February 13, 2016
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Theracys

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Theracys




Indications
Dosage
How Supplied

INDICATIONS

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).

Limitation of Use

TheraCys is not recommended for

DOSAGE AND ADMINISTRATION

For intravesical instillation only.

Do not inject intravenously, subcutaneously, intradermally or intramuscularly.

Dose And Schedule

Begin intravesical treatment of the urinary bladder a minimum of 14 days after biopsy or transurethral resection. Treatment consists of induction and maintenance therapy. For the induction therapy, administer one dose (81mg) of TheraCys each week for 6 consecutive weeks.

For the maintenance therapy, administer one dose at 3, 6, 12, 18, and 24 months following the initial dose.

Preparation

To avoid cross-contamination, do not prepare parenteral drugs in areas where TheraCys has been prepared. Handle and dispose of all equipment, supplies and receptacles in contact with TheraCys as biohazardous waste (or material). Wear gloves and eye protection and take precautions to avoid contact of BCG with broken skin. In addition, if the preparation cannot be performed in a biocontainment hood, wear a mask and gown.

Use aseptic techniques.

  • Clean surface of the rubber stopper of the vial of TheraCys with a suitable antiseptic. Do not remove the rubber stopper from the vial.
  • Using a syringe, draw up 3 mL of sterile preservative-free saline solution.
  • Pierce the rubber stopper in the vial of freeze-dried material.
  • Hold the vial of freeze-dried material upright and pull the plunger of the syringe back to create a mild vacuum in the vial.
  • Release the plunger and allow the vacuum to pull the saline from the syringe into the vial of freeze-dried material. After all the saline has passed into the freeze-dried material, remove the syringe.
  • 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. Return the vial to an upright position before removing the syringe from the vial.
  • Further dilute the reconstituted material from the vial (1 dose) in sterile, preservative-free saline to a final volume of 50 mL for intravesical instillation.
  • Use TheraCys immediately after reconstitution. Any delay between reconstitution and administration must not exceed 2 hours at a temperature between 2° and 25°C (35° and 77°F).

Do not use any reconstituted product that exhibits flocculation or clumping that cannot be dispersed with gentle shaking.

Do not expose reconstituted product to sunlight, direct or indirect.

Keep exposure to artificial light to a minimum.

Administration

Insert a urethral catheter into the bladder under aseptic conditions, drain the bladder, instill 50 mL suspension of TheraCys slowly by gravity, and then withdraw the catheter.

Have the patient retain the suspension for as long as possible for up to two hours. During the first 15 minutes following instillation, the patient should lie prone. Thereafter, allow the patient to be in an upright position.

At the end of 2 hours, have the patient void in a seated position for safety reasons.

Instruct the patient to increase fluid intake in order to flush the bladder in the hours following BCG treatment.

Instructions For Disposal

Immediately place unused product, packaging, and all equipment and materials used for instillation of the product (e.g., syringes, catheters) in a container for biohazardous materials, and dispose of them according to local requirements applicable to biohazardous materials.

Properly dispose of voided urine during the 6 hr period following TheraCys instillation with an equal volume of 5% hypochlorite solution. [See PATIENT INFORMATION]

HOW SUPPLIED

Dosage Forms And Strengths

One dose of TheraCys consists of one 81 mg vial of freeze-dried BCG reconstituted and diluted in 50 mL sterile, preservative-free saline.

Vial, 1 dose of the freeze dried product. NDC No. 49281-880-58; in package of 1 vial, NDC No. 49281-880-03

Storage And Handling

  • Store at 2 to 8 °C (35 to 46 °F).
  • Do not expose to sunlight, direct or indirect.
  • Keep exposure to artificial light to a minimum.
  • Do not use beyond the expiration date.

Manufactured by: Sanofi Pasteur Limited, Toronto Ontario Canada. Distributed by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. Revised: September 2013

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/4/2016

Indications
Dosage
How Supplied

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