TICE BCG Dosage

Preparation of Agent

The preparation of the TICE BCG suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG has been prepared. A separate area for the preparation of the TICE BCG suspension is recommended. All equipment, supplies, and receptacles in contact with TICE BCG should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves and take precautions to avoid contact of BCG with broken skin. If preparation cannot be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin.

Draw 1 mL of sterile, preservative-free saline (0.9% Sodium Chloride Injection USP) at 4–25°C into a small syringe (e.g., 3 mL) and add to 1 vial of TICE BCG to resuspend. Ensure that the needle is inserted through the center of the rubber stopper of the vial. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria.

Dilute the cloudy TICE BCG suspension in sterile, preservative-free saline to a final volume of 50 mL. Mix the suspension gently prior to intravesical instillation.

The reconstituted TICE BCG should be kept refrigerated (2–8°C), protected from exposure to direct sunlight, and used within 2 hours. Discard unused portion.

Note: DO NOT filter the contents of the TICE BCG vial. Precautions should be taken to avoid exposing the TICE BCG to direct sunlight. Bacteriostatic solutions must be avoided. In addition, use only sterile, preservative-free saline, 0.9% Sodium Chloride Injection USP as diluent.

Treatment and Schedule

Allow 7 to 14 days to elapse after bladder biopsy before TICE BCG is administered. Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to TICE BCG administration. The reconstituted TICE BCG is instilled into the bladder by gravity flow via the catheter. After instillation of the TICE BCG suspension is complete, remove the catheter. The TICE BCG is retained in the 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 the BCG is retained in the bladder, the patient ideally should be repositioned from left side to right side and also should lie upon the back and the abdomen, changing these positions every 15 minutes to maximize bladder surface exposure to the agent.

A standard treatment schedule consists of 1 intravesical instillation per week for 6 weeks. This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Thereafter, intravesical TICE BCG administration should continue at approximately monthly intervals for at least 6 to 12 months. There are no data to support the interchangeability of BCG LIVE products.