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Molecule

Bacillus calmette-guerin substrain tice live antigen

Live Attenuated Bacillus Calmette-Guerin Immunotherapy
Available on requestBiologicCold chainImmune stimulantsVaccines
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Bacillus calmette-guerin substrain tice live antigen is a live attenuated bacillus calmette-guerin immunotherapy. It is available as powder for injectable suspension for intravesical use. MedsAcross supplies Bacillus calmette-guerin substrain tice live antigen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Live Attenuated Bacillus Calmette-Guerin Immunotherapy, Live Attenuated Bacillus Calmette-Guerin Vaccine, Vaccines, Actively Acquired Immunity, Increased Immunologically Active Molecule Activity, Increased Macrophage Proliferation
ATC classification
J07AN01 Bacillus calmette-guerin substrain tice live antigen · Tuberculosis vaccinesL03AX03 Bacillus calmette-guerin substrain tice live antigen · Cytovir-3
US FDA first approval
Not recorded
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Intravesical
Dosage forms
Powder for injectable suspension
Biologic
Yes
Identifiers
UNII 2XQ558L16ZDrugBank DB12768Q798309

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. TICE BCG is not indicated for papillary tumors of stages higher than T1.

Source: US FDA prescribing information

Dosing overview

The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of 1 vial of TICE ® BCG suspended in 50 mL preservative-free saline. Do not inject subcutaneously or intravenously. Preparation of Agent The preparation of the TICE BCG suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG has been prepared. A separate area for the preparation of the TICE BCG suspension is recommended. All equipment, supplies, and receptacles in contact with TICE BCG should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves and take precautions to avoid contact of BCG with broken skin.

Source: US FDA prescribing information

Contraindications

Immunosuppressed Patients TICE ® BCG should not be used in immunosuppressed patients with congenital or acquired immune deficiencies, whether due to concurrent disease (e.g., AIDS, leukemia, lymphoma) cancer therapy (e.g., cytotoxic drugs, radiation), or immunosuppressive therapy (e.g., corticosteroids). Patients with Increased Risk of BCG Infection Treatment should be postponed until resolution of a concurrent febrile illness, urinary tract infection, or gross hematuria. Seven to 14 days should elapse before BCG is administered following biopsy, TUR, or traumatic catheterization. Active Tuberculosis TICE BCG should not be administered to persons with active tuberculosis.

Source: US FDA prescribing information

Warnings and precautions

Boxed 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. 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. BCG LIVE (TICE ® BCG) is not a vaccine for the prevention of cancer. BCG Vaccine, not BCG LIVE (TICE BCG), should be used for the prevention of tuberculosis. For vaccination use, refer to BCG Vaccine prescribing information. Handling Precautions TICE BCG is an infectious agent.

Source: US FDA prescribing information

Side effects

Symptoms of bladder irritability, related to the inflammatory response induced, are reported in approximately 60% of patients receiving TICE ® BCG. The symptoms typically begin 4 to 6 hours after instillation and last 24 to 72 hours. The irritative side effects are usually seen following the third instillation, and tend to increase in severity after each administration. The irritative bladder adverse effects can usually be managed symptomatically with products such as pyridium, propantheline bromide, oxybutynin chloride, and acetaminophen. The mechanism of action of the irritative side effects has not been firmly established, but is most consistent with an immunological mechanism. 3 There is no evidence that dose reduction or antituberculous drug therapy can prevent or lessen the irritative toxicity of TICE BCG.

Source: US FDA prescribing information

Interactions

Drug Interaction Drug combinations containing immunosuppressants and/or bone marrow depressants and/or radiation interfere with the development of the immune response and should not be used in combination with TICE BCG. Antimicrobial therapy for other infections may interfere with the effectiveness of TICE BCG. There are no data to suggest that the acute, local urinary tract toxicity common with BCG is due to mycobacterial infection, and antituberculosis drugs (e.g., isoniazid) should not be used to prevent or treat the local, irritative toxicities of TICE BCG.

Source: US FDA prescribing information

Storage

The intact vials of TICE ® BCG should be stored refrigerated, at 2–8°C (36–46°F). This agent contains live bacteria and should be protected from direct sunlight.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Bacillus calmette-guerin substrain tice live antigen, sorted by availability.

MedicineManufacturerRegisterAvailability
Tice BCG 50 mg/50 mL powder for injectable suspensionIntravesical Cold chainMerck Sharp & DohmeUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDANot recorded—
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Bacillus calmette-guerin substrain tice live antigen available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Bacillus calmette-guerin substrain tice live antigen and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Bacillus calmette-guerin substrain tice live antigen have?

The catalogue lists 1 brand names for Bacillus calmette-guerin substrain tice live antigen, including Tice BCG.

Does Bacillus calmette-guerin substrain tice live antigen need cold chain shipping?

At least one listed presentation of Bacillus calmette-guerin substrain tice live antigen must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.

Which ATC class is Bacillus calmette-guerin substrain tice live antigen in?

Bacillus calmette-guerin substrain tice live antigen is classified under ATC code J07AN01 (Bacillus calmette-guerin substrain tice live antigen).

References

  1. TICE BCG prescribing information (Merck Sharp & Dohme). U.S. National Library of Medicine, DailyMed. Retrieved 20 February 2026

Request Bacillus calmette-guerin substrain tice live antigen for export supply

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