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Important Safety Information | | | Prescribing Information
Esperoct® is used to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A.
Elevate your factor levels and reduce severity
If you are an adult or adolescent with severe hemophilia A, treating with Esperoct® 50 IU/kg every 4 days could help you achieve factor levels defined as mild for 90% of the time and mild-to-moderate for 100% of the time.a,b
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a | Mild hemophilia A was defined as factor VIII (FVIII) activity >5 IU/dL (>5% of normal), moderate as 1-5 IU/dL (1-5% of normal), and severe as <1 IU/dL (<1% of normal).
b | Steady-state factor VIII (FVIII) activity levels were estimated in 143 adults and adolescents using PK modeling.
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Selected Important Safety Information
Who should not use Esperoct®?
| • | You should not use Esperoct® if you are allergic to factor VIII or any of the other ingredients of Esperoct® or if you are allergic to hamster proteins
What is the most important information I need to know about Esperoct®?
| • | Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia treatment center
| • | Call your healthcare provider right away or get emergency treatment right away if you get any signs of an allergic reaction, such as: hives, chest tightness, wheezing, dizziness, difficulty breathing, and/or swelling of the face
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From severe to mild: Esperoct® helps children too.
With Esperoct® 60 IU/kg (50-75 IU/kg) twice weekly, children <12 years with severe hemophilia A could achieve factor levels defined as mild for 72% of the time and mild-to-moderate for 97.9% of the time.a,c
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c | Steady-state factor VIII (FVIII) activity levels were estimated using PK modeling in children <12 years. Twice weekly dosing was a dosing interval of every 3 or 4 days.
What is Esperoct®?
Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is an injectable medicine to treat and prevent or reduce the number of bleeding episodes in people with hemophilia A. Your healthcare provider may give you Esperoct® when you have surgery
| • | Esperoct® is not used to treat von Willebrand Disease
Important Safety Information (cont’d)
What should I tell my healthcare provider before using Esperoct®?
| • | Before taking Esperoct®, you should tell your healthcare provider if you have or have had any medical conditions, take any medicines (including non-prescription medicines and dietary supplements), are nursing, pregnant or planning to become pregnant, or have been told that you have inhibitors to factor VIII
| • | our body can make antibodies called “inhibitors” against Esperoct®, which may stop Esperoct® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Esperoct®
What are the possible side effects of Esperoct®?
| • | Common side effects of Esperoct® include rash or itching, and swelling, pain, rash or redness at the location of infusion
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Esperoct® is a prescription medication.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Esperoct® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2020 Novo Nordisk All rights reserved. US20ESP00119 January 2021 |