What Cinryze is used for and how to use it
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Cinryze - Consumer Medicine Information

Manufacture: Shire, Inc.
Country: Canada
Condition: Hereditary Angioedema
Class: Miscellaneous coagulation modifiers
Form: Intravenous (IV), Powder
Ingredients: c1 esterase inhibitor, human, L-alanine, L-threonine, L-valine, sodium chloride, sodium citrate, sucrose, sterile water for injections

(C1 inhibitor [human])

About This Medication

What the Medication is Used For

CINRYZE is used for

  • Routine prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE)

What It Does

Hereditary angioedema (HAE) is a hereditary disorder that is the most direct consequence of a lack of a functional naturally occurring blood protein called C1 inhibitor. C1 inhibitor deficiency in HAE patients can result in attacks of non -itching swellings of various regions of the body, including the hands and feet, face, intestines, genitals or the throat. Swelling of the throat can be life-threatening.

CINRYZE is a concentrate of C1 inhibitor. Clinical data has shown CINRYZE to treat and prevent the swelling associated with HAE by increasing the levels of functional C1 inhibitor in the body.

When It Should not be Used

CINRYZE should not be used if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis, to C1 inhibitor products used to treat HAE or any of the CINRYZE ingredients or container.

What the Medicinal Ingredient Is

C1 inhibitor (human) is a concentrate of the naturally occurring C1 inhibitor found in human blood.

What the Nonmedicinal Ingredients Are

Powder: L-alanine, L-threonine, L-valine, sodium chloride, sodium citrate, sucrose

Diluent: Sterile Water for Injections

What Dosage Forms It Comes In

CINRYZE is available in a single-use vial containing 500 IU of dried, pasteurized and lyophilized human C1 inhibitor concentrate to be reconstituted with 5 mL of Sterile Water for Injections prior to its intravenous administration. 1000 IU equals one dose of CINRYZE.

Warnings and Precautions

BEFORE you use CINRYZE talk to your doctor or pharmacist if:

  • You have a history of blood clotting problems. Very high doses of C1 inhibitor could increase the risk of blood clots.
  • You are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
  • You are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.
  • You have any allergies to this drug or its ingredients or components of the container. Tell your doctor immediately if you experience allergic symptoms (sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching) after taking this medicine. Although they are rare, allergic symptoms can be severe (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM).

CINRYZE is made from human blood and it may carry a risk of transmitting infectious agents, e.g. viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, and unknown or emerging viruses and other pathogens.

Interactions With This Medication

To date, no relevant interactions are known.

Proper Use of This Medication

Usual Dose

Routine prevention of angioedema attacks

  • 1000 IU of CINRYZE every 3 or 4 days for routine prevention against angioedema attacks.

CINRYZE is usually injected into a vein (intravenously) by your doctor or nurse. You or your caregiver may also administer CINRYZE as an injection, but only after receiving adequate training. If your doctor decides that you may be suitable for such home-treatment, he/she will give you detailed instructions. Regular review of your/your caregiver’s injection technique will be performed to ensure continued appropriate handling.

A patient/caregiver should not attempt to home- or self-administer unless trained by a healthcare provider.

Reconstitution and administration of CINRYZE

Reconstitution, product administration and handling of the needles must be done with caution. A silicone-free syringe is recommended for reconstitution and administration of CINRYZE.

Use either a filter transfer device or a commercially available double-ended needle.

Preparation and handling

CINRYZE is intended for intravenous administration after reconstitution with Sterile Water for Injections. Each vial of CINRYZE is for single use only.

If you have any further questions regarding the use of this medicine, ask your doctor or pharmacist.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

Call your healthcare provider if you miss a dose of CINRYZE.

Reconstitution

Each product vial should be reconstituted with 5 ml Sterile Water for Injections. Two vials of reconstituted CINRYZE are combined for ONE dose (1000 IU).

  1. Bring the powder vial and the diluent vial to room temperature (15ºC–25ºC).
  2. Wash your hands before performing the following procedures.
  3. Aseptic technique should be used during the reconstitution procedure.
  4. Remove plastic caps from the powder and diluent vials.
  5. Cleanse stoppers with an alcohol wipe and allow them to dry prior to use.
  6. Remove protective covering from the top of the transfer device package. Do not remove the device from the package.

  7. Note: the transfer device must be attached to the diluent vial before being attached to the powder vial, so that the vacuum in the powder vial is not lost. Place the diluent vial on a flat surface and insert the blue end of the transfer device into the diluent vial, pushing down until the spike penetrates through the centre of the diluent vial stopper and the device snaps in place. The transfer device must be vertical prior to penetrating the stopper closure.

  8. Remove the plastic package from the transfer device and discard it. Take care not to touch the exposed end of the transfer device.

  9. Place the powder vial on a flat surface. Invert the transfer device and the diluent vial containing Sterile Water for Injections and insert the clear end of the transfer device into the powder vial, pushing down until the spike penetrates the rubber stopper and the transfer device snaps into place. The transfer device must be vertical prior to penetrating the stopper closure of the powder vial. The vacuum in the powder vial will draw in the diluent. If there is no vacuum in the vial, do not use the product.

  10. Gently swirl the powder vial until all powder is dissolved. Do not shake the powder vial. Make sure all the powder is completely dissolved.

  11. Disconnect the diluent vial by turning it counter-clockwise. Do not remove the clear end of the transfer device from the powder vial.

ONE vial of reconstituted CINRYZE contains 500 IU of C1 inhibitor in 5 mL, resulting in a concentration of 100 IU/mL.

TWO vials of CINRYZE powder must be reconstituted to make one dose (1000 IU/10 mL). Therefore repeat instructions 1 to 11 above using an additional transfer device to reconstitute the second of two powder vials. Do not reuse the transfer device. CINRYZE must be administered at room temperature within 3 hours after reconstitution.

Administration process

  1. Aseptic technique should be used during the administration procedure.
  2. After reconstitution, the CINRYZE solutions are colourless to slightly blue and clear. Do not use the product if the solutions are cloudy or discoloured.
  3. Using a sterile, disposable 10 mL syringe, draw back the plunger to allow approximately 5 mL of air into the syringe. Use of a silicone-free syringe is recommended.

  4. Attach the syringe onto the top of the clear end of the transfer device by turning it clockwise.

  5. Invert the vial and inject air into the solution and then slowly withdraw the reconstituted CINRYZE solution into the syringe.

  6. Detach the syringe from the vial by turning it counter-clockwise and releasing it from the clear end of the transfer device.

  7. Using the same syringe, repeat steps 3 to 6 with a second vial of reconstituted CINRYZE to make one complete 10 mL dose. CINRYZE should be administered promptly after preparation in the syringe and should not be used if particles are observed or if the solution is cloudy.
  8. Attach a needle to the syringe containing CINRYZE solution and inject intravenously into the patient. Administer 1000 IU (reconstituted in 10 mL of Sterile Water for Injections) of CINRYZE by intravenous injection at a rate of 1 mL per minute over 10 minutes.

Side Effects and What to Do About Them

Like all medicines, CINRYZE can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are rare, allergic symptoms can be severe.

  • Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).

The most common side effect is rash.

Other side effects include: dizziness, headache, blood clot, painful veins, hot flush, nausea, vomiting, skin flaking, itching or redness, infusion site rash or pain, and fever.

This is not a complete list of side effects. For any unexpected effects while taking CINRYZE, contact your doctor or pharmacist.

How to Store It

Keep out of the reach and sight of children.

Do not use CINRYZE after the expiry date which is stated on the carton or vials after “EXP”. Store and transport between 2°C-25°C. Do not freeze. Store in the original package in order to protect from light.

Once reconstituted, CINRYZE solution should be used immediately.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at
www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

If You Want More Information About CINRYZE

  • Talk to your healthcare professional
  • Find the full Product Monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website http://hc-sc.gc.ca; or by calling Innomar Strategies, Inc. at 1-888-960-8746.

www.shirecanada.com