Hemlibra

Generic name: Emicizumab
Drug class: Miscellaneous coagulation modifiers

Usage of Hemlibra

Hemlibra is a monoclonal antibody that functions in place of a natural blood-clotting factor that is missing in people with hemophilia A. Emicizumab works as a "bridge" between other clotting factors to replace missing factor VIII.

Hemlibra is for adults and children with hemophilia A with or without factor VIII inhibitors. Hemlibra is used to help prevent bleeding episodes or make them occur less often.

Hemlibra will not stop a bleeding episode that has already begun.

Hemlibra side effects

Get emergency medical help if you have signs of an allergic reaction to Hemlibra : hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If you also use a bypassing agent, call your doctor right away if you have any of these side effects:

  • headache, weakness, confusion;
  • feeling light-headed or unusually sick;
  • back pain, little or no urination;
  • stomach pain, vomiting;
  • chest pain, feeling short of breath, coughing up blood;
  • swelling or redness in your arms or legs;
  • eye pain or swelling, vision problems;
  • numbness in your face; or
  • yellowing of your skin or eyes.

    • Common Hemlibra side effects may include:

  • headache;
  • joint pain; or
  • pain, swelling, burning, or irritation where the medicine was injected.

    • This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

    Before taking Hemlibra

    You should not use Hemlibra if you are allergic to emicizumab.

    Tell your doctor if you use factor VIII or a bypassing agent such as FEIBA (or "aPCC"; activated prothrombin complex concentrate). Emicizumab can cause unwanted blood clots when used together with aPCC. These blood clots can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

    You will most likely need to stop using bypassing agents the day before you begin using Hemlibra. But you may keep using factor VIII for the first week of using Hemlibra.

    If your doctor tells you to keep using a bypassing agent, you may need to limit your emicizumab dose to more than 100 units/kilogram per 24 hours. Follow all instructions carefully.

    Follow your doctor's instructions about using Hemlibra if you are pregnant. It is not known whether this medicine will harm an unborn baby. Control of bleeding episodes is very important during pregnancy. The benefit of preventing these episodes may outweigh any risks to the baby.

    If you are not pregnant, use effective birth control to prevent pregnancy while using this medicine.

    It is not known whether emicizumab passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

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    How to use Hemlibra

    Usual Adult Dose for Hemophilia A with Inhibitors:

    3 mg/kg suBCUTAneously once a week for the first 4 weeks, followed by 1.5 mg/kg once a week. Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

    Usual Pediatric Dose for Hemophilia A with Inhibitors:

    3 mg/kg subcutaneously once a week for the first 4 weeks, followed by 1.5 mg/kg once a week. Use: Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors.

    Warnings

    Hemlibra can cause unwanted blood clots when used together with a bypassing agent such as FEIBA. This can damage small blood vessels in your arms and legs, brain, kidneys, lungs, or other organs.

    Tell your doctor if you use a bypassing agent or factor VIII. You will most likely need to stop using them the day before you begin using Hemlibra.

    If you use Hemlibra and a bypassing agent together, call your doctor at once if you have any of these symptoms: weakness, confusion, stomach or back pain, vomiting, decreased urination, chest pain, trouble breathing, coughing up blood, swelling or redness in your arms or legs, eye pain, or vision problems.

    What other drugs will affect Hemlibra

    Other drugs may interact with emicizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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