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    Nov.30.2022

    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

      † Off-label indication

      For monkeypox virus (mpox) prophylaxis in patients who are at high risk for monkeypox 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 indication
      Revision Date: 11/30/2022, 03:07:36 PM

      References

      64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.67650 - Center for Disease Control and Prevention (CDC). Monkeypox and smallpox vaccine guidance. Retrieved May 26, 2022. Available on the World Wide Web at: https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html.67654 - Centers for Disease Control and Prevention (CDC). Interim Clinical Guidance for the Treatment of Monkeypox. July 28, 2022. Retrieved July 29, 2022. Available on the World Wide Web at https://www.cdc.gov/poxvirus/monkeypox/treatment.html.67763 - Centers for Disease Control and Prevention. Use of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the advisory committee on imunization practices - United States, 2022. MMWR 2022;71:734-42.67802 - Centers for Disease Control and Prevention (CDC). Clinical Considerations for Monkeypox in Children and Adolescents. Retrieved July 26, 2022. Available on the World Wide Web at https://www.cdc.gov/poxvirus/monkeypox/clinicians/pediatric.html?ACSTrackingID=USCDC_1052-DM86528&ACSTrackingLabel=COCA%20Now%3A%20Clinical%20Considerations%20for%20Monkeypox%20in%20Children%20and%20Adolescents&deliveryName=USCDC_1052-DM86528#anchor_1658856112226.67840 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Jynneos (Smallpox and Monkeypox Vaccine) Vaccine for prevention of Monkeypox disease in individuals determined to be at high risk for monkeypox infection. Retrieved August 9, 2022.67847 - Centers for Disease Control and Prevention (CDC). Interim Clinical Guidance for the Jynneos Vaccine. August 31, 2022. Available on the World Wide Web at https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/jynneos-vaccine.html#interim.

      How Supplied

      Modified Vaccinia Ankara Suspension for injection

      JYNNEOS Suspension for Injection (50632-0001) (Bavarian Nordic, Inc.) null

      Description/Classification

      Description

      Smallpox and monkeypox vaccine, live, nonreplicating is used for the prevention of smallpox and monkeypox disease in patients at high risk for infection. 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). Smallpox and monkeypox vaccine, live, nonreplicating does not contain the viruses that cause smallpox virus (variola) or monkeypox, 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. 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 disease 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]

      Classifications

      • General Anti-infectives Systemic
        • Vaccines
          • Pure Vaccines
            • Smallpox and Monkeypox Vaccines
      Revision Date: 08/10/2022, 04:51:17 PM

      References

      64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.64667 - US Food and Drug Administration (FDA). FDA News Release: FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox. Retrieved September 25, 2019. Available on the World Wide Web at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-live-non-replicating-vaccine-prevent-smallpox-and-monkeypox?utm_campaign=092419_PR_FDA%20approves%20smallpox%20and%20monkeypox%20vaccine&utm_medium=email&utm_source=Eloqua67763 - Centers for Disease Control and Prevention. Use of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the advisory committee on imunization practices - United States, 2022. MMWR 2022;71:734-42.67840 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Jynneos (Smallpox and Monkeypox Vaccine) Vaccine for prevention of Monkeypox disease in individuals determined to be at high risk for monkeypox infection. Retrieved August 9, 2022.

      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.[64646][67763][67840]

      Subcutaneous Administration

      • Thaw vaccine to room temperature before use.
      • 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 (deltoid) 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 up to 8 weeks. Do not refreeze.[64646][67763]

      Other Injectable Administration

      Intradermal Injection

       

      • Thaw vaccine to room temperature before use.
      • 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 12 hours. Once the vial is punctured and a dose withdrawn, discard if not used within 8 hours of the first puncture. Do not refreeze.[67840]

      Clinical Pharmaceutics Information

      From Trissel's 2‚Ñ¢ Clinical Pharmaceutics Database
        Revision Date: 08/26/2022, 08:51:52 AM

        References

        64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.67763 - Centers for Disease Control and Prevention. Use of Jynneos (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the advisory committee on imunization practices - United States, 2022. MMWR 2022;71:734-42.67840 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Jynneos (Smallpox and Monkeypox Vaccine) Vaccine for prevention of Monkeypox disease in individuals determined to be at high risk for monkeypox infection. Retrieved August 9, 2022.

        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]

        Revision Date: 10/08/2019, 02:12:21 PM

        References

        64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.

        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]

        Revision Date: 08/10/2022, 05:08:40 PM

        References

        64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.65107 - Kroger A, Bahta L, Hunter P. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP).Available on the world wide web at https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Revised April 27, 2022. Accessed on July 14, 2022.67840 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Jynneos (Smallpox and Monkeypox Vaccine) Vaccine for prevention of Monkeypox disease in individuals determined to be at high risk for monkeypox infection. Retrieved August 9, 2022.67847 - Centers for Disease Control and Prevention (CDC). Interim Clinical Guidance for the Jynneos Vaccine. August 31, 2022. Available on the World Wide Web at https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/jynneos-vaccine.html#interim.

        Mechanism of Action

        The smallpox and monkeypox vaccine is an attenuated, live, non-replicating 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.[64646]

        Revision Date: 10/07/2019, 09:52:31 PM

        References

        64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.

        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]

        Revision Date: 08/11/2022, 10:59:21 AM

        References

        64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.67840 - Food and Drug Administration (FDA). Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization (EUA) of Jynneos (Smallpox and Monkeypox Vaccine) Vaccine for prevention of Monkeypox disease in individuals determined to be at high risk for monkeypox infection. Retrieved August 9, 2022.

        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.

        Revision Date: 10/02/2019, 07:13:56 PM

        References

        64646 - Jynneos (smallpox and monkeypox vaccine, live, non-replicating) package insert. Kvistgaard, Denmark: Bavarian Nordic A/S; 2022 April.

        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
        • Daclizumab
        • 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
        • Rituximab
        • Rituximab; Hyaluronidase
        • Siltuximab
        • Sirolimus
        • Streptozocin
        • Tacrolimus
        • Temozolomide
        • Temsirolimus
        • Thiotepa
        • Tisagenlecleucel
        • Tositumomab
        • Triamcinolone
        • Upadacitinib
        • Ustekinumab
        • Vincristine
        • Vincristine Liposomal
        • Vinorelbine

        Level 2 (Major)

        • Anakinra
        • Anifrolumab
        • Baricitinib
        • Belimumab
        • Brodalumab
        • Canakinumab
        • Deucravacitinib
        • Dupilumab
        • Efgartigimod Alfa
        • Emapalumab
        • Guselkumab
        • Inebilizumab
        • Interferon Gamma-1b
        • Ixekizumab
        • Ocrelizumab
        • Ofatumumab
        • Ozanimod
        • Risankizumab
        • Sarilumab
        • Satralizumab
        • Secukinumab
        • Siponimod
        • Spesolimab
        • Teriflunomide
        • Tezepelumab
        • Tildrakizumab
        • Tocilizumab
        • Tofacitinib
        • Tralokinumab
        • Vaccinia Immune Globulin, VIG
        • Vedolizumab
        • Venetoclax
        • Voclosporin
        Abatacept: (Contraindicated) If possible, administer all needed vaccines before abatacept initiation. Live vaccines should not be given concurrently with abatacept or within 3 months of its discontinuation. The immune response of the immunocompromised patient to vaccines may be decreased and adjusted doses or boosters that are more frequent may be required. The immune response to an inactive vaccine may still be suboptimal. Live virus vaccines may induce the illness they are intended to prevent and are contraindicated for use during immunosuppressive treatment. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [31761] [43236] Abrocitinib: (Contraindicated) Avoid administration of live virus vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [67277] Adalimumab: (Contraindicated) Do not administer live vaccines to adalimumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving adalimumab. Before initiation of adalimumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Adalimumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27939] [43236] Aldesleukin, IL-2: (Contraindicated) Aldesleukin, IL-2 is associated with impaired neutrophil function. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [41853] [43236] Alemtuzumab: (Contraindicated) Do not administer live vaccines to alemtuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving alemtuzumab. At least 6 weeks before initiation of alemtuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Alemtuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58461] Alkylating agents: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Alpha interferons: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient, including those receiving Interferon therapy. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Altretamine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Anakinra: (Major) Avoid concurrent use of live vaccines during treatment with anakinra due to potentially increased risk of infections; clinical safety of live vaccines during anakinra treatment has not been established. Live virus vaccines should generally not be administered to an immunosuppressed patient, as they may induce the illness they are intended to prevent. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving anakinra. The interval between live vaccinations and initiation of anakinra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [27940] [43236] Anifrolumab: (Major) Avoid concurrent use of live vaccines during treatment with anifrolumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving anifrolumab. Before initiation of anifrolumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. [43236] [66846] Antimetabolites: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Antithymocyte Globulin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Axicabtagene Ciloleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during axicabtagene ciloleucel therapy, and prior to immune recovery following treatment with axicabtagene ciloleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [62530] [65107] Azathioprine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Baricitinib: (Major) Do not administer live virus vaccines to patients taking baricitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during baricitinib receipt. Before baricitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines. [63229] Basiliximab: (Contraindicated) Do not administer live vaccines to basiliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving basiliximab. At least 2 weeks before initiation of basiliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Basiliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [41849] [43236] Belatacept: (Contraindicated) Avoid the use of live vaccines such as the intranasal influenza vaccine; measles/mumps/rubella vaccines, MMR; Bacillus Calmette-Guerin Live, BCG; yellow fever vaccine; oral polio vaccine; varicella virus vaccine live; and TY21a typhoid vaccine during belatacept treatment. Further, inactive vaccine receipt may not illicit an acceptable response; belatacept may blunt the effectiveness of some immunizations. Consult the most current CDC guidances for vaccination recommendations. [44667] Belimumab: (Major) Live vaccines should not be given for 30 days before or concurrently with belimumab, as clinical safety has not been established. Because of its mechanism of action, belimumab may interfere with the response to immunizations. No data are available on the secondary transmission of infection from persons receiving live vaccines. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [43658] Bexarotene: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Blinatumomab: (Contraindicated) Do not administer live vaccines to blinatumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving blinatumomab. At least 2 weeks before initiation of blinatumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Blinatumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58559] Brexucabtagene Autoleucel : (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during brexucabtagene autoleucel therapy, and prior to immune recovery following treatment with brexucabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [65739] Brodalumab: (Major) Avoid administration of live vaccines to brodalumab recipients. Before initiation of brodalumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving brodalumab therapy. [61762] Busulfan: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Canakinumab: (Major) Do not administer live vaccines to a patient who is receiving canakinumab; other vaccination schedules should be complete as recommended prior to initiating canakinumab treatment. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving canakinumab. The immune response to vaccines or toxoids may be decreased, as canakinumab may interfere with normal immune response to new antigens. Limited data are available on the effectiveness of vaccination with inactivated antigens in patients receiving canakinumab. Because interleukin-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with canakinumab, adult and pediatric patients receive any recommended vaccination (including pneumococcal vaccine and inactivated influenza vaccines). [41378] [43236] Carmustine, BCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Certolizumab pegol: (Contraindicated) Do not administer live vaccines concurrently with certolizumab. No data are available on the response to vaccinations or to the secondary transmission of infection by live vaccines in patients receiving certolizumab. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33930] [43236] Chlorambucil: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Ciltacabtagene Autoleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during ciltacabtagene autoleucel therapy, and prior to immune recovery following treatment with ciltacabtagene autoleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] Cisplatin: (Contraindicated) Do not administer live vaccines to cisplatin recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cisplatin. At least 2 weeks before initiation of cisplatin therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cisplatin recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28393] [43236] Clofarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system [43236] Cortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [49489] Cyclosporine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Cytarabine, ARA-C: (Contraindicated) Do not administer live vaccines to cytarabine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving cytarabine. At least 2 weeks before initiation of cytarabine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Cytarabine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48339] Dacarbazine, DTIC: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Daclizumab: (Contraindicated) Do not administer live vaccines to daclizumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving daclizumab. At least 2 weeks before initiation of daclizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Daclizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60841] Deflazacort: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [61750] Deucravacitinib: (Major) Avoid administration of live vaccines to deucravacitinib recipients. Before initiation of deucravacitinib therapy, consider completion of all age-appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving deucravacitinib therapy. [67943] Dexamethasone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [54286] Docetaxel: (Contraindicated) Do not administer live vaccines to docetaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving docetaxel. At least 2 weeks before initiation of docetaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Docetaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [58408] Dupilumab: (Major) Avoid administration of live vaccines to dupilumab recipients. Before initiation of dupilumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving dupilumab therapy. [61836] Efgartigimod Alfa: (Major) Avoid the use of live vaccines and live attenuated vaccines during efgartigimod treatment. Live vaccinations may be less effective during efgartigimod treatment and may carry the risk of infection. Administer indicated vaccines prior to initiating efgartigimod. [67194] Emapalumab: (Major) Do not administer live or live attenuated vaccines to patients receiving emapalumab and for at least 4 weeks after the last dose of emapalumab. The safety of immunization with live vaccines during or after emapalumab therapy has not been studied. [63767] Estramustine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Etanercept: (Contraindicated) Etanercept has not been found to act as a general immunosuppressant; however, the patient's underlying disease state may result in the immunosuppression. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune syste [28060] [29646] [43236] Everolimus: (Contraindicated) Do not administer live vaccines to everolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving everolimus. Before initiation of everolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Everolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [49823] [49903] Fingolimod: (Contraindicated) Do not administer live vaccines to a patient who is receiving fingolimod or has discontinued the drug in the last 2 months because of the risk of infection. No data are available regarding the risk of secondary transmission of infection by live vaccines, and the efficacy and safety of live vaccines have not been established in patients receiving fingolimod. Before fingolimod initiation, test patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) for antibodies to VZV. Consider VZV vaccination of antibody-negative patients before fingolimod initiation, and do not start fingolimod for 1 month to allow the full effect of vaccination to occur. In addition to the concerns with live virus vaccines, the immune response to inactive vaccines or toxoids may be decreased, as fingolimod may interfere with normal immune response to new antigens. No data are available on the effectiveness of vaccination with inactivated antigens in patients receiving fingolimod. Vaccination may be less effective during and for up to 2 months after fingolimod discontinuation. For example, as compared with the response of placebo recipients, the capacity to mount a skin delayed-type hypersensitivity reaction to Candida and to tetanus toxoid was decreased by approximately 30% among fingolimod 0.5 mg daily recipients. Further, in healthy patients, antigen-specific IgM titers were decreased by 25% in response to pneumococcal polysaccharide vaccine (PPV-23) immunization as compared with the response by placebo recipients. Similarly, IgG titers were decreased by 50% among fingolimod recipients as compared with placebo. [41823] [43236] Floxuridine: (Contraindicated) Do not administer live vaccines to floxuridine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving floxuridine. At least 2 weeks before initiation of floxuridine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Floxuridine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48344] Fludrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [49507] Fluorouracil, 5-FU: (Contraindicated) Do not administer live vaccines to fluorouracil recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving fluorouracil. At least 2 weeks before initiation of fluorouracil therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Fluorouracil recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [53824] Folate analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Golimumab: (Contraindicated) Do not administer live vaccines to golimumab recipients. Limited data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [35501] [43236] Guselkumab: (Major) Avoid use of live vaccines in patients being treated with guselkumab; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving guselkumab. In addition, guselkumab may decrease the vaccine-induced immune response. Before initiation of guselkumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. [62120] Hydrocortisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [32057] [43236] [54049] Idecabtagene Vicleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during idecabtagene vicleucel therapy, and prior to immune recovery following treatment with idecabtagene vicleucell. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] Ifosfamide: (Contraindicated) Do not administer live vaccines to ifosfamide recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving ifosfamide. Before initiation of ifosfamide therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Ifosfamide recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [51027] Imatinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Inebilizumab: (Major) Administer all immunizations according to immunization guidelines at least 4 weeks before initiation of inebilizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion. In a neonate or infant with in utero exposure to inebilizumab, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B-cells in the exposed infant may increase the risks from live or live-attenuated vaccines. [43236] [60092] [65576] Infliximab: (Contraindicated) Do not administer live vaccines to infliximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving infliximab. Before initiation of infliximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Infliximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27994] [43236] Interferon Gamma-1b: (Major) Avoid the concomitant use of interferon gamma-1b with other immunological preparations such as live vaccines due to the risk of an unpredictable or amplified, immune response. [49610] Ixabepilone: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Ixekizumab: (Major) Do not administer live vaccines to ixekizumab recipients. Before initiation of ixekizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving Ixekizumab therapy. [60658] Leflunomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [49634] Lenalidomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Lisocabtagene Maraleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during lisocabtagene maraleucel therapy, and prior to immune recovery following treatment with lisocabtagene maraleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [65107] [66383] Lomustine, CCNU: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Mechlorethamine, Nitrogen Mustard: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Melphalan Flufenamide: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence. [41904] [44928] [60092] [65107] Melphalan: (Contraindicated) Avoid administration of live virus vaccines in patients who are receiving melphalan. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period or altered immunocompetence. [41904] [44928] [60092] [65107] Methylprednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [41361] [43236] Mitoxantrone: (Contraindicated) Do not administer live vaccines to mitoxantrone recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mitoxantrone. At least 2 weeks before initiation of mitoxantrone therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mitoxantrone recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [48215] Mycophenolate: (Contraindicated) Do not administer live vaccines to mycophenolate recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving mycophenolate. At least 2 weeks before initiation of mycophenolate therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Mycophenolate recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [27985] [43236] Nanoparticle Albumin-Bound Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28610] [43236] Natalizumab: (Contraindicated) The immune response to vaccines or toxoids may be decreased in patients who receive natalizumab; however, no data are available. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [30470] [43236] Nelarabine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Nilotinib: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Obinutuzumab: (Contraindicated) Do not administer live vaccines to obinutuzumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving obinutuzumab. Before initiation of obinutuzumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Obinutuzumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56353] Ocrelizumab: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during ocrelizumab use, vaccination with live vaccines or live-attenuated vaccines is not recommended in patients taking ocrelizumab. Withhold vaccination with live or live-attenuated virus vaccines to patients during ocrelizumab treatment and until B-cell repletion. Administer all live or live-attenuated vaccinations according to current vaccination guidelines at least 4 weeks before initiation of ocrelizumab. Do not administer live or live-attenuated vaccines to infants born to mothers exposed to ocrelizumab during pregnancy before confirming B-cell count recovery as measured by CD19+ B-cells. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination. [43236] [60092] [61838] Ofatumumab: (Major) Administer all live and live-attenuated vaccines according to immunization guidelines at least 4 weeks before initiation of ofatumumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with ofatumumab; wait until B-cell recovery occurs after discontinuation of ofatumumab before administering these vaccines to a patient. [43236] [60092] [65850] Ozanimod: (Major) Avoid the use of live vaccines and live attenuated vaccines during ozanimod treatment and for up to 3 months after discontinuation of ozanimod treatment. Live vaccinations may be less effective during ozanimod treatment and also may carry the risk of infection. [65169] Paclitaxel: (Contraindicated) Do not administer live vaccines to paclitaxel recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving paclitaxel. At least 2 weeks before initiation of paclitaxel therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Paclitaxel recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29200] [43236] Ponesimod: (Contraindicated) Avoid vaccines containing live virus (live attenuated vaccines) during treatment with ponesimod. If a live attenuated vaccine is required, administer at least 1 month (4 weeks) before initiation of ponesimod. The use of live attenuated vaccines may carry the risk of infection and should therefore be avoided during ponesimod treatment and for 1 to 2 weeks after discontinuation of ponesimod. During treatment, and for up to 1 to 2 weeks after discontinuation of ponesimod, vaccinations may also be less effective. [60092] [65107] [66527] Prednisolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [43740] [45339] Prednisone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [43319] Procarbazine: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Purine analogs: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Rilonacept: (Contraindicated) Do not administer live vaccines to a patient who is receiving rilonacept. No data are available regarding the use of live vaccines during rilonacept treatment. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33837] [43236] Risankizumab: (Major) Avoid administration of live vaccines to risankizumab recipients. Before initiation of risankizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving risankizumab therapy. [64073] Rituximab: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29025] [43236] Rituximab; Hyaluronidase: (Contraindicated) Do not administer live vaccines to rituximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving rituximab. At least 4 weeks before initiation of rituximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Rituximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [29025] [43236] Sarilumab: (Major) Avoid concurrent use of live vaccines during treatment with sarilumab due to potentially increased risk of infections; clinical safety of live vaccines during sarilumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving sarilumab. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [51778] [61976] Satralizumab: (Major) Administer all live vaccines according to immunization guidelines at least 4 weeks before initiation of satralizumab. Vaccination with live-attenuated or live vaccines is not recommended during treatment with satralizumab. [43236] [60092] [65841] Secukinumab: (Major) Do not administer live vaccines to secukinumab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving secukinumab. Before initiation of secukinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Secukinumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. Similar antibody responses were seen when healthy individuals who received a single 150 mg dose of secukinumab 2 weeks before vaccination with a non-US approved group C meningococcal polysaccharide conjugate vaccine and a non-US approved inactivated seasonal influenza vaccine. The efficacy of meningococcal and influenza vaccines has not been evaluated in patients undergoing treatment with secukinumab. [58739] Siltuximab: (Contraindicated) Do not administer live vaccines to siltuximab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving siltuximab. Before initiation of siltuximab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Siltuximab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [57062] Siponimod: (Major) Avoid the use of live vaccines during treatment with siponomid and for 4 weeks after stopping treatment due to the risk of secondary infection. Additionally, vaccines may be less effective if administered during siponimod treatment and for 4 weeks after siponimod treatment discontinuation. [64031] Sirolimus: (Contraindicated) Do not administer live vaccines to sirolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving sirolimus. At least 2 weeks before initiation of sirolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Sirolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [28610] [43236] Spesolimab: (Major) Avoid administration of live vaccines to spesolimab recipients. Before initiation of spesolimab therapy, consider completion of all age-appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving spesolimab therapy. [67922] Streptozocin: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Tacrolimus: (Contraindicated) Do not administer live vaccines to tacrolimus recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tacrolimus. At least 2 weeks before initiation of tacrolimus therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tacrolimus recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60497] Temozolomide: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Temsirolimus: (Contraindicated) The use of live vaccines should be avoided during treatment with temsirolimus. Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [33280] [43236] Teriflunomide: (Major) Due to the lack of clinical information related to the safety and efficacy of vaccine administration during teriflunomide use, concomitant vaccination with live vaccines is not recommended. The long half-life of teriflunomide should be considered when contemplating administration of a live vaccine after stopping the medication if the teriflunomide drug elimination procedure has not been performed. [51794] Tezepelumab: (Major) Avoid administration of live vaccines to tezepelumab recipients. Before initiation of tezepelumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available regarding the response to live vaccines in patients receiving tezepelumab therapy. [67195] Thiotepa: (Contraindicated) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] Tildrakizumab: (Major) Avoid administration of live vaccines to tildrakizumab recipients. Before initiation of tildrakizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live or inactive vaccines in patients receiving tildrakizumab therapy. [62970] Tisagenlecleucel: (Contraindicated) Avoid administration of live virus vaccines in the six weeks prior to the start of lymphodepleting chemotherapy, during tisagenlecleucel therapy, and prior to immune recovery following treatment with tisagenlecleucel. Patients with altered immunocompetence, including those receiving or those that have recently received immunosuppressive drug therapy, may be at increased risk for an adverse reaction because of uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [62282] [65107] Tocilizumab: (Major) Avoid concurrent use of live vaccines during treatment with tocilizumab due to potentially increased risk of infections; clinical safety of live vaccines during tocilizumab treatment has not been established. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving tocilizumab. The interval between live vaccinations and initiation of tocilizumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. [38283] [51778] Tofacitinib: (Major) Do not administer live virus vaccines to patients taking tofacitinib, as no data are available on the secondary transmission of infection by live vaccines. Also, no data are available on the response to vaccination with any vaccine during tofacitinib receipt. Before tofacitinib initiation, review the vaccination status of patients, and update immunizations in agreement with current immunization guidelines. [52315] Tositumomab: (Contraindicated) Do not administer live vaccines to tositumomab recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving tositumomab. At least 2 weeks before initiation of tositumomab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Tositumomab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [55836] Tralokinumab: (Major) Avoid administration of live vaccines to tralokinumab recipients. Before initiation of tralokinumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. No data are available on the response to live vaccines in patients receiving tralokinumab therapy. [67217] Triamcinolone: (Contraindicated) Live vaccines should generally not be administered to an immunosuppressed patient. Live vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. The immunosuppressive effects of steroid treatment differ, but many clinicians consider a dose equivalent to either 2 mg/kg/day or 20 mg/day of prednisone as sufficiently immunosuppressive to raise concern about the safety of immunization with live vaccines. Patients on corticosteroid treatment for 2 weeks or more may be vaccinated after steroid therapy has been discontinued for at least 3 months in accordance with general recommendations for the use of live vaccines. The CDC has stated that discontinuation of steroids for 1 month prior to live vaccine administration may be sufficient. Live vaccines should not be given to individuals who are considered to be immunocompromised until more information is available. [43236] [56146] Upadacitinib: (Contraindicated) Avoid administration of live virus vaccines with immunosuppressive drug therapy and prior to immune recovery following treatment with immunosuppressive drug therapy. When feasible, administer indicated live virus vaccines at least four weeks before planned immunosuppression or wait until at least three months after discontinuation. The time to restoration of immune competence may be longer in some patients. Patients with altered immunocompetence may be at increased risk for severe adverse reactions due to uninhibited growth of the attenuated live virus. Additionally, vaccines may be less effective if administered during a period of altered immunocompetence. [60092] [64572] [65107] Ustekinumab: (Contraindicated) If possible, administer all recommended vaccines before ustekinumab initiation. Ustekinumab recipients may receive inactive vaccines, but the elicited immune response may be insufficient to prevent disease. Do not administer live vaccines to a ustekinumab recipient. Furthermore, do not administer BCG live vaccines for either 1 year before or 1 year after ustekinumab receipt, due to the infectious risk for Mycobacteria. No data are available on the response to live vaccination or on the risk of infection or infection transmission after the administration of other live vaccines to ustekinumab recipients. Cautious administration of ustekinumab to household contacts of ustekinumab recipients may be warranted due to the potential risk for shedding from the household contact and transmission to the patient. Practitioners should also refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [36889] [43236] Vaccinia Immune Globulin, VIG: (Major) Defer vaccination with live attenuated virus vaccines until approximately 3 months after administration of vaccinia immune globulin (VIG). Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines may be impaired by vaccinia immune globulin (VIG) administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines. [48345] Vedolizumab: (Major) Avoid administering live vaccines to vedolizumab recipients unless the benefits outweigh the risks; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vedolizumab. Before initiation of vedolizumab therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vedolizumab recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [57235] Venetoclax: (Major) Avoid live vaccines to venetoclax recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving venetoclax. Before initiation of venetoclax therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Venetoclax recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [60706] Vincristine Liposomal: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56085] Vincristine: (Contraindicated) Do not administer live vaccines to vincristine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vincristine. At least 2 weeks before initiation of vincristine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vincristine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56085] Vinorelbine: (Contraindicated) Do not administer live vaccines to vinorelbine recipients; no data are available regarding the risk of secondary transmission of infection by live vaccines in patients receiving vinorelbine. Before initiation of vinorelbine therapy, consider completion of all age appropriate vaccinations per current immunization guidelines. Vinorelbine recipients may receive inactivated vaccines, but the immune response to vaccines or toxoids may be decreased. [43236] [56871] Voclosporin: (Major) Live virus vaccines should generally not be administered to an immunosuppressed patient. Live virus vaccines may induce the illness they are intended to prevent and are generally contraindicated for use during immunosuppressive treatment. The immune response of the immunocompromised patient to vaccines may be decreased, even despite alternate vaccination schedules or more frequent booster doses. If immunization is necessary, choose an alternative to live vaccination, or, consider a delay or change in the immunization schedule. Practitioners should refer to the most recent CDC guidelines regarding vaccination of patients who are receiving drugs that adversely affect the immune system. [43236] [66336]
        Revision Date: 11/18/2022, 02:26:00 AM

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        Monitoring Parameters

        • laboratory monitoring not necessary

        US Drug Names

        • JYNNEOS
        ;
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