C1 Esterase Inhibitor (C1 ES-ter-ase in-HIB-i-ter)

Treats and prevents hereditary angioedema (HAE) attacks.

Brand Name(s):

Berinert, Cinryze, Haegarda, Ruconest

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 into one of your veins or as a shot under your skin.
• 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.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are itchy, swollen, painful, red, bruised, or have scars or stretch marks.
• Use a new needle and syringe each time you inject your medicine. Use a silicone-free syringe when using this medicine.
• Do not use this medicine if it is cloudy, discolored, or if it has particles in it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Store unopened vials in the original carton in the refrigerator or at room temperature. Do not freeze. Let the medicine come to room temperature before you mix it with the sterile water for injection.
• Berinert® and Haegard®: After you mix the medicine, use it within 8 hours. Do not refrigerate or freeze the mixed liquid.
• Cinryze®: After you mix the medicine, use it within 3 hours. Do not refrigerate or freeze the mixed liquid.
• Ruconest®: After you mix the medicine, use it right away, or store it in the refrigerator and use it within 8 hours.
• Throw away the vial after use, even if there is medicine left in it.
• 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.

• Some medicines can affect how this medicine works. Tell your doctor if you are using birth control pills or other hormones.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a history of blood clots or heart or blood vessel disease.
• This medicine may increase your risk for blood clots.
• Berinert®, Cinryze®, and Haegarda® are made from donated human blood. All donated blood is tested for certain viruses. Although your risk of infection from the medicine is very low, talk with your doctor if you have concerns.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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
• Chest pain or tightness, trouble breathing, coughing up blood
• Numbness or weakness on one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Pain in your lower leg (calf)

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

• Mild headache, dizziness
• Pain, redness, or burning 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