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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.
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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
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HugInterested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.
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Safety is a different issue. I do not feel unsafe despite side effects. The Evenity site does list side effects.
We can decline the second shot. It is less effective but still effective enough for me. Basically for 100lbs., 10% vs 16% effective.
The fact remains that the standardized dose is based on 3mg/kg for 150 pounds and even the info on the drug insert says it is less effective for higher weight with "less exposure" of the drug. Elsewhere I have seen reference to more exposure with lower weights. Effectiveness increases with exposure, and the studies include higher doses, as high as 10mg/kg.
Most people do absolutely fine on the standard dose. Many have no side effects at all. Some of us tend toward med sensitivities!
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1 ReactionI found this snapshot of the trials interesting. Nothing about weight; only sex, race, and age.
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-evenity
FDA trials vs research studies!
Do you have the link to the study administering 10 mg/kg?
Hi Ladies.
I have been taking Evenity for 7 months now. I have other medications also. But I’ve noticed I have been having hand tremors that have started in this time period. Not sure if it’s from Evenity or something else. Has anyone had this reaction to Evenity? Thank you
Lorie
I may just be impatient but I have had 2 responses from FDA regarding my letter and 0 from Amgen, whom I had forwarded it to the following day.
If , "less is more" or even close... and I understand what you said, those are my words, I'd choose that route of 1 injection considering my weight. Having CLL the less I can get away with and have some good efficacy, I'd be grateful. In an already compromised system I am trying to be as careful as possible with all these unknowns. I know you, @windyshores, have other issues (autoimmune & kidney) so this information of 10% vs 16% in efficacy is interesting to say the least! TY
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1 Reaction@loriec, I'm sorry I can't answer this for you, hopefully someone else can. I sometimes use the search at the top of our screen within the Mayo site. Try "hand tremors."
Curious to know what sort of response from Amgen might be considered a 'success?' The second response from FDA is quite interesting.
And who would have logically thought that 'FDA trials' and research studies would be distinctly different? Does not the FDA consider everything? Or does the agency put on blinders about info not part of the FDA trials?
I understand that not all research studies or maybe even trials are reliable or conclusive. I hardly waste my time anymore on anything not peer-reviewed.....there is a lot of crap out there in research land....but I have always had faith in the scientific methodology.
My heartfelt thanx to Norma and WindyShores for their extraordinary efforts on the dosage issue. You have educated us all....even someone like me who is not presently a candidate for Evenity.
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1 Reaction@rjd most people on here and who I know have no side effects with Evenity. I just want to make that clear!