Altuviiio Generic Name & Formulations
Kit—1 (single-dose vial + diluent, adapter)
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.
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 Boxed Warnings
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.
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 Adverse Reactions
Headache, arthralgia; hypersensitivity reactions.
Altuviiio Clinical Trials
Altuviiio Patient Counseling