No

Biological Response Modulator; Vaccine

Immunization against tuberculosis and immunotherapy for cancer; treatment of bladder cancer

BCG vaccine is strongly recommended for infants and children with negative tuberculin skin tests who:

are at high risk of intimate and prolonged exposure to persistently untreated or ineffectively treated patients with infectious pulmonary tuberculosis, and

cannot be removed from the source of exposure, and

cannot be placed on long-term preventive therapy

are continuously exposed with tuberculosis who have bacilli resistant to isoniazid and rifampin

BCG is also recommended for tuberculin-negative infants and children in groups in which the rate of new infections exceeds 1% per year and for whom the usual surveillance and treatment programs have been attempted but are not operationally feasible

BCG should be administered with caution to persons in groups at high risk for HIV infection or persons known to be severely immunocompromised. Although limited data suggest that the vaccine may be safe for use in asymptomatic children infected with HIV, BCG vaccination is not recommended for HIV infected adults or for persons with symptomatic disease. Until further research can clearly define the risks and benefits of BCG vaccination for this population, vaccination should be restricted to persons at exceptionally high risk for tuberculosis infection. HIV infected persons thought to be infected with Mycobacterium tuberculosis should be strongly recommended for tuberculosis preventive therapy.

C

Tuberculin-positive individual, hypersensitivity to BCG vaccine or any component, immunocompromized, AIDS and burn patients

Protection against tuberculosis is only relative, not permanent, nor entirely predictable; for live bacteria vaccine, proper aseptic technique and disposal of all equipment in contact with BCG vaccine as a biohazardous material is recommended; systemic reactions have been reported in patients treated as immunotherapy for bladder cancer

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967.

Genitourinary: Bladder infection, dysuria, polyuria, prostatitis

Miscellaneous: Flu-like syndrome

<1%: Skin ulceration, abscesses, hematuria, rarely anaphylactic shock in infants, lymphadenitis, tuberculosis in immunosuppressed patients

Decreased effect: Antimicrobial or immunosuppressive drugs may impair response to BCG or increase risk of infection; antituberculosis drugs

Refrigerate, protect from light, use within 2 (TICE® BCG) hours of mixing

BCG live is an attenuated strain of Bacillus Calmette-Guérin used as a biological response modifier; BCG live, when used intravesicular for treatment of bladder carcinoma in situ, is thought to cause a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder. By a mechanism not fully understood, this local inflammatory response leads to destruction of superficial tumor cells of the urothelium. Evidence of systemic immune response is also commonly seen, manifested by a positive PPD tuberculin skin test reaction, however, its relationship to clinical efficacy is not well-established. BCG is active immunotherapy which stimulates the host's immune mechanism to reject the tumor.

Children >1 month and Adults:

Immunotherapy for bladder cancer:

Intravesical treatment: Instill into bladder for 2 hours

TheraCys®: One dose diluted in 50 mL NS (preservative free) instilled into bladder once weekly for 6 weeks followed by one treatment at 3, 6, 12, 18, and 24 months after initial treatment

Tice® BCG: One dose diluted in 50 mL NS (preservative free) instilled into the bladder once weekly for 6 weeks followed by once monthly for 6-12 months

Use immediately after reconstitution

PPD intradermal test

None reported

None reported

No information available to require special precautions

No effects or complications reported

Notify physician of persistent pain on urination or blood in urine

Should only be administered intradermally; do not administer I.V.

Freeze-dried suspension for reconstitution

Injection, intravesical: 27 mg (3 vials)

Badalament RA and Farah RN, "Treatment of Superficial Bladder Cancer With Intravesicle Chemotherapy," Semin Surg Oncol, 1997, 13(5):335-41.

Lamm DL, Steg A, Boccon-Gibod L, et al, "Complications of Bacillus Calmette-Guérin Immunotherapy: Review of 2602 Patients and Comparison of Chemotherapy Complications," Prog Clin Biol Res, 1989, 310:335-55.

Martinez-Pineiro JA and Martinez-Pineiro L, "BCG Update: Intravesical Therapy," Eur Urol, 1997, 31(Suppl 1):31-41.

Nathanson L, "Use of BCG in the Treatment of Human Neoplasms: A Review," Semin Oncol, 1974, 1(4):337-50.

Nseyo UO and Lamm DL, "Immunotherapy of Bladder Cancer," Semin Surg Oncol, 1997, 13(5):342-9.