factor

Know Your Factor Products

A recent tweet by a doctor I follow had me realizing we could all do with reviewing all hemophilia products… or at least, just knowing which product we use, and why. Currently, there are so many products and options. Do you know what your product’s name is, what “class” is it, and why you are using it?

First, know that all products approved by the US FDA for treatment are considered safe (from infectious disease) and efficacious (does its job). We always start by talking about products by first saying that there are two basic classes for standard factor: plasma-derived and recombinant.

The major difference between the two types is the origin of the factor, called the source material. Plasma-derived factor originates from human blood plasma. Recombinant factor originates from genetically engineered mammalian cells containing the human gene for factor. Most people with hemophilia in the US are now using recombinant products.

Recombinants can even be further classified according to their manufacturing process: first generation, second generation, and third generation. Several recombinant factor products also have a prolonged half-life, allowing you to infuse less frequently. The first of these new products was introduced in 2014.

First generation products contain human/animal proteins in culture medium; albumin added in final formulation

Second generation products contain human/animal proteins in culture medium; sugar added in final formulation, no albumin added

Third generation products contain no human/animal proteins added at any stage; formulated with sugar, not albumin

There is mention of a fourth generation–those products that are made not from mammalian cells but from human cells, so there is no risk of animal cells in the formulation, which may limit the formation of inhibitors.

And of course, there are nonfactor products, like Hemlibra.

So, know your treatment and why you use it! Ask:

Who selected your therapy—you, your doctor, or both? Could you explain to another patient or parent why you chose that product over the others Don’t leave the decision making to your doctor only, and absolutely not to your payer only. Remember that your payer may prefer to reimburse the least expensive product and not necessarily the best for you. Decide with your physician which product is best for your child. One day you may need to justify your product choice to your payer. It will help if you can learn to speak the language of therapies!

And use our chart, which we update frequently on our homepage. You can download this by clicking on the image on our homepage.

Know Your Factor Choices

It’s truly a new era in bleeding disorders with new products, new therapies and new indications. Octapharma’s wilate just got approval for indication in adults and adolescents with hemophilia A; previously it was indicated only for VWD. With this news, I realized that we should remind everyone to know what product they use, where it comes from, and why they are using it.

Who chose your product? Was it your hematologist? Did you have any input? You should, and this means bearing the responsibility to read about products, as questions about them and be part of the decision making process.

Back in 1990, when Raising a Child with Hemophilia was first published, we were the first ones to describe parents and patients as consumers, and to treat products like any other commercial product you would buy. We provided the question to ask your doctor, and we explained the different manufacturing processes, and the difference between safety and purity. And we urged parents not to be passive in the treatment process but to help make medical decisions.

It’s more important now than ever. We have a dazzling choice of products, and novel therapies like Hemlibra. Maybe there’s no reason for you to switch products, but you might want to get up to speed on what’s available. Please note: all US FDA-approved products are considered safe and efficacious.

We’ve been writing about products and product choice for decades. I hope you read up on them and be prepared! To help you, we created a chart of products that you can download. Take it to the HTC with you and discuss with your hematologist about choice. You can download it right from our home page or go here.

We also have a chart for VWD products too!

We did our part. Now do yours; know your product, manufacturer, and why you use it. Keep learning… more therapy choices are coming!

An IXperience that’s anything but ordinary

The hemophilia community has always taken care of its own, and I’m happy to help support the efforts of Aptevo, makers of the factor IX treatment IXINITY® [coagulation factor IX (recombinant)] to continue this tradition as part of the IXINITY IXperience. Read on to learn more about the FACTOR IT FORWARDTM program and how you can help give back to the factor IX community by signing the 9!

 

This is a paid public announcement from Aptevo and does not constitute an endorsement of products or services. When you click on the links in this blog entry, you will be directed to the IXINITY website. LA Kelley Communications always advises you to be a savvy consumer when contacting any company; do not reveal identifying information against your will.

FACTOR IT FORWARD

As part of the IXINITY experience, every IXINITY patient has the opportunity to give back to the US factor IX community just by choosing to infuse. When your healthcare professional enrolls in the program, for every 10 IU of IXINITY distributed, 1 IU is donated to factor IX families in need across the United States. That means a nine who infuses 4000 IU twice a week helps FACTOR IT FORWARD donate more than 40,000 units a year to US factor IX families in need!

Learn more at IXINITY.com

Sign the 9

Sign the 9 is another way you can help give back to your community. When you Sign the 9, every signature received will make 9 IU available for donation to people in need across the United States as part of the FACTOR IT FORWARD program for IXINITY.

Already this year, almost 1,000 people have signed the 9! It’s another step we’re all taking to make sure we leave no nine behind. Connect with your local rep, or if you plan to attend the National Hemophilia Foundation Bleeding Disorders Conference in Anaheim, CA on October 3-5, be sure to stop by and Sign the 9!

LIVE LIFE YOUR WAY WITH IXINITY 

Predictable bleed control for your unpredictable life
  • In a clinical trial, 71% of bleeding episodes were resolved with 1 infusion and 13% were resolved with 2 infusions.1 Individual response may vary
Higher recovery means more factor on board after infusion
  • IXINITY has an average incremental recovery of 98%1
Flexibility to plan peak factor levels for your everyday, active lifestyle
  • 24-hour half-life for peak factor IX levels when you need them1
See why switching to IXINITY may be right for you

INDICATIONS AND IMPORTANT SAFETY INFORMATION

What is IXINITY®?

IXINITY [coagulation factor IX (recombinant)] is a medicine used to replace clotting factor (factor IX) that is missing in adults and children at least 12 years of age with hemophilia B. Hemophilia B is also called congenital factor IX deficiency or Christmas disease. Hemophilia B is an inherited bleeding disorder that prevents clotting. Your healthcare provider may give you IXINITY to control and prevent bleeding episodes or when you have surgery.

IXINITY is not indicated for induction of immune tolerance in patients with hemophilia B.

IMPORTANT SAFETY INFORMATION FOR IXINITY

  • You should not use IXINITY if you are allergic to hamsters or any ingredients in IXINITY.
  • You should tell your healthcare provider if you have or have had medical problems, take any medicines, including prescription and non-prescription medicines, such as over-the-counter medicines, supplements, or herbal remedies, have any allergies, including allergies to hamsters, are nursing, are pregnant or planning to become pregnant, or have been told that you have inhibitors to factor IX.
  • You can experience an allergic reaction to IXINITY. Contact your healthcare provider or get emergency treatment right away if you develop a rash or hives, itching, tightness of the throat, chest pain, or tightness, difficulty breathing, lightheadedness, dizziness, nausea, or fainting.
  • Your body may form inhibitors to IXINITY. An inhibitor is part of the body’s defense system. If you develop inhibitors, it may prevent IXINITY from working properly. Consult with your healthcare provider to make sure you are carefully monitored with blood tests for development of inhibitors to IXINITY.
  • If you have risk factors for developing blood clots, the use of IXINITY may increase the risk of abnormal blood clots.
  • Call your healthcare provider right away about any side effects that bother you or do not go away, or if your bleeding does not stop after taking IXINITY.
  • The most common side effect that was reported with IXINITY during clinical trials was headache.
  • These are not all the side effects possible with IXINITY. You can ask your healthcare provider for information that is written for healthcare professionals.
 For more information about IXINITY, please see full Prescribing Information, including Important Patient Information.
 
You are encouraged to report side effects of prescription drugs to the Food and Drug Administration. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Reference: 1. IXINITY [coagulation factor IX (recombinant)] prescribing information. Seattle, WA: Aptevo BioTherapeutics LLC; December 2018.

Aptevo BioTherapeutics LLC, Seattle, WA 98121

IXINITY® [coagulation factor IX (recombinant)] and any and all Aptevo BioTherapeutics LLC brand, product, service and feature names, logos, and slogans are trademarks or registered trademarks of Aptevo BioTherapeutics LLC in the United States and/or other countries.

©2019 Aptevo BioTherapeutics LLC.               All rights reserved.          CM-FIX-0327

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