New formulation of Rebif

scoobyjude · Posted: Sun Feb 10, 2008 10:03 pm Post subject:

Totally understand what you're saying. Let us know how it goes for future shots.

bebe · Family Member Joined: Oct 27, 2004 Posts: 50

dignan · Family Elder Joined: Aug 12, 2004 Posts: 1186

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.

scoobyjude · Posted: Fri Mar 07, 2008 10:05 pm Post subject:

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.

Punchy · Posted: Sat Mar 08, 2008 8:48 pm Post subject:

I've had two new formulation shots - less sting, and the plunger and needle went down smooth as butter Very Happy

wmroche · Newbie Joined: Mar 20, 2008 Posts: 1

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.

Sandrine · Posted: Wed Apr 16, 2008 9:30 am Post subject:

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" Razz

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

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.

Rene966 · Newbie Joined: Apr 18, 2008 Posts: 3

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?

dignan · Family Elder Joined: Aug 12, 2004 Posts: 1186

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."

Sandrine · Posted: Sat Apr 19, 2008 3:48 am Post subject:

@Rene966 and dignan: Thank you! Smile

Ok, that's really strange...

@Rene966: Welcome here Very Happy

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" Question

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 Rolling Eyes

package insert!

Thank you two so much, now I'm really looking forward to the rockfestival I'm going to join in June Smile

3,5 days with music, camping... My sister will be happy, too, I think.

Sandrine

Rene966 · Newbie Joined: Apr 18, 2008 Posts: 3

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?

Punchy · Posted: Sat Apr 19, 2008 1:20 pm Post subject:

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.

Sandrine · Posted: Mon Apr 21, 2008 2:28 am Post subject:

@Punchy: Thank you Very Happy

I'm relieved now!

@Rene966: Hurricane-Festival > www.hurricane.de Smile

Sandrine

Rene966 · Newbie Joined: Apr 18, 2008 Posts: 3

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