New formulation of Rebif

A board to discuss the Multiple Sclerosis modifying drug Rebif
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Sandrine
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Post by Sandrine » Wed Jan 14, 2009 1:58 am

Hi Lisbeth,

I found some tests (the patent application) in the web for an interferon beta stabilization solution NEARLY the same as the new Rebif formulation (with polaxamer 188 and L-methionine) compared with the old formulation with serum albumin.

The experiments were about aggregat formation, oxidized forms, bioidentity etc. at different temperatures (4°C, 25°C, 40°C). There was not much a difference between the old and the new formulation at 25°C.

This is why I ignore the new storage conditions and if there is no fridge I keep my Rebif at room temperature for short time periods... But I do not guarantee for anything!!! Maybe its risky.

I also have a "Frio" pocket for insulin which cools with evaporation. You just need water.

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I hope that was helpful,
Sandrine

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Lisbeth
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Refrigeration and Rebif New Formulation

Post by Lisbeth » Wed Jan 14, 2009 2:31 am

Dear Sandrine,

This is very helpful. I'll try to get the insulin pack that you mentioned. My Rebif nurse didn't mention this. She just said to keep in a cooler bag with one of those special ice packs and change the pack every day.

Thank you. Lisbeth

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Sandrine
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Post by Sandrine » Wed Jan 14, 2009 3:55 am

Be carefull, the moist Frio pocket could mold (UGH!)... :)

Concerning Afrika: I made a test with the pocket in our 37°C-room (I work in a lab), and the temperature in the pocket was below 30°C, but not 25°C.

Sandrine

P.S. Celcius-Fahrenheit converter:
http://www.wbuf.noaa.gov/tempfc.htm

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Lisbeth
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Refrigeration and Rebif New Formulation

Post by Lisbeth » Wed Jan 14, 2009 5:12 am

Sandrine,

Thanks again. I guess after I do my first trip, I'll decide whether it's so inconvenient as to be impossible. If that's the case, I'll ask my neurologist about switching to Betaferon, which doesn't require any refrigeration at all. But maybe by then Serono will rewrite its refrigeration requirements!

Lisbeth

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NHE
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Re: Refrigeration and Rebif New Formulation

Post by NHE » Wed Jan 14, 2009 3:26 pm

Lisbeth wrote:Thanks again. I guess after I do my first trip, I'll decide whether it's so inconvenient as to be impossible. If that's the case, I'll ask my neurologist about switching to Betaferon, which doesn't require any refrigeration at all. But maybe by then Serono will rewrite its refrigeration requirements!
You might also want to look into Avonex. The powdered form of Avonex can go 30 days at room temperature without refrigeration.

NHE

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GeoGuy
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Post by GeoGuy » Wed Jan 14, 2009 4:43 pm

Lisbeth,

When I first started Rebif two years ago my nurse told me it was ok to take an entire week of shots out of the fridge and leave them out. So apparently, short term lack of refigeration doesn't bother it. If your trips to Africa last a week or less the lack of refigeration might not be an issue. Definately ask your Rebif nurse about it.

Jack
RRMS since 01/07.

Lyon
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Post by Lyon » Wed Jan 14, 2009 5:06 pm

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Last edited by Lyon on Sun Nov 27, 2011 10:20 am, edited 1 time in total.

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Lisbeth
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Refrigeration and Rebif New Formulation

Post by Lisbeth » Wed Jan 14, 2009 5:26 pm

Thanks everyone for input. This is the first time I've used "This is MS," and was heartened to see so many people writing back.

For the last responses--Rebif New Formulation was approved in 2008. The earlier version can live outside of the refrigerator for up to 30 days. So I've been a happy user. Question is whether RNF can. I'm going to start out by following Sandrine's suggestions. Thank you again. Lisbeth

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BEZALEL
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Post by BEZALEL » Fri Apr 03, 2009 5:18 am

Hi, I am new to this side and MS, I startet taken REBIF since DEC. '08 in the States. Am here in Israel on vacation and met a REBIF Nurse here. She asked me, if I use the new formulation and showed me how the package looks like. I would have to ask my Neurologist when I am back in the States. Does anyone know if it got approved by the FDA in the States yet? The package in Israel for the new formulation is greenish for the 44mcg. The package in the States, which I receive is white. Are they different in other countries, or would we receive all the same, just with a different language? Thanks for a reply and reading what you write, helps me that I am not alone out there. J. :)

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Lisbeth
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Rebif New Formulation

Post by Lisbeth » Fri Apr 03, 2009 7:06 am

Dear Bezalel,

To the best of my knowledge, RNF has not yet been approved by the FDA. I've been following the US sites to check approval. Liz

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Lisbeth
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Refrigeration and Rebif New Formulation

Post by Lisbeth » Mon Apr 13, 2009 12:24 am

Just wanted to let Sandrine and the others know that I emailed one of the researchers from the RNF study group to ask about refrigeration. Serono is doing "stability studies." I specifically asked him about whether it was okay to try the Frio cooling wallet and he said yes. My neurologist also told me to go ahead and use it for when refrigeration is impossible. So I'm going to try. Has anyone other than Sandrine tried the Frio?

Lisbeth

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