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Hemlibra

Generic name: emicizumab [EM-a-SIZ-ue-mab]
Drug class: Other coagulation modifiers

What is Hemlibra?

Hemlibra, a monoclonal antibody, replaces a blood-clotting component that is absent in people who have hemophilia. Emicizumab serves as an intermediary to replace missing VII clotting factors in the body.Hemlibra can be used by adults and children who have hemophilia A, with or without factor VIII inhibitors. Hemlibra helps to prevent bleeding episodes or reduce their frequency.Hemlibra won't stop the bleeding that has already started.

Side effects of Hemlibra

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of the face, lips, or throat, and/or difficulty breathing, seek emergency medical attention.

Call your doctor immediately if you experience any of the following side effects if you use a bypass drug.

  • Headache, weakness, confusion;
  • Feeling light-headed or unusually sick
  • Back pain with little or no urination
  • Stomach pain, vomiting;
  • Chest pain, shortness of breath, and blood in the cough
  • You may experience swelling or redness on your arms or legs.
  • Eye pain or swelling can cause vision problems.
  • You may feel numbness in your face.
  • Yellowing of the skin or eyes.

Hemlibra may cause side effects such as:

  • Headache;
  • Joint pain
  • Pain, swelling, irritation, or burning where the medicine has been injected

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Warnings

Hemlibra may cause blood clots if used with a bypassing drug such as FEIBA. This can cause damage to small blood vessels, including those in the arms, legs, brains, kidneys, and lungs.Inform your doctor if you are using a bypassing agent or factor VIII. Most likely, you will need to stop using these products the day before starting Hemlibra.Call your doctor immediately if any of the following symptoms occur: weakness or confusion, stomach or back pain, or nausea.

Before you take this drug

Hemlibra should not be used if you have an allergy to emicizumab.Inform your doctor if using factor VIII or a bypassing agent like FEIBA ("aPCC", activated prothrombin compound concentrate) or Emicizumab, when combined with aPCC, can cause unwanted blood clots. These blood clots may damage the small blood vessels of your arms, legs, brains, kidneys, or lungs.The day before using Hemlibra, you will need to stop using the bypassing agent. You can continue to use factor VIII during the first week after starting Hemlibra.Your doctor may tell you to continue using a bypass drug. You will need to limit the emicizumab dosage to no more than 100 units per kilogram in 24 hours. Be sure to follow all instructions.If you are pregnant, follow your doctor's advice about Hemlibra. There is no way to know if this medication will harm a baby. During pregnancy, it is important to control bleeding episodes. Preventing these episodes can be more beneficial than the risks for your baby.Use effective contraception to avoid pregnancy while taking this medication.It is unknown if emicizumab can pass into breast milk or if the drug could harm a nursing infant. Inform your doctor if breastfeeding is taking place.

Similar/related drugs

Tranexamic Acid, Desmopressin, DDAVP, Cyklokapron, Roctavian, Antihemophilic Factor, and Profilenine

How to take Hemlibra?

Follow the directions on your prescription label. Please follow all the instructions on the prescription label. Your doctor may occasionally alter your dosage. Use this medication only as prescribed.Do not exceed the recommended dose or use it for longer than necessary.Hemlibra can be injected into the skin once to four times per week. You may be taught how to use the medication properly by a healthcare provider.Carefully read and follow all instructions for use that come with your medicine. If you need assistance understanding the instructions, consult your physician or pharmacist.A syringe with a needle is required to remove Hemlibra from the vial. A separate needle is needed to inject the medication into your skin. Only use the syringes and needles that your pharmacist has recommended to inject Hemlibra.

Shake the bottle gently. Do not prepare your dose until you are ready for an injection. If the color of your medicine has changed or if it contains particles, do not use it. For new medication, call your pharmacist.You should not let a child under 7 years of age self-inject the medicine. An adult must help.Hemlibra may interfere with some blood clotting tests. Inform any doctor that treats you about your use of emicizumab.This medicine should be stored in its original container in the refrigerator. Do not expose yourself to light.For a limited time, you can store a vial (bottle) that has not been opened at room temperature. If the vial is not used in 7 days, place it back in the refrigerator.Use the medication immediately after opening and puncturing the vial. Don't save it to use later. After one use, throw away the vial, even if it still contains medicine.Only use a needle or syringe once, and then store them in an "as sharps" container that is puncture-proof. Be sure to follow local or state laws on how to properly dispose of the container. Keep the container out of reach of children and pets.

Details on dosage

Adult dose for hemophilia A with inhibitors:

After the first four weeks, 3 mg/kg is administered subcutaneously every week. Then 1.5 mg/kg is given once a week.
Use: Routine prophylaxis in hemophilia (congenital deficiency of factor VIII) patients who are taking factor VIII inhibitors.

The usual pediatric dose for Hemophilia A with inhibitors:

After the first four weeks, 3 mg/kg is administered subcutaneously every week. Then 1.5 mg/kg is given once a week.
Use: Routine prophylaxis in order to reduce or prevent bleeding episodes among pediatric patients with hemophilia (congenital deficiency of factor VIII) and factor VIII inhibitors.

What happens if I miss the dose?

As soon as you realize that you have missed a dose, take it as soon as possible. Continue to use your normal once-weekly schedule and inject the next dose as usual. Do not take extra medication to make up for the missed dose.

What happens if I overdose?

Reach out for help right away by dialing the poison helpline 1-800-222-1222, or seek medical attention right away.

What should be avoided?

Do not inject this medicine into a mole or on skin that has been bruised, scarred, red, irritated, hard, or broken.

Interaction with other drug

Herbal products, prescription and over-the-counter medicines, vitamins, and other drugs can interact with emicizumab. Inform your doctor of all the medicines you are currently taking and those that you will begin or stop using.