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

[Yorkiegirl]

I know mine is mixed when I get there. I have heard it does have a shelf life not sure of the amount of time.


Vicki

[Martha McKendrick]

I live in Wisconsin and I asked if I could watch them prepare my "cocktails" and the staff said sure so I was able to actully watch them prepare my Herceptin so I know it is fresh. Maybe you can ask to watch so you can feel more assured you are getting good stuff?

[sassy]

I am weighed each time and then herceptin is mixed accordingly.


Sassy
________
Cumm4uu

[Barbara H.]

Hi Everyone,
I do not see my oncologist every time, but he has to order it for me to receive it. They always weigh me before they mix it. I receive it every three weeks. The infusion takes 30 minutes and that procedure does not cause a problem for me. The whole procedure at the Dana Farber from parking to leaving usually only takes an hour when I don't see my oncologist. I'm happy about that because I will be on it for the rest of my life, or until it stops working, or until something better is found. I have been taking it since July 04. It put my tumor markers into the normal range and seems to be doing its job so far without having to add something else.
Best wishes,
Barbara H.

[karenann]

Mine is mixed when I get there. I sit really close to the really cold, chemical mixing room (for lack of a better description) and I see the whole transaction take place.

Karen

[Lolly]

Mine is also mixed after I'm weighed in each time...always has been done that way at my treatment center. Now that I'm also on chemo, the nurse draws my blood for labs to check my counts, then mixes my Herceptin and gets it started while we wait for the lab work to come back.

[Sandy H]

I live in rural Maine where people think we still travel in horse and wagon!! I am weighed in each week and my Herceptin is mixed after the nurse calls and lets them know I am there. I was told it is mixed on demand for these reasons. I may not be able to keep my appointment, my weight may have changed, and because of its short shelf life. Even worse is platlets and so they are being flown in from where ever they can get them. After so many hours I forget how many, I am sure Gina knows, they are thrown out. I know at my hospital if they know they are not going to use them they will let the other hospitals know that they have some that need to be used up soon. hugs, Sandy

[Barbara2]

I am in the chair and pluged into the IV before the herceptin is mixed. I am not weighed before each treatment, though, and have often wondered if my dose is correct. I am weighed every 3 months when I have a chat with the onc. My weight has increased quite a bit since starting herceptin. I maybe should ask him if the amount I am receiving needs to be adjusted.

Also, the nurses have told me I get 130 mg of Herceptin (weekly), which doesn't ad up to what I've read here which indicates 2mg/kg for weekly dose. Should I be checking into this??

Barbara

[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).

[Sandy H]

I am in rural Maine and people think we still use horse and buggy but this is what they do here. I don't always see the oncologist but I am weighed in and vital signs checked by a nurse. When I am in the treatment room the nurse will order my Herceptin from nearby oncology pharmacy and as soon as it is mixed she will hang it. She says these are the reasons why it will not be mixed ahead of my arriving. 1. I may not be able to keep my appointment for that day, 2. It goes by my weight, 3. It is short shelf life and I don't remember how long she told me. If anyone of the two happened it would have to be thrown out as they would not use it on anyone else. At a cost of around $1400.00 for each bag it would be ashamed to have to waste when so many of us need it. I thought it was always mixed this way! hugs, Sandy

[Becky]

I know mine is mixed after I get there. I have seen it done. I am weighted every other time (I get an infusion every 3 weeks) but my weight is relatively the same and rarely flucuates (by a pound or so). I sometimes get nervous on this as I typically go for the long appointment (CBC and onco - where I get weighed) in the am (where I know I weigh less) and the "off" week is as late in the day as I can get (where I know I weigh more as lunch is my big meal). So, all in all, I get the right dose one time and probably alittle bit more the second time. Not enough to worry about unless you are a person who is on the edge with their muga readings.


Good night for now. Sweet dreams.

Becky

[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

[Gina]

I am worried most about reconstituted herceptin in saline that is not refrigerated...would it lose its strength sitting outside of refrigeration at about 70 degrees F over a period of 9 or 10 hours...just wondering...if anybody knows anything else...please keep sharing...THANKS!!

Take care everybody,
Gina

[Barb]

I went to UK from Australia for 2 months and had to officially export from Australia, 4 doses of Herceptin confident that 2 double doses would be sufficient as I know it stays in the body for at least 4 weeks. (as it turns out, I was ultimately given 2 triple doses). The day before I left, my oncology unit packed it in cold ice in an insulated bag, and then put it in a big polystyrene box! I found a smaller insulated bag that held the first one. The airlines were not interested in helping keep it cool (I'd made enquiries beforehand) so we just kept it in our hand luggage. Next time if all is well and willing next year, I would look for even smaller insulated icebags as the vials are very tiny!
But be warned, in UK, as probably elsewhere, one must register with a local doctor and have him liaise with the nearest onc unit. I did all this before we went to UK and kept in touch to keep him reminded that I was going to turn up on his doorstep when I arrived in UK!
I don't feel that there was any problem with the doses that I took Gina. I did find John's letter from London, was interesting to read.
Keep with it girls, we're doing OK on Herceptin
Barb