ALTUVIIIO® Dosing Regimen | Sanofi

Simple dosing for all your patients' needs

Recommended dose 50 IU/kg¹

Perform infusion slowly over 1 to 10 minutes, based on the patient's comfort level.

Prophylaxis

For routine prophylaxis in adults, adolescents, and children, 50 IU/kg administered once weekly

On-Demand Bleed Resolution

For on-demand bleed resolution, a single dose of 50 IU/kg
For minor/moderate bleeding episodes within 2 to 3 days after prophylactic dose, 30 IU/kg dose may be used
For minor/moderate/ major bleeding episodes, additional doses of  30 IU/kg or 50 IU/kg every 2 to 3 days may be considered

Perioperative Management

For perioperative management, a single dose of 50 IU/kg
For minor surgery, an additional postoperative dose of 30 IU/kg or 50 IU/kg after 2 to 3 days may be considered
For major surgery, additional postoperative doses of 30 IU/kg or 50 IU/kg every 2 to 3 days may be administered as clinically needed

Select storage requirements¹

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. After storage at room temperature, do not return the product to the refrigerator.

Store ALTUVIIIO in the original package to protect vials from light.

Discard ALTUVIIIO if it is not used within 3 hours of reconstitution, if solution is cloudy or has particulate matter, or any drug is unused.

For additional information on storage, please see Section 16 of the Prescribing Information.

Dosage strengths¹

ALTUVIIIO is available in 6 vial strengths to optimize administration.
These include single-dose vials containing nominally 250, 500, 1000, 2000, 3000, or 4000 international units (IU) per vial.

There’s no need for routine pharmacokinetic testing with ALTUVIIIO¹

Sanofi has contracted with LabCorp (Esoterix) to provide a central lab to perform standardized, one-stage clotting assays with a national network of local laboratories for specimen collection at no extra cost to the patient or healthcare provider.

For more information about monitoring with LabCorp, contact your ALTUVIIIO Representative.

Learn About ALTUVIIIO Patient Support Services

Watch a step-by-step infusion-demonstration video for your patients

ALTUVIIIO Dosing Calculator

Select the intended use and then enter your patient’s weight to determine their dose.

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Resources for HCPs

Learn about resources and tools for your practice as well as billing and coding information for ALTUVIIIO.

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Indication

ALTUVIIIO^® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is a von Willebrand Factor (VWF) independent recombinant DNA-derived, Factor VIII concentrate 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

Limitation of Use

ALTUVIIIO is not indicated for the treatment of von Willebrand disease.

Important Safety Information

Contraindications

ALTUVIIIO is contraindicated in patients who have had severe hypersensitivity reactions, including anaphylaxis, to the product or its excipients.

Warnings and Precautions

Allergic-type hypersensitivity reactions, including anaphylaxis, may occur with ALTUVIIIO. Allergic-type hypersensitivity reactions were not reported in the clinical trials. Advise patients to discontinue use of ALTUVIIIO if hypersensitivity symptoms occur and contact a physician and/or seek immediate emergency care.
Formation of neutralizing antibodies (inhibitors) to Factor VIII are possible following administration of ALTUVIIIO. Neutralizing antibodies were not reported in the clinical trials. Monitor all patients for the development of Factor VIII inhibitors by appropriate clinical observations and laboratory tests.
If assessment of plasma Factor VIII activity is needed, it is recommended to use a validated one-stage clotting assay. The ALTUVIIIO Factor VIII activity level is overestimated by the chromogenic assay and a specific ellagic acid-based aPTT reagent in one-stage clotting assay by approximately 2.5-fold. If these assays are used, divide the result by 2.5 to approximate the patient's ALTUVIIIO Factor VIII activity level.

Adverse Reactions

The most common adverse reactions (>10% of subjects) reported in clinical trials were headache and arthralgia.

Please see full Prescribing Information.

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IndicationImportant Safety Information

IU=international unit.

Reference: 1. ALTUVIIIO Prescribing Information. Bioverativ Therapeutics Inc. Waltham, MA.

Dosing regimen