New formulation of Rebif

A board to discuss the Multiple Sclerosis modifying drug Rebif

Postby scoobyjude » Sun Feb 10, 2008 9:03 pm

Totally understand what you're saying. Let us know how it goes for future shots.
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Postby bebe » Wed Mar 05, 2008 7:49 pm

scoobyjude wrote:Punchy, the last 3 batches I've received have had faulty syringes too. I couldn't completely push the plunger down. I called the helpline and all they said was-if you can't push it anymore than don't. Great advice huh?


Are you in the US? If so, call MS Lifelines...they will absolutely replace faulty syringes.
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Postby dignan » Wed Mar 05, 2008 11:12 pm

Just a quick update, I've done about 12-13 shots with the new formulation and it definitely stings a lot less than the old formulation. I'd say so far I've had fewer injection site reactions too.
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Postby scoobyjude » Fri Mar 07, 2008 9:05 pm

Bebe, it was MS Lifelines that I called and that's what they had to say. The woman didn't even suggest replacement. I was kind of surprised. It was almost as if she thought I was overreacting or something.

Dignan, sounds good. Can't wait till we get it in the US.
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Postby Punchy » Sat Mar 08, 2008 7:48 pm

I've had two new formulation shots - less sting, and the plunger and needle went down smooth as butter :D
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New Formulation

Postby wmroche » Thu Mar 20, 2008 9:05 am

Been using new formulation for 2 months. Price went up by $200 to $2000 for 12 syringes, so now costs $26 000 per year in Canada.

May go off Rebif since white blood cell count is low (1.5)

Still typically day after injection is what I call a "bad day".-headache, dizziness, foggy. Really cannot tell if it doing any good. Been using 4 months now.
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Postby Sandrine » Wed Apr 16, 2008 8:30 am

Hallo,

Rebif new formulation (RNF) is on the market in Germany... And according to the Helpline and the package insert the storage now has to be 2-8°C (36-46°F) continuously...

It is rumored here in Germany that the Canadian package insert for RNF still says "If a refrigerator is not available, Rebif® may be stored at or, below 25° C/77° F for up to 30 days and away from heat and light." and that the new storage conditions are "typically german" :P

So any Canadian here who can tell me something about the storage of the "new" Rebif? :D

Thanks,
Sandrine

P.S. According to the data (experimental data) I found about the RNF I can't see why it should be less stable than the old one - stability at diff. temperatures, aggregate formation etc. No big differences.
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Postby Rene966 » Fri Apr 18, 2008 3:12 pm

Hi to all of you, this is my first message!

Sandrine, I was a bit surprised by your message, because I'm Austrian and the info sheet that came with my (new formulation of) Rebif says: "Sollte eine Kühlung vorübergehend nicht möglich sein, kann Rebif beim Anwender bei einer Temperatur von unter 25C bis zu 30 Tage lang aufbewahrt werden." (In English: If cooling is temporarily unavailable, Rebif can be stored at a temperature below 25C for up to 30 days).

rebif.com also says: "Room temperature storage up to 30 days "

Is it possible that the German version is different from the Austrian?
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Postby dignan » Fri Apr 18, 2008 6:52 pm

In Canada, on the box it just says to store at 2-8 degrees C. Then, on the information inside (amazing how much they pack in to a little fold-out thing) it says, "Rebif syringes should be stored refrigerated at 2-8 C. Rebif syringes may be stored for a limited period of time at room temperature (up to 25C), for up to 1 month. Do not freeze."
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Postby Sandrine » Sat Apr 19, 2008 2:48 am

@Rene966 and dignan: Thank you! :)

Ok, that's really strange...

@Rene966: Welcome here :D

Here is the german "Fachinformation", similar to the package insert: http://www.leben-mit-ms.de/pdf/rebif44.pdf

The sentence "If cooling is temporarily unavailable, Rebif can be stored at a temperature below 25C for up to 30 days)." is missed.

That storage problem was also heavily discussed in the German MS-forums, because Rebif users were also told by their pharmacists to store the new formulation 2-8°C. I was really pissed. For me storage at room temperature/25°C is very convenient e.g. during holidays (hiking) or flights to conferences etc.

Then I called the (german) helpline and they confirmed, no storage at room temperature "but maybe that will change" :?: Maybe they test it with the Austrians and Canadians :wink:

I searched for information and found out, that according to the data (e.g. in the patent application publication) RNF is stable enough at room temperature, like the old one...

Ok, so I will ignore that 2-8°C-sh*t only mentioned in the German :roll: package insert!

Thank you two so much, now I'm really looking forward to the rockfestival I'm going to join in June :) 3,5 days with music, camping... My sister will be happy, too, I think.

Sandrine
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Postby Rene966 » Sat Apr 19, 2008 8:30 am

Just a word of caution: My information is dated August 2007 and may already be outdated, whereas the pdf you mentioned is from December.

I'm going to ask my neurologist when I next see her on May 15th.

A rock festival in june? Nova Rock?
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Postby Punchy » Sat Apr 19, 2008 12:20 pm

I checked my package too and yep, we're still allowed to store it at room temp up until 30 days.

It's so much easier that way - I would take three syringes out every Sunday and leave them out for the week so I didn't have to worry about forgetting and having to inject it cold.
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Postby Sandrine » Mon Apr 21, 2008 1:28 am

@Punchy: Thank you :D I'm relieved now!


@Rene966: Hurricane-Festival > http://www.hurricane.de :)


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Postby Rene966 » Thu May 15, 2008 9:05 am

Asked my neuro today: She couldn't tell me anything about the room temperature issue, sorry!
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Refrigeration and Rebif New Formulation

Postby Lisbeth » Wed Jan 14, 2009 1:42 am

Hello everyone,

This is my first posting and I hope that I am doing this correctly. I am about to switch to RNF. My Rebif nurse told me that it has to be refrigerated all the time. This is very inconvenient because I travel to Africa for work, where there is often no refrigeration available in hotel rooms and sometimes the electricity goes off anyway. Is there any more recent experience with the refrigeration issue? I've checked the web and can't find anything. Thanks. Lisbeth.
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