Altuviiio

Generic name: antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
Drug class: Miscellaneous coagulation modifiers

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 30, 2023.

What is Altuviiio?

Altuviiio is a once-weekly recombinant factor VIII replacement therapy that can be used by Hemophilia A patients routinely to prevent bleeding, or used on-demand to treat an acute bleed. Altuviiio works as a replacement for the missing coagulation factor VIII that hemophilia A patients need for effective blood clotting, so Altuviiio lowers their risk of bleeding.

Hemophilia is a genetic disorder that impairs the ability of a person’s blood to clot correctly, this leads to excessive and unexpected bleeding. Hemophilia A is caused by a missing or defective clotting protein called factor VIII (FVIII), which means the blood does not clot when it needs to.  Patients with severe hemophilia A can have excessive spontaneous bleeds without apparent cause, this can be bleeding inside the body or outside the body. Patients with milder hemophilia A are likely only to have significant bleeding if they have surgery or after severe injury. 

Altuviio is given as a weekly infusion to hemophilia A patients, as a replacement for their missing or defective factor VIII clotting protein, to decrease their risk of bleeding  

Altuviiio is a first-in-class FDA-approved high-sustained factor VIII replacement therapy that is given as a once-weekly intravenous infusion. FDA approval was supported by data from the Phase 3 XTEND-1 study (NCT04161495) and XTEND-Kids study (NCT04759131).

How does Altuviiio work?

Altuviiio  (antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl) is a recombinant or man-made factor VIII (FVIII) replacement therapy that is independent of von Willebrand factor (VWF). Because Altuviiio is independent of VWF, its half-life is increased 3 to 4 times more than other standard and extended half-life FVIII products. This means Altuviiio is longer lasting and has a simplified dosing schedule of only once a week.

Related/similar drugs

tranexamic acid, desmopressin, Cyklokapron, DDAVP, Hemlibra, antihemophilic factor

Who can use Altuviiio?

Altuviiio is FDA-approved to be used in adults and children 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 is not indicated for the treatment of von Willebrand disease.

Warnings

Hypersensitivity Reactions: Allergic-type hypersensitivity reactions, including anaphylaxis, may occur using Altuviiio. Tell your doctor if you have any signs of an allergic reaction including, shortness of breath, wheezing, hives, chest tightness, hypotension, and itching. If you have hypersensitivity symptoms, you should discontinue the use of this medicine and contact a physician and/or seek immediate emergency care.

Important information

Neutralizing Antibodies: Formation of neutralizing antibodies to FVIII is possible after using Altuviiio. If bleeding is not controlled or plasma Factor VIII levels do not increase as expected, testing for neutralizing antibodies should be performed.

What should I tell my doctor before receiving Altuviiio?

Tell your doctor if you have had allergic reaction to Altuviiio is the past. Do not use Altuviiio is you have had a severe hypersensitivity reactions, including anaphylaxis, to Altuviiio or inactive ingredients contained in this medicine.

Pregnancy

• Tell your healthcare professional if you are planning to become pregnant or are pregnant. 
• It is not known if this medicine can affect reproductive capacity or cause fetal harm when given to pregnant women.

Breastfeeding

• Tell your healthcare professional if you are planning to breastfeed or are breastfeeding .
• It is not known if Altuviiio passes into breast milk, its effects on the breastfed infant, or its effects on milk production. 
• Talk to your healthcare provider about the best way to feed your baby while using this  medicine.

How will I receive Altuviiio?

Altuviiio is given as an intravenous infusion into your vein.

The infusion rate is dependent on the dose you will receive and  your age.

Dosing information

Altuviiio dose for:

Routine prophylaxis (adults and children) 

• once weekly.

On-demand Treatment and Control of Bleeding Episodes

• dose is dependant on type of bleeding (minor, moderate or major)
• initially a single dose with an additional dose every 2 to 3 days may be considered.

Perioperative management

• dose is dependant on type of surgery (minor or major)
• initially a single dose with an additional dose every 2 to 3 days may be considered if clinically necessary.

Available strenths of Altuviiio

Altuviiio strength is in international units (IU) of Factor VIII potency.

Altuviiio is available in the following strengths:

• 250 IU 
• 500 IU
• 750 IU 
• 1000 IU 
• 2000 IU 
• 3000 IU 
• 4000 IU

What are the side effects of Altuviiio ?

Most common Altuviiio side effects are: 

• headache and 
• arthralgia.

Storage

Storage Prior to reconstitution:

• Store in the original package to protect vials from light.
• Store Altuviiio in powder form at 2°C to 8°C (36°F to 46°F). Do not freeze to avoid damage to the prefilled diluent syringe.
• Altuviiio may be stored at room temperature, not to exceed 30°C (86°F), for a single period of up to 6 months, within the expiration date printed on the label.
• If  Altuviiio in powder is stored at room temperature, record the date on the carton when it was  removed from refrigeration. After storage at room temperature, do not return the product to the refrigerator.
• Do not use beyond the expiration date printed on the vial, or 6 months after the date that was written on the carton, if it had been removed front he refrigerator, whichever is earlier.

Storage After Reconstitution:

• The reconstituted product may be stored at room temperature, not to exceed 30°C (86°F), for up to 3 hours.
• Protect from direct sunlight. 
• After reconstitution, if the product is not used within 3 hours, it must be discarded.
• Do not use this medicine if the reconstituted solution is cloudy or has particulate matter.
• Discard any unused Altuviiio. 

Manufacture

Bioverativ Therapeutics Inc. Waltham, MA 02451.

A Sanofi Company.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer