For Patients & Caregivers

In Pediatric Patients

HEMLIBRA was studied in pediatric hemophilia A patients with and without factor VIII inhibitors1,5

HEMLIBRA® (emicizumab-kxwh) Pediatric Patients Graphic

Children with inhibitors4
n=88
1.5 mg/kg QW, 3 mg/kg Q2W, or 6 mg/kg Q4W

“The decision to prescribe HEMLIBRA was made together with the patient’s family. They were excited about a subcutaneous option and the potential for better efficacy and less bleeding.”

—Michael Callaghan, MD, Children’s Hospital of Michigan

Starting early Patients with inhibitors Patients without inhibitors
Starting early

Starting prophylaxis at a young age helps prevent breakthrough bleeds17

HEMLIBRA® (emicizumab-kxwh) Pediatric Patients Joint

Breakthrough bleeds impact patients in several ways.17-19

  • Clinical bleeds and subclinical bleeds can both result in increased joint damage over time
  • Repeated bleeds can cause irreversible damage, leading to chronic pain and arthropathy, even in early childhood
  • A single serious bleed can cause new bleeds to occur in a damaging cycle

Prophylactic FVIII in young boys (≤6 years of age) with severe hemophilia A reduced the risk of joint damage by 83% vs on-demand treatment*20

Percentage of patients observed at 6 years of age with normal ankle, knee, and elbow joints 

 

Based on a randomized trial (N=65) with a mean observation period of 49 months.

*Results from a multicenter, randomized, open-label trial of young boys (<30 months old) with severe hemophilia A without inhibitors randomized to regular prophylactic recombinant FVIII infusions or to an enhanced episodic infusion schedule. Clinical assessments of index joints were performed with plain-film x-rays or magnetic resonance imaging at age 6.20

The MASAC recommendations discuss using HEMLIBRA early on in hemophilia A patients experiencing bleeds13,21

  • MASAC recommends that prophylaxis be considered optimal therapy for individuals with severe hemophilia A and should be instituted early (prior to the onset of frequent bleeding)
  • MASAC further recommends that infants should be considered for prophylaxis with HEMLIBRA at any time after birth, given the increased risk of intracranial hemorrhage prior to initiation of FVIII prophylaxis
    • There are no data on HEMLIBRA in the context of intracranial hemorrhage
  • There are limited data on the use of HEMLIBRA in infants under 6 months of age, and the pharmacokinetic exposure is likely to be lower compared with older infants and children
    • In pediatric patients less than 6 months old, the predicted concentrations of HEMLIBRA were 19% to 33% lower than in the older patients, especially with the 3 mg/kg Q2W or 6 mg/kg Q4W maintenance doses1
Patients with inhibitors

Additional HEMLIBRA data for pediatric patients with FVIII inhibitors22:

  • 70% of patients receiving HEMLIBRA Q2W (3 mg/kg) had zero treated bleeds
  • 60% of patients receiving HEMLIBRA Q4W (6 mg/kg) had zero treated bleeds
  • The ABRs* were 0.2 (95% CI: 0.06; 0.54) for the Q2W arm and 1.8 (95% CI: 0.32; 10.59) for the Q4W arm
  • The median efficacy periods were 67.1 weeks (54.7-129.4) for the Q2W arm (n=10) and 66.6 weeks (8.1-140.4) for the Q4W arm (n=10)
  • HAVEN 2 was designed to be a descriptive study

HEMLIBRA prophylaxis showed improvement at 25 weeks from baseline in physical health score.1

The HAVEN 2 study evaluated patient-reported hemophilia-related symptoms (painful swellings and presence of joint pain) and physical functioning (pain with movement) using the Physical Health Score of the Hemophilia-specific Quality of Life Short Form (Haemo-QoL-SF) questionnaire for patients ≥8 to <12 years of age.

ABRs shown are for treated bleeds.
*ABR was calculated with a negative binomial regression model, accounting for the different follow-up times.

Intra-patient data for pediatric patients with FVIII inhibitors taking HEMLIBRA

67% of pediatric patients receiving HEMLIBRA had zero treated bleeds vs 7% on prior BPAs.4

HAVEN 2†: Individual patient ABR at a median study duration of 89 weeks in QW cohort (N=15)‡4

INTRA-INDIVIDUAL COMPARISON

  • HAVEN 2 intra-patient comparison was not prespecified to show superiority in ABR vs prior BPAs

ABRs shown are for treated bleeds.
†Based on HAVEN 2: Non-randomized, multicenter, open-label clinical trial in pediatric patients (age <12 years, or 12–17 years who weigh <40 kg) with hemophilia A with FVIII inhibitors. All patients received HEMLIBRA prophylaxis at 3 mg/kg QW for the first 4 weeks. Sixty-eight patients received 1.5 mg/kg QW, 10 patients received 3 mg/kg Q2W, and 10 patients received 6 mg/kg Q4W thereafter.4

‡A comparison of data from HAVEN 2 vs data in the NIS prior to enrollment.

Intraindividual comparison of 15 participants who previously took BPA prophylaxis showed that emicizumab prophylaxis reduced the ABR by 99% (95% CI: 97.4; 99.4).4

Patients without inhibitors

Most patients on HEMLIBRA had zero bleeds requiring treatment, regardless of dosing option

  • HAVEN 2: 77% of pediatric patients with FVIII inhibitors taking HEMLIBRA QW (n=65) had zero treated bleeds4
  • HAVEN 4*: 56% of adults and adolescents with or without FVIII inhibitors taking HEMLIBRA Q4W (n=41) had zero treated bleeds1

As observed over at least 52 weeks (HAVEN 2) and at least 24 weeks (HAVEN 4).1,4
*Based on HAVEN 4: A single-arm, multicenter, open-label trial in 41 adult and adolescent males with hemophilia A with or without FVIII inhibitors who previously received either on-demand or prophylactic treatment with FVIII or BPAs. All patients received HEMLIBRA prophylaxis at 3 mg/kg QW for the first 4 weeks followed by 6 mg/kg Q4W thereafter.1

HOHOEMI†: A multicenter, open-label study of pediatric patients without FVIII inhibitors5

  • Patients were <12 years old
  • One patient in the Q4W cohort who was 4 months old had never been treated with FVIII
  • This trial had a limited sample size (N=13) and was conducted in Japan
  • HOHOEMI was a descriptive study with no formal hypothesis testing

HEMLIBRA Q2W prophylaxis

1.3 ABR‡

(95% Cl: 0.6; 2.9)
(n=6)

HEMLIBRA Q4W prophylaxis

0.7 ABR‡

(95% Cl: 0.2; 2.6)
(n=7)

In a safety analysis of the HOHOEMI study:5

  • The most common adverse reactions were contusion (n=10), nasopharyngitis (n=5), excoriation (n=4), and falls (n=4)
  • Two serious adverse events were reported, which consisted of bleeding from soft tissue surrounding a right knee and pain from bruised lower leg, both of which were unrelated to HEMLIBRA

†HOHOEMI was a non-randomized study in pediatric patients (Japanese children <12 years) with hemophilia A without FVIII inhibitors. All patients received HEMLIBRA prophylaxis at 3 mg/kg once weekly for the first 4 weeks. Six patients received 3 mg/kg Q2W an 7 patients received 6 mg/kg Q4W thereafter.5
‡ABR was calculated with a negative binomial regression model, accounting for the different follow-up times.
ABRs shown are for treated bleeds.

Frequently Asked Questions

Get your questions about HEMLIBRA answered

Get the Facts

ABR=annualized bleed rate. ABR calculated with a negative binomial regression model, which accounts for different follow-up times; BPA=bypassing agent; CI=confidence interval; FVIII=factor VIII; MASAC=Medical and Scientific Advisory Council; NIS=non-interventional study; QW=once weekly; Q2W=once every 2 weeks; Q4W=once every 4 weeks.

Doctor Discussion Guide

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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.

    • HEMLIBRA package insert. South San Francisco, CA: Genentech, Inc.; 2023.

      HEMLIBRA package insert. South San Francisco, CA: Genentech, Inc.; 2023.

    • Data on File. Genentech, Inc.

      Data on File. Genentech, Inc.

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      Shima M, Nagao A, Taki M, et al. Long-term safety and efficacy of emicizumab for up to 5.8 years and patients’ perceptions of symptoms and daily life: A phase 1/2 study in patients with severe haemophilia A. Haemophilia. 2021;27(1):81​-89. doi:10.1111/hae.14205

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      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. doi:10.1182/blood.2019001869

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      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. doi:10.1111/hae.13848

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      Négrier C, Mahlangu J, Lehle M, et al. Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study. Lancet Haematol. 2023;10(3):e168-e177. doi:10.1016/S2352​-3026(22)00377-5

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      Pipe S, Collins P, Dhalluin C, et al. Emicizumab prophylaxis for the treatment of infants with severe hemophilia A without factor VIII inhibitors: results from the primary analysis of the HAVEN 7 study. Slide deck presented at: 65th Ash Annual Meeting, December 9-12, 2023.

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      Jiménez-Yuste V, Peyvandi F, Klamroth R, et al. Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY). Res Pract Thromb Haemost. 2022;6(8):e12837. Published 2022 Nov 14. doi:10.1002/rth2.12837

    • https://clinicaltrials.gov/ct2/show/NCT03315455. NLM identifier: NCT03315455. Accessed February 28, 2023.

      https://clinicaltrials.gov/ct2/show/NCT03315455. NLM identifier: NCT03315455. Accessed February 28, 2023.

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      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. doi:10.1160/TH17-01-0030

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      Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Supplementary materials. Blood. 2021;137(16):2231​​-2242. doi:10.1182/blood.2020009217

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      Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Blood. 2021;137(16):2231​​-2242. doi:10.1182/blood.2020009217

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      National Bleeding Disorders Foundation. MASAC Document 268: Recommendation on the use and management of emicizumab-kxwh (HEMLIBRA) for hemophilia A with and without inhibitors. April 27, 2022; New York, NY.

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      Mahlangu J, Jiménez-Yuste V, Ventriglia G, et al. Long-term outcomes with emicizumab prophylaxis for severe haemophilia A without FVIII inhibitors: safety and efficacy analyses from HAVEN 3 & 4. Poster presented at: The European Association for Haemophilia and Allied Disorders (EAHAD) Annual Meeting 2023; February 7​-10, 2023; Manchester, United Kingdom.

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      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.

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      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. doi:10.1016/j.blre.2018.08.003

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      National Bleeding Disorders Foundation. MASAC Document 267: MASAC Recommendation Concerning Prophylaxis for Hemophilia A and B with and without Inhibitors. April 27, 2022; New York, NY.

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      Pipe SW, Shima M, Lehle M, et al. Efficacy, safety, and pharmacokinetics of emicizumab prophylaxis given every 4 weeks in people with haemophilia A (HAVEN 4): a multicentre, open-label, non-randomised phase 3 study. Lancet Haematol. 2019;6(6):e295​-e305.

    • HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2022.

      HEMLIBRA Summary of Product Characteristics. Roche Registration Limited; 2022.

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      Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Blood Adv. 2022;6(24):6140​​-6150. doi:10.1182/bloodadvances.2022007458

    • Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Supplementary materials. Blood Adv. 2022;6(24):6140​​-6150. doi:10.1182/bloodadvances.2022007458

      Kruse-Jarres R, Peyvandi F, Oldenburg J, et al. Surgical outcomes in people with hemophilia A taking emicizumab prophylaxis: experience from the HAVEN 1-4 studies. Supplementary materials. Blood Adv. 2022;6(24):6140​​-6150. doi:10.1182/bloodadvances.2022007458

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      HEMLIBRA Instructions For Use. Roche Registration Limited; 2022.

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