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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

Understanding Inhibitors

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.

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.

0
Factor VIII inhibitors or serious allergic reactions were reported in XTEND-1 and XTEND-Kids studies

In the postmarketing setting, people taking ALTUVIIIO have reported:

Factor VIII inhibitors*
Call your healthcare provider or treatment facility if your Factor VIII therapy does not seem to be working, as this may be a sign of inhibitor development.
Call your healthcare provider or treatment facility if your Factor VIII therapy does not seem to be working, as this may be a sign of inhibitor development.
Serious allergic reactions
Call your healthcare provider or go to the emergency room right away if you experience any of the signs of an allergic reaction, which include rash, hives, itching, facial swelling, chest tightness, or wheezing.
Call your healthcare provider or go to the emergency room right away if you experience any of the signs of an allergic reaction, which include rash, hives, itching, facial swelling, chest tightness, or wheezing.

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)
*
The potential for inhibitor development is a known risk that can occur with any factor replacement therapy, including ALTUVIIIO.
†
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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