C1 Inhibitor, Injection

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KEY POINTS

• This medicine is given by IV to treat attacks of hereditary angioedema. Use it exactly as directed. After you have given yourself a dose of this medicine for an HAE attack that involves the throat, get medical care right away. Bring the medicine with you.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: C1 inhibitor

Generic and brand names: C1 inhibitor, injection; Cinryze

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to prevent attacks of hereditary angioedema (HAE).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergy to any medicine
• A heart attack, stroke, or transient ischemic attack (TIA)
• Bleeding problems or blood clots
• Heart or blood vessel disease

Tell your healthcare provider if you have recently had or are scheduled to have a long period of bed rest such as after major surgery or a broken bone in a cast.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is usually given by a healthcare provider. Sometimes you can give yourself this medicine at home or have someone at home give it to you. Your healthcare provider will teach you how to safely prepare and give this medicine at home. Check the label on the medicine for directions about your specific dose. Also, carefully follow the instructions in the medicine package for how to prepare and administer this medicine. Be sure you know how and when to have the medicine and how much medicine to use. If you are not sure of how to give yourself the medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 13.

What if I miss a dose?

If you use Cinryze on a regular schedule and you miss a dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: Sudden, severe headache; sudden partial or complete loss of vision; speech problems; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; pain or swelling in lower leg.

What should I watch out for?

This medicine may cause serious allergic reactions. Symptoms may include hives, chest tightness, wheezing, trouble breathing, fast heartbeat, swelling of the face, feeling faint, and rash. Since these symptoms may be similar to symptoms of an HAE attack, it is important that you discuss this with your healthcare provider. Contact your healthcare provider right away if you have symptoms of an allergic reaction. Talk with your provider about having epinephrine with you at all times.

This medicine may increase your risk for blood clots. Talk with your healthcare provider about this. You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine is made from human blood. It is tested for viruses. The risk of getting an infection from this medicine is very low, but it is still possible. Talk with your healthcare provider about this.

Wear some form of ID stating that you are taking this medicine (such as a Medic Alert bracelet). Talk with your healthcare provider about this.

Before traveling, make sure you have enough of this medicine. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, trouble breathing, swelling of your lips, tongue and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; chest pain; coughing up blood; sudden shortness of breath; unexplained fast heartbeat; pain, swelling, or warmth in an arm or leg.

Serious (Report these to your healthcare provider right away.): New swelling or pain; severe dizziness; fainting.

Other: Headache, nausea, vomiting, diarrhea, mild dizziness, mild rash, bad taste in mouth, stuffy or runny nose, pain or redness at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Androgen hormones such as danazol, fluoxymesterone (Androxy), methyltestosterone (Android, Testred), oxandrolone (Oxandrin), and testosterone (Androderm, AndroGel, Axiron, Testim)
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), and norethindrone (Aygestin, Micronor)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

You may store this medicine at room temperature or in the refrigerator. Keep the medicine in the original carton and tightly closed. Protect it from heat, high humidity, and bright light. Do not freeze.

Once you have mixed the medicine with liquid, store the mixed liquid at room temperature. Use this medicine within 3 hours of mixing it. Do not refrigerate or freeze the mixed liquid.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.