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
Theracys Indications, Dosage, Storage, Stability - BCG Live (Intravesical)
Theracys Indications, Dosage, Storage, Stability - BCG Live (Intravesical)
INDICATIONS
AND USAGE
TheraCysÒ 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). TheraCysÒ
is not recommended for stage TaG1 papillary tumors, unless they
are judged to be at high risk of tumor recurrence.
TheraCysÒ is not
indicated as an immunizing agent for the prevention of tuberculosis.
DOSAGE AND ADMINISTRATION
One dose of TheraCysÒ
[BCG Live (Intravesical)] consists of the intravesical instillation of
81 mg (dry weight) BCG. This dose is prepared by reconstituting the vial containing
freeze-dried BCG with the contents of the vial containing diluent. The vial
of reconstituted BCG is further diluted in 50 mL of sterile, preservative-free
saline, for a total of 53 mL instillation volume (see reconstitution instructions).
Do not inject subcutaneously or intravenously.
A urethral catheter is inserted into the bladder under aseptic
conditions, the bladder is drained, and then 53 mL suspension of TheraCysÒ
is instilled slowly by gravity, following which the catheter is
withdrawn.
The patient retains the suspension for as long as possible
for a total of up to two hours. During the first 15 minutes following instillation,
the patient should lie prone. Thereafter, the patient is allowed to be up. At
the end of 2 hours, all patients should void in a seated position for safety
reasons. Patients should be instructed to maintain adequate hydration.
Preparation of Agent: The preparation of the TheraCysÒ
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 TheraCysÒ
suspension is recommended. All equipment, supplies and receptacles
in contact with TheraCysÒ should
be handled and disposed of as biohazardous. The pharmacist or individual responsible
for mixing the agent should wear gloves and eye protection, and take precautions
to avoid contact of BCG with broken skin. If the preparation cannot be performed
in a biocontainment hood, then a mask and gown may be worn to avoid inhalation
of BCG organisms and inadvertent exposure to broken skin.
TheraCysÒ should
not be handled by persons with an immunologic deficiency. Do not remove the
rubber stopper from the vial.
Apply a sterile piece of cotton moistened with a suitable antiseptic
to the surface of the rubber stoppers of the vial of diluent and vial of TheraCysÒ
. Reconstitute the freeze-dried material with the total 3 mL volume of diluent.
Shake the vial gently until a fine, even suspension results. Avoid foaming since
this will prevent withdrawal of the proper dose. Withdraw the entire contents
(approximately 3 mL) of the reconstituted material into the syringe.
TheraCysÒ should
be reconstituted only with the diluent provided to ensure proper dispersion
of the organisms.
The reconstituted material from the vial (1 dose) is further
diluted in an additional 50 mL of sterile, preservative-free saline to a final
volume of 53 mL for intravesical instillation.
TheraCysÒ should
be used immediately after reconstitution. However, if there is an unavoidable
delay between reconstitution and administration, this delay must not exceed
2 hours. Any reconstituted product which exhibits flocculation or clumping that
cannot be dispersed with gentle shaking should not be used.
Treatment Schedule: Intravesical treatment of the urinary
bladder should begin 7 to 14 days after biopsy or transurethral resection, and
consists of induction and maintenance therapy. For the induction therapy, one
dose of TheraCysÒ is administered
each week for 6 consecutive weeks. Induction therapy should be followed by maintenance
therapy, consisting of one dose given 3, 6, 12, 18, and 24 months following
the initial dose.
HOW SUPPLIED
TheraCysÒ is supplied
in packages containing one vial of the freeze-dried product, containing 81 mg
(dry weight) (10.5 ± 8.7 x 108 CFU) and one vial containing 3 mL of diluent
- Product No. 49281-880-01.
STORAGE
TheraCysÒ [BCG
Live (Intravesical)] and the accompanying diluent should be kept in a refrigerator
at a temperature between 2¡Ð 8¡C (35¡Ð 46¡F). It should not be used
after the expiration date marked on the vial, otherwise it may be inactive.
At no time should the freeze-dried TheraCysÒ
be exposed to sunlight, direct or indirect. Exposure to artificial
light should be kept to a minimum.
REFERENCES
1. O'Donnell MA, DeWolf WC. BCG immunotherapy for superficial
bladder cancer. New prospects for an old warhorse. Surg Oncol Clin North Amer
1995;4:189-202.
2. Lamm DL, et al. A randomized trial of intravesical doxorubicin
and immunotherapy with Bacille Calmette-Gu rin for transitional-cell carcinoma
of the bladder. N Eng J Med 1991;325:1205-1209.
3. Stone MM, et al. Brief report: Meningitis due to iatrogenic
BCG infection in two immunocompromised children. N Engl J Med 1995,333:561-563.
4. Lamm DL, et al. Incidence and treatment of complications
of Bacillus Calmette-Gu rin intravesical therapy in superficial bladder cancer.
J Urol 1992;147:596-600.
5. Wittes RC, et al. Characterization of BCG-associated
sterile arthritis and Reiter’s syndrome. New Delhi, India: 10th International
Congress of Immunology. 1998:1245-1249.
Product Information as of October 1999.
Manufactured by: Aventis Pasteur Limited,
Toronto, Ontario, Canada
Distributed by: Aventis Pasteur Inc., Swiftwater
PA 18370 USA
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