BCG (BACILLUS CALMETTE-GUÉRIN) VACCINE

BCG (BACILLUS CALMETTE-GU?RIN) VACCINE
(ba-cil'lus cal'met-te guer'in)
Tice, TheraCys
Classifications: vaccine; antineoplastic; immunomodulator; biologic response modifier;
Therapeutic: antineoplastic
; immunomodulator
Pregnancy Category: C

Availability

50 mg, 81 mg, 120 mg powder for suspension

Action

BCG vaccine is an immunization agent for tuberculosis (TB). This vaccine is also active immunotherapy. BCG vaccine stimulates the reticuloendothelial system (RES) to produce macrophages that do not allow mycobacteria to multiply. BCG live is thought to cause a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder. This leads to destruction of superficial tumor cells.

Therapeutic Effect

BCG vaccine is an immunization agent for tuberculosis (TB). BCG is active immunotherapy that stimulates the immune mechanism to reject the tumor. It enhances the cytotoxicity of macrophages. BCG live is used intravesically as a biological response modifier for bladder cancer in situ.

Uses

To protect tuberculin skin test-negative infants and children, and groups with an excessive rate of new TB infections; carcinoma in situ of the bladder.

Unlabeled Uses

Malignant melanoma.

Contraindications

Impaired immune responses, immunosuppressive corticosteroid therapy, active TB, concurrent infections; recent TURP, severe hematuria; asymptomatic carriers with positive HIV serology; fever; UTI; pregnancy (category C); lactation.

Cautious Use

Hypersensitivity to BCG; high risk for HIV; aneurysm or prosthesis.

Route & Dosage

Prevention of Tuberculosis (Tice only)
Adult: Intradermal 0.1 mL
Adult/Child (>1 mo): Percutaneous After reconstitution, 0.2–0.3 mL of vaccine is dropped onto the cleansed surface of the skin and administered using a multiple-puncture disk applied through the vaccine
Child: Intradermal <3 mo, 0.05 mL; >3 mo, 0.1 mL
Child (<1 mo): Percutaneous Reduce adult dose by ? (reconstitute with 2 mL), may need to revaccinate with full dose at 1 y; same as adult

Carcinoma of the Bladder
Adult: Intravesical 3 vials of TheraCys at 27 mg each (81 mg total) of BCG reconstituted with accompanying diluent 7–14 d after biopsies/transurethral resections once/wk for 6 wk plus one treatment at 3, 6, 12, 18, and 24 mo; 1 vial of Tice per intravesical instillation once/wk for 6 wk plus one treatment/mo for 6–12 mo

Administration

WARNING: Do not inject intravenously, subcutaneously, or intradermally.

Percutaneous
  • Prepare solution: Add 1 mL sterile water for injection to 1 ampule of vaccine. Draw into syringe and expel back into ampule 3 times to mix.
  • Administer drug by dropping 0.2–0.3 mL onto clean surface of skin; then use a sterile multiple-puncture disk to create percutaneous skin punctures.
  • Instruct to keep vaccination site dry for 24 h; no dressing is needed.
  • Important: Avoid contact with BCG vaccine during preparation and administration.
  • Store dry BCG powder, reconstituted vaccine, and diluent refrigerated at 2°–8° C (35°–46° F). Use reconstituted solution within 2 h.
Intravesical Instillation
  • TheraCys: Dilute 3 vials of TheraCys in 50 mL of sterile preservative free NS and instill into bladder slowly by gravity flow via urethral catheter. Patient retains suspension for 2 h and then voids.
  • Tice: Instill 1 vial of Tice intravesically once/wk for 6 wk plus one per mo for 6–12 mo.
  • Important: Exercise care when handling BCG vaccine to avoid contact with the product.

Adverse Effects (≥1%)

CNS: Intravesical administration: malaise, dizziness, headache, weakness. Endocrine: Hyperpyrexia. GI: Abdominal pain, anorexia, constipation, nausea, vomiting, diarrhea; hepatic dysfunction following intratumor injection, granulomatous hepatitis. Urogenital: Intravesical administration: bladder spasms, clot retention, decreased bladder capacity, decreased urine flow, dysuria, hematuria, incontinence, nocturia, UTI, cystitis, hemorrhagic cystitis, penile pain, prostatism. Hematologic: Thrombocytopenia, eosinophilia, anemia, leukopenia, disseminated intravascular coagulation. Respiratory: Cough (rare), pulmonary granulomas, pulmonary infection. Skin: Abscess with recurrent discharge, red papule that scales or ulcerates in about 5–6 wk, dermatomyositis, granulomas at injection site 4–6 wk after inoculation, keloid formation, lupus vulgaris. Body as a Whole: Systemic BCG infection, chills, flu-like syndrome, anaphylaxis (rare), allergic reactions, lymphadenitis.

Diagnostic Test Interference

Prior BCG vaccination may result in false-positive tuberculin skin test (PPD). Following BCG vaccination, tuberculin sensitivity may persist for months to years.

Interactions

Drug: Concurrent antimycobacterial therapy (aminosalicylic acid, capreomycin, cycloserine, ethambutol, ethionamide, isoniazid, pyrazinamide, rifabutin, rifampin, streptomycin) that inhibits multiplication of BCG bacilli has the potential to antagonize or altogether negate the BCG vaccine-mediated immune response. Cyclosporine may reduce the immunologic response to BCG vaccine. Cytomegalovirus immune globulin and other live vaccines (measles/mumps/rubella, oral polio) may interfere with immune response to BCG. Previous vaccination with or other exposure to BCG may induce variable sensitivity to tuberculin. A greater booster effect following repeat tuberculin testing has been reported in individuals with prior BCG vaccination when compared with individuals without prior vaccination.

Pharmacokinetics

Not studied.

Nursing Implications

Assessment & Drug Effects

  • Monitor for S&S of systemic BCG infection: Fever, chills, severe malaise, or cough.
  • Culture blood and urine, if systemic infection is suspected.
  • Assess for regional lymph node enlargement and report fistula formation.

Patient & Family Education

  • Review potential adverse effects.
  • Keep vaccination site clean until local reaction has subsided.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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