TICE® BCG - BCG LIVE (for Intravesical Use)
About Bladder CancerAbout TICE® BCGYou & TICE® BCGFAQs

Understanding Your Therapy for Bladder Cancer

Welcome to TICEBCG.com, a Web site where patients who have been diagnosed with carcinoma in situ (CIS) of the urinary bladder or stage Ta and/or T1 papillary tumors can find information about therapy.

This site will help you understand your condition, its treatment with TICE® BCG, and the importance of following your doctor’s instructions to make your treatment as effective as possible.

If you would like to print the information on this Web site, please click here.

TICE® BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). 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.


WARNING

TICE® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, it should be prepared, handled, and disposed of 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. 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.

TICE® BCG is contraindicated in immunocompromised patients. 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. TICE® BCG should not be administered to persons with active tuberculosis.

BCG LIVE (TICE® BCG) is not a vaccine for the prevention of cancer.

TICE® BCG is an infectious agent. Physicians using it should be familiar with the prevention and treatment of BCG-related complications. Deaths have been reported as a result of BCG infection and sepsis.

There is a ≤1% incidence of life-threatening reactions such as BCG sepsis, coagulopathy, leukopenia, thrombocytopenia, hepatic granuloma, hepatitis, disseminated sepsis with associated mortality, and M. bovis infections of several organs.

Many patients (60%) experience symptoms of bladder irritability beginning 4 to 6 hours after instillation and lasting for 24 to 72 hours. Adverse reactions tend to progress in frequency and severity with subsequent instillations.

Adverse reactions (frequency ≥5%) reported during clinical trials in patients with superficial bladder cancer, including carcinoma in situ, were dysuria (60%), urinary frequency (40%), flu-like syndrome (33%), hematuria (26%), fever (20%), malaise/fatigue (7%), cystitis (6%), urgency (6%), and nocturia (5%).

Adverse reactions (frequency ≥5%) reported during clinical trials in patients with TaT1 bladder cancer following transurethral resection were dysuria (52%), urgency/frequency (50%), hematuria (38%), flu-like symptoms (24%), fever (17%), pain (17%), hemorrhagic cystitis (9%), chills (9%), bladder cramps (8%), and nausea (7%).

You are encouraged to report negative side effects of prescription drugs to the FDA.Visit  www.fda.gov/medwatch,
or call 1-800-FDA-1088.

For additional important product information please click the “Prescribing Info” link below.
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