What Is CINRYZE® (C1 esterase inhibitor [human])?

CINRYZE® (C1 esterase inhibitor [human]) is the first and only FDA-approved C1 esterase inhibitor therapy for routine prevention of HAE attacks in teenagers and adults.

C1 esterase inhibitor is a protein found in the blood that, at normal levels, helps regulate inflammation in the body.

By regulating the systems in the body that cause inflammation, C1 esterase inhibitor ultimately limits the production of bradykinin.

When bradykinin production is not limited, blood vessel walls can become leaky, causing the swelling of an HAE attack.

How CINRYZE® (C1 esterase inhibitor [human]) Works

CINRYZE contains C1 esterase inhibitor—the protein your body needs if you have hereditary angioedema—to prevent HAE attacks. CINRYZE is administered as an intravenous injection (IV) to prevent attacks and swelling in teenagers and adults with HAE. CINRYZE therapy provides the body with enough working C1 esterase inhibitor to help prevent the causes of swelling and is proven to reduce the frequency, duration, and severity of HAE attacks. Patient responses vary.

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Normal levels of C1 esterase inhibitor

image of blood vessels and normal production of c1 esterase inhibitor – www.cinryze.com
Normally, C1 esterase inhibitor prevents production of bradykinin, which is a protein that causes your vessels to leak a large amount of fluid into the tissues.

Levels of C1 esterase inhibitor in a person with HAE
image of blood vessel and dysfunctional levels of c1esterase inhibitor – www.cinryze.com
In people with deficient or dysfunctional levels of C1 esterase inhibitor, a cascade of events is triggered in the body. Eventually, this leads to the production of bradykinin. Fluid moves out through the leaky blood vessel walls and builds up between the tissue cells underneath the skin, which results in localized swelling.

Administration Options

The Path to Independence Program is a complimentary service for eligible patients.

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

Important Safety 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:

  • have an indwelling catheter/access device in one of your veins.
  • have a history of blood clots, heart disease, or stroke.
  • are taking birth control pills or androgens.
  • 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.

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

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

  • pain and/or swelling of an arm or leg with warmth over the affected area
  • discoloration of an arm or leg
  • unexplained shortness of breath
  • chest pain or discomfort that worsens on deep breathing
  • unexplained rapid heart rate
  • numbness or weakness on one side of the body

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

The most common side effects seen with CINRYZE were headache, nausea, rash, and vomiting. 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You can also report side effects to ViroPharma Medical Information at (866) 331-5637.

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 accompanying Patient 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.

Please see the Full Prescribing Information.

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