INDICATION

CINRYZE^® (C1 esterase inhibitor [human]) is an injectable medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with hereditary angioedema (HAE).

IMPORTANT RISK INFORMATION

You should not use CINRYZE if you have had life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product.

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

• Are pregnant or planning to become pregnant. It is not known if CINRYZE can harm your unborn baby.
• Are breastfeeding or plan to breastfeed. It is not known if CINRYZE passes into your milk and if it can harm your baby.
• Have a history of blood clotting problems. Very high doses of C1 esterase inhibitor could increase the risk of blood clots.

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.

Allergic reactions may occur with CINRYZE. Call your healthcare provider or get emergency support services right away if you have any of the following symptoms:

• wheezing
• difficulty breathing
• chest tightness
• turning blue (look at lips and gums)
• fast heartbeat
• swelling of the face
• faintness
• rash
• hives

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

In clinical studies, the most common side effects seen with CINRYZE were upper respiratory tract infection, sinusitis, rash and headache. These are not all the possible side effects of CINRYZE. 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.

Do not attempt to self-administer unless you have been taught how by your healthcare provider.

Medicines are sometimes prescribed for purposes other than those listed here. Do not use CINRYZE for a condition for which it is not prescribed. Do not share CINRYZE with other people, even if they have the same symptoms that you have.

Before starting CINRYZE, please read the Full Prescribing Information carefully and each time you get a refill. This information does not take the place of talking with your healthcare provider, and it does not include all of the important information about CINRYZE. If you have questions after reading this, ask your healthcare provider.