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Cinryze

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Cinryze

Cinryze

INDICATIONS

CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

DOSAGE AND ADMINISTRATION

For Intravenous Use, Freeze-Dried powder for Reconstitution.

Routine prophylaxis against HAE Attacks

  • A dose of 1,000 Units CINRYZE (c1 esterase inhibitor [human] freeze dried powder) can be administered every 3 or 4 days for routine prophylaxis against angioedema attacks in HAE patients.
  • CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is administered at an injection rate of 1 mL per minute.

Table 1: Routine Prophylaxis Dosing

Indication Dose Initial Infusion rate Maintenance infusion rate (if tolerated)
Routine prophylaxis against HAE attacks 1,000 units Intravenous every 3 or 4 days 1 mL/min (10 min) 1 mL/min (10 min)

Instructions for Use

The procedures below are provided as general guidelines for the reconstitution and administration of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

Always work on a clean surface and wash your hands before performing the following procedures.

Reconstitution, product administration, and handling of the administration set and needles must be done with caution. Percutaneous puncture with a needle contaminated with blood can transmit infectious viruses including HIV (AIDS) and hepatitis. Obtain immediate medical attention if injury occurs. Place needles in a sharps container after single use. Discard all equipment, including any reconstituted CINRYZE (c1 esterase inhibitor [human] freeze dried powder) in an appropriate container.

Preparation and Handling

  • Prior to reconstitution, CINRYZE (c1 esterase inhibitor [human] freeze dried powder) should be protected from light.
  • CINRYZE (c1 esterase inhibitor [human] freeze dried powder) should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be colorless to slightly blue, and free from visible particles. Do not use if turbid or discolored.
  • The CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial is for single use only. CINRYZE (c1 esterase inhibitor [human] freeze dried powder) contains no preservative. Any vial that has been entered should be used promptly. Partially used vials should be discarded in accordance with biohazard procedures.
  • Do not mix CINRYZE (c1 esterase inhibitor [human] freeze dried powder) with other materials.
  • Do not use if frozen.
  • Do not use after expiration date.

Reconstitution:

Two vials of reconstituted CINRYZE (c1 esterase inhibitor [human] freeze dried powder) are combined for a single dose. Sterile Water for Injection, USP, is required and not supplied with CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .

  1. Aseptic technique should be used during the reconstitution procedure.
  2. Bring the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) (powder) and Sterile Water for Injection, USP (diluent) (not supplied) to room temperature if refrigerated.
  3. Remove caps from the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) and diluent vials (Step 1).
  4. Cleanse stoppers with germicidal solution, and allow them to dry prior to use. (Step 2)
  5. Remove protective covering from one end of the double-ended transfer needle and insert exposed needle through the center of the diluent vial stopper (Step 3).
  6. Remove protective covering from the other end of the double-ended transfer needle. Invert diluent vial containing 5 mL Sterile Water for Injection, USP, over the upright and slightly angled CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial allowing (Step 4); then rapidly insert the free end of the needle through the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial stopper at its center. The vacuum in the vial will draw in the diluent. If there is no vacuum in the vial, do not use the product.
  7. Disconnect the two vials by removing the needle from the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial stopper and discard the diluent vial, along with the transfer needle directly into the sharps container. Gently swirl the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial until all powder is dissolved. Be sure that CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is completely dissolved.

One vial of reconstituted CINRYZE (c1 esterase inhibitor [human] freeze dried powder) contains 5 mL of C1 esterase inhibitor at a concentration of 100 Units/mL. Reconstitute two vials of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) for one dose.

Reconstitution - Illustration

Administration:

Two vials of reconstituted CINRYZE (c1 esterase inhibitor [human] freeze dried powder) are combined for a single dose.

  1. Use Aseptic Technique.
  2. After reconstitution, the solution is colorless to slightly blue and clear. Do not use the product if the solution is turbid or discolored.
  3. CINRYZE (c1 esterase inhibitor [human] freeze dried powder) must be administered at room temperature within 3 hours after reconstitution.
  4. Attach the filter needle to a sterile, disposable syringe and draw back the plunger to admit air into the syringe.
  5. Insert the filter needle into the vial of reconstituted CINRYZE (c1 esterase inhibitor [human] freeze dried powder) .
  6. Inject air into the vial and then withdraw the reconstituted CINRYZE (c1 esterase inhibitor [human] freeze dried powder) into the syringe. This should be repeated with a second vial of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) to make the complete dose.
  7. Remove and discard the filter needle in a hard-walled sharps container for proper disposal. Filter needles are intended to filter the contents of a single dose (2 vials) of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) only.
  8. Attach a suitable needle or infusion set with winged adapter, and inject intravenously. As a guideline, administer 1,000 Units ( reconstituted in 10ml) of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) by intravenous injection at a rate of 1 mL per minute over 10 minutes (see Clinical Studies)
  9. Dispose of all unused solution, the empty vial(s), and the used needles and syringes in an appropriate container for throwing away waste that might hurt others if not handled properly.

HOW SUPPLIED

Dosage Forms And Strengths

  • CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is a lyophilized preparation available in a single-use vial that contains 500 Units (U) human C1 esterase inhibitor.
  • Each vial must be reconstituted with 5 mL Sterile Water for Injection, USP (diluent) (not supplied).
  • Two reconstituted vials must be used to make a single, 1,000 Units, dose.
  • CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is available in single-use vials that contain 500 Units per vial.
  • CINRYZE (c1 esterase inhibitor [human] freeze dried powder) is supplied as a single glass vial of CINRYZE (c1 esterase inhibitor [human] freeze dried powder) powder to be reconstituted with 5 mL Sterile Water for Injection, USP (Not supplied).
  • CINRYZE (c1 esterase inhibitor [human] freeze dried powder) , packaged for sale, is stable for 1 year when stored at 2°C–25°C (36°F-77°F).
  • Do not freeze.
  • Store the vial in the original carton to protect it from light.
  • The reconstituted solution must be used within 3 hours of reconstitution.
  • Do not use beyond the expiration date on the CINRYZE (c1 esterase inhibitor [human] freeze dried powder) vial.

Manufactured by: Sanquin Blood Supply Foundation Amsterdam, The Netherlands. Distributed by: Lev Pharmaceuticals, Inc. New York, NY 10017.

Last reviewed on RxList: 10/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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