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TICE® 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). TICE® BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.
TICE® BCG is not indicated for papillary tumors of stages higher than T1.
DOSAGE AND ADMINISTRATION
Do not inject subcutaneously or intravenously.
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.
Option-1 (Using Syringe Method)
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 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 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.
Option-2 (Using Reconstitution Accessories)
Reconstitution Accessories may be provided with each TICE® BCG product order. Please refer to the Instructions For Use provided with the accessories for a full description of the product reconstitution procedures using these accessories.
The reconstituted TICE® BCG 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 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 U.S.P. as diluent.
Treatment And Schedule
Allow 7–14 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. DO NOT depress plunger and force the flow of the TICE® BCG. The TICE® BCG 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 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.
TICE® BCG is supplied in a box of one vial of TICE® 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.
The intact vials of TICE® BCG 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.
1. DeJager R, Guinan P, Lamm D, Khanna O, Brosman S, DeKernion J, et al. Long-Term Complete Remission in Bladder Carcinoma in Situ with Intravesical TICE Bacillus Calmette Guerin. Urology 1991;38:507-513.
2. Rawls WH, Lamm DL, Lowe BA, Crawford ED, Sarosdy MF, Montie JE, Grossman HB, Scardino PT. Fatal Sepsis Following Intravesical Bacillus Calmette-Guerin Administration For Bladder Cancer. J Urol 1990;144:1328-1330.
3. Lamm DL, van der Meijden APM, Morales A, Brosman SA, Catalona WJ, Herr HW, et al. Incidence and Treatment of Complications of Bacillus Calmette-Guerin Intravesical Therapy in Superficial Bladder Cancer. J. Urol 1992; 147: 596-600.
4. Stone MM, Vannier AM, Storch SK, Nitta AT, Zhang Y. Brief Report: Meningitis Due to Iatrogenic BCG Infection in Two Immunocompromised Children. NEJM 1995: 333:561-563.
5. Steg A, Leleu C, Debre B, Gibod-Boccon L, Sicard D. Systemic Bacillus Calmette-Guerin Infection in Patients Treated by Intravesical BCG Therapy for Superficial Bladder Cancer. EORTC Genitourinary Group Monograph 6: BCG in Superficial Bladder Cancer. Edited by F.M. J. Debruyne, L. Denis and A.P.M. van der Meijden. New York: Alan R. Liss Inc., pp. 325-334.
6. van der Meijden, APM. Practical Approaches to the Prevention and Treatment of Adverse Reactions to BCG. Eur Urol 1995;27(suppl 1):23-28.
7. Lamm DL, Blumenstein BA, Crawford ED, Crissman JD, Lowe BA, Smith JA, Sarosdy MF, Schellhammer PF, Sagalowsky AI, Messing EM, et al. Randomized Intergroup Comparison of Bacillus Calmette-Guerin Immunotherapy and Mitomycin C Chemotherapy Prophylaxis in Superficial Transitional Cell Carcinoma of the Bladder. Urol Oncol 1995; 1:119-126.
8. Witjes JA, van der Meijden APM, Witjes WPJ, et al. A Randomized Prospective Study Comparing Intravesical Instillations of Mitomycin-C, BCG-Tice, and BCG-RIVM in pTa-pT1 Tumours and Primary Carcinoma In Situ of the Urinary Bladder. Eur J Cancer 1993;29A(12):1672-1676.
Manufactured for: Organon USA Inc. Roseland, NJ 07068. Manufactured by: Organon Teknika Corporation LLC, 100 Rodolphe Street, Building 1300, Durham, NC 27712This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/18/2014
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