51
10
Treatment and Schedule
Allow 7to 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 NOTdepress 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.
Astandard 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 6to 12 months. There are no data to support the
interchangeability of BCG LIVE products.
HOW SUPPLIED
TICE
®
BCG is supplied in a box of 1 vial of TICE BCG. Each vial contains 1 to 8 x 10
8
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 should be stored refrigerated, at 2-8°C (36-46°F).
This agent contains live bacteria and should be protected from directsunlight. The product
should not be used after the expiration date printed on the label.
REFERENCES
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. Urology1991;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 Urol1990;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. Urol1992;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. NEJM1995:333:561-563.
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.
EORTCGenitourinary 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 Urol1995;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