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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
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
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
- Your 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
Please click here for Esperoct® Prescribing Information.
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-10881-800-FDA-1088.
What is Novoeight®?
Novoeight® (antihemophilic factor, recombinant) is an injectable medicine used to control and prevent bleeding in people with hemophilia A. Your healthcare provider may give you Novoeight when you have surgery
- Novoeight® is not used to treat von Willebrand Disease
Important Safety Information
Who should not use Novoeight®?
- You should not use Novoeight® if you are allergic to factor VIII or any of the other ingredients of Novoeight® or if you are allergic to hamster proteins
What is the most important information I need to know about Novoeight®?
- Do not attempt to do an infusion yourself unless you have been taught how by your healthcare provider or hemophilia center
- Call your healthcare provider right away and stop treatment if you get any of the following signs of an allergic reaction: rashes or hives, difficulty breathing or swallowing, tightness of the chest, swelling of the lips and tongue, light-headedness, dizziness or loss of consciousness, pale and cold skin, fast heartbeat, or red or swollen face or hands
What should I tell my healthcare provider before using Novoeight®?
- Before taking Novoeight®, 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
- Your body can make antibodies called “inhibitors” against Novoeight®, which may stop Novoeight® from working properly. Call your healthcare provider right away if your bleeding does not stop after taking Novoeight®
What are the possible side effects of Novoeight®?
- Common side effects of Novoeight® include inhibitors in patients who were not previously treated with factor VIII products, swelling or itching at the location of injection, and fever
Please click here for Novoeight® Prescribing Information.
Novoeight® 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-10881-800-FDA-1088.
Prescribing Novoeight®? Consider Esperoct®.
If you like the efficacy and fixed dosing of Novoeight (antihemophilic factor, recombinant), take a look at Esperoct® for your hemophilia A patients. With a longer half-life across age groups than standard half-life FVIII products, Esperoct® could be right for your patients.1,a,b
Please click here for Esperoct® Prescribing Information
Please click here for Novoeight® Prescribing Information
aA phase 1, open-label study evaluated the safety and pharmacokinetic properties of Esperoct® in 26 PTPs. Patients received a single dose of 25, 50, or 75 IU/kg of their previous SHL product (pdFVIII or rFVIII), followed by the same dose of Esperoct®. To allow for comparison, all results were adjusted to a 50 IU/kg dose of each product.1
bIn a phase 3 study of children (aged <12 years) a single-dose PK comparison was performed in 27 children between previous SHL products and Esperoct® at the same administered dose prior to the start of routine prophylaxis. Half-life comparison is based upon the estimated half-life derived from a population-based model. During the main phase, 68 children received prophylaxis at an average dose of approximately 65 IU/kg twice weekly for 26 weeks.2
References:
- Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013;11(4):670-678.
- Meunier S, Alamelu J, Ehrenforth S, et al. Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A. Thromb Haemost. 2017;117:1705-1713.