Kogenate®FS

What’s Happening with Helixate® FS?

Laurie Kelley October 16, 2017
We’ve had a tremendous number of factor products enter the US hemophilia market the past few years. in fact, we have exploded from under 10 to about 26 now, not including inhibitor products! 
Rarely do we speak of a product exiting the market. But as of December 31, one will no longer be manufactured—Helixate® FS (Antihemophilic Factor (Recombinant)). 
I’ve read on Facebook some conspiracy-theory explanations!  But here are the facts:
1. Helixate® FS is the exact same product as Kogenate® FS. Exactly.
2. Both products are made by Bayer Corporation. The therapy that makes Kogenate FS has been sold to CLS Behring annually as part of a lawsuit settlement many years ago. CSL then markets the product as Helixate® FS. This was good for CSL, which at the time did not have a recombinant factor VIII product.
3. The resultant contract is coming to an end; CSL Behring and Bayer will no longer partner to product and market Helixate FS.
4. And CSL now has recombinant FVII products that it has created, namely Afstyla (Antihemophilic Factor [Recombinant], Single Chain, a next-generation factor VIII with twice-weekly dosing available).As with Helixate FS, Afstyla uses the Mix2Vial® system, which will keep patients’ reconstitution process consistent. 
5. CSL wants to assure the community that it will update patients, prescribers and specialty pharmacies with updated supply information. Community members can sign up here for direct updates.
6. The products that are already manufactured will still be in the distribution pipeline, probably through to early 2019. This gives patients and their families plenty of time to consider treatment options. 
If you currently use Helixate FS, you should speak with your HTC hematologist soon about what treatment options you have, given your insurance policy and specialty pharmacy. You can also contact a  CSL Behring My SourceSM Care Coordinator at 1-800-676-4266 Monday–Friday, 8 AM to 8 PM ET–but please speak with your hematologist, who can help you find the right therapy for you.
Helixate FS is a great product, and there are many more also great to choose from. Use our factor chart here to start looking. Good luck and always Factor Up!

This is an unpaid public service announcement.

Kogenate® FS’s New Vial Adapter

Laurie Kelley October 27, 2013
Every now and then, I’ll be posting news items from the news wires, to keep our readers updated with new offerings related to their treatment. Today I’m posting about a new reconstitution system for Bayer HealthCare’s Kogenate®FS antihemophilic factor (recombinant). (Please note this is not a paid advertisement but just an educational service to our readers. The new “Vial Adapter” offers Kogenate® FS users an additional choice in reconstitution systems.Vial Adapter is a needleless reconstitution system that contains a sterile chamber with a built-in 15-micrometer filter and a prefilled diluent syringe.

From Bayer’s press release: “Innovating in order to provide two reconstitution systems, Vial Adapter and BIO-SET®, is a great example of our commitment to delivering options that meet the needs of the entire hemophilia A community,” said Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.

Both Kogenate® FS with BIO-SET® and Kogenate® FS with Vial Adapter are available in Grab and Go packaging, which includes:
·        A prefilled diluent syringe
·        The Terumo® SURFLO® Winged Infusion Set
·        Alcohol swabs, a cotton pad and a latex-free bandage
·        Exclusive anti-counterfeiting and tamper-evident features
·        Alcohol swabs, a cotton pad and a latex-free bandage
·        Exclusive anti-counterfeiting and tamper-evident features

Kogenate® FS, antihemophilic factor (recombinant) is indicated for:
·        Control and prevention of bleeding episodes in adults and children (0-16 years) with hemophilia A
·        Peri-operative management in adults and children with hemophilia A
·        Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children with hemophilia A and to reduce the risk of joint damage in children without pre-existing joint damage

Kogenate® FS is not indicated for the treatment of von Willebrand disease.

Kogenate® FS is contraindicated in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components, including mouse or hamster proteins.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see the full prescribing information at https://www.kogenatefs.com/webapp/prescribing-information.jsp

Great Book I Just Read
Something Wicked This Way Comes by Ray Bradbury

Many of us read Ray Bradbury books, like Fahrenheit 451, in high school. He is so worth reading again. In time for Halloween comes this 1962 October horror/mystery story that reads lyrically, like poetry, like artwork. Two 14-year-old best friends, Jim Nightshade and William Halloway, who live in Green Town, in the midwest, are intrigued by the dark and mysterious carnival that roars into town at 3 am one morning, long after all carnivals have packed up for the season. Headed by a fully illustrated, tattooed Mr. Dark, the carnival has a deep secret to protect, and becomes a threat to the townspeople. Mr. Dark bears a tattoo for each person in town he manages to lure into the carnival–to the carousel that twists time, or the house of mirrors that strands souls… and never lets them go. Only one person can save the townspeople… The writing is absolutely superb, colorful, vivid and memorable. The three page description of the carnival train pulling into the outskirts of town alone will stay with you. Great fall/Halloween reading for young and old… which is, by the way, one of the themes of the book! Five/five stars.
HemaBlog Archives
Categories