Hemlibra (Emicizumab)

Prescription medicineOnly Available By Prescription

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What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Hemlibra (emicizumab-kxwh) is a prescription injectable medication used to prevent or decrease the number of bleeding episodes in adults and pediatric patients with hemophilia A.

Hemlibra single-dose vials come in various concentrations:

  • 30 mg/mL
  • 60 mg/0.4 mL
  • 105 mg/0.7 mL
  • 150 mg/mL
  • 300 mg/2 mL

Directions

Your doctor will decide on a treatment regimen for you, including Hemlibra dosing.

Hemlibra is given as an injection in the upper outer arms, thighs, or abdomen. You or your caregiver may administer Hemlibra once you or your caregiver receives training on how to prepare, administer, and discard the medication properly.

The medication guide that comes with your prescription contains further directions for use. Any questions or concerns may be referred to your doctor or pharmacist.

Storage:

Store Hemlibra vials in their original container in the refrigerator between 2°C to 8°C (36°F to 46°F). Keep out of the light. Avoid freezing and shaking. Appropriately discard any used vials, needles, and syringes after using.

Unopened Hemlibra vials can be stored out of the refrigerator at a maximum temperature of 30°C (86°F) for a maximum of 7 days.

Never share your needles or syringes with others.

Ingredients

Emicizumab-kxwh is the active ingredient in Hemlibra. L-arginine, L-histidine, poloxamer 188, and L-aspartic acid are the inactive ingredients included.

Contraindications

There are no contraindications to Hemlibra per the most recent Prescribing Information. However, patients and their doctors should discuss appropriate treatment regimens.

Cautions

  • Hemlibra is associated with the following FDA Boxed Warning:
    • Hemlibra has been associated with thrombotic microangiopathy and thrombotic events when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was given to patients for 24 hours and were receiving Hemlibra. Monitoring of these events should occur in patients receiving aPCC. aPCC should be stopped and Hemlibra dosing should be placed on hold if symptoms occur.
  • Before you start treatment with Hemlibra, inform your doctor of:
    • All the prescription and nonprescription medications you take
    • Your allergies
    • Your current health problems
    • Your past medical history
    • Your status of pregnancy or breastfeeding
  • Antibodies may be produced by your immune system that can impact the effects of Hemlibra.
  • Coagulation laboratory tests can be altered by Hemlibra.

Side Effects

Hemlibra side effects include but are not limited to injection site reactions, headache, and joint pain. Contact your doctor right away if you have bothersome or persistent side effects.

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Reference

Hemlibra. South San Francisco, CA: Genentech, Inc.; 2023.




IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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