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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › IMMUNOSTIMULANTS › IMMUNOSTIMULANTS › Other immunostimulants
BCG vaccine
L03AX03
Forms & Strengths
- Intravesical suspension: 50 mg live attenuated Mycobacterium bovis (Bacillus Calmette-Guérin, Connaught or Tice strain) per vial
- Percutaneous/Intradermal powder for suspension: Live attenuated M. bovis (Danish strain 1331) 2-8 x 10^5 CFU per dose
Adult Dosing
- Intravesical (Bladder Cancer): 50 mg suspended in 50 mL sterile saline instilled intravesically weekly for 6 weeks, followed by maintenance therapy as indicated
- Intradermal/Percutaneous (Tuberculosis Prevention): 0.1 mL or 2-3 drops administered percutaneous or intradermal once (rarely used currently in US)
Pediatric Dosing
- Intradermal (Tuberculosis Prevention): 0.05 mL for infants under 1 month; 0.1 mL for infants over 1 month and children, administered intradermally once
- Intravesical: Safety and efficacy not established in children
Indications
- Prophylaxis of tuberculosis in high-risk neonates and infants
- Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder
- Prophylaxis of primary or recurrent stage Ta and/or T1 papillary transitional cell carcinoma of the bladder
Mechanism of Action
- Live attenuated strain of Mycobacterium bovis induces a local inflammatory and delayed-type hypersensitivity immune response
- Triggers cellular immunity through activation of macrophages, T-helper cells, and natural killer cells
- Upregulation of cytokines (IL-1, IL-2, IL-6, TNF-alpha, IFN-gamma) leads to destruction of superficial bladder tumor cells via nonspecific immunotherapy
Contraindications
- Hypersensitivity to BCG vaccine or its components
- Immunocompromised patients (HIV-positive, congenital immunodeficiencies, immunosuppressive therapy, systemic malignancies)
- Active tuberculosis infection
- Pregnancy
- Concurrent administration with immunosuppressants or antimycobacterial drugs
- For intravesical use: active urinary tract infection, traumatic catheterization, gross hematuria
Adverse Reactions
- Common (Intravesical): Dysuria, urinary frequency, urgency, cystitis, hematuria, pelvic pain, low-grade fever, malaise
- Common (Intradermal): Induration, ulceration, and scarring at injection site, regional lymphadenopathy
- Severe: Systemic BCG infection (disseminated BCG-itis), hypersensitivity reactions, anaphylaxis, contracted bladder, epididymitis, prostatitis, hepatic dysfunction
Drug Interactions
- Immunosuppressive agents (corticosteroids, chemotherapy): May diminish effectiveness of BCG vaccine and increase risk of severe systemic infection
- Antimycobacterial agents (antitubercular drugs such as isoniazid, rifampin): May inhibit the therapeutic efficacy of BCG
- Prophylactic antibiotics for catheterization: Fluoroquinolones or other antimicrobials given around instillation may reduce BCG viability and efficacy
Curated Content: Needs Vetting Before Put to Clinical Use