Herceptin Diluents Specifics

[StephN]

Hi Everyone -
I tried to post this last weekend from my sis's house when we had the power outage and it did not "take." So, will do it again, since there has been some discussion (lately initiated by kate) about aches and pains associated with the Herceptin treatments. I was curious so inquired at my cancer center, which is connected to a major university hospital.
Seems that there is only the smallest amount of the benzyl alcohol used, and I have asked whether they can cut it out altogether, or if it is actually part of the Bacteriostatic water. Will post that info when I get it.

WISHING YOU ALL A WARM AND BRIGHT HOLIDAY TIME.
(My Dad noted this morning that my joyous mood must be because I have overcome so much with my brain and head this year!) I know some others who have been having the same Stage IV fight will feel the same way ... just glad to be here and able to make a holiday breakfast for their loved ones! http://www.her2support.org/vbulletin/images/icons/icon7.gif

Hi Stephanie,

Good question. Trastuzumab (herceptin) is delivered to the pharmacy in powdered form. This powder is then "reconstituted" (mixed with water to dissolve it) with a kind of water called bacteriostatic water. Bacteriostatic water is sterile and contains a very small amount of benzyl alcohol as a preservative. The amount of bacteriostatic water used to dissolve the herceptin is 20mL (one tablespoon + 1 teaspoonful) and the benzyl alcohol in this water is only 1.1% of the total volume. The dissolved herceptin is then mixed into an larger bag of saline which is then infused through your port or vein.

I haven't heard of this cramping issue with Herceptin and I honestly don't think it would be related to the benzyl alcohol. I'm wondering have you started any other therapies lately? Happy to help in any way. Julie

__________________________________________________ __

Julie Garrison, Pharm.D.
Breast Cancer Clinical Research Manager
Seattle Cancer Care Alliance
Clinical Assistant Professor, University of Washington

[tousled1]

Steph,

Here is what the www.gene.com (http://www.gene.com) website says about reconstituttion of Herceptin:

Reconstitution Each vial of Herceptin should be reconstituted with 20 mL of BWFI, USP, 1.1% benzyl alcohol preserved, as supplied, to yield a multi‑dose solution containing 21 mg/mL Trastuzumab. The reconstituted preparation results in a colorless to pale yellow transparent solution. Parenteral drug products should be inspected visually for particulates and discoloration prior to administration. Reconstituted Herceptin must be discarded after 28 days.

Use of diluents other than BWFI should be avoided unless contraindicated. For patients with known hypersensitivity to benzyl alcohol, Herceptin must be reconstituted with Sterile Water for Injection; discard any unused portion.

When I had my last Herceptin infusion, it was reconstituted with saline water and I had a noticeable reduction in the amount of muscle, joint, bone pain. I'm on Herceptin only and didn't have these problems before starting the Herceptin. Also, if you you go to the website you should look at Table 9 which details adverse affects of Herceptin. I will complete my year of Herceptin in June 2007!

[CPA]

If I did my math right, there is a reason for diluting herceptin in the solution provided... As you all know, Herceptin is very expensive. It is supplied in powder form, reconstituted as described above, then (usually) added to a 250ml bag of normal saline solution (NSS) for infusion.

The amount required by a 155 lb (70kg) patient, with 2mg/kg dose is 140mg. This means that the pharmacist draws about 6.7ml (about 1/3 as mixed) of the reconstituted solution. The remaining herceptin solution can then be stored for up to 28 days.

If herceptin is mixed with only sterile water, it must be discarded within 24 hours, essentially wasting approximately 2/3 of the solution if it cannot be used during this 24 hour period.

I agree with the pharmacist that the benzyl alcohol (BnOH) is probably not causing the problems. At 1.1% in 20ml, you are only getting about .07 ml of BnOH if you get the dose used in the above example. This is much lower than amounts shown to be safe. Remember, BnOH is naturally found in some fruits and other foods. It is used in other foods as a carrier for flavorings. It is also relatively common in other pharmaceuticals.

[KellyA]

I wonder if the alcohol affects people differently. Not sure if this is the same alcohol or not, but they used some kind of alcohol with my chemo (in between changing bags, to flush my port) and it made me very sick, almost immediately. They had to use saline from that point on and the problems stopped. I am having some strong pain in my hips since Herceptin and wondered if that could be it. Might not be, just curious. I was going to ask about trying the saline mix. Didn't know that it would put a time frame on using it though.


Kelly

[tousled1]

I think since Herceptin is provided to the oncologist in powder form that they can just take the required amount of powdered Herceptin and reconsitute it with the saline water. All I know is that my last Herceptin treatment I had it reconstituted with saline water and my bone/joint pain was remarkably less. Also, when I suggested this to my oncologist she had no problem with my request.

[Lee]

My onc's office only mixes up as much as needed, and uses saline to do it. They never pre-mix the herceptin or use some that is left over from another preparation.

[Unregistered]

Hi All,

Thanks for sharing all the valuable info about herceptin. Last month when my mother had pain after herceptin treatment I was looking for the same information.

My mother was treated with Herceptin+Xeloda with 1st dosage of 8mg/kg. Incidentally there was no pain after the first cycle. During the second cycle, doctors reconstituted the remaining herceptin from first cycle with saline. There was severe joint and bone pain after the second cycle.

I read through these blogs and asked the doctor to administer a fresh batch of herceptin every cycle, as the batch size of 440 mg is almost equal to one cycle's requirement.

The third round onwards, there is no pain. It is to be noticed that the second round which caused pain was also reconstituted using saline only, and not benzyl alcohol. So it seems that the pain is caused by part usage of one batch regardless of the mode of reconstitution.

She has undergone her 4th cycle as well last week and is fine with regard to bone and joint pain.

Hope it helps someone.