months after discontinuing ozanimod. .paliferminSerious - Use Alternative (1)palifermin increases toxicity of BCG vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.paromomycinSerious - Use Alternative (1)paromomycin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.penicillin G aqueousSerious - Use Alternative (1)penicillin G aqueous decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.penicillin VKSerious - Use Alternative (1)penicillin VK decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until antibiotic treatment complete to administer live bacterial vaccine.piperacillinSerious - Use Alternative (1)piperacillin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until antibiotic treatment complete to administer live bacterial vaccine; antibiotics may diminish therapeutic effects of BCG.pivmecillinamSerious - Use Alternative (1)pivmecillinam decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.ponesimodMonitor Closely (1)ponesimod decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Use Caution/Monitor. If possible, complete all age-appropriate vaccinations at least 4 weeks before initiating ponesimod.prednisoloneSerious - Use Alternative (1)prednisolone decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.prednisoneSerious - Use Alternative (1)prednisone decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.procarbazineContraindicated (1)procarbazine decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3 mo after cessation of immunosuppressive therapy.quinupristin/dalfopristinSerious - Use Alternative (1)quinupristin/dalfopristin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.rabies immune globulin, human (RIG)Monitor Closely (1)rabies immune globulin, human (RIG) decreases effects of BCG vaccine live by Other (see comment). Use Caution/Monitor. Comment: High dose rabies immunoglobulin may impair response to active immunization.Rho(D) immune globulinMinor (1)Rho(D) immune globulin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Minor/Significance Unknown. Separate by 3 months.rifabutinSerious - Use Alternative (1)rifabutin decreases levels of BCG vaccine live by pharmacodynamic antagonism. Contraindicated.rifampinSerious - Use Alternative (1)rifampin decreases levels of BCG vaccine live by pharmacodynamic antagonism. Contraindicated.rifapentineSerious - Use Alternative (1)rifapentine decreases levels of BCG vaccine live by pharmacodynamic antagonism. Contraindicated.rilonaceptSerious - Use Alternative (1)rilonacept decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.risankizumabSerious - Use Alternative (1)risankizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting risankizumab, complete age appropriate immunizations.ritlecitinibSerious - Use Alternative (1)ritlecitinib, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during or shortly before initiating ritlecitinib. No data are available on vaccination response in ritlecitinib treated patients. Before initiating, review patient immunization status (including herpes zoster) and immunize accordingly in agreement with current immunization guidelines.roxithromycinSerious - Use Alternative (1)roxithromycin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.sarilumabSerious - Use Alternative (1)sarilumab, BCG vaccine live. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid concurrent use of live virus vaccines, owing to potentially increased risk of infections. The interval between live vaccinations and initiation of sarilumab therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.satralizumabSerious - Use Alternative (1)satralizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.secukinumabContraindicated (1)secukinumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Contraindicated. Secukinumab may interfere with immune response of live vaccines and increase risk for vaccine adverse effects; prior to initiating secukinumab, complete all age appropriate immunizations.siponimodSerious - Use Alternative (1)siponimod decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.sirolimusSerious - Use Alternative (1)sirolimus decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.streptomycinSerious - Use Alternative (1)streptomycin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated.sulfadiazineSerious - Use Alternative (1)sulfadiazine decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.sulfamethoxazoleSerious - Use Alternative (1)sulfamethoxazole decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.sulfisoxazoleSerious - Use Alternative (1)sulfisoxazole decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.tacrolimusSerious - Use Alternative (1)tacrolimus decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.teicoplaninSerious - Use Alternative (1)teicoplanin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.temocillinSerious - Use Alternative (1)temocillin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.temsirolimusSerious - Use Alternative (1)temsirolimus decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.teplizumabSerious - Use Alternative (1)teplizumab decreases effects of BCG vaccine live by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.tetanus immune globulin (TIG)Monitor Closely (1)tetanus immune globulin (TIG) decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Separate by 3 months.tetracyclineSerious - Use Alternative (1)tetracycline decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.ticarcillinSerious - Use Alternative (1)ticarcillin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.tigecyclineSerious - Use Alternative (1)tigecycline decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.tildrakizumabSerious - Use Alternative (1)tildrakizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiating tildrakizumab therapy, consider completion of all age appropriate immunizations according to current immunization guidelines. Avoid use of live vaccines in patients treated with tildrakizumab. No data are available on the response to live or inactive vaccines.tobramycinSerious - Use Alternative (1)tobramycin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.tocilizumabSerious - Use Alternative (1)tocilizumab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.tralokinumabSerious - Use Alternative (1)tralokinumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live vaccines. Before starting tralokinumab, complete age appropriate immunizations.triamcinolone acetonide injectable suspensionSerious - Use Alternative (1)triamcinolone acetonide injectable suspension decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Corticosteroids also increase risk of infection with concomitant live vaccines.trimethoprimSerious - Use Alternative (1)trimethoprim decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.ublituximabMonitor Closely (1)ublituximab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.upadacitinibSerious - Use Alternative (1)upadacitinib decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.ustekinumabSerious - Use Alternative (1)ustekinumab decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines. BCG vaccines should not be given during ustekinumab treatment, for one year prior to initiating treatment, or one year following discontinuation of treatment.vaccinia immune globulin intravenousMonitor Closely (1)vaccinia immune globulin intravenous decreases effects of BCG vaccine live by pharmacodynamic antagonism. Use Caution/Monitor. Defer live vaccines for 3 months after immune globulin administration.vancomycinSerious - Use Alternative (1)vancomycin decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.vedolizumabSerious - Use Alternative (1)vedolizumab decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live virus vaccines while receiving vedolizumab; live vaccines may be administered concurrently with vedolizumab only if the benefits outweigh the risks.voclosporinSerious - Use Alternative (1)voclosporin decreases effects of BCG vaccine live by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants. >10% Malaise (7-40%) Fever (17-38%) Pain (17%) Chills (9-34%) Nausea/vomiting (3-16%) Dysuria (52-60%) Hematutia (26-39%) Urinary urgency (6-18%) Infection (2-18%) Anemia (21%) Flu-lik syndrome (24-33%) 1-10% Rash (2-3%) Diarrhea (6%) Abdominal pain (2-3%) Headache (2%) Leukopenia (6%) Genital inflammation /abscess (2%) Renal toxicity (10%) Hemorrhagic cystitis (9%) Nocturia (5%) Urinary incontinence (2-6%) Arthralgia/myalgia (3-7%) Pulmonary infection (3%) <1% Urea nitrogen in blood increased Creatinine increased Disseminated sepsis Hepatitis Coagulopathy Myoglobinuria Nephritis Uveitis Black Box Warning Intravesical administration may cause disseminated infections Contains live attenuated mycobacteria (handle with care and dispose properly)Contraindications Hypersensitivity, immunosuppression (corticosteroids) Acquired immune deficiencies Active tuberculosis HIV infected patients Bladder Febrile illness Urinary tract infection Gross hematuria Biopsy Transurethral resection Traumatic catherization Cautions Bacillus Calmette-Guérin strain of Mycobacterium bovis Patient should have Mantoux skin test prior to vaccine administration Following vaccination, Mantoux skin test usually positive; this is not a sensitive indicator of degree of protection Immunity not permanent; duration unpredictable Treat anaphylactoid reactions immediately Intravesical administration may cause symptoms of bladder irritability 4-6 hr after instillation and increase in severity following each instillation; may last 24-72 hr Use caution in patients with small bladder capacity Postpone intravesical instillation during antibiotic therapy Vaccination not recommended for patients with positive PPD reaction Not for the treatment of active tuberculosis or prevention of cancer May not result in effective immunity in all patients Packaging may contain latex Suspected adverse events after administration of any vaccine may be reported to Vaccine Adverse Events Reporting System (VAERS), 1-800-822-7967 Up-to-date vaccination schedules available at www.cdc.gov/nip/publications Pregnancy Category: C Lactation: Not known if excreted in breast milk, not recommendedPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action M. bovis strain in the vaccine, immunologically similar to M. tuberculosis, produces cell-mediated immunity and simulates M. tuberculosis infection May convey active immunity via stimulation of production of endogenously produced antibodies The onset of protection from disease is relatively slow, but duration is long lasting (years) In bladder cancer a local inflammatory reaction may lead to destruction of superficial tumor cells of the endothellium; stimulates the host's immune system to reject the tumor No images available for this drug. No images available for this