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.
To see target joint data for patients without inhibitors, visit Patients Without Inhibitors.
For data on the use of HEMLIBRA in pediatric patients, visit HEMLIBRA Efficacy in Pediatric Patients.
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.
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.
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.
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
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.
Data on file. Genentech, Inc.
Data on file. Genentech, Inc.
Our commitment to provide transparent and timely safety information about emicizumab-kxwh. Genentech, Inc. https://www.emicizumabinfo.com/content/emicizumabinfo/en_us/patient.html#. Accessed August 25, 2020.
Our commitment to provide transparent and timely safety information about emicizumab-kxwh. Genentech, Inc. https://www.emicizumabinfo.com/content/emicizumabinfo/en_us/patient.html#. Accessed August 25, 2020.
Chugai Pharmaceutical Co., Ltd. Randomized, placebo-controlled, double-blind, single ascending dose study and open-label multiple ascending dose study. https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-121934. Main ID: JPRN-JapicCTI-121934. Accessed August 25, 2020.
Chugai Pharmaceutical Co., Ltd. Randomized, placebo-controlled, double-blind, single ascending dose study and open-label multiple ascending dose study. https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-121934. Main ID: JPRN-JapicCTI-121934. Accessed August 25, 2020.
Chugai Pharmaceutical Co., Ltd. Extension study of the phase 1 study of ACE910. https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-132195. Main ID: JPRN-JapicCTI-132195. Accessed August 25, 2020.
Chugai Pharmaceutical Co., Ltd. Extension study of the phase 1 study of ACE910. https://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-132195. Main ID: JPRN-JapicCTI-132195. Accessed August 25, 2020.
HEMLIBRA [package insert]. South San Francisco, CA: Genentech, Inc.
HEMLIBRA [package insert]. South San Francisco, CA: Genentech, Inc.
National Hemophilia Foundation. MASAC update on the approval and availability of the new treatment: Emicizumab (HEMLIBRA), for persons with hemophilia A with inhibitors to factor VIII: Interim guidance on acute bleed management and use of laboratory assays. November 24, 2017; New York, NY.
National Hemophilia Foundation. MASAC update on the approval and availability of the new treatment: Emicizumab (HEMLIBRA), for persons with hemophilia A with inhibitors to factor VIII: Interim guidance on acute bleed management and use of laboratory assays. November 24, 2017; New York, NY.
Kitazawa T, Esaki K, Tachibana T, et al. Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens. Thromb Haemost. 2017;117(7):1348-1357.
Kitazawa T, Esaki K, Tachibana T, et al. Factor VIIIa-mimetic cofactor activity of a bispecific antibody to factors IX/IXa and X/Xa, emicizumab, depends on its ability to bridge the antigens. Thromb Haemost. 2017;117(7):1348-1357.
Young G, Liesner R, Chang T, et al. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019;134(24):2127-2138.
Young G, Liesner R, Chang T, et al. A multicenter, open-label phase 3 study of emicizumab prophylaxis in children with hemophilia A with inhibitors. Blood. 2019;134(24):2127-2138.
Shima M, Hanabusa H, Taki M, et al. Long-term safety and efficacy of emicizumab in a phase 1/2 study in patients with hemophilia A with or without inhibitors. Blood Adv. 2017;1(22):1891-1899.
Shima M, Hanabusa H, Taki M, et al. Long-term safety and efficacy of emicizumab in a phase 1/2 study in patients with hemophilia A with or without inhibitors. Blood Adv. 2017;1(22):1891-1899.
Shima M, Nagao A, Masashi T, et al. Long-term safety and efficacy of emicizumab for up to >5 years in a phase 1/2 study in patients with severe hemophilia A. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.
Shima M, Nagao A, Masashi T, et al. Long-term safety and efficacy of emicizumab for up to >5 years in a phase 1/2 study in patients with severe hemophilia A. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.
Wang S, Zhao X, Wang X, et al. A randomized, multicenter, open-label, phase III clinical trial to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in persons with hemophilia A in the Asia-Pacific region (HAVEN 5). Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.
Wang S, Zhao X, Wang X, et al. A randomized, multicenter, open-label, phase III clinical trial to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in persons with hemophilia A in the Asia-Pacific region (HAVEN 5). Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.
Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979-987.
Shima M, Nogami K, Nagami S, et al. A multicentre, open-label study of emicizumab given every 2 or 4 weeks in children with severe haemophilia A without inhibitors. Haemophilia. 2019;25(6):979-987.
Jiménez-Yuste V, Klamroth R, Castaman G, et al. Second interim analysis results from the STASEY trial: a single-arm, multicenter, open-label, phase III clinical trial to evaluate the safety and tolerability of emicizumab prophylaxis in people with hemophilia A (PwHA) with FVIII inhibitors. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.
Jiménez-Yuste V, Klamroth R, Castaman G, et al. Second interim analysis results from the STASEY trial: a single-arm, multicenter, open-label, phase III clinical trial to evaluate the safety and tolerability of emicizumab prophylaxis in people with hemophilia A (PwHA) with FVIII inhibitors. Poster presented at: International Society on Thrombosis and Haemostasis 2020 Virtual Congress; July 12–14, 2020.
Callaghan M, Negrier C, Paz-Priel I, et al. Emicizumab treatment is efficacious and well tolerated long term in persons with haemophilia (PwHA) with or without FVIII inhibitors: pooled data from four HAVEN studies. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.
Callaghan M, Negrier C, Paz-Priel I, et al. Emicizumab treatment is efficacious and well tolerated long term in persons with haemophilia (PwHA) with or without FVIII inhibitors: pooled data from four HAVEN studies. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.
Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809-818.
Oldenburg J, Mahlangu JN, Kim B, et al. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017;377(9):809-818.
Young G, Liesner R, Sidonio R Jr, et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia A with inhibitors: results from the HAVEN 2 study. Presented at: ASH 60th Annual Meeting of the American Society of Hematology; December 1–4, 2018; San Diego, CA.
Young G, Liesner R, Sidonio R Jr, et al. Emicizumab prophylaxis provides flexible and effective bleed control in children with hemophilia A with inhibitors: results from the HAVEN 2 study. Presented at: ASH 60th Annual Meeting of the American Society of Hematology; December 1–4, 2018; San Diego, CA.
Di Minno A, Spadarella G, Nardone A, et al. Attempting to remedy sub-optimal medication adherence in haemophilia: the rationale for repeated ultrasound visualisations of the patient’s joint status. Blood Rev. 2019;33:106-119.
Di Minno A, Spadarella G, Nardone A, et al. Attempting to remedy sub-optimal medication adherence in haemophilia: the rationale for repeated ultrasound visualisations of the patient’s joint status. Blood Rev. 2019;33:106-119.
Rocino A, Franchini M, Coppola A. Treatment and prevention of bleeds in haemophilia patients with inhibitors to factor VIII/IX. J Clin Med. 2017;6(4):46.
Rocino A, Franchini M, Coppola A. Treatment and prevention of bleeds in haemophilia patients with inhibitors to factor VIII/IX. J Clin Med. 2017;6(4):46.
Schrijvers LH, Schuurmans MJ, Fischer K. Promoting self-management and adherence during prophylaxis: evidence-based recommendations for haemophilia professionals. Haemophilia. 2016;22(4):499-506.
Schrijvers LH, Schuurmans MJ, Fischer K. Promoting self-management and adherence during prophylaxis: evidence-based recommendations for haemophilia professionals. Haemophilia. 2016;22(4):499-506.
Manco-Johnson MM, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.
Manco-Johnson MM, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.
National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA®) for hemophilia A with and without inhibitors. December 6, 2018; New York, NY.
National Hemophilia Foundation. Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA®) for hemophilia A with and without inhibitors. December 6, 2018; New York, NY.
FDA approves Genentech’s HEMLIBRA (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors. [press release]. South San Francisco, CA: Genentech; October 4, 2018.
FDA approves Genentech’s HEMLIBRA (emicizumab-kxwh) for hemophilia A without factor VIII inhibitors. [press release]. South San Francisco, CA: Genentech; October 4, 2018.
Hoffmann-La Roche. A study to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in hemophilia A participants with inhibitors (HAVEN 1). https://clinicaltrials.gov/ct2/show/NCT02622321. NLM identifier: NCT02622321. Accessed August 25, 2020.
Hoffmann-La Roche. A study to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in hemophilia A participants with inhibitors (HAVEN 1). https://clinicaltrials.gov/ct2/show/NCT02622321. NLM identifier: NCT02622321. Accessed August 25, 2020.
Hoffmann-La Roche. A study of emicizumab administered subcutaneously (SC) in pediatric participants with hemophilia A and factor VIII (FVIII) inhibitors (HAVEN 2). https://clinicaltrials.gov/ct2/show/NCT02795767. NLM identifier: NCT02795767. Accessed August 25, 2020.
Hoffmann-La Roche. A study of emicizumab administered subcutaneously (SC) in pediatric participants with hemophilia A and factor VIII (FVIII) inhibitors (HAVEN 2). https://clinicaltrials.gov/ct2/show/NCT02795767. NLM identifier: NCT02795767. Accessed August 25, 2020.
Hoffmann-La Roche. A clinical trial to evaluate prophylactic emicizumab versus no prophylaxis in hemophilia A participants without inhibitors (HAVEN 3). https://clinicaltrials.gov/ct2/show/NCT02847637. NLM identifier: NCT02847637. Accessed August 25, 2020.
Hoffmann-La Roche. A clinical trial to evaluate prophylactic emicizumab versus no prophylaxis in hemophilia A participants without inhibitors (HAVEN 3). https://clinicaltrials.gov/ct2/show/NCT02847637. NLM identifier: NCT02847637. Accessed August 25, 2020.
Hoffmann-La Roche. A study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab given every 4 weeks in participants with hemophilia A (HAVEN 4). https://clinicaltrials.gov/ct2/show/NCT03020160. NLM identifier: NCT03020160. Accessed August 25, 2020.
Hoffmann-La Roche. A study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab given every 4 weeks in participants with hemophilia A (HAVEN 4). https://clinicaltrials.gov/ct2/show/NCT03020160. NLM identifier: NCT03020160. Accessed August 25, 2020.
Kruse-Jarres R, Callaghan MU, Croteau SE, et al. Surgical experience in two multicenter, open-label phase 3 studies of emicizumab in persons with hemophilia A with inhibitors (HAVEN 1 and HAVEN 2) [abstract]. Presented at: 59th Annual Meeting of the American Society of Hematology; December 9-12, 2017; Atlanta, GA.
Kruse-Jarres R, Callaghan MU, Croteau SE, et al. Surgical experience in two multicenter, open-label phase 3 studies of emicizumab in persons with hemophilia A with inhibitors (HAVEN 1 and HAVEN 2) [abstract]. Presented at: 59th Annual Meeting of the American Society of Hematology; December 9-12, 2017; Atlanta, GA.
Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018;379(9):811-822.
Mahlangu J, Oldenburg J, Paz-Priel I, et al. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018;379(9):811-822.
HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2019.
HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2019.
Santagostino E, Oldenburg J, Chang T, et al. Surgical experience from four phase III studies (HAVEN 1–4) of emicizumab in persons with haemophilia A (PwHA) with or without FVIII inhibitors. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.
Santagostino E, Oldenburg J, Chang T, et al. Surgical experience from four phase III studies (HAVEN 1–4) of emicizumab in persons with haemophilia A (PwHA) with or without FVIII inhibitors. Slide deck presented at: International Society on Thrombosis and Haemostasis 2019 Congress; July 6–10, 2019; Melbourne, Australia.
Sampei Z, Igawa T, Soeda T, et al. Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity. PLoS One. 2013;8(2):e57479.
Sampei Z, Igawa T, Soeda T, et al. Identification and multidimensional optimization of an asymmetric bispecific IgG antibody mimicking the function of factor VIII cofactor activity. PLoS One. 2013;8(2):e57479.
Santagostino E, Parnes A, Dhalluin C, et al. Surgical procedures in persons with haemophilia A (PwHA) without inhibitors receiving emicizumab – experience from the HAVEN 3 study. Presented at: 12th Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD); February 6–8, 2019; Prague, Czech Republic.
Santagostino E, Parnes A, Dhalluin C, et al. Surgical procedures in persons with haemophilia A (PwHA) without inhibitors receiving emicizumab – experience from the HAVEN 3 study. Presented at: 12th Annual Congress of the European Association of Haemophilia and Allied Disorders (EAHAD); February 6–8, 2019; Prague, Czech Republic.
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