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ALTUVIIIO is a first-in-class, once-weekly treatment for hemophilia A
The unique design of ALTUVIIIO helps Factor VIII levels stay higher in your body for a longer period of time.
ALTUVIIIO is a first-in-class Factor VIII replacement therapy that keeps Factor VIII levels above 40% (near-normal to normal range) for most of the week in adults and for ~3 days in kids with 1 weekly infusion.†‡§
In a Phase 3 study,‡ ALTUVIIIO offered a 48-hour half-life in adults, the longest half-life of any Factor VIII replacement therapy. The average half-life for children under 12 was 40 hours.||
Data from the XTEND-1 study showed 0.7 mean bleeds per year (primary outcome).
Data from the XTEND-Kids study showed 0.6 mean bleeds per year.
*Data based on treated bleeds.
†Average trough levels were 18% for adults 18 years and older, 9% for adolescents aged 12 years to under 18 years, 17% for children aged 6 years to under 12 years, and 11% for children aged 1 year to under 6 years.
‡159 adults and adolescents with severe hemophilia (aged 12 years and older) were enrolled in the XTEND-1 study; 133 people were in Group 1 and switched to ALTUVIIIO prophylaxis from prior prophylaxis therapy. Efficacy of prophylaxis was evaluated in 128 of these patients.
§ALTUVIIIO was studied in the XTEND-Kids study. The primary goal of the study was to determine whether or not children under 12 years of age developed inhibitors to ALTUVIIIO. Zero inhibitors were detected. Efficacy of prophylaxis was evaluated in 72 of these patients.
||The half-life was 44.6 hours for adolescents aged 12 years to under 18 years, 42.4 hours for children aged 6 years to under 12 years, and 38 hours for children aged 1 year to under 6 years.
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Because ALTUVIIIO has a longer half-life, fewer infusions are needed, providing flexibility and freedom for people with hemophilia A. Infusions are only needed once weekly.
ALTUVIIIO offers children under 12 years of age high sustained Factor VIII levels throughout the week and proven bleed protection.
Copay savings from ALTUVIIIO*
Eligible patients pay as little as $0.
*Terms and restrictions apply.
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.
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 and joint 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.
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