine-experienced. The higher number of patients who experienced cardiac adverse events was driven by 28 cases of asymptomatic post-vaccination elevation of troponin-I above 2 times the upper limit of normal (ULN) in 2 studies, 1 which enrolled HIV-infected patients and 1 which enrolled patients with atopic dermatitis. An additional 127 cases of asymptomatic post-vaccination elevation of troponin-I above the ULN, but not above 2 times the ULN, were documented in smallpox and monkeypox vaccine, live, nonreplicating recipients, 124 of which occurred in trials which enrolled HIV-infected patients and patients with atopic dermatitis. The clinical significance of the asymptomatic post-vaccination elevations of troponin-I is unknown. Among the cardiac adverse events reported, 6 cases (0.08%) were considered to be causally related to smallpox and monkeypox vaccine, live, nonreplicating vaccination and included sinus tachycardia, electrocardiogram T wave inversion, abnormal electrocardiogram, electrocardiogram ST segment elevation, abnormal electrocardiogram T wave, and palpitations. None of the cardiac adverse events were considered serious.[64646]
References
Contraindications/Precautions
Absolute contraindications are italicized.
- acquired immunodeficiency syndrome (AIDS)
- agammaglobulinemia
- breast-feeding
- corticosteroid therapy
- egg hypersensitivity
- fever
- human immunodeficiency virus (HIV) infection
- hypogammaglobulinemia
- immunosuppression
- intramuscular administration
- intravenous administration
- leukemia
- lymphoma
- neoplastic disease
- pregnancy
- radiation therapy
- severe combined immunodeficiency (SCID)
Patients suffering significant immunosuppression may have a diminished immune response to vaccination with smallpox and monkeypox vaccine, live, nonreplicating.[64646] [67840] Immunosuppressed persons may include patients with acquired immunodeficiency syndrome (AIDS); asymptomatic or symptomatic human immunodeficiency virus (HIV) infection; severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to diseases such as leukemia, lymphoma, or generalized neoplastic disease; or an immune system compromised by corticosteroid therapy with greater than physiologic doses, alkylating drugs, antimetabolites, or radiation therapy. Short-term (less than 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive.[65107]
Data on administration of smallpox and monkeypox vaccine, live, nonreplicating during human pregnancy are not available; however, animal data have not identified a vaccine associated risk of fetal harm. A single human dose of smallpox and monkeypox vaccine, live, nonreplicating in female rats and rabbits on 2 or 3 different occasions (prior to mating, and on gestation days 0 and 14) showed no vaccine-related fetal malformations or variations and no adverse effects on female fertility or pre-weaning development.[64646]
There are no data on the presence of the smallpox and monkeypox vaccine, live, nonreplicating in human milk, the effects on a breast-fed infant, or the effects on milk production.[64646] 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 administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The smallpox and monkeypox vaccine, live, nonreplicating is indicated for subcutaneous and intradermal administration; do not give via intravenous administration or intramuscular administration. Incorrect administration may result in inadequate immunity.[64646] [67840]
The smallpox and monkeypox vaccine, live, nonreplicating is contraindicated in patients with a history of a severe allergic reaction after a previous dose of smallpox and monkeypox vaccine, live, nonreplicating. These patients should not be vaccinated; consider referral to an allergist-immunologist to assess the risks versus benefits of administering a dose. Use caution when administering to patients with a history of severe allergic reaction to gentamicin, ciprofloxacin, or in patients with an egg hypersensitivity; the vaccine contains small amounts of gentamicin and ciprofloxacin and is produced using chicken embryo fibroblast cells. Discuss the risks and benefits of vaccination with the patient. If vaccinated, observe for 30 minutes after administration. Alternatively, vaccination can be delayed until an allergist-immunologist is consulted; consider the impact of delaying vaccination. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy.[67847]
Consider deferring vaccination with the smallpox and monkeypox vaccine, live, nonreplicating in patients with moderate to severe acute illness, with or without fever, until acute illness has improved.[67847]
References
Mechanism of Action
The smallpox and monkeypox vaccine is an attenuated, live, nonreplicating vaccine that elicits humoral and cellular immune responses to orthopoxviruses. Vaccinia neutralizing antibody responses in humans were evaluated to establish vaccine effectiveness for prevention of smallpox and monkeypox (mpox).[64646]
Revision Date: 12/01/2022, 12:36:19 PMReferences
Pharmacokinetics
The smallpox and monkeypox vaccine, live, nonreplicating is administered subcutaneously and intradermally.[64646][67840]
Route-Specific Pharmacokinetics
Subcutaneous Route
The geometric mean titer (GMT) of vaccinia neutralizing antibodies assessed by plaque reduction neutralization test (PRNT) 2 weeks after the second dose of smallpox and monkeypox vaccine, live, nonreplicating in smallpox vaccine naive adults was 152.8 compared to 10.1 prevaccination. The GMT of neutralizing antibodies 4 weeks after a single dose of a licensed smallpox vaccine was 84.4 compared to 10 prevaccination. The GMTs at 2 and 4 weeks after the first dose of smallpox and monkeypox vaccine were 23.4 and 23.5, respectively.[64646][67840]
Other Route(s)
Intradermal administration
In a clinical study, patients were randomized to receive 2 intradermal 0.1 mL doses (n = 191) or 2 subcutaneous 0.5 mL doses (n = 167) of smallpox and monkeypox vaccine, live, nonreplicating administered 4 weeks apart. Using 4 different assays to evaluate immunogenicity, the development of the immune response to smallpox and monkeypox vaccine, live, nonreplicating over time after subcutaneous and intradermal administration was nearly identical, and the log2 transformed peak titers obtained after intradermal administration were non-inferior to those obtained after subcutaneous administration.[67840]
References
Pregnancy/Breast-feeding
pregnancy
Data on administration of smallpox and monkeypox vaccine, live, nonreplicating during human pregnancy are not available; however, animal data have not identified a vaccine associated risk of fetal harm. A single human dose of smallpox and monkeypox vaccine, live, nonreplicating in female rats and rabbits on 2 or 3 different occasions (prior to mating, and on gestation days 0 and 14) showed no vaccine-related fetal malformations or variations and no adverse effects on female fertility or pre-weaning development.[64646]
breast-feeding
There are no data on the presence of the smallpox and monkeypox vaccine, live, nonreplicating in human milk, the effects on a breast-fed infant, or the effects on milk production.[64646] 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 administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
References
Interactions
Level 1 (Severe)
- Abatacept
- Abrocitinib
- Adalimumab
- Aldesleukin, IL-2
- Alemtuzumab
- Alkylating agents
- Alpha interferons
- Altretamine
- Antimetabolites
- Antithymocyte Globulin
- Axicabtagene Ciloleucel
- Azathioprine
- Basiliximab
- Belatacept
- Bexarotene
- Blinatumomab
- Brexucabtagene Autoleucel
- Busulfan
- Carmustine, BCNU
- Certolizumab pegol
- Chlorambucil
- Ciltacabtagene Autoleucel
- Cisplatin
- Clofarabine
- Cortisone
- Cyclosporine
- Cytarabine, ARA-C
- Dacarbazine, DTIC
- Deflazacort
- Dexamethasone
- Docetaxel
- Estramustine
- Etanercept
- Everolimus
- Fingolimod
- Floxuridine
- Fludrocortisone
- Fluorouracil, 5-FU
- Folate analogs
- Golimumab
- Hydrocortisone
- Idecabtagene Vicleucel
- Ifosfamide
- Imatinib
- Infliximab
- Ixabepilone
- Leflunomide
- Lenalidomide
- Lisocabtagene Maraleucel
- Lomustine, CCNU
- Mechlorethamine, Nitrogen Mustard
- Melphalan
- Melphalan Flufenamide
- Methylprednisolone
- Mitoxantrone
- Mycophenolate
- Nanoparticle Albumin-Bound Sirolimus
- Natalizumab
- Nelarabine
- Nilotinib
- Obinutuzumab
- Paclitaxel
- Ponesimod
- Prednisolone
- Prednisone
- Procarbazine
- Purine analogs
- Rilonacept
- Ritlecitinib
- Rituximab
- Rituximab; Hyaluronidase
- Siltuximab
- Sirolimus
- Streptozocin
- Tacrolimus
- Temozolomide
- Temsirolimus
- Thiotepa
- Tisagenlecleucel
- Triamcinolone
- Ublituximab
- Ustekinumab
- Vincristine
- Vincristine Liposomal
- Vinorelbine
Level 2 (Major)
- Anakinra
- Anifrolumab
- Baricitinib
- Belimumab
- Brodalumab
- Canakinumab
- Deucravacitinib
- Dupilumab
- Efgartigimod Alfa
- Efgartigimod Alfa; Hyaluronidase
- Emapalumab
- Guselkumab
- Inebilizumab
- Interferon Gamma-1b
- Ixekizumab
- Ocrelizumab
- Ofatumumab
- Ozanimod
- Risankizumab
- Sarilumab
- Satralizumab
- Secukinumab
- Siponimod
- Spesolimab
- Teriflunomide
- Tezepelumab
- Tildrakizumab
- Tocilizumab
- Tofacitinib
- Tralokinumab
- Upadacitinib
- Vaccinia Immune Globulin, VIG
- Vedolizumab
- Venetoclax
- Voclosporin
Level 3 (Moderate)
- Elivaldogene Autotemcel
- Leniolisib
References
Monitoring Parameters
- laboratory monitoring not necessary
US Drug Names
- JYNNEOS
