Prescription medicine
Emicizumab Brand names: Hemlibra
Emicizumab (Hemlibra) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the emicizumab FDA label on DailyMed (effective July 11, 2025, Genentech, Inc.); the BLA 761083 record on Drugs@FDA; every emicizumab label on DailyMed.
Highlights of the record
FDA label of July 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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 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. WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM See full prescribing information for complete boxed warning. 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.
Used for
From the label: indications and usageHEMLIBRA 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.
Forms and strengths
- 12 mg/.4ml
- 30 mg/ml
- 60 mg/.4ml
- 105 mg/.7ml
- 150 mg/ml
- 300 mg/2ml
Injection (solution).
On the market
- Earliest approval on file
- November 16, 2017 Hemlibra, Genentech Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 12,284 through July 30, 2026
What is emicizumab used for?
From the label: indications and usageHEMLIBRA 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.
Source: FDA drug label (Hemlibra), Genentech, Inc., effective July 11, 2025 (SPL set 2483adba-fab6-4d1b-96c5-c195577ed071), via openFDA; the full label on DailyMed
What does the patient leaflet for emicizumab say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about HEMLIBRA?HEMLIBRA increases the potential for your blood to clot. Carefully follow your healthcare provider's instructions regarding when to use an on-demand bypassing agent or factor VIII (FVIII) and the recommended dose and schedule to use for breakthrough bleed treatment. HEMLIBRA may cause the following serious side effects when used with activated prothrombin complex concentrate (aPCC; FEIBA ® ), including: Thrombotic microangiopathy (TMA). This is a condition involving blood clots and injury to small blood vessels that may cause harm to your kidneys, brain, and other organs. Get medical help right away if you have any of the following signs or symptoms during or after treatment with HEMLIBRA: confusion weakness swelling of arms and legs yellowing of skin and eyes stomach (abdomen) or back pain nausea or vomiting feeling sick decreased urination Blood clots (thrombotic events). Blood clots may form in blood vessels in your arm, leg, lung, or head. Get medical help right away if you have any of these signs or symptoms of blood clots during or after treatment with HEMLIBRA: swelling in arms or legs pain or redness in your arms or legs shortness of breath chest pain or tightness fast heart rate cough up blood feel faint headache numbness in your face eye pain or swelling trouble seeing If aPCC (FEIBA ® ) is needed, talk to your healthcare provider in case you feel you need more than 100 U/kg of aPCC (FEIBA ® ) total. Your body may make antibodies against HEMLIBRA, which may stop HEMLIBRA from working properly. Contact your healthcare provider immediately if you notice that HEMLIBRA has stopped working for you (e.g., increase in bleeds). See " What are the possible side effects of HEMLIBRA? " for more information about side effects.
From the patient leaflet: How should I store HEMLIBRA?Store HEMLIBRA in the refrigerator at 36°F to 46°F (2°C to 8°C). Do not freeze. Store HEMLIBRA in the original carton to protect the vials from light. Do not shake HEMLIBRA. If needed, unopened vials of HEMLIBRA can be stored out of the refrigerator and then returned to the refrigerator. HEMLIBRA should not be stored out of the refrigerator for more than a total of 7 days or at a temperature greater than 86°F (30°C). After HEMLIBRA is transferred from the vial to the syringe, HEMLIBRA should be used right away. Throw away (dispose of) any unused HEMLIBRA left in the vial. Keep HEMLIBRA and all medicines out of the reach of children.
Source: FDA drug label (Hemlibra), Genentech, Inc., effective July 11, 2025 (SPL set 2483adba-fab6-4d1b-96c5-c195577ed071), via openFDA; the full label on DailyMed
Is there a generic for emicizumab (Hemlibra)?
No generic emicizumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the emicizumab label say about other medicines?
The emicizumab label names no other medicine on this site. The labels of 1 other medicine name emicizumab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name emicizumab
Source: FDA drug label (Hemlibra), Genentech, Inc., effective July 11, 2025 (SPL set 2483adba-fab6-4d1b-96c5-c195577ed071), via openFDA; the full label on DailyMed
What do FAERS reports show for emicizumab?
The FDA Adverse Event Reporting System holds 12,284 reports that list emicizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 393 are coded as a death and 1,944 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (3,633, against a median of 527 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Emicizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other