BCG Vaccine
- Atc Codes:L03AX03
Table of contents
- Brand Names
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Toxicological Effects
- Caution and personalized dose adjustment in patients with the following genotypes
- Drug Interactions
- Dosage
- Special Considerations
Brand Names
Europe
Austria: Immucyst; Belgium: Immucyst, Oncotice; Bulgaria: Calgevax; Czech Republic: Immucyst; Denmark: BCG Kultur «SSI», BCG «medac»; Estonia: Immucyst; Finland: Oncotice; France: Immucyst; Germany: Immucyst, Oncotice; Greece: Oncotice; Hungary: Immucyst; Italy: Immucyst, Oncotice; Latvia: BCG-medac, ImmuCyst BCG; Lithuania: BCG-medac; Netherlands: Oncotice; Poland: Immucyst; Portugal: BCG Vacina SSI, Immucyst, Oncotice; Slovakia: BCG-medac, Immucyst; Slovenia: BCG-medac; Spain: Oncotice, Vacuna BCG; Sweden: Oncotice; UK: Immucyst, Oncotice.
North America
Canada: BCG Vaccine, Immucyst, Oncotice.
Latin America
Argentina: BCG cultivo SSI; Mexico: Oncotice.
Asia
Japan: Freeze-dried BCG vaccine.
Drug combinations
Chemistry
Pharmacologic Category
Vaccines. Antineoplastic Agents; Immunostimulants. (ATC-Code: L03AX03).
Mechanism of action
This vaccine is an attenuated strain of bacillus Calmette-Guérin (Mycobacterium bovis) used as a biological response modifier. When used for treatment of bladder carcinoma in situ, it is thought to cause a local, chronic inflammatory response, involving macrophage and leukocyte infiltration of the bladder, leading to destruction of superficial tumor cells of the urothelium.
Therapeutic use
Immunization against tuberculosis and immunotherapy for cancer. Treatment and prophylaxis of carcinoma in situ of the bladder. Prophylaxis of primary or recurrent superficial papillary tumors following transurethral resection.
Pregnancy and lactiation implications
Both intravesicular and percutaneous BCG vaccines are not recommended for use in pregnant women. Not recommended during lactation.
Unlabeled use
Contraindications
Hypersensitivity to BCG vaccine or any component of the formulation. Immunocompromised state, HIV-infected, and burn patients. Active tuberculosis. Avoid intravesicular BCG in febrile illness, urinary tract infection, gross hematuria and recent (<7-14 days) biopsy, transurethral resection, or traumatic catheterization. Do not administer I.V., subcutaneous or intradermally.
Warnings and precautions
Vaccination should be restricted to persons at exceptionally high risk for tuberculosis infection. Systemic reactions reported after immunotherapy for bladder cancer. BCG vaccination is not recommended for HIV-infected adults. Use with caution in severely immunocompromised patients (may have reduced response to vaccination). BCG vaccination is not recommended for persons with a positive PPD reaction.