Drug updated on 9/4/2024
| Dosage Form | Injection (subcutaneous; 12 mg/0.4 mL, 30 mg/mL, 60 mg/0.4 mL, 105 mg/0.7 mL, 150 mg/mL) |
| Drug Class | Bispecific factor IXa- and factor X-directed antibodies |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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 (congenital factor VIII deficiency) with or without factor VIII inhibitors.
Latest News
Summary
- Hemlibra (emicizumab) is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients, from newborns and older, with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Emicizumab prophylaxis demonstrated superior efficacy compared to FVIII prophylaxis in reducing total treated bleed rates, with a rate ratio (RR) of 0.36 (95% CrI: 0.13-0.95), and consistent findings in subgroup analyses with RR values of 0.380 (95% CI: 0.186-0.790) and 0.472 (95% CI: 0.258-0.866).
- Emicizumab maintained a consistent pharmacokinetic profile across various subgroups, including those defined by FVIII inhibitor status, age groups (children, adolescents, adults), and dosing intervals, with moderate variability in trough concentrations (32%), suggesting the potential for lower dosing without compromising efficacy.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Hemlibra (emicizumab) Prescribing Information. | 2022 | Genentech, Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Pharmacokinetics and associated efficacy of emicizumab in humans: a systematic review. | 2021 | Clinical Pharmacokinetics |
| Efficacy of emicizumab prophylaxis versus factor VIII prophylaxis for treatment of hemophilia A without inhibitors: network meta-analysis and sub-group analyses of the intra-patient comparison of the HAVEN 3 trial. | 2019 | Current Medical Research and Opinion |