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Tice Bcg (bacillus-calmette-guerin)
At a glance
| Generic name | bacillus-calmette-guerin |
|---|---|
| Sponsor | Pfizer |
| Drug class | Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC] |
| Target | Mycobacterium tuberculosis |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder
- Prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR)
- Prophylaxis of stage TaG1 papillary tumors at high risk of tumor recurrence
Boxed warnings
- WARNING TICE ® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TICE ® BCG as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections). BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS sections).
Common side effects
- Dysuria
- Arthritis/myalgia
- Urinary frequency
- Headache/dizziness
- Flu-like syndrome
- Urinary incontinence
- Hematuria
- Anorexia/weight loss
- Fever
- Urinary debris
- Malaise/fatigue
- Allergy
Drug interactions
- immunosuppressants and/or bone marrow depressants and/or radiation
- antimicrobial therapy
- antituberculosis drugs (e.g., isoniazid)
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer (PHASE2)
- A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003) (PHASE1, PHASE2)
- ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG (PHASE1, PHASE2)
- Early vs Delayed Intravesical Blad-Care During BCG Therapy (NA)
- A Clinical Study of Intismeran Autogene (V940) and BCG in People With Bladder Cancer (V940-011/INTerpath-011) (PHASE2)
- S1602: Different Strains of BCG With or Without Vaccine in High Grade Non- Muscle Invasive Bladder Cancer (PHASE3)
- A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- Evaluating Safety and Efficacy of Verity-BCG in BCG-naïve Patients With Intermediate and High-risk Non-muscle Invasive Bladder (NMIBC) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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