A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tice Indications, Dosage, Storage, Stability - Bacillus of Calmette and Guerin
Tice Indications, Dosage, Storage, Stability - Bacillus of Calmette and Guerin
INDICATIONS
AND USES
TICEŽ 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). TICEŽ BCG is not recommended for stage TaG1 papillary tumors, unless
they are judged to be at high risk of tumor recurrence.
TICEŽ 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 TICEŽ
BCG suspended in 50 ml preservative-free saline.
Do not inject subcutaneously or intravenously.
Preparation of Agent
The preparation of the TICEŽ 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 TICEŽ
BCG suspension is recommended. All equipment, supplies and receptacles in contact
with TICEŽ 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
U.S.P.) at 4-25°C, into a small syringe (e.g., 3 ml) and add to one vial of
TICEŽ 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 TICEŽ 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. The suspended TICEŽ BCG should be
used immediately after preparation. Discard after two hours.
Note: DO NOT filter the contents of the TICEŽ BCG vial. Precautions
should be taken to avoid exposing the TICEŽ 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 TICEŽ BCG is administered.
Patients should not drink fluids for 4 hours before treatment and should empty
their bladder prior to TICEŽ BCG administration. The reconstituted TICEŽ BCG
is instilled into the bladder or gravity flow via the catheter. DO NOT depress
plunger and force the flow of the TICEŽ BCG. The TICEŽ 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
TICEŽ 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.
HOW SUPPLIED
TICEŽ BCG is supplied in a box of one vial of TICEŽ BCG. Each vial contains
1 to 8 × 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 TICEŽ 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.
Rx Only
REFERENCES
- 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.
- 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.
- 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.
- 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.
- 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.
- van der Meijden, APM. Practical Approaches to the Prevention and Treatment
of Adverse Reactions to BCG. Eur Urol 1995;27(suppl 1):23-28.
- 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.
- 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, Inc.
West Orange, NJ 07052
Manufactured by: Organon Teknika Corporation
100 Akzo Avenue
Durham, NC 27712
U.S. License No. 956
TICEŽ is a registered trademark owned by the University of Illinois and licensed
to Organon Teknika Corporation.
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