TICEŽ BCG - BCG LIVE (for Intravesical Use)
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Your Doctor Needs to Know

You should talk to your doctor about possible side effects associated with TICEŽ BCG treatment. Some reactions such as painful or frequent urination can be related to irritation of the bladder. These symptoms typically begin 4 to 6 hours after instillation and last 24-72 hours. They are usually seen after the third treatment and tend to increase in severity after each administration. Other symptoms, such as flu-like symptoms, fever, fatigue, and chills may affect your whole body. These symptoms also may get more frequent or worse with subsequent treatments.

>Report Side Effects

Notify your doctor at once if you experience any problems, particularly severe urinary symptoms such as burning or painful urination, an urgent or frequent need to urinate, or blood in the urine. Also report joint pain, coughing, or rash. It is especially important to report these symptoms to your doctor before you receive the next treatment of BCG. They may be a sign that you have an infection requiring immediate attention. You should be aware that infections associated with TICEŽ BCG treatment have led to death on rare occasions. Symptoms lasting longer than 48 hours or a fever of 101.3°F (or higher) should be reported to your physician immediately.

>Record How You Feel

Your doctor needs as much information as possible about how each treatment makes you feel. Use the after-treatment notes form to keep a record of how you feel after every treatment. Show it to your doctor before your next treatment to help him or her know if you have side effects that should be treated and what course the rest of your treatment should follow.

TICEŽ 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). TICEŽ BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.
 

TICEŽ BCG is not indicated for papillary tumors of stages higher than T1.


WARNING

TICEŽ 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.

TICEŽ 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. TICEŽ BCG should not be administered to persons with active tuberculosis.

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

TICEŽ 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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