Important News About the Availability of Helixate FS

CSL Behring is fully committed to supporting Helixate FS patients and customers for as long as product is in the marketplace.

Based on current supply, Helixate FS will remain available into early 2019. Supply for individual patients may vary, so speak with your specialty pharmacy for more information. However, you will soon need to talk to your doctor about another treatment option.

At CSL Behring, we listen and address the needs of those who depend on our therapies. That’s why we’ve developed AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, a long-acting therapy, as an advanced treatment option that may suit your needs. AFSTYLA offers:

  • Twice-weekly dosing: FDA approved for dosing 2 to 3 times a week
  • Long-lasting bleed protection: Zero bleeds (median AsBR*), regardless of age and dosing schedule
  • Zero inhibitors with previously treated people in the largest hemophilia A clinical trial program

For more updates about Helixate FS availability, or questions about patient support for AFSTYLA, call My SourceSM at 1-800-676-4266, Monday–Friday, 8 AM to 8 PM ET.

Learn about AFSTYLA Continue to Helixate FS

*Annualized spontaneous bleeding rate in clinical trials.

Important Safety Information for AFSTYLA

AFSTYLA®, Antihemophilic Factor (Recombinant), Single Chain, is used to treat and control bleeding episodes in people with hemophilia A. Used regularly (prophylaxis), AFSTYLA can reduce the number of bleeding episodes and the risk of joint damage due to bleeding. Your doctor might also give you AFSTYLA before surgical procedures.

AFSTYLA is administered by intravenous injection into the bloodstream, and can be self-administered or administered by a caregiver. Your healthcare provider or hemophilia treatment center will instruct you on how to do an infusion. Carefully follow prescriber instructions regarding dose and infusion schedule, which are based on your weight and the severity of your condition.

Do not use AFSTYLA if you know you are allergic to any of its ingredients, or to hamster proteins. Tell your healthcare provider if you previously had an allergic reaction to any product containing Factor VIII (FVIII), or have been told you have inhibitors to FVIII, as AFSTYLA might not work for you. Inform your healthcare provider of all medical conditions and problems you have, as well as all medications you are taking.

Immediately stop treatment and contact your healthcare provider if you see signs of an allergic reaction, including a rash or hives, itching, tightness of chest or throat, difficulty breathing, lightheadedness, dizziness, nausea, or a decrease in blood pressure.

Your body can make antibodies, called inhibitors, against FVIII, which could stop AFSTYLA from working properly. You might need to be tested for inhibitors from time to time. Contact your healthcare provider if bleeding does not stop after taking AFSTYLA.

In clinical trials, dizziness and allergic reactions were the most common side effects. However, these are not the only side effects possible. Tell your healthcare provider about any side effect that bothers you or does not go away.

Please see full prescribing information for AFSTYLA, including patient product information.

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.

Important Safety Information for HELIXATE FS

You should not use Helixate FS if you are allergic to rodents (like mice and hamsters) or are allergic to any ingredients in Helixate FS.

Tell your healthcare provider if you have been told you have heart disease or are at risk for heart disease.

You could have an allergic reaction to Helixate FS. Call your healthcare provider right away and stop treatment if you get rash or hives, itching, tightness of the chest or throat, difficulty breathing, light-headed, dizziness, nausea or a decrease in blood pressure.

Your body can make antibodies, called "inhibitors," against Helixate FS, which may stop Helixate FS from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for the development of inhibitors to factor VIII.

Other common side effects of Helixate FS are local injection-site reactions (pain, swelling, irritation at infusion site) and infections from implanted injection device. Tell your healthcare provider about any side effect that bothers you or does not go away.

Call your healthcare provider right away if bleeding is not controlled after using Helixate FS.

Indications for HELIXATE FS

Helixate FS, Antihemophilic Factor (Recombinant), is medicine used to replace the clotting factor (factor VIII or antihemophilic factor) that is missing in people with hemophilia A.

Helixate FS is used to treat and control bleeding in adults and children with hemophilia A. Your healthcare provider may give you Helixate FS when you have surgery. Helixate FS can reduce the number of bleeding episodes in adults and children when used regularly (prophylaxis), and can reduce the risk of joint damage in children without preexisting joint damage when used regularly.

Helixate FS is not used to treat von Willebrand disease.

Please see the full Prescribing Information for HELIXATE FS, including approved patient labeling.

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.