Bacillus Calmette-guerin

INDICATIONS AND USAGE 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.

ADVERSE REACTIONS 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.

Pregnancy Animal reproduction studies have not been conducted with TICE BCG. It is also not known whether TICE BCG can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. TICE BCG should not be given to a pregnant woman except when clearly needed. Women should be advised not to become pregnant while on therapy.

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. WARNINGS 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. Physicians using this product should be familiar with the literature on the prevention and treatment of BCG-related complications, and should be prepared in such emergencies to contact an infectious disease specialist with experience in treating the infectious complications of intravesical BCG. The treatment of the infectious complications of BCG requires long-term, multiple-drug antibiotic therapy. 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).