Bleeding disorders:

Indications for: ALTUVIIIO

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. 

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 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 Classification:

Recombinant FVIII analogue fusion protein.

Adverse Reactions:

Headache, arthralgia; hypersensitivity reactions. 

Drug Elimination:

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

Generic Drug Availability:

NO

How Supplied:

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