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Emicizumab-kxwh Injection

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Emicizumab-kxwh may cause blood clots in your arms, legs, lung, or head, particularly if you use activated prothrombin complex concentrate (aPCC) to treat breakthrough bleeds. TMA is a condition characterized by blood clots and damage to blood vessels that damages the kidneys, brain, and other organs. Get emergency medical care if you encounter any of the following symptoms, or call your doctor right away: Confusion, weakness, swollen, painful, or red arms or legs, yellowing of the skin or eyes, stomach, chest, or back pain, nausea, or vomiting, feeling faint, decreased urination, swollen, painful, or difficult-to-see eyes, rapid heartbeat, facial numbness, headache, shortness of breath, or coughing up blood are all symptoms that can occur.

Consult your physician for advice on when and how to handle breakthrough bleeding.

Keep all of your appointments with your doctor and the lab. In order to monitor your body’s reaction to the emicizumab-kxwh injection, your doctor may prescribe specific tests.

When you start receiving therapy with emicizumab-kxwh injectable and each time you get a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the information and consult your doctor or pharmacist. The Medication Guide can also be found on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The dangers of using emicizumab-kxwh injection should be discussed with your doctor.

Why is this medication prescribed?

Adults, kids, and newborns with hemophilia A (condition in which the blood does not clot normally due to a missing or defective blood clotting factor) can be treated with emicizumab-kxwh injection to prevent or lessen the frequency of bleeding. A group of drugs known as hemostatic antibodies includes emicizumab-kxwh. Your blood will clot with its assistance by serving as a link between clotting components.

How should this medicine be used?

Emicizumab-kxwh is available as a solution (liquid) that is administered through subcutaneous injection. It is initially administered for 4 weeks once a week. It can be injected subcutaneously once per week, twice weekly, or four times weekly after the first four weeks. How frequently to administer emicizumab-kxwh will be determined by your physician. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Inject emicizumab-kxwh exactly as prescribed. Never take it in larger or less amounts or more frequently than advised by your doctor.

Your doctor could approve of having an assistant administer the injections for you. Your doctor will instruct you or a caregiver on how to administer the shots at home. Read the enclosed written instructions before using emicizumab-kxwh injection for the first time. For a copy of the manufacturer’s directions for use information for the patient, ask your pharmacist or doctor. If you have any concerns regarding how to administer the drug through injection, be sure to see your physician or pharmacist.

Injections of emicizumab-kxwh are sold in single-use vials. Before injecting the drug, let the vial come to room temperature for 15 minutes away from direct sunlight. The medication should not be warmed in any other ways, including the microwave, hot water, or any other manner. Used syringes, needles, and vials should be disposed of in a container that won’t puncture easily. Regarding how to get rid of the puncture-resistant container, see your physician or pharmacist.

To ensure that the vial’s printed expiration date has not past, check the vial. The liquid in the vial deserves a close look. The liquid shouldn’t be hazy, discolored, or have noticeable particles in it; instead, it should be clear and colorless to slightly yellow. Do not inject the drug if the vial or the box are defective; instead, contact your pharmacist.

Except for your navel and the region 2 inches (5 centimeters) around it, you can inject emicizumab-kxwh anyplace on the front of your legs (upper leg) or stomach (middle of your stomach). The outside of the upper arm may also be used if someone else is administering your prescription. Every time you inject the drug, choose a different location at least an inch apart from the one you’ve previously used. Injecting into skin that is painful, bruised, red, hard, or not intact, or that has scars or moles is not advised.

Although it does not treat hemophilia, emicizumab-kxwh reduces bleeding in those who have it. Even if you feel well, keep using emicizumab-kxwh injectable. Avoid discontinuing emicizumab-kxwh injection without first seeing your physician.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving emicizumab-kxwh injection,

  • If you have an allergy to emicizumab-kxwh, any other drugs, or any of the ingredients in emicizumab-kxwh injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use.
  • If you have or have ever had any additional medical conditions, let your doctor know.
  • If you are pregnant or plan to become pregnant, let your doctor know. Pregnancy should not occur while using emicizumab-kxwh injection. Consult your physician about birth control options you can take while undergoing therapy. Call your doctor if you become pregnant while taking emicizumab-kxwh injection.
  • Inform your doctor if you are nursing a baby.
  • Inform the surgeon or dentist that you are using the emicizumab-kxwh injection if you are having surgery, including dental surgery.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, administer it as soon as you remember. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missed dose, do not provide a second injection the same day.

What side effects can this medication cause?

Side effects from emicizumab-kxwh are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Redness, soreness, warmth, or itching at the injection site
  • Headache
  • Joints hurt

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you encounter any of the signs and symptoms mentioned in the IMPORTANT WARNING section:

  • More bleeding

Emicizumab-kxwh could have additional negative effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at or by phone at 1-800-332-1088 if you have a serious side event.

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and away from light, heat, and moisture.

The best way to preserve your medication will be advised by your doctor. Just as prescribed, only store your prescription. Be sure to know the right way to store your medications.

All medications should be kept out of the sight and reach of children, as many containers (such as weekly pill containers and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for toddlers to open. Always lock safety caps and put the medication in a secure spot right away that is up and away from where young children can access it and cannot access it, in order to prevent poisoning in young children.

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Inform the lab staff and your doctor that you are using emicizumab-kxwh injection prior to any laboratory test.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Hemlibra®
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