Prescription medicine
Antihemophilic factor and fc-vwf-xten fusion protein-ehtl Brand names: Altuviiio
Antihemophilic factor and fc-vwf-xten fusion protein-ehtl (Altuviiio) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the antihemophilic factor and fc-vwf-xten fusion protein-ehtl FDA label on DailyMed (effective February 23, 2026); every antihemophilic factor and fc-vwf-xten fusion protein-ehtl label on DailyMed.
Highlights of the record
FDA label of February 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, Factor VIII concentrate indicat
Forms and strengths
Kit.
On the market
- 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
- 1,318 through July 30, 2026
What is antihemophilic factor and fc-vwf-xten fusion protein-ehtl used for?
From the label: indications and usageALTUVIIIO is indicated for use in adults and pediatric patients with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment and control of bleeding episodes Perioperative management of bleeding ALTUVIIIO [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a recombinant DNA-derived, Factor VIII concentrate indicated for use in adults and children with hemophilia A (congenital factor VIII deficiency) for: Routine prophylaxis to reduce the frequency of bleeding episodes On-demand treatment & control of bleeding episodes Perioperative management of bleeding ( 1 ) Limitation of Use: ALTUVIIIO is not indicated for the treatment of von Willebrand disease. […]
Source: FDA drug label (ALTUVIIIO), Bioverativ Therapeutics Inc., effective February 23, 2026 (SPL set 01411972-df40-4ccf-88f0-d3220e5abda9), via openFDA; the full label on DailyMed
What does the patient leaflet for antihemophilic factor and fc-vwf-xten fusion protein-ehtl 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 need to know about ALTUVIIIO?Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider's instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.
From the patient leaflet: How should I store ALTUVIIIO?Keep ALTUVIIIO in its original package. Protect it from light. Do not freeze. Store refrigerated 2°C to 8°C (36°F to 46°F) up to 48 months or at room temperature [not to exceed 30°C (86°F)], for a single period up to 6 months. Do not use ALTUVIIIO after the expiration date printed on the label and carton of each vial. When storing at room temperature: – Note on the carton the date on which the product is removed from refrigeration. – Use the product before the end of this 6-month period or discard it. – Do not return the product to the refrigerator. After mixing with the diluent: Do not use ALTUVIIIO if the mixed solution is not clear and colorless to slightly yellowish. Use mixed product as soon as possible. You may store mixed ALTUVIIIO at room temperature, not to exceed 30°C (86°F), for up to 3 hours. Protect the mixed ALTUVIIIO from direct sunlight. […]
Source: FDA drug label (ALTUVIIIO), Bioverativ Therapeutics Inc., effective February 23, 2026 (SPL set 01411972-df40-4ccf-88f0-d3220e5abda9), via openFDA; the full label on DailyMed
Is there a generic for antihemophilic factor and fc-vwf-xten fusion protein-ehtl (Altuviiio)?
No generic antihemophilic factor and fc-vwf-xten fusion protein-ehtl is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for antihemophilic factor and fc-vwf-xten fusion protein-ehtl?
The FDA Adverse Event Reporting System holds 1,318 reports that list antihemophilic factor and fc-vwf-xten fusion protein-ehtl among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 144 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 received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Antihemophilic factor and fc-vwf-xten fusion protein-ehtl side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other