Emicizumab-kxwh Injection

IMPORTANT WARNING:

Emicizumab-kxwh may cause thrombotic microangiopathy (TMA; a condition involving blood clots and injury to blood vessels that damages the kidneys, brain, and other organs) and blood clots in your arms, leg, lung, or head, especially if you use activated prothrombin complex concentrate (aPCC) to treat breakthrough bleeds. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: confusion; weakness; swelling, pain, or redness in arms or legs; yellowing of eyes or skin; stomach, chest, or back pain; nausea or vomiting; feeling faint; decreased urination; eye pain, swelling, or trouble seeing; fast heartbeat; numbness in your face; headache; shortness of breath; or coughing up blood.

Talk to your doctor about how and when you should treat breakthrough bleeds.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body's response to emicizumab-kxwh injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with emicizumab-kxwh injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using emicizumab-kxwh injection.

WHY is this medicine prescribed?

Emicizumab-kxwh injection is used to prevent or reduce the frequency of bleeding in adults, children, and infants with hemophilia A (condition in which the blood does not clot normally because of a missing or faulty blood clotting factor). Emicizumab-kxwh is in a class of medications called hemostatic antibodies. It works by acting as a bridge between clotting factors to help your blood clot.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Emicizumab-kxwh comes as a solution (liquid) to be injected subcutaneously (under the skin). Initially, it is given once a week for 4 weeks. After 4 weeks, it may be injected subcutaneously once every week, once every 2 weeks, or once every 4 weeks. Your doctor will tell you how often to inject emicizumab-kxwh. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use emicizumab-kxwh injection exactly as directed. Do not use more or less of it or take it more often than prescribed by your doctor.

Your doctor may allow you or a caregiver to perform the injections at home. Your healthcare provider will teach you or a caregiver how to perform the injections at home. Before you use emicizumab-kxwh injection yourself for the first time, read the written instructions that come with it. Ask your pharmacist or doctor for a copy of the manufacturer's instructions for use information for the patient. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

Emicizumab-kxwh injection comes in single use vials. Allow the vial to warm to room temperature for 15 minutes away from direct sunlight before you inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method. Dispose of used syringes, needles, and vials in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Check the vial to be sure that the expiration date printed on the vial has not passed. Look closely at the liquid in the vial. The liquid should be clear and colorless to slightly yellow and should not be cloudy or discolored or contain large particles. Call your pharmacist if there are any problems with the package or the vial and do not inject the medication.

You can inject emicizumab-kxwh anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If another person is injecting your medication, the outer area of the upper arm may also be used. Choose a different spot each time you inject the medication, at least 1 inch away from a spot that you have used before. Do not inject into an area where the skin is tender, bruised, red, hard, or not intact, or where you have scars or moles.

Emicizumab-kxwh controls bleeding in people with hemophilia but does not cure it. Continue to use emicizumab-kxwh injection even if you feel well. Do not stop using emicizumab-kxwh injection without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before receiving emicizumab-kxwh injection,

• tell your doctor and pharmacist if you are allergic to emicizumab-kxwh, any other medications, or any of the ingredients in emicizumab-kxwh injection. Ask your pharmacist or check the Medication Guide 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.

• tell your doctor if you have or have ever had any other medical conditions.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are using emicizumab-kxwh injection. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while using emicizumab-kxwh injection, call your doctor.

• tell your doctor if you are breast-feeding.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Inject the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose on the same day to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Emicizumab-kxwh may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• injection site redness, tenderness, warmth, or itching
• headache
• joint pain

Some side effects can be serious. If you experience any symptoms listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment

• increased bleeding

Emicizumab-kxwh 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light excess heat and moisture (not in the bathroom).

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

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. http://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 (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are using emicizumab-kxwh injection.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.