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Prescribing Information
Instructions For Use
3 people (two women and a man) at the gym doing a spin class 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 233 people across both the clinical studies*:

  • 15% experienced headache (35 people)
  • 13% experienced joint pain (31 people)
  • 4% experienced fever (10 people)
  • 4% experienced pain in extremities (10 people)
  • 4% experienced back pain (9 people)
  • 3% experienced vomiting (7 people)
  • 15% experienced headache (35 people)
  • 13% experienced joint pain (31 people)
  • 4% experienced fever (10 people)
  • 4% experienced pain in extremities (10 people)
  • 4% experienced back pain (9 people)
  • 3% experienced vomiting (7 people)
*
Included participants of the XTEND-1 and XTEND-Kids studies.
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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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Prescribing Information.
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