Extavia

[erinchicago87]

Hi all,
Just recently was diagnosed and my neuro wanted to put me on Rebif, but insurance denied. Instead, they want me to start on Extavia. Anyone taking Extavia? I work full time and have 2 young kids - worried about the flu symptoms and frequency of shots. E

[phoebe.]

Hi, E.

I'm pretty sure Extavia is the same thing as Betaseron...just a different name (and different drug company).

I've been on Beta for about 3 weeks now. Overall, no major problems. Some redness at the injection site. I was worried about flu symptoms but outside of feeling tired and achy for a few days during the 2nd week, I've been okay.

I am titrating up to the full dose. I am only now on the half dose (.50 cc).

I let the syringe sit for a few minutes after mixing it. Do you have to mix Extavia or is it a pre-filled syringe?

I use the ice pack to cool site the injection site. I use an alcohol pad with benzocaine to clean the site. I also have been rubbing the site with a refrigerated preparation H pad after injection. Oh, and I take 2 ibufrofen 45 minutes or so before injection. Not sure if these little things make a difference, but I am hesitant to change!

The frequency of the shots isn't too bad. With Beta it is every other day. Is Extavia similar?

phoebe.

[0485c10]

Extavia is new just came out---it is the first generic MS med, as betaseron patent expired so a generic could be developed. Betaseron came out in 1993, the rest of the standard MS drugs came out between 1993-1996. With copaxone last in 1996.

[MrsBones]

http://www.nationalmssociety.org/new....aspx?nid=1940

Extavia became available last summer under an agreement between Bayer and Novartis who wanted to establish a presence in the MS market before Gilenya was approved.

It is not a generic. It is the exact same drug as Betaseron , made by the same manufacturer right next to Betseron. Extavia is simply Betaseron manufactured by Bayer and distributed in the US by Novartis under the name Extavia.

http://www.stockholders-newsletter-q...ory-notes.aspx


I don't have any experience with Betaseron and I'm not too sure many members take Extavia since I rarely see a reference to it. Maybe if you reposted with Betaseron/Extavia in the title,you'd have more Beta users respond.

[0485c10]

Biosimilar

Excuse me. That's correct its not a generic as it cannot be duplicated chemically. Its a biosimilar. Biological substances cannot be duplicated exactly as a chemical substance can.

It took congress almost a year to determine how to control and identify bilogic meds as similar. But its correct its not chemically the same as a generic is chemically the same. A biologic is as similar as a compound can be made through biological process not chemical & congress took almost a year to identify how that is determined & tested before biosimilars were allowed.

I didn't want to get into that whole generic versus biosimilar thing. Europe developed their standard for determining when something was biosimilar and the US was about a year or two later.


On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPAC Act). The PPAC Act contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that amends the Public Health Service Act (PHS Act) and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA licensed reference biological product.[7]
(like generic is the same and interchangeble with... biologic are bio-similar

http://en.wikipedia.org/wiki/Biologic


Some sites on biosimilar I have been following it for a few years as a standard was developed.

http://www.egagenerics.com/FAQ-biosimilars.htm
http://en.wikipedia.org/wiki/Biosimilar
http://www.europabio.org/documents/FS-Biosimilar.pdf
http://www.in-pharmatechnologist.com...lar-or-generic

I have a chemical background so I am aware of the difference--its kind of obvious they "simplify" it for the general reader.

And what is biosimilar has only been defined since March 2010--so you are trying a "new" drug or the process of biosimilarity so your a first generation user to it.

I was trying to gloss over this biotech stuff

[Crewser]

Hi all,
Just recently was diagnosed and my neuro wanted to put me on Rebif, but insurance denied. Instead, they want me to start on Extavia. Anyone taking Extavia? I work full time and have 2 young kids - worried about the flu symptoms and frequency of shots. E

I started out on Betaseron and when Extavia became available my prescription automatically changed. In other words I went to pick up my Betseraon and was given Extavia. I've been on Extavia for about 8 or 9 months maybe. No side effects for me but I went through the side effects when on Betaseron. Those lasted about 4 months. Total time on both has been about 18 months now. The only difference I see is the price tag. Extavia's price tag on my insurance receipt is about half the price of Betaseron, at last comparison.

[MrsBones]

I was trying to gloss over this biotech stuff

Thank you. Pretty sure we can understand the idea.

Betaseron was developed by Berlex Labratories,Inc and Chiron Corp. who manufactured it. In 1993, Schering signed an agreement with Chiron to market Betaseron. In 2006, Novartis accquired Chiron Corp. and Bayer accquired Schering, all the while Chiron Corp. (now a subsidiary of Novartis) continued to manufacture Betaseron at a facility in Emeryville, CA.

In 2007, Novartis tranferred the manufacturing equipment,inventory and the leasing of the buildings at which Betaseron is manufactured to Bayer Schering for approximately $200 million US. In addition, they received royalties from the sales of Betaseron until October of 2008. Beyer Schering retained the rights to market Betaseron and manufacture it at the Emeryville facility.

In addition to all that, Bayer Schering would also support Novartis in the regulatory filing process for a Novartis branded Betaseron in 2008 for Europe and 2009 in the US. Bayer Schering now manufctures Extavia for Novartis and Betaseron under the agreement.

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (PPAC Act). The PPAC Act contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that amends the Public Health Service Act (PHS Act) and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA licensed reference biological product.[7]
(like generic is the same and interchangeble with... biologic are bio-similar

In August of 2009, before President Obama signed that act into law,Extavia was approved, without any clinical trials, by the FDA and was on the market shortly there after. How? No clinical trials were required by the FDA, since they are made by the same manufacturer, at the same facility, with the same equipment, same active and inactive ingredients. The only difference is packaging. If it was indeed a biosimilar (let's say in 2009 that they would have used their guidelines for generics) and not the same product, the FDA would have required some sort of studies done to show the safety and efficacy of Extavia.

Extavia is as "biosimilar" to Betaseron as one batch of Betaseron is to another.

[Bob698]

I heard Extavia came in a box of 15 doses as opposed to Beta in a pack of 14? True or not?
BTW, is it a 30 gauge needle like Beta or a 28?
I'd actually like to "talk to my doctor" about this one. If I can save the VA some bucks it would make me feel good.

[QuickType]

I gotta say, MrsBones, your knowledge (and/or research ability) is impressive, whether it's fingernails or medications. Nice post, very interesting.

[Redwings]

According to the prescribing information, Extavia uses a 27-gauge needle and comes 15 units to a box.

[MrsBones]

I gotta say, MrsBones, your knowledge (and/or research ability) is impressive, whether it's fingernails or medications. Nice post, very interesting.

Thank you. I just like to know not only what I may potentially inject myself with, but also who's making it.