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