Quick answers
- What is Emicizumab used for?
- The FDA-approved label (Hemlibra, Genentech, Inc., July 11, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Emicizumab have a boxed warning?
- Yes. The FDA label for Hemlibra has a boxed warning (“WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Emicizumab?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Emicizumab been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Emicizumab?
- 1 company lists prescription products of Emicizumab in the FDA NDC Directory, including Genentech, Inc..
What Emicizumab is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Hemlibra, Genentech, Inc., effective July 11, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: THROMBOTIC MICROANGIOPATHY AND THROMBOEMBOLISM
. Read it on the full label →
Forms and how it is given
| Dosage forms | Injection, solution |
|---|---|
| Route | Subcutaneous |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Hemlibra |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Genentech, Inc.6 products
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA761083 HEMLIBRA | Genentech Inc | November 16, 2017 | 7, latest July 8, 2025 2025: Labeling · 2024: Labeling · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Hemlibra, Genentech, Inc., effective July 11, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →