Hemlibra

Eligibility

Patients are eligible if they:

Have been prescribed HEMLIBRA for an FDA-approved indication
Are 18 years of age or older, or have a caregiver or have a legally authorized person to manage the patient's co-pay assistance
Have commercial (private or non-governmental) insurance.* This includes plans available through state and federal health insurance exchanges
Reside and receive treatment in the United States or U.S. Territories
Are not receiving assistance through the Genentech Patient Foundation or any other charitable organization for the same expenses covered by the program
Are not a government beneficiary and/or participant in a federal or state-funded health insurance program (e.g., Medicare, Medicare Advantage, Medigap, Medicaid, VA, DoD, TRICARE)

*Commercial insurance includes plans you receive from your job or plans from the Health Insurance Marketplace. Government programs like Medicare and Medicaid are not commercial insurance.

If a patient is not eligible for the HEMLIBRA Co-pay Program, there may be other options for co-pay assistance. Call (866) 436-5427 or visit HEMLIBRA.com/access to learn more.

Indication and Important Safety Information

Indication

HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Important Safety Information

Boxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

Warnings and Precautions

Immunogenicity: Anti-emicizumab antibodies (including neutralizing antibodies) have developed in HEMLIBRA-treated patients
In case of clinical signs of loss of efficacy, promptly assess the etiology and consider a change in treatment if neutralizing antibodies are suspected
Laboratory coagulation test interference: 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

Most Common Adverse Reactions

The most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING.

Program Offering and Eligibility

Program offering

Eligibility