VERITY-BCG

VERITY-BCG Uses, Dosage, Side Effects, Food Interaction and all others data.

Bacillus Calmette-Guerin (BCG) substrain Russian BCG-I is a live BCG vaccine administered directly into the bladder for the adjuvant treatment of papillary urothelial cell carcinoma of the bladder. Live BCG vaccines administered intravesically have been a gold standard therapy in the adjuvant treatment of non-muscle-invasive bladder cancers for decades, used after tumor resection, and are thought to work by stimulating a local immune and inflammatory response in the bladder.

The live Russian BCG-I substrain of BCG was granted a notice of compliance with conditions by Health Canada in February 2021. It is to be marketed by Verity Pharmaceuticals, under the trade name VERITY-BCG, and manufactured by the Serum Institute of India. It was developed to alleviate Canada's multi-year shortage of BCG vaccine, and is expected to be available by mid-2021.

VERITY-BCG
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Trade Name	VERITY-BCG
Generic	Bacillus calmette-guerin substrain russian BCG-I live antigen
Bacillus calmette-guerin substrain russian BCG-I live antigen Other Names	Bacillus Calmette-Guérin (BCG) - strain russian BCG-I
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Groups	Approved
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Last Updated:	September 19, 2023 at 7:00 am

Uses

VERITY-BCG is an intravesically-administered live BCG vaccine used to treat papillary urothelial cell carcinoma of the bladder.

The live BCG vaccine (substrain Russian BCG-I, i.e. VERITY-BCG) is indicated for adjuvant therapy following transurethral resection of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder in stages Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ. It may also be used for stage Ta grade 1 papillary tumors, but only when the risk of recurrence is high (>50%).

VERITY-BCG is also used to associated treatment for these conditions: Ta Bladder Papillary Urothelial Carcinoma, Stage T1 Bladder Papillary Urothelial Carcinoma

How VERITY-BCG works

The precise mechanism through which live BCG vaccines exert antineoplastic activity is unclear. It is likely that instillation of the vaccine into the bladder results in a non-specific immune response, involving both the innate and adaptive immune systems, followed by a local inflammatory response involving a variety of immune cells. BCG itself may exert direct cytotoxic effects on tumor cells, though its primary mechanism of action appears to be via internalization into tumor cells where it stimulates the aforementioned inflammatory pathways.

Toxicity

There are no data regarding overdosage with intravesically administered live BCG vaccines. Systemic BCG infection is more likely in the context of an overdose, and patients suspected of overdose should therefore be monitored for evidence of systemic infection and treated with anti-tuberculosis medications if clinically warranted.