Bacillus calmette-Guerin strain (BCG vaccine)

Bacillus calmette-Guerin strain (BCG vaccine) is used for: Prevention of tuberculosis, Urothelial bladder carcinoma, Carcinoma in situ

Intradermal Active immunisation against tuberculosis Adult: 0.2-0.3 ml (full strength dilution); conduct postvaccinal tuberculin test (5 TU of PPD) 2-3 mth later; if test is negative, repeat vaccination. Dose to be given via intradermal inj. Intravesical Immunotherapy of bladder cancer Dosage: The content of 1 vial is required for 1 bladder instillation. Duration: A standard treatment schedule consists of 1 intravesical instillation of BCG-Medac per week for 6 consecutive weeks as induction therapy. BCG treatment must not start until 2-3 weeks after transurethral resection (TUR). After a treatment-free interval of 4 weeks, intravesical administration should continue using maintenance therapy for at least 1 year. Induction Therapy (Prophylactic Treatment of Recurrence): BCG therapy should begin about 2-3 weeks after TUR or bladder biopsy, and without traumatic catheterisation, and be repeated at weekly intervals for 6 weeks. In intermediate and high-risk tumours, this should be followed by maintenance therapy. Maintenance Therapy: One schedule consists of a 12-month therapy with treatments at monthly intervals. Another maintenance scheme consists of 3 instillations at weekly intervals at month 3, 6, 12, 18, 24, 30 and 36. In this scheme, a total of 27 instillations are administered during a period of 3 years.

Intradermal Active immunisation against tuberculosis Child: <1 mth: 0.2-0.3 ml (half-strength dilution). Conduct tuberculin test (5 TU of PPD) 2-3 mth later; repeat vaccination after 1 yr of age for negative tuberculin test if indications persist. >1 mth: 0.2-0.3 ml (full strength dilution); conduct postvaccinal tuberculin test (5 TU of PPD) 2-3 mth later; if test is negative, repeat vaccination. Dose to be given via intradermal inj.

Administration: BCG-Medac should be administered in the conditions required for intravesical endoscopy. The bladder must be emptied before BCG instillation. BCG-Medac is introduced into the bladder by means of a catheter and at low pressure.

Hypersensitivity to any of the ingredients of BCG-Medac. BCG-Medac should not be used in immunosuppressed patients or persons with congenital or acquired immune deficiencies, whether due to concurrent disease (eg, positive HIV serology, leukaemia, lymphoma), cancer therapy (eg, cytostatic drugs, radiation) or immunosuppressive therapy (eg, corticosteroids). BCG-Medac should not be administered to persons with active tuberculosis. Active tuberculosis should be ruled out in individuals by anamnesis. Past history of radiotherapy of the bladder. BCG-Medac must not be instilled before 2-3 weeks after a TUR, a bladder biopsy or a traumatic catheterisation. Perforation of the bladder. Acute urinary tract infection (UTI). Use in lactation: There are no adequate data from the excretion of these bacteria in breastmilk. This treatment is contraindicated in nursing women.

BCG-Medac may not be used for SC, intradermal, IM or IV administration or vaccination. Number of BCG instillations: Side effects of BCG-treatment are frequent but generally mild and transient. Adverse reactions usually increase with the number of BCG instillations. Severe Systemic BCG Infection/Reaction: Systemic BCG infections/reactions have been rarely reported and are described as fever >39.5°C during at least 12 hrs, fever >38.5°C during at least 48 hrs, miliary pneumonia, granulomatous hepatitis, liver function test abnormalities, organic dysfunction (other than genitourinary tract) with granulomatous inflammation at biopsy. Reiter's syndrome. The possibility of severe systemic BCG infections has to be considered before starting the therapy.

Pregnancy Category: C Lactation: Not known if excreted in breast milk, not recommended

Concurrent use with antimicrobials may interfere with efficacy of intravesicular BCG and suppress the immune response to BCG vaccination. Immune globulins may reduce the therapeutic effect of live organism vaccines. Increased risk of infections associated with vaccines (live organism) when used with immunosuppressants. Immune response of BCG vaccination may be compromised when used within 30 days of another live organism vaccine.

Side effects of Bacillus calmette-Guerin strain (BCG vaccine) : Side effects of BCG treatment are frequent but generally mild and transient. Adverse reactions usually increase with the number of BCG instillations. In uncommon cases of arthritis/arthralgias, skin rash may occur. In most cases of arthritis, arthralgias and skin rash, these can be attributed to hypersensitivity reactions of the patient to BCG. It may be necessary in some cases to discontinue the administration of BCG-Medac. Local Adverse Reactions: Discomfort and pain when urinating and frequent urination occur in up to 90% of the patients. The cystitis and inflammatory reaction (granulomata) may be an essential part of the antitumour activity. Further local side effects which are uncommonly observed: Macroscopic haematuria, UTI, bladder retraction, urinary obstruction, bladder contracture, symptomatic granulomatous prostatitis, orchitis and epididymitis. Renal abscess is rarely observed. Furthermore, genital disorders (eg, vaginal pain, dyspareunia) may occur with an unknown frequency. Transient Systemic BCG Reaction: Low grade fever, flu-like symptoms and general discomfort may occur. These symptoms usually subside within 24-48 hrs and should be managed by standard symptomatic treatment. These reactions are signs of a starting immune reaction. All patients receiving BCG-Medac should be carefully monitored and advised to report all incidences of fever and other events outside the urinary tract. Severe Systemic Adverse Reactions/Infections: Systemic adverse reactions/infections are defined as: Fever >39.5°C during at least 12 hrs, fever >38.5°C during at least 48 hrs, miliary pneumonia due to BCG, granulomatous hepatitis, liver function test abnormalities, organic dysfunction (other than genitourinary tract) with granulomatous inflammation at biopsy, Reiter's syndrome. Severe systemic BCG reaction/infection can lead to BCG sepsis which is a life-threatening situation.

Live BCG vaccine is an attenuated strain of bacillus Calmette-Guérin; used for active immunisation against tuberculosis. It is also used as an active immunotherapy for the treatment of bladder carcinoma in situ by causing a local, chronic inflammatory response involving macrophage and leukocyte infiltration of the bladder. This local inflammatory response results in destruction of superficial tumor cells of the urothelium.