C1 esterase inhibitor, human (Injection)

Introduction

C1 Esterase Inhibitor, Human (C1 ES-ter-ase in-HIB-i-ter, HUE-man)

Treats hereditary angioedema (HAE).

Brand Name(s)

Cinryze, Berinert

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given through a needle placed in one of your veins.
• A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• Make sure family members and other people you are with know how to inject the medicine in case you are not able to do it yourself during an HAE attack.
• Use a new needle and syringe each time you inject your medicine.
• Carry this medicine with you at all times in case you have an HAE attack.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have a history of blood clots.
• An HAE attack is a life-threatening reaction and requires immediate medical attention. Check with your doctor right away, or go to an emergency room as soon as possible, even if you feel better after you use this medicine.
• This medicine may increase your risk of blood clots. Check with your doctor right away if you have swelling, pain, or numbness in your arms, legs, or stomach; chest pain; trouble breathing; sudden headache; or problems with muscle control or speech.
• This medicine is made from donated human blood. The risk of getting a virus from medicines made from human blood is low. Talk to your doctor if you have concerns about this.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain or tightness, trouble breathing, or coughing up blood
• Numbness or weakness in your arm or leg or on one side of your body
• Pain in your lower leg (calf)
• Sudden or severe headache or problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Change in or loss of taste

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the injection kits at room temperature, away from heat, moisture, and direct light. Keep the medicine in the original carton until you are ready to use it. You may store the vial of Berinert® powder in the refrigerator. Do not freeze.
• You may store the mixed liquid at room temperature and use it within 8 hours. Do not refrigerate or freeze the mixed liquid.
• Do not use this medicine if the powder or liquid has changed color or if there are solids in the mixed liquid.
• Throw away the vial after you have used it, even if there is medicine left in it.
• Keep all medicine away from children and never share your medicine with anyone.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.