SII-ONCO-BCG (Bacillus Calmette-Guerin) Vaccine is manufactured by Serum Institute of India for intravesical instillation which is a live lyophilized preparation derived from attenuated strain of Mycobacterium bovis (Bacillus Calmette Guerin).
Adverse effects are generally mild and transient. They appear to be directly related to cumulated CFU count of BCG administered in various instillations. Common side effects are:
Frequency, urgency of micturition and dysuria- these symptoms usually occur from 2nd or 3rd instillation onwards.
Cystitis and typical granulomatous inflammatory reactions which occur in the mucosa of Urinary bladder may be an essential component of anti-tumour activity of the drug. The symptoms usually disappear within 2 days and do not require treatment. Cystitis may be more prolonged during maintenance treatment and if severe, Isoniazid 300 mg daily can be given with analgesics until symptoms disappear.
Malaise and low-medium grade fever and/ or a flu like syndrome. These symptoms usually occur after 4 hours of instillation and disappear within 24-48 hours.