• Bleeding disorders

Altuviiio Generic Name & Formulations

General Description

Antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl; 250 IU, 500 IU, 750 IU, 1000 IU, 2000 IU, 3000 IU, 4000 IU; per vial; lyophilized pwd for IV inj after reconstitution.

Pharmacological Class

Recombinant FVIII analogue fusion protein.

How Supplied

Kit—1 (single-dose vial + diluent, adapter)


Generic Availability


Mechanism of Action

Antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl temporarily replaces the missing coagulation factor VIII needed for effective hemostasis. Appending the D’D3 domain of VWF to a recombinant FVIII-Fc fusion protein provides protection and stability to FVIII, and prevents FVIII interaction with endogenous VWF, thus overcoming the limitation on FVIII half-life imposed by VWF clearance. The 2 XTEN polypeptides alter the hydrodynamic radius of the fusion protein, thus reducing rates of clearance and degradation, and improving pharmacokinetic properties.

Altuviiio Indications


In patients with Hemophilia A: for on-demand treatment and control of bleeding episodes, for perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.

Limitations of Use

Not for von Willebrand disease. 

Altuviiio Dosage and Administration

Adults and Children

Dosage Required (IU) = Body Weight (kg) x Desired Factor VIII Increase (IU/dL or % normal) x 0.5 (IU/kg per IU/dL). Individualize. Give as IV inj at max rate of 6mins/vial (<20kg); 2–3mins/vial (≥20kg); 1–2mins/vial (adults and adolescents). Routine prophylaxis: 50 IU/kg once weekly. On-demand (Minor and moderate): 50 IU/kg once; use 30 IU/kg if bleeding episode occurs within 2–3 days after prophylactic dose; may consider additional doses of 30 or 50 IU/kg every 2–3 days; (Major): 50 IU/kg once; may consider additional doses of 30 or 50 IU/kg every 2–3 days. May resume prophylaxis after ≥72 hours interval. Perioperative (Minor): 50 IU/kg once; may consider additional doses of 30 or 50 IU/kg after 2–3 days; (Major): 50 IU/kg once; may give additional doses of 30 or 50 IU/kg every 2–3 days, as clinically needed.

Altuviiio Contraindications

Not Applicable

Altuviiio Boxed Warnings

Not Applicable

Altuviiio Warnings/Precautions


Discontinue if hypersensitivity reactions (eg, anaphylaxis) occur. Neutralizing antibodies formation. Monitor for development of FVIII inhibitors. If bleeding uncontrolled and FVIII activity plasma levels not attained, perform assay to determine presence of FVIII inhibitors. Pregnancy. Nursing mothers. 

Altuviiio Pharmacokinetics


Half-life: 48.2 hours (adults), 44.6 hours (12–<18 years), 42.4 hours (6–<12 years), 39.9 hours (1–<6 years). 

Altuviiio Interactions

Not Applicable

Altuviiio Adverse Reactions

Adverse Reactions

Headache, arthralgia; hypersensitivity reactions. 

Altuviiio Clinical Trials

See Literature

Altuviiio Note

Not Applicable

Altuviiio Patient Counseling

See Literature