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TheraCys is indicated for intravesical use in 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). TheraCys (bcg live (intravesical)) is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk oftumor recurrence.
TheraCys (bcg live (intravesical)) is not indicated as an immunizing agent for the prevention oftuberculosis.
DOSAGE AND ADMINISTRATION
One dose of TheraCys, BCG Live (Intravesical) consists of the intravesical instillation of 81 mg (dry weight) BCG. This dose is prepared by reconstituting 1 vial containing 81 mg freeze-dried BCG with the contents of 1 vial containing 3 mL diluent. The reconstituted BCG is further diluted in 50 mL of sterile, preservative-free saline, for a total of 53 mL instillation volume. (See Preparation ofAgent.)
For intravesical instillation only. 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53 mL suspension of TheraCys (bcg live (intravesical)) is instilled slowly by gravity, following which the catheter is withdrawn.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 increase fluid intake in order to flush the bladder in the hours following BCG treatment.
The preparation of the TheraCys (bcg live (intravesical)) 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 TheraCys (bcg live (intravesical)) suspension is strongly recommended. All equipment, supplies and receptacles in contact with TheraCys (bcg live (intravesical)) 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.
TheraCys (bcg live (intravesical)) 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 TheraCys (bcg live (intravesical)) . 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.
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.
TheraCys (bcg live (intravesical)) 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.
Reconstituted product should not be exposed to sunlight, direct or indirect. Exposure to artificial light should be kept to a minimum.
Instructions for Disposal
After use, unused product, packaging and all equipment and materials used for instillation of the product (eg, syringes, catheters) should be placed immediately in a container for biohazardous materials and disposed of according to local requirements applicable to biohazardous materials.
Urine voided during the 6 hour period following TheraCys (bcg live (intravesical)) instillation should be disinfected with an equal volume of 5% hypochlorite solution (undiluted household bleach) and allowed to stand for 15 minutes before flushing. (See PRECAUTIONS: PATIENT INFORMATION.)
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 TheraCys (bcg live (intravesical)) 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.
TheraCys (bcg live (intravesical)) 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.
CPT Code: 90586
CPT is a registered trademark ofthe American Medical Association.
TheraCys, BCG Live (Intravesical) and the accompanying diluent should be refrigerated at 2°to 8°C (35°to 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 TheraCys (bcg live (intravesical)) be exposed to sunlight, direct or indirect. Exposure to artificial light should be kept to a minimum.
Manufactured by: Sanofi Pasteur Limited, Toronto, Ontario, Canada. Distributed by: Sanofi Pasteur Inc. Swiftwater, PA 18370 USA. FDA Rev date: n/a
Last reviewed on RxList: 10/28/2008
This monograph has been modified to include the generic and brand name in many instances.
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