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For Healthcare Professionals
Prescribing Information
Instructions For Use
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Factor VIII levels at 42%, 4 days after infusion
Hypothetical patient and scenario
Factor VIII levels at 42%, 4 days after infusion
Hypothetical patient and scenario

One infusion, once a week, that’s how you Factor UP!

ALTUVIIIO offers the fewest weekly infusions among Factor VIII prophylaxis treatments

In a Phase 1 study, ALTUVIIIO had a 3-4x longer half-life than EHL and SHL therapies

Chart shows how ALTUVIIIO offers up to 3-4x longer half-life than other treatments like EHL and SHL therapies
*
This is information from a study of 13 previously treated adults with with severe hemophilia A that had the goal of comparing how long ALTUVIIIO, Adynovate® [Antihemophilic Factor (Recombinant), PEGylated], and Advate® [Antihemophilic Factor (Recombinant)] stayed in the body after 1 dose. Half-life was 43 hours for ALTUVIIIO, 15 hours for Adynovate, and 11 hours for Advate.
†
Doses and dosing intervals may be adjusted.
Adynovate and Advate are registered trademarks of Baxalta Incorporated, a Takeda company.
EHL=extended half-life; SHL=standard half-life.

Watch a step-by-step video on how ALTUVIIIO is prepared and infused

One infusion to fit your needs. Factor Up with ALTUVIIIO prophylaxis

Expect the same infusion process whether weekly prophylaxis use, on-demand bleed control, or pre- and post-surgical management.

For information on the administration of ALTUVIIIO, including storage and handling, please refer to the Instructions For Use, as well as the video below. Do not attempt to infuse by yourself unless you have been taught how by your healthcare provider or hemophilia treatment center.

Expect the same infusion process whether weekly prophylaxis use, on-demand bleed control, or pre- and post-surgical management.

For information on the administration of ALTUVIIIO, including storage and handling, please refer to the Instructions For Use, as well as the video below. Do not attempt to infuse by yourself unless you have been taught how by your healthcare provider or hemophilia treatment center.

6 ALTUVIIIO vials

Where can you take ALTUVIIIO?

ALTUVIIIO can travel almost anywhere you go, as long as you follow these storage instructions:

  • Store refrigerated up to 48 months (2 °C to 8 °C or 36 °F to 46 °F) or at room temperature (below 30 °C [86 °F]) for up to 6 months. Do not freeze
  • Keep ALTUVIIIO in its original package
  • Keep carton and vials out of direct light
  • Use ALTUVIIIO before the expiration date on carton and vials
  • When storing at room temperature, note on the carton the date on which the product is removed from refrigeration. Use the product before the end of this 6-month period or discard it. Do not return the product to the refrigerator. After mixing, store at room temperature up to 3 hours (below 30 °C [86 °F]), dispose after 3 hours. Protect the reconstituted product from direct sunlight

ALTUVIIIO can travel almost anywhere you go, as long as you follow these storage instructions:

  • Store refrigerated up to 48 months (2 °C to 8 °C or 36 °F to 46 °F) or at room temperature (below 30 °C [86 °F]) for up to 6 months. Do not freeze
  • Keep ALTUVIIIO in its original package
  • Keep carton and vials out of direct light
  • Use ALTUVIIIO before the expiration date on carton and vials
  • When storing at room temperature, note on the carton the date on which the product is removed from refrigeration. Use the product before the end of this 6-month period or discard it. Do not return the product to the refrigerator. After mixing, store at room temperature up to 3 hours (below 30 °C [86 °F]), dispose after 3 hours. Protect the reconstituted product from direct sunlight
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Indication
ALTUVIIIO® [antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl] is an injectable medicine that is used to control and reduce the number of bleeding episodes in people with hemophilia A (congenital Factor VIII deficiency). Your healthcare provider may give you ALTUVIIIO when you have surgery.
Important safety information
What is the most important information I need to know about ALTUVIIIO?
Do not attempt to give yourself an injection unless you have been taught how by your healthcare provider or hemophilia center. You must carefully follow your healthcare provider’s instructions regarding the dose and schedule for injecting ALTUVIIIO so that your treatment will work best for you.
Who should not use ALTUVIIIO?
You should not use ALTUVIIIO if you have had an allergic reaction to it in the past.
What should I tell my healthcare provider before using ALTUVIIIO?
Tell your healthcare provider if you have had any medical problems, take any medications, including prescription and non-prescription medicines, supplements, or herbal medicines, are breastfeeding, or are pregnant or planning to become pregnant.
What are the possible side effects of ALTUVIIIO?
You can have an allergic reaction to ALTUVIIIO. Call your healthcare provider or emergency department right away if you have any of the following symptoms: difficulty breathing, chest tightness, swelling of the face, rash, or hives. Your body can also make antibodies called “inhibitors” against ALTUVIIIO. This can stop ALTUVIIIO from working properly. Your healthcare provider may give you blood tests to check for inhibitors. The common side effects of ALTUVIIIO are headache, joint pain, and back pain. These are not the only possible side effects of ALTUVIIIO. Tell your healthcare provider about any side effect that bothers you or does not go away.
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