FOR US RESIDENTS ONLY
For Healthcare Professionals
Prescribing Information
Instructions For Use
Three People (two women and a man) at the gym doing spinning on indoor bicycles
Factor VIII levels at 43%, 4 days after infusion
Hypothetical patient and scenario
Factor VIII levels at 43%, 4 days after infusion
Hypothetical patient and scenario

Factor UP! with an established safety profile

In XTEND-1 and XTEND-Kids, people taking ALTUVIIIO had:

0
inhibitors
0
serious allergic reaction
Although no inhibitors were found, and no serious allergic reactions occurred in clinical studies, inhibitors and serious allergic reactions are possible with ALTUVIIIO.

In 159 people taking ALTUVIIIO in the XTEND-1 study:

  • 21% of people had headache (33 people)
  • 16% of people had joint pain (26 people)
  • 6% of people had back pain (9 people)
  • 21% of people had headache (33 people)
  • 16% of people had joint pain (26 people)
  • 6% of people had back pain (9 people)

In 67 children taking ALTUVIIIO in the XTEND-Kids study:

1% of children had headache (1 child)

1% of children had headache (1 child)

Find your CoRe Manager and connect today!
Sanofi Hemophilia Community Relations and Education (CoRe) Managers offer education to people living with hemophilia and their families. CoRe Managers provide information about living with hemophilia and treatment options. Use our handy CoRe Locator to find the CoRe team member nearest you.
Altuviiio branding design
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.
Please see full
Prescribing Information.
Learn more about
Sanofi’s commitment to fighting counterfeit drugs.