Hemlibra 105 mg/.7mL
emicizumab · INJECTION, SOLUTION · Genentech, Inc.
Hemlibra is a injection, solution containing emicizumab at 105 mg/.7mL, taken subcutaneous. Manufactured by Genentech, Inc..
Key Facts
- Brand Name
- Hemlibra
- Generic Name
- emicizumab
- NDC Code (Product)
50242-922- Manufacturer
- Genentech, Inc.
- Strength
- 105 mg/.7mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761083
- Marketing Start
- 11/16/2017
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 (congenital factor VIII deficiency) with or without factor VIII inhibitors. HEMLIBRA is a bispecific factor IXa- and factor X-directed antibody 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. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended loading dose is 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by a maintenance dose of: 1.5 mg/kg once every week, or 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks. ( 2.1 ) See Full Prescribing Information for important preparation and administration instructions. ( 2.2 ) 2.1 Recommended Dosage For subcutaneous use only. The recommended loading dose is 3 mg/kg by subcutaneous injection once weekly for the first 4 weeks, followed by a maintenance dose of: 1.5 mg/kg once every week, or 3 mg/kg once every two weeks, or 6 mg/kg once every four weeks. The selection of a maintenance dose should be based on healthcare provider preference with consideration of regimens that may increase patient adherence. Discontinue the prophylactic use of bypassing agents the day before starting HEMLIBRA prophylaxis. The prophylactic use of factor VIII (FVIII) products may be continued during the first week of HEMLIBRA prophylaxis. Missed Dose If a dose of HEMLIBRA is missed administer as soon as possible and then resume usual dosing schedule. Do not administer two doses on the same day to make up for a missed dose. …
Contraindications
4 CONTRAINDICATIONS None. None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Hypercoagulability with Concomitant Use of aPCC Clinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC [see Warnings and Precautions (5.1 , 5.2) ] . 7.2 Drug-Laboratory Test Interactions HEMLIBRA restores the tenase cofactor activity of missing activated factor VIII (FVIIIa). Coagulation laboratory tests based on intrinsic clotting (i.e., aPTT) measure the total clotting time including time needed for activation of FVIII to FVIIIa by thrombin. Such intrinsic pathway-based tests will yield overly shortened clotting times with HEMLIBRA, which does not require activation by thrombin. The overly shortened intrinsic clotting time will then disturb all single-factor assays based on aPTT, such as the one-stage FVIII activity assay; however, single-factor assays utilizing chromogenic or immuno-based methods are unaffected by HEMLIBRA and may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays as described below. Chromogenic FVIII activity tests may be manufactured with either human or bovine coagulation proteins. Assays containing human coagulation factors are resp…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Thrombotic Microangiopathy Associated with HEMLIBRA and aPCC [see Warnings and Precautions (5.1) ] Thromboembolism Associated with HEMLIBRA and aPCC [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥ 10%) are injection site reactions, headache, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions are based on pooled data from two randomized trials in adult and adolescent patients (HAVEN 1 and HAVEN 3), one single-arm trial in adult and adolescent patients (HAVEN 4), one single-arm trial in pediatric patients (HAVEN 2), and one dose-finding trial, in which a total of 391 male patients with hemophilia A received at least one dose of HEMLIBR…
Frequently Asked Questions
What is Hemlibra used for?
Hemlibra contains emicizumab. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Hemlibra a controlled substance?
Hemlibra is not classified as a controlled substance by the DEA.
What is the generic name for Hemlibra?
The generic name for Hemlibra is emicizumab. There are no other listed brand versions of emicizumab.
What is the NDC code for Hemlibra 105 mg/.7mL?
The NDC (National Drug Code) for Hemlibra 105 mg/.7mL is 50242-922, listed by Genentech, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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