Tice Bcg (BCG live)

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BCG is administered by intravesical instillation after reconstitution. Do not inject subcutaneously or IV.

Intact vials of BCG lyophilized powder for intravesical instillation should be refrigerated at 2-8degreesC. The powder should be protected from direct sunlight.

To prepare the suspension, withdraw 1 mL of 0.9% sodium chloride injection at 4-25degreesC into a small syringe (e.g., 3 mL) and add to 1 vial of TICE(R) BCG to resuspend; avoid the use of bacteriostatic solutions. Ensure that the needle is inserted through the center of the rubber stopper of the vial. Gently swirl vial until a homogenous suspension is obtained. Avoid forceful agitation, which may cause clumping of the mycobacteria. Dilute the cloudy BCG suspension in sterile, preservative-free saline to a final volume of 50 mL. Mix the suspension gently prior to intravesical instillation. Do not filter contents of the BCG vial. Store the reconstituted suspension refrigerated (2-8degreesC) and protect from exposure to direct sunlight; use within 2 hours and discard any unused portion.

After reconstitution, instill the BCG suspension into the bladder by gravity flow via a catheter. After instillation is complete, remove the catheter; BCG should be retained in the patient's bladder for 2 hours and then voided. Patients unable to retain the suspension for 2 hours should be allowed to void sooner, if necessary. While BCG is retained in the bladder, patients should be repositioned every 15 minutes to maximize bladder surface exposure to the drug.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*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.

*Patients with active tuberculosis.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Bladder irritability is a common adverse effect of intravesical BCG, reported in approximately 60% of patients. Other common adverse effects occurring at a frequency of >=5% include dysuria, urinary frequency, flu-like syndrome, hematuria, fever, malaise/fatigue, cystitis, urgency, and nocturia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and effectiveness of intravesical BCG for the treatment of superficial bladder cancer in pediatric patients have not been established.

Animal reproduction studies have not been conducted with intravesical BCG. It is also not known whether BCG can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Intravesical BCG should not be given to a pregnant woman except when clearly needed.

It is not known whether intravesical BCG is excreted into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions from BCG in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.

Of the total number of patients in clinical studies of intravesical BCG, the average age was 66 years. No overall difference in safety or effectiveness was observed between older and younger subjects. Other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals to BCG cannot be ruled out.