Prescription medicine
Concizumab Brand names: Alhemo
Concizumab (Alhemo) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the concizumab FDA label on DailyMed (effective July 1, 2025); the BLA 761428 record on Drugs@FDA; every concizumab label on DailyMed.
Highlights of the record
FDA label of July 1, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAlhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors
hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophyla
Forms and strengths
- 40 mg/ml
- 100 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- July 31, 2025 Alhemo, Novo Nordisk Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- 37 through July 30, 2026
What is concizumab used for?
From the label: indications and usageAlhemo is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors
hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors Alhemo is a tissue factor pathway inhibitor (TFPI) antagonist indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with:
hemophilia A (congenital factor VIII deficiency) with or without FVIII inhibitors
hemophilia B (congenital factor IX deficiency) with or without FIX inhibitors […]
FDA pharmacologic class: Tissue Factor Pathway Inhibitor Antagonist.
Source: FDA drug label (Alhemo), Novo Nordisk, effective July 1, 2025 (SPL set 156f6404-1f6f-417f-bcf8-f07a27a82cc1), via openFDA; the full label on DailyMed
What does the patient leaflet for concizumab 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 Alhemo?It is important to follow the daily dosing schedule of Alhemo to stay protected against bleeding. This is especially important during the first 4 weeks of treatment to make sure a correct maintenance dose is established. Use Alhemo exactly as prescribed by your healthcare provider. Do not stop using Alhemo without talking to your healthcare provider. If you miss doses, or stop using Alhemo, you may no longer be protected against bleeding. • Your healthcare provider may prescribe factor VIII, factor IX or bypassing agents during treatment with Alhemo. Carefully follow your healthcare provider’s instructions regarding when to use on-demand factor VIII, factor IX or bypassing agents, and the recommended dose and schedule for breakthrough bleeds. See “How should I use Alhemo?” for more information on how to use Alhemo.
From the patient leaflet: How should I store Alhemo?Before first use: o Store unused Alhemo pens in the refrigerator between 36°F to 46°F (2°C to 8°C). • After first use: o Store the Alhemo pen in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature below 86°F (30°C) for up to 28 days. o Write the date of first use in the space provided on the carton. o Throw away (discard) the Alhemo pen 28 days after first opening even if some medicine is left in the pen. • Store Alhemo with the cap on and keep it in the original carton to protect from light. • Do not store Alhemo in direct sunlight and keep away from direct heat. • When stored in the refrigerator, do not store the pen directly next to the cooling element (the part that cools the refrigerator). • Do not freeze Alhemo. • Do not use Alhemo if it has been frozen or if it has been stored above 86°F (30°C). Keep Alhemo and all medicine out of the reach of children.
Source: FDA drug label (Alhemo), Novo Nordisk, effective July 1, 2025 (SPL set 156f6404-1f6f-417f-bcf8-f07a27a82cc1), via openFDA; the full label on DailyMed
Is there a generic for concizumab (Alhemo)?
No generic concizumab is approved (Drugs@FDA, October 8, 2026).
- 2025 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for concizumab?
The FDA Adverse Event Reporting System holds 37 reports that list concizumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2 are coded as a death and 14 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Concizumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other