After having found out that my pharmacy had forgotten to refrigerate my
Enbrel refill for a day and a half, I called Amgen/Enbrel to update my
understanding of their policy in such cases. Not totally satisfied with the
nurse's response, I was redirected to a second level nurse. I was
essentially told the following.
Amgen does not recommend any deviation from the 36 to 46 degree temperature
range for Enbrel storage.
She went on to state, however, that Amgen has "effectiveness studies" that
indicate Enbrel retains a level of viability as long as the temperature is
not kept higher than 77 degrees F for up to 45 days. Amgen's effectiveness
studies indicate that Enbrel is to be consumed before the 45th day beginning
when the medicine was first discovered being stored outside the recommended
temperature. In other words, if one had a two-week supply that was
discovered outside the recommended temperature range on Day 1, that supply
must be used before Day 45 -- which essentially means that Enbrel could sit
around at 77 degrees for more than 30 days and still retain some level of
effectiveness. However, a copy of this effectiveness study is not available
to the consumer as far as I could determine. I was unable to find out
anything about the characteristics of this study, i.e., what is the
effectiveness level at Day 1 outside the recommended temperature range, at
Day 2, at Day 30. It would stretch believability that the Food and Drug
Administration has approved usage of Enbrel for up to 45 days when the
medicine is not stored in compliance with the stated 36 to 46 degrees F
temperature range that was established during the testing trials.
The bottom line according to this second level nurse is, again, Amgen does
not recommend any deviation from the 36 to 46 degree F temperature range
while stored. This is their official policy. The nurse further went on to
state that it is always up to the user to decide if they will use Enbrel
that has been improperly stored -- notwithstanding Amgen's effectiveness
studies.
Jayne - 11 Oct 2004 21:05 GMT
> snipped
> The bottom line according to this second level nurse is, again, Amgen does
[quoted text clipped - 3 lines]
> Enbrel that has been improperly stored -- notwithstanding Amgen's
> effectiveness studies.
That is interesting thanks. Back at the beginning of May, I did my
injection before bed, and left my box of Enbrel on the kitchen worktop
accidentally overnight. It contained 4 weeks worth of injections, and I
suppose the temperature was about minimum 16 degrees centigrade (eg at least
8 degrees above recommended maximum).
I was worried about it, but didn't notice any loss of effectiveness.
Jayne
Kitty Kelly - 11 Oct 2004 23:23 GMT
Jayne wrote -
~~~and I suppose the temperature was about minimum 16 degrees centigrade
(eg at least 8 degrees above recommended maximum).~~~~
Thanks for the translation, Jayne! We spoiled Americans have fought for
decades to NOT learn the celsius scale. We don't care if all the rest
of the world uses it, we ain't learnng it!
-vbg-
Kitty
Jayne - 12 Oct 2004 17:26 GMT
> Jayne wrote -
>
[quoted text clipped - 8 lines]
>
> Kitty
LOL - I sort of guessed that would be the case! It took some time for me,
but I now work in celsius. As far as the weather forecasts are concerned I
know where I am with them now - when they say zero, I know how cold its
going to be, whereas I don't even know what freezing point is in fahrenheit.
Jayne
Char - 11 Oct 2004 21:16 GMT
Very interesting Charlie. Thanks for posting this information.
Char
"Remember, I'm pulling for ya'. We're all in this together." Red Green
Mary Z - 11 Oct 2004 22:22 GMT
>Amgen's effectiveness
>studies indicate that Enbrel is to be consumed before the 45th day beginning
[quoted text clipped - 4 lines]
>around at 77 degrees for more than 30 days and still retain some level of
>effectiveness.
Great information Charlie. I had Enbrel in a cooler but when I had
returned after a 5 day trip the ice had melted and the Enbrel was
warm. I did not notice any difference in effectiveness, some people
have. -- MZ
Visit my website:
http://www.mzuschlag.com
MassReader - 11 Oct 2004 23:27 GMT
>The nurse further went on to
>state that it is always up to the user to decide if they will use Enbrel
>that has been improperly stored -- notwithstanding Amgen's effectiveness
>studies.
Charlie,
What have you decided to do? What is your recourse with the pharmacy if you
decide not to use it?
Cindy, a newbie Enbrel user
charlie - 12 Oct 2004 01:56 GMT
The pharmacy didn't push the issue and reordered. My recourse if they had
not done so would be to refuse accepting the Enbrel on the grounds that
Amgen does not recommend any deviation from the 36 to 46 degree requirement,
and that I believe the pharmacy was making a decision not in accordance with
FDA requirements. If they refused to reorder I would call my insurance
company and read to them what I posted here.
>>The nurse further went on to
>>state that it is always up to the user to decide if they will use Enbrel
[quoted text clipped - 8 lines]
>
> Cindy, a newbie Enbrel user