Short shelf life for Herceptin???

[Gina]

Just when I thought I had taken Herceptin every way possible..., I recently was dismayed to discover, that apparently, when Herceptin is pre-mixed in solution for the IV and allowed to sit for many, many hours before being infused...it loses its potency and some of its effectiveness in direct proportion to how many hours it just sits on the shelf..., even if it is refrigerated....

My question to you all, is this REALLY true??? Do any of you have personal experiences about limited shelf life of pre-mixed Herceptin to share? I would be very interested. This could be very important for folks to check into, especially for those where it is claimed the HERCEPTIN has "stopped" working. If this has happened to you, check your recent herceptin infusion schedules and see if you recently switched from MORNING appointments to Afternoon or worse...LATE Afternoon appointments as the preparations are usually mixed in the early am by the pharmacy FYI. The later your appointment, the longer your herceptin mix has been allowed to just sit. Also, be sure your herceptin dosage is matched closely to your CURRENT weight as it is important..even a difference of 5 to 7 pounds can make a difference...especially if you have GAINED weight...if you have lost, you will just be getting a little EXTRA boost..smile.

One friend told me that at Georgetown, what we hope is a pre-eminent oncology establishment in my area, the herceptin is not mixed until the patient is in the infusion chair with IV in and is infused immediatedly to prevent degradation of the monoclonal antibody? Has Genentech written anything about this phenomenon??? Is there any documentation in the literature????

Just sign me..., VERY CURIOUS in ALEXANDRIA...smile,
Gina
Gpopp@comcast.net

[Barb]

Hi Gina
In Australia, I understand it is the norm here for one to enter the onc treatment room before they are allowed to order the Herceptin to be made up. I also had infusions when I went to UK earlier this year, and it was only made up when we signed in for treatment.
As for it losing its potency, I must confess I was most nervous that it might, as I took some Herceptin with me to UK in a 'freezer' bag. I wasn't allowed to put it in the aircraft fridge, so it was outside its normal cold environment for about 48 hours! I guess I won't know until maybe sometime down the track if my tumour markers start climbing.
I was interested to read the various comments of ladies as to how often they have their infusions in the US and some of the reactions felt by them.
I have been having Herceptin weekly for 2 years until I went to UK. There, the practice is to have a triple dose every 3 weeks over 1.5hrs. When I returned to Australia end of Sept, patients here had just been given the OK to receive it every 3 weeks as a triple dose so I felt it was a good step in the right direction trying to lead a normal life. However it was administered in 1/2hr. I became intolerably tired, I am not sure if others were the same, but the time for infusion has been changed to 1.5hrs.
Although I am described as a junior member (I don't know the reason for this), I am quite senior, so all my aches and pains, which sometimes are many, have mostly been attributed to the old degenerative disease, arthritis! For me, who knows but I shall keep on trying to be mobile! Barb

[al from Canada]

Hello Gina,
I can't understand how this can happen. Assuming that all countries are at least as backward as Canada, herceptin has to be filled at the hospital pharmacy which must be first, ordered by the consulting physican. I can't imagine someone just walking-in off the street, sitting down and getting a herceptin infusion without first seeing a doctor. To my knowledge, the pharmacy can't fill the Rx without a doctors note. My experience is that the most time in the infusion room is spent waiting for the pharmacy to fill the Rx, not getting the infusion itself.
As for weight gain.....who knows? What makes more sense to me, that is; if you want to pursue this line of reasoning, is that the doseage should get adjusted to the level of HER2 expression from your IHC / FISH test. The higher the expression, the higher the doseage? I'm not a pharmacist though so at this point.......
Al

[sarah]

Herceptin is very expensive so whether or not you have to see a doctor before the infusion, I doubt very much that they would make it up before they see you and you're about to get your infusion.
sarah

[Susan]

I know when I get my herceptin, they mix it when I get there. They have'nt told me because of short shelf life. But it only takes a few minutes to do it.

Sue

[RhondaH]

I think a lot of this has to do with not wanting to prepare it and not use it or possibly changing the dosing schedule or possibly weight etc.

Rhonda Hoffman

[JohnL]

Panic not...! Herceptin if prepared as advised can safely be stored for a reasonable period without hurting its efficacy. Even up to 24 hours unrefrigerated.

Stability and Storage Vials of HERCEPTIN are stable at 2—8°C (36—46°F) prior to reconstitution. Do not use beyond the expiration date stamped on the vial. A vial of HERCEPTIN reconstituted with BWFI, as supplied, is stable for 28 days after reconstitution when stored refrigerated at 2—8°C (36—46°F), and the solution is preserved for multiple use. Discard any remaining multi-dose reconstituted solution after 28 days. If unpreserved SWFI (not supplied) is used, the reconstituted HERCEPTIN solution should be used immediately and any unused portion must be discarded. DO NOT FREEZE HERCEPTIN THAT HAS BEEN RECONSTITUTED.

The solution of HERCEPTIN for infusion diluted in polyvinylchloride or polyethylene bags containing 0.9% Sodium Chloride Injection, USP, may be stored at 2—8°C (36—46°F) for up to 24 hours prior to use. Diluted HERCEPTIN has been shown to be stable for up to 24 hours at room temperature (2—25°C). However, because diluted HERCEPTIN contains no effective preservative, the reconstituted and diluted solution should be stored refrigerated (2—8°C).

[geraldine]

I am weighed and must see onc before they make up Herceptin because, I am told it is so expensive!!!!

Glasgow will be home to a new state of the art " Beatson Oncology Unit" in 2007

I was told, it was discussed, that patients who are on Herceptin only and back working, could be phoned on the day of their treatment to find out if they are well. A time can then be arranged and Herceptin will be ordered to suit.

I think this is excellent as it would empty the waiting rooms, free the nurses to deal with those who need them plus it would be very convenient for people like myself who can go back to work and some normality!!

God Bless You All
Geraldine