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Tice

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Tice

Tice

INDICATIONS

TICE® BCG (bacillus of calmette and guerin) 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 (bacillus of calmette and guerin) is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.

TICE® BCG (bacillus of calmette and guerin) is not indicated for papillary tumors of stages higher than T1.

DOSAGE AND ADMINISTRATION

The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of one vial of TICE (bacillus of calmette and guerin) ® BCG suspended in 50 ml preservative-free saline.

Do not inject subcutaneously or intravenously.

Preparation of Agent

The preparation of the TICE® BCG (bacillus of calmette and guerin) 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 (bacillus of calmette and guerin) suspension is recommended. All equipment, supplies and receptacles in contact with TICE® BCG (bacillus of calmette and guerin) 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 U.S.P.) at 4–25°C, into a small syringe (e.g., 3 ml) and add to one vial of TICE® BCG (bacillus of calmette and guerin) to resuspend. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria.

Dispense the cloudy TICE® BCG (bacillus of calmette and guerin) suspension into the top end of a catheter-tip syringe which contains 49 ml of saline diluent, bringing the total volume to 50 ml. To mix, gently rotate the syringe. The reconstituted TICE® BCG (bacillus of calmette and guerin) should be kept refrigerated (2–8°C), protected from exposure to direct sunlight, and used within 2 hours. Unused solution should be discarded after 2 hours.

Note: DO NOT filter the contents of the TICE® BCG (bacillus of calmette and guerin) vial. Precautions should be taken to avoid exposing the TICE® BCG (bacillus of calmette and guerin) to direct sunlight. Bacteriostatic solutions must be avoided. In addition, use only sterile preservative-free saline, 0.9% Sodium Chloride Injection U.S.P. as diluent.

Treatment and Schedule

Allow 7–14 days to elapse after bladder biopsy before TICE® BCG (bacillus of calmette and guerin) is administered. Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to TICE® BCG (bacillus of calmette and guerin) administration. The reconstituted TICE (bacillus of calmette and guerin) ® BCG is instilled into the bladder by gravity flow via the catheter. DO NOT depress plunger and force the flow of the TICE® BCG (bacillus of calmette and guerin) . The TICE® BCG (bacillus of calmette and guerin) is retained in the bladder 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 one 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 (bacillus of calmette and guerin) administration should continue at approximately monthly intervals for at least 6–12 months. There are no data to support the interchangeability of BCG LIVE products.

HOW SUPPLIED

TICE® BCG (bacillus of calmette and guerin) is supplied in a box of one vial of TICE (bacillus of calmette and guerin) ® BCG. Each vial contains 1 to 8 x 108 CFU, which is equivalent to approximately 50 mg (wet weight), as lyophilized (freeze-dried) powder, NDC 0052-0602-02.

Storage

The intact vials of TICE® BCG (bacillus of calmette and guerin) should be stored refrigerated, at 2–8°C (36–46°F).

This agent contains live bacteria and should be protected from direct sunlight. The product should not be used after the expiration date printed on the label.

Manufactured for: Organon USA Inc., Roseland, NJ 07068. Manufactured by: Organon Teknika Corporation LLC, 100 Rodolphe Street Building 1300 Durham, NC 27712. Dec. 2006. FDA revision date: n/a

Last reviewed on RxList: 11/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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