TICEŽ BCG - BCG LIVE (for Intravesical Use)
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After Treatment

After each BCG treatment, it is important to know...

Once outside your body, the TICEŽ BCG fluid may be unsafe for you or others to touch. With proper and simple precautions, the bacteria are not likely to be passed along to other people. After treatment, there are some important steps you must follow.

After the TICEŽ BCG treatment, drink plenty of fluids to wash out your bladder as instructed by your doctor.

For the 6 hours after each treatment, follow all the steps below each time you urinate.

  • To get the medicine out of your bladder and avoid splashing, sit down on the toilet to pass your urine. Touching the medicine outside the bladder may be unsafe for you and others.
  • After you urinate, add two cups of chlorine bleach to the toilet, close the lid, and wait 15 minutes before flushing.
  • Wash your genital area and your hands carefully with soap each time you urinate.

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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