Identification
- Summary
Bacillus calmette-guerin substrain russian BCG-I live antigen is an intravesically-administered live BCG vaccine used to treat papillary urothelial cell carcinoma of the bladder.
- Brand Names
- VERITY-BCG
- Generic Name
- Bacillus calmette-guerin substrain russian BCG-I live antigen
- DrugBank Accession Number
- DB16648
- Background
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,1 used after tumor resection, and are thought to work by stimulating a local immune and inflammatory response in the bladder.2,1
The live Russian BCG-I substrain of BCG was granted a notice of compliance with conditions by Health Canada in February 2021.3 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-2021.3
- Type
- Biotech
- Groups
- Approved
- Biologic Classification
- Vaccines
Attenuated - Synonyms
- Bacillus Calmette-Guérin (BCG) - strain russian BCG-I
Pharmacology
- Indication
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.2 It may also be used for stage Ta grade 1 papillary tumors, but only when the risk of recurrence is high (>50%).2
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Adjunct therapy in treatment of Ta bladder papillary urothelial carcinoma •••••••••••• ••••••• ••• •••••••••• Adjunct therapy in treatment of Stage t1 bladder papillary urothelial carcinoma •••••••••••• ••••••• ••• •••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
Not Available
- Mechanism of action
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.2 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.1
- Absorption
Not Available
- Volume of distribution
Not Available
- Protein binding
Not Available
- Metabolism
- Not Available
- Route of elimination
Not Available
- Half-life
Not Available
- Clearance
Not Available
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- 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.2
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs Browse all" title="About SNP Mediated Effects/ADRs" id="snp-actions-info" class="drug-info-popup" href="javascript:void(0);">
- Not Available
Interactions
- Drug Interactions Learn More" title="About Drug Interactions" id="structured-interactions-info" class="drug-info-popup" href="javascript:void(0);">
- This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
Drug Interaction Integrate drug-drug
interactions in your softwareAbacavir The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Abacavir. Abatacept The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Abatacept. Acyclovir The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Acyclovir. Adalimumab The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Adalimumab. Adefovir dipivoxil The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Adefovir dipivoxil. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- International/Other Brands
- VERITY-BCG (Verity Pharmaceuticals Inc.)
- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Verity-bcg Powder, for suspension 40 mg / vial Intravesical Verity Pharmaceuticals Inc. 2021-08-30 Not applicable Canada 
Categories
- Drug Categories
- Classification
- Not classified
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- 6NDGUCSPCL
- CAS number
- Not Available
References
- General References
- Han J, Gu X, Li Y, Wu Q: Mechanisms of BCG in the treatment of bladder cancer-current understanding and the prospect. Biomed Pharmacother. 2020 Sep;129:110393. doi: 10.1016/j.biopha.2020.110393. Epub 2020 Jun 16. [Article]
- Health Canada Product Monograph: Verity-BCG (Bacillus Calmette-Guérin Strain Russian BCG-I) for bladder instillation [Link]
- BioSpace: Bladder Cancer drug shortage resolved with health canada approval [Link]
- External Links
- Not Available
Clinical Trials
- Clinical Trials Learn More" title="About Clinical Trials" id="clinical-trials-info" class="drug-info-popup" href="javascript:void(0);">
Phase Status Purpose Conditions Count 3 Not Yet Recruiting Treatment Bladder Cancer / Non-Invasive Bladder Urothelial Carcinoma / Recurrent Bladder Cancer / Transitional Cell Carcinoma of the Bladder / Tumor Recurrence / Urothelial Carcinoma Recurrent 1
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Powder, for suspension Intravesical 40 mg / vial - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Drug created at March 21, 2021 21:16 / Updated at March 26, 2021 03:55