Corifact :FDA Approves Corifact

The U.S. Food and Drug Administration has approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.

Patients with congenital Factor XIII deficiency don't make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Corifact Patient Product Information

This leaflet summarizes important information about Corifact. Please read it carefully before using Corifact and each time you get a refill. There may be new information provided. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about Corifact. If you have any questions after reading this, ask your healthcare provider.

What is Corifact?

Corifact is an injectable medicine used for routine prophylactic treatment of congenital Factor XIII (FXIII) deficiency in adults and pediatric patients. Corifact is a coagulation FXIII concentrate made from human plasma, and has important functions in hemostasis (stopping of bleeding).

Who should not use Corifact?

You should not use Corifact if you have experienced hypersensitivity reactions, including anaphylactic or severe systemic reactions to human plasma-derived products.

What should I tell my healthcare provider before Corifact is given?

Tell your healthcare provider about all of your medical conditions, including:

• If you are pregnant or planning to become pregnant. It has not been established if Corifact can harm your unborn baby.
• Labor and Delivery: Safety and effectiveness in labor and delivery have not been established.
• Breast feeding: It has not been established if Corifact passes into your milk.

Tell your healthcare provider and pharmacist about all of the medicines you take, including all prescription and non-prescription medicines such as over-the-counter medicines, supplements, or herbal remedies.

How is Corifact given?

Corifact is administered into your vein (intravenous injection). Before infusing, Corifact is dissolved using sterile water provided in the package. Your healthcare provider will prescribe the dose that you receive.

Corifact side effects

Call your healthcare provider or the emergency department right away if you have any of the following symptoms after using Corifact:

• shortness of breath
• rash
• pruritus (itching)
• erythema (redness of the skin)
• fainting/dizziness
• chest pain
• signs of a blood clot including pain, swelling, warmth, redness, or a lump in your legs or arms.

Other possible side effects may include:

• chills/rise in temperature
• arthralgia (joint pain)
• headache
• increase in liver enzymes
• breakthrough bleeding and pain resulting from formation of antibodies against Corifact.

Because Corifact is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob (CJD) agent.

These are not all the possible side effects of Corifact.

Tell your healthcare provider about any side effect that bothers you or that does not go away. You can also report side effects to the FDA at 1-800-FDA-1088.

What else should I know about Corifact?

Medicines are sometimes prescribed for purposes other than those listed here. Do not use Corifact for a condition for which it is not prescribed.

Do not share Corifact with other people, even if they have the same symptoms that you have.

This leaflet summarizes the most important information about Corifact. If you would like more information, talk to your healthcare provider. You can ask your healthcare provider or pharmacist for information about Corifact that was written for healthcare professionals.

Talk to your healthcare provider before traveling.

http://www.drugs.com/corifact.html