Simplicity
in dosing1

Simple dosing for prophylaxis, on-demand, and perioperative management

RECOMMENDED DOSE
50 IU/kg1

  • Once-weekly calendar

    Prophylaxis

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

    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
  • Doctor

    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

Simple dosing
for all your
patients’ needs

SELECT STORAGE REQUIREMENTS1

  • Do not freeze

    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.

  • Home temperature

    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.

  • Restrict sunlight

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

  • Trash bin

    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

  • Pharmacy

    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

WHILE TESTING IS NOT REQUIRED, FREE
LABORATORY TESTS FOR ALTUVIIIO ARE AVAILABLE

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 INJECTION-DEMONSTRATION VIDEO FOR YOUR PATIENTS

Calculate your
patient’s dose

USE THE DOSING CALCULATOR

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 is 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.

See full Prescribing Information.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

IU=international unit.

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

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 is 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.

Learn more about Sanofi’s commitment to fighting counterfeit drugs.

aPTT=activated partial thromboplastin time; PK=pharmacokinetics.