C1-Esterase Inhibitor Human Injection

C1-esterase inhibitor human injection (Cinryze, Haegarda) is used to prevent swelling and painful attacks of hereditary angioedema (HAE; an inherited condition that causes episodes of swelling in the hands, feet, face, airway, or intestines) in adults and children 6 years of age or older. C1-esterase inhibitor human injection (Berinert) is used to treat acute attacks of hereditary angioedema in adults and children who have symptoms affecting the stomach, intestines, face, throat, and airway. C1-esterase inhibitor human is in a class of medications called complement inhibitors. It works by replacing C1-esterase inhibitor that is normally produced by the body and that helps control inflammation and swelling.

C1-esterase inhibitor human (Haegarda) comes as a powder in a vial to be mixed with a liquid to inject subcutaneously (under the skin). C1-esterase inhibitor human (Berinert, Cinryze) comes as a powder in a vial to be mixed with a liquid to inject intravenously (into a vein). For the prevention of swelling and painful attacks of hereditary angioedema, C1-esterase inhibitor human injection is usually injected intravenously (Cinryze) over a period of 5 or 10 minutes or subcutaneously (Haegarda) every 3 to 4 days. For the treatment of acute attacks of hereditary angioedema, C1-esterase inhibitor human injection (Berinert) is usually injected intravenously when needed, according to your doctor's directions. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use C1-esterase inhibitor human injection exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

You may receive your of C1-esterase inhibitor human injection in your doctor's office or your doctor may allow you or a caregiver to perform the injections at home. If you using C1-esterase inhibitor human injection at home, your healthcare provider will show you or a caregiver how to mix and inject a dose of the medication at home. Before you use C1-esterase inhibitor human injection for the first time, you and the person who will be giving the injections should read the manufacturer's information for the patient that comes with it. These instructions describe how to mix and inject a dose of C1-esterase inhibitor human. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to mix or inject the medication or how to dispose of used needles and syringes after you inject the medication.

You may receive your of C1-esterase inhibitor human injection in your doctor's office or your doctor may allow you or a caregiver to perform the injections at home. If you using C1-esterase inhibitor human injection at home, your healthcare provider will show you or a caregiver how to mix and inject a dose of the medication at home. Before you use C1-esterase inhibitor human injection for the first time, you and the person who will be giving the injections should read the manufacturer's information for the patient that comes with it. These instructions describe how to mix and inject a dose of C1-esterase inhibitor human. Be sure that you understand these directions. Ask your healthcare provider if you have any questions about how to mix or inject the medication or how to dispose of used needles and syringes after you inject the medication.

You should mix the medication right before you plan to inject it. However, you may mix the medication in advance, store it at room temperature, and use within 8 hours (Berinert, Haegarda) or within 3 hours (Cinryze). Be sure that the medication is at room temperature before you inject it.

If you are using C1-esterase inhibitor human (Haegarda), inject the medication under the skin of your stomach area. Do not inject C1-esterase inhibitor human (Haegarda) into the navel or into any scarred, reddened, irritated, itchy, painful, or bruised areas of skin. Also, do not inject into areas with scars or stretch marks. Choose a different area (at least 2 inches away from your previous injection) for each injection.

If you are using C1-esterase inhibitor human (Berinert) to treat an acute attack of hereditary angioedema, you should call your doctor immediately or seek medical care at a healthcare facility. If you are using C1-esterase inhibitor human (Cinryze, Haegarda) to prevent swelling and painful attacks of hereditary angioedema, be sure to talk to your doctor about what you should do if you have an acute attack of hereditary angioedema.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using C1-esterase inhibitor human injection,

• tell your doctor and pharmacist if you are allergic to C1-esterase inhibitor human, other C1-esterase inhibitor products, any other medications, or any of the ingredients in C1-esterase inhibitor human injection products. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: androgens such as danazol, methyltestosterone (Android 25), or testosterone (Androderm, Jatenzo, Natesto, others) and medications that contain estrogen (including birth control pills). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have an indwelling catheter (a flexible plastic tube that is placed into the bladder to allow the urine to drain out) or if you have been on bedrest or unable to move around for a long time. Also tell your doctor if you have or have ever had atherosclerosis (narrowing of the blood vessels from fatty deposits); a stroke; blood clots in the legs, lungs, eyes, brain, or anywhere in the body; or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using C1-esterase inhibitor human injection, call your doctor.
• if you are having surgery or will be on bed rest, tell the doctor or dentist that you are using C1-esterase inhibitor human injection.

Unless your doctor tells you otherwise, continue your normal diet.

C1-esterase inhibitor human injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• vomiting
• bad taste in mouth
• fever or chills
• injection site redness or pain
• runny nose, sneezing, watery eyes, or sore throat
• dizziness

Some side effects can be serious. If you experience any of these symptoms and call your doctor immediately or get emergency medical treatment:

• hives; rash; itching; difficulty breathing or swallowing; blue lips and skin; swelling of your face, tongue, or throat; sweating; hoarseness; lightheadedness; or fainting
• warmth, pain, discoloration, or swelling in one leg or arm
• rapid heartbeat
• chest pain
• shortness of breath
• numbness or weakness on one side of body

C1-esterase inhibitor human may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in to protect from light, tightly closed, and out of reach of children. Store unmixed vials of medication in a refrigerator or at room temperature and away from excess heat and moisture (not in the bathroom). Store medication that has been mixed at room temperature and use within 8 hours (Berinert, Haegarda) or 3 hours (Cinryze). Do not allow the medication to freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• warmth, pain, discoloration, or swelling in one leg or arm
• chest pain
• shortness of breath

Keep all appointments with your doctor and the laboratory.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Berinert^®
• Cinryze^®
• Haegarda^®