For Patients & Caregivers

Frequently Asked Questions About HEMLIBRA

What makes HEMLIBRA different from factor VIII?

HEMLIBRA has a half-life of 4 weeks (646 hours).5 Learn more about the half-life of HEMLIBRA.

HEMLIBRA offers maintenance dose options of every week (1.5 mg/kg), every 2 weeks (3 mg/kg), and every 4 weeks (6 mg/kg) after a once weekly loading dose (3 mg/kg) for the first 4 weeks.5 Learn more about dosing for HEMLIBRA.  

How may HEMLIBRA help target joints?

To see target joint data for patients without inhibitors, visit Patients Without Inhibitors.

Where can I find information about managing pediatric patients with HEMLIBRA?

For data on the use of HEMLIBRA in pediatric patients, visit HEMLIBRA Efficacy in Pediatric Patients.

Questions about breakthrough bleed management?

Patients without inhibitors taking HEMLIBRA can be treated with FVIII in the event of a breakthrough bleed.5 Remember, HEMLIBRA cannot be used to treat a breakthrough bleed. To learn more about breakthrough bleed management for patients with or without inhibitors, visit Treating Breakthrough Bleeds or download the Treating Breakthrough Bleeds Guide .

FVIII=factor VIII.

To learn about breakthrough bleed management, visit Treating Breakthrough Bleeds.

Questions about recreational activity level while on HEMLIBRA?

Specific guidelines on recreational activities should be based on the patient’s individual needs and goals. For information about recreational activities, consider consulting the National Hemophilia Foundation’s guidelines, “Playing it Safe,” for safe activities for people living with hemophilia A. You may want to consider reviewing the NHF guidelines with your patients to determine which activities may be safe for them to participate in. Genentech has no control over the content of this site and is not responsible for the information therein.

Questions about HEMLIBRA safety?

To read more about HEMLIBRA’s safety profile, visit Demonstrated Safety Profile. For more questions, please refer to the full Prescribing Information, or contact your HEMLIBRA Representative.

Looking for tools to help calculate your patient’s dose of HEMLIBRA?

Use the HEMLIBRA Dosing Calculator as a guide to help determine your patient’s weight-based dose and vial size of HEMLIBRA. Infant dosing follows the same weight-based formula.5 The information provided is not a substitute for clinical judgment.

To use the calculator, go to the Dosing Calculator page of this website.

There is no weight restriction or weight limitation for the use of HEMLIBRA in the treatment of patients with hemophilia A.5

Where can I find access and patient assistance resources?

HEMLIBRA Access Solutions will help walk your patients through their insurance coverage and financial assistance options for their HEMLIBRA.

The HEMLIBRA Co-pay Program can help eligible patients with the OOP costs associated with HEMLIBRA.*

If patients don’t have insurance coverage or have financial concerns and meet eligibility criteria, they may be able to get free medicine from the Genentech Patient Foundation.†

Find out if your patients could be eligible by using the Patient Assistance Tool.

*This HEMLIBRA Co-Pay Program is valid ONLY for patients with commercial insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medication. Patients using Medicare, Medicaid or any other federal or state government program to pay for their medications are not eligible.

Under the program, the patient will pay a co-pay. After reaching the maximum program benefit, the patient will be responsible for all remaining out-of-pocket expenses. The amount of the program benefit cannot exceed the patients’ out-of-pocket expenses for the cost associated with HEMLIBRA.

All participants are responsible for reporting the receipt of all program benefits as required by any insurer or by law. No party may seek reimbursement for all or any part of the benefit received through this Program. The program is only valid in the United States and U.S. Territories. This program is void where prohibited by law and shall follow state restrictions in relation to AB-rated generic equivalents (e.g., MA, CA) where applicable. The patient, guardian, prescriber, hospital and any other person using the program agree not to seek reimbursement for all or any part of the benefit received by the patient through the offer of this program. Genentech reserves the right to rescind, revoke or amend the program without notice at any time. Additional terms and conditions apply. Please visit HEMLIBRACopay.com for the full list of Terms and Conditions.

†To be eligible for free Genentech medicine from the Genentech Patient Foundation, insured patients who have coverage for their medicine must have pursued all other forms of financial assistance and meet certain income requirements. Uninsured patients and insured patients without coverage for their medicine must meet different income requirements.

You can download our Access Process Tips Worksheet  to make sure you have all the necessary information for your patients’ prior authorization forms.

Indication & 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
Thrombotic Microangiopathy (TMA) and Thromboembolism Associated With HEMLIBRA and aPCC
In clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic events were reported in 0.5% of patients (2/391). In patients who received at least one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic events were reported in 5.4% of patients (2/37). Patients with TMA presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13.

Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Due to the long half-life of HEMLIBRA, the potential for an interaction with aPCC may persist for up to 6 months after the last dose. Monitor for the development of TMA and/or thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA and/or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of TMA and/or thrombotic events on a case-by-case basis.

Immunogenicity
Treatment with HEMLIBRA may induce anti-drug antibodies. Anti-emicizumab-kxwh antibodies were reported in 5.1% of patients (34/668) treated with HEMLIBRA in clinical trials. Most patients with anti-emicizumab-kxwh antibodies did not experience a change in HEMLIBRA plasma concentrations or an increase in bleeding events; however, in uncommon cases (incidence <1%), the presence of neutralizing antibodies with decreasing plasma concentration may be associated with loss of efficacy.

Monitor for clinical signs of loss of efficacy (eg, increase in breakthrough bleeding events) and if observed, promptly assess the etiology and consider a change in treatment if neutralizing anti-emicizumab-kxwh antibodies are suspected.

Laboratory Coagulation Test Interference
HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based on aPTT, such as one-stage, factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based coagulation laboratory test results in patients who have been treated with HEMLIBRA prophylaxis should not be used to monitor HEMLIBRA activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers.

Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.

Results unaffected by HEMLIBRA: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrombin time (PT)-based single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation factors (eg, Factor V Leiden, Prothrombin 20210).

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

Adverse Reactions
Characterization of aPCC Treatment in Pooled Clinical Trials
There were 130 instances of aPCC treatment in 37 patients, of which 13 instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; 2 of the 13 were associated with thrombotic events and 3 of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.

Injection Site Reactions
In total, 85 patients (22%) reported injection site reactions (ISRs). All ISRs observed in HEMLIBRA clinical trials were reported as mild to moderate intensity and 93% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (11%), injection site pruritus (4%), and injection site pain (4%).

Other Less Common (<1%) Reactions
Rhabdomyolysis was reported in 2 adult patients with asymptomatic elevations in serum creatine kinase without associated renal or musculoskeletal symptoms. In both instances, the event occurred following an increase in physical activity.

Drug Interactions
Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC.

Pregnancy, Lactation, Females and Males of Reproductive Potential
Women of childbearing potential should use contraception while receiving HEMLIBRA. It is not known whether HEMLIBRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMLIBRA should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HEMLIBRA and any potential adverse effects on the breastfed child from HEMLIBRA or from the underlying maternal condition.

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.

    • Data on file. Genentech, Inc.

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