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

Treats and prevents hereditary angioedema (HAE).

Brand Name(s):

Berinert, Cinryze

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein.
• A nurse or other health provider 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.
• Carry this medicine with you at all times in case you have an HAE attack.
• 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.
• The mixed liquid should be clear and colorless to slightly blue. Do not use this medicine if it is cloudy, discolored, or if there are solids in the mixed liquid.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Call your doctor or pharmacist for instructions.
• 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 powder vial in the refrigerator. Do not freeze.
• Store the mixed liquid at room temperature. Use Berinert® within 8 hours of mixing it, and use Cinryze® within 3 hours of mixing it. Do not refrigerate or freeze the mixed liquid.
• Throw away the vial after you have used it, even if there is medicine left in it.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. 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.

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:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a history of blood clots.
• An HAE attack is life-threatening 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 for blood clots.
• This medicine is made from donated human blood. Blood banks test all donated blood for HIV, hepatitis, and West Nile Virus. The risk that you will get a virus from this medicine is low. Talk to your doctor if you have concerns about this.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Blue lips and gums
• 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 calf
• Sudden or severe headache, or problems with vision, speech, or walking

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

• Nausea or vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

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