Bacillus calmette-guerin substrain russian BCG-I live antigen

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

Pharmacology
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Associated Conditions
Contraindications & Blackbox Warnings
Contraindications
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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
Adverseeffects
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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
Not Available

Interactions

Drug Interactions
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.
DrugInteraction
AbacavirThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Abacavir.
AbataceptThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Abatacept.
AcyclovirThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Acyclovir.
AdalimumabThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Adalimumab.
Adefovir dipivoxilThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Adefovir dipivoxil.
AldesleukinThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Aldesleukin.
AlefaceptThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Alefacept.
AlemtuzumabThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Alemtuzumab.
AltretamineThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Altretamine.
AmantadineThe therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Amantadine.
Interactions
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Food Interactions
No interactions found.

Products

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International/Other Brands
VERITY-BCG (Verity Pharmaceuticals Inc.)
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
Verity-bcgPowder, for suspension40 mg / vialIntravesicalVerity Pharmaceuticals Inc.2021-08-30Not applicableCanada flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
Not Available

Chemical Identifiers

UNII
6NDGUCSPCL
CAS number
Not Available

References

General References
  1. 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]
  2. Health Canada Product Monograph: Verity-BCG (Bacillus Calmette-Guérin Strain Russian BCG-I) for bladder instillation [Link]
  3. BioSpace: Bladder Cancer drug shortage resolved with health canada approval [Link]
Not Available

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
3Not Yet RecruitingTreatmentBladder Cancer, Cancer / Bladder transitional cell carcinoma / Neoplasms Recurrence / Non-Invasive Bladder Urothelial Carcinoma / Recurrent Bladder Cancer / Urothelial Carcinoma Recurrent1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
Powder, for suspensionIntravesical40 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