General Information

Altuviiio [antihemophilic factor (recombinant) is a recombinant DNA-derived, Factor VIII concentrate.

Altuviiio is specifically 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

Altuviiio is suppled as a lyophilized powder for solution, for intravenous use. Each Altuviiio vial label states Factor VIII activity in international units (IU or unit). 

• For routine prophylaxis: 50 IU/kg once weekly. 
• For on-demand treatment and control of bleeding episodes and perioperative management: 50 IU/kg. Estimated Increment of Factor VIII (IU/dL or % of normal) = 50 IU/kg x 2 (IU/dL per IU/kg.) 

To achieve a specific target Factor VIII activity level, use the following formula: Dosage (IU) = Body Weight (kg) x Desired Factor VIII Increase (IU/dL or % normal) x 0.5 (IU/kg per IU/dL).

Mechanism of Action

Altuviiio [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] temporarily replaces the missing coagulation factor VIII needed for effective hemostasis. Altuviiio has demonstrated 3- to 4-fold prolonged half-life relative to other standard and extended half-life FVIII products.

Side Effects

Side effects associated with the use of Altuviiio may include, but are not limited to, the following:

• headache
• arthralgia

Clinical Trial Results

The FDA approval of Altuviiio was based on data from the pivotal XTEND-1 Phase 3 study. Once-weekly Altuviiio prophylaxis met the primary endpoint, providing significant bleed protection for people with severe hemophilia A with a mean annualized bleeding rate (ABR) of 0.70  and a median ABR of 0.0.  Altuviiio met the key secondary endpoint with a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison.

Additional data showed prevention of joint bleeds with a median annualized joint bleeding rate of 0. Treatment with Altuviiio provided 100% resolution of target joints, which are joints that have recurrent bleeds (e.g., knee, ankle, or elbow). Altuviiio provided mean factor VIII activity greater than 40% for most of the week and greater than 10% at Day 7; these levels were associated with a low bleed risk. 

Additionally, interim data from XTEND-Kids showed that children younger than 12 years of age receiving once-weekly Altuviiio for 26 weeks (n=23) experienced a mean ABR of 0.5 and a median ABR of 0.