Connect
Evenity - My Email to FDA
Below is the email I sent to the FDA. If you wish to chime in, the addy is druginfo@fda.hhs.gov.
~~~~~~
I would like to express some concerns with an aspect of the approval process for Evenity (Amgen’s romosozumab-aqqg ). This may apply to other medications but Evenity is the one I am dealing with now. Evenity is recommended as the best medication for my osteoporosis but I am hesitant to take it for the reasons below.
It seems that all of the initial studies took weight into consideration with 3 mg/kg of body weight the maximum dosage used. Amgen then applied for approval setting the dosage as if all people weighed 150 lb. (Average weight currently for women is 170 lb.) The result is that the approved dosage is 210 mg. This one-size-fits-all approach has the dosage for me at 5.7 mg/kg. (I weigh 100 lb). No study included that high of a dosage. I was told by an Amgen representative that weight was not considered in the trials. Based on the 3 mg/kg criteria, the dosage for me should be 135 mg instead of 210. That is a HUGE difference. Why does the FDA not require consideration of weight when approving medications? Does the FDA require information on those who drop out of trials? Do those who are overmedicated drop out at a proportionally higher rate due to more severe adverse reactions? Or is that information hidden from the FDA? Which of you would like to go into surgery with the anesthesia appropriate for my weight or would you want the amount appropriate for your individual weights? I realize that not all medications can be completely individualized based on weight but at least 2 dosages could be offered.
Evenity does come in a manner that is possible to adjust in a gross manner for weight differences. Each dose comes in 2 syringes each containing 105 mg. However, health care providers are fearful of going off-label. They would prefer to poison us rather that to do what is right for the patients. Using only one of the syringes each time is reducing the dosage but not changing the actual use it is intended for. I can name some other medications that are used in what I would call a true off-label manner. Almost daily we read about Ozempic, a diabetes, medication being used for weight loss. Then there was Hydroxychloroquine, a malaria drug, used unsuccessfully for Covid-19. And Ivermectin, a drug used to treat heart worm in dogs, also tried for Covid-19. (desperate measures in desperate times.) Somehow, using a weight appropriate dosage does not seem to me to fall in the category of off-label usage.
Is there a way the FDA can help those of us with low BMI get the treatment we need in as safe a manner as possible?
Thanks in Advance for considering my request
Like
Helpful
HugInterested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.
Connect
Again the way to have an impact is to report to MedWatch!
I am declining the second shot. That works for me. I think Amgen was reasonable in the initial dosing (studies showed higher exposure had better results and side effects were the same) and most people do fine with it.
Perhaps if they hear that enough of us who are sensitive, are doing one of the two shots, or perhaps if docs are aware of this (I notified my doc) there will be a sanctioned half dose. I am having the same side effects with the half dose to be honest.
I think benefit is dose dependent, but side effects maybe aren't!
I am doing what I can as I have not started Evenity; therefore, no adverse reactions to report. The NP at the fragility clinic has made it clear that she will only agree to partial doses the first 2 months. I cannot see her agreeing to a test dose of ReClast down the way.
"I had mentioned I was willing to give half of a dose twice but then we must go to a full dose as the studies show the medication does not work with only a portion of the dose. I could refer you to an endocrinologist if you wish to pursue another provider who, by law, would be able to do this; I however, cannot go against the label and continue to give only a portion of the dose. "
We both know that partial doses are effective.
Since Evenity stays in the body for something like 64 days, not the 2 days the NP told me, I wonder if taking the full dose the first time is contributing to the effect experienced after the partial second dose.
I thought of that. I am considering alternating. Then again, I am considering not doing any more because both my P1NP and my CTX are so low.
Half life is 12.8 days after three doses. Peak is 2-7 days with the average being 5 days.
With that half-life, I would think about 1/32 of the dose is present at day 64. Biological half life may be different from plasma half life though.
After 5 weeks (the space between my doses) I would expect about 1/8 or a little more still to be active in plasma.
The study I saw said 10% effective vs 16% but that did not take weight into account. You can still decline the second shot but it sounds like this NP will discharge you. Perhaps NP's are more nervous about this since they are supervised.
My second opinion doc told me that partial doses of Reclast are "done all the time."
Most people do fine with Evenity. I already has neurological sensation issues and am generally sensitive to everything. It really builds bone and fast. The full dose may be good for you. I would gladly do full dose if I didn't have yet another strange drug reaction. My immune system does not behave.
After emailing Amgen for the 4th time, I had a call today while I was out. It seems that they are more willing to discuss my concern verbally than to put something in writing that I could share with you. I am to receive another call on Monday.
-
Like -
Helpful -
Hug
1 ReactionDid you do a report on MedWatch? They might be calling for permission to call your doctor to confirm a problem. That's what they did with me. If you didn't file a report, let us know what they say!
I had my first Evenity shot yesterday. I feel slightly
woozy.
-
Like -
Helpful -
Hug
2 ReactionsIt will get better. My first shot's more intense effects lasted 4 days.
I felt very tired the day after my first Evenity injections. After that, fine.
-
Like -
Helpful -
Hug
2 Reactions