Emicizumab

What is Emicizumab?

• Emicizumab (Hemlibra) is a bispecific factor IXa- and factor X-directed antibody used for the treatment of haemophilia A.

What are the uses of this medicine?

• This medicine is used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.
• Hemophilia A is a bleeding condition people can be born with where a missing or faulty blood clotting factor (factor VIII) prevents blood from clotting normally.
• Hemlibra is a therapeutic antibody that bridges clotting factors to help your blood clot.

How does this medicine work?

• Emicizumab (e" mi ciz' ue mab) is a recombinant, humanized, bispecific monoclonal antibody to two human coagulation factors – factor IXa and factor X – that is used to prevent bleeding episodes in patients with severe hemophilia A.
• Hemophilia A is a serious genetic disease associated with deficiency in product of factor VIII leading to recurrent episodes of bleeding that result in major disability and premature death.
• Hemophilia A is typically treated with infusions of factor VIII isolated and concentrated from human plasma or produced by recombinant techniques.
• Some patients given factor VIII infusions, however, develop neutralizing antibodies which inhibit the anticoagulation activity of the infusions.
• Emicizumab is a recombinant bispecific monoclonal antibody that binds to both factor IXa and X, which mimics the co-factor function of factor VIII, bypassing its need in the coagulation cascade.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Hemlibra interferes with activated clotting time (ACT), activated partial thromboplastin time (aPTT), and coagulation laboratory tests based on aPTT, including one-stage aPTT-based single-factor assays, aPTT-based Activated Protein C Resistance (APC-R), and Bethesda assays (clotting-based) for factor VIII (FVIII) inhibitor titers. Intrinsic pathway clotting-based laboratory tests should not be used.
• Hemlibra may cause serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA®).

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosage: The recommended loading dose is 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by a maintenance dose of:

• 1.5 mg/kg once every week, or
• 3 mg/kg once every two weeks, or
• 6 mg/kg once every four weeks.

Administration

• Use Hemlibra exactly as prescribed by your healthcare provider.
• Stop (discontinue) prophylactic use of bypassing agents the day before starting Hemlibra prophylaxis.
• You may continue prophylactic use of FVIII for the first week of Hemlibra prophylaxis.
• Hemlibra is given as an injection under your skin (subcutaneous injection) by you or a caregiver.
• Your healthcare provider should show you or your caregiver how to prepare, measure, and inject your dose of Hemlibra before you inject yourself for the first time.
• Do not attempt to inject yourself or another person unless you have been taught how to do so by a healthcare provider.
• Your healthcare provider will prescribe your dose based on your weight. If your weight changes, tell your healthcare provider.
• You will receive Hemlibra 1 time a week for the first four weeks. Then you will receive a maintenance dose as prescribed by your healthcare provider.
• If you miss a dose of Hemlibra on your scheduled day, you should give the dose as soon as you remember. You must give the missed dose as soon as possible before the next scheduled dose, and then continue with your normal dosing schedule. Do not give two doses on the same day to make up for a missed dose.
• Hemlibra may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading. Talk to your healthcare provider about how this may affect your care.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 30 mg/mL in a single-dose vial
• 60 mg/0.4 mL in a single-dose vial
• 105 mg/0.7 mL in a single-dose vial
• 150 mg/mL in a single-dose vial

This medicine is available in fallowing brand namesː

• Hemlibra

What side effects can this medication cause?

The most common side effects of this medicine include:

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

Hemlibra may cause the following serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA®), including:

• Thrombotic microangiopathy (TMA)
• Blood clots (thrombotic events)

What special precautions should I follow?

• Hemlibra interferes with activated clotting time (ACT), activated partial thromboplastin time (aPTT), and coagulation laboratory tests based on aPTT, including one-stage aPTT-based single-factor assays, aPTT-based Activated Protein C Resistance (APC-R), and Bethesda assays (clotting-based) for factor VIII (FVIII) inhibitor titers. Intrinsic pathway clotting-based laboratory tests should not be used.
• Inform the patient and/or caregiver that Hemlibra interferes with some laboratory tests that measure blood clotting and may cause a false reading.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Hemlibra use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage.

Can this medicine be used in children?

• The safety and efficacy of Hemlibra have been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: emicizumab-kxwh
• Inactive ingredients: L-arginine, L-histidine, poloxamer 188, and L-aspartic acid.

Who manufactures and distributes this medicine?

• Manufactured by: Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco

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

• Store Hemlibra in the refrigerator at 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Store Hemlibra in the original carton to protect the vials from light.
• Do not shake Hemlibra.
• If needed, unopened vials of Hemlibra can be stored out of the refrigerator and then returned to the refrigerator.
• Hemlibra should not be stored out of the refrigerator for more than a total of 7 days or at a temperature greater than 86°F (30°C).
• After Hemlibra is transferred from the vial to the syringe, Hemlibra should be used right away.
• Throw away (dispose of) any unused Hemlibra left in the vial.

• Dailymed label info on Emicizumab
• FDA Emicizumab

Emicizumab Resources
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Emicizumab Resources
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