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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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BRAVO!!! As another 100lb woman, I want to thank you for finding a place and way to let the FDA know that not everyone should get a "standard dosage" for any drug. THANK YOU!!!
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1 Reaction@normahorm there are plenty of studies showing different doses of rosozumab and all are effective. A half dose is 10% vs 16% for full in terms of effect, according to one. I just declined a second time to have two, and the nurse is committed to working with me. But this is based on known med sensitivities, not weight.
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1 ReactionThank you for this topic. I too am petite at 110pds and often find the dose is too much for my body. I am trying to decide my drug course to start for my severe osteoporosis if anyone with this issue has some advice I’m grateful
I am having pins and needles and some burning sensations with just one of the two shots to be honest. So my response may not be dose-dependent. For those not having an adverse reaction, it might even be an advantage to be lower weight. It is those with higher weights who get less exposure to the Evenity. Honestly, who knows!
I weigh 118 lbs and took full dose for three months, which means I have actually had about three and two-thirds dose. I am trying to figure out the time frame regarding when this drug will be out of my system. I have to quit because I need major oral surgery and want to be sure the drug is gone. The drug is said to reach a steady state at month three and has a non linear elimination. Anyone have any ideas?
I would suggest calling Amgen and explaining your situation. They SHOULD be the best ones to provide the needed information.
@marymj7 I don't know if anyone knows how anti-resorptive Evenity is at that point. Ben Leder has a chart on his you tube video "Combining and Sequential Approaches to Osteroporosis." It is a mild anti-resorptive, I was told. Evenity has only been around since 2019. Do they even know the risk for oral surgery? Is it hypothetical, anecdotal or proven in studies?
The half life at 3 months is 12.8 days so half is gone by that time.
https://www.drugs.com/medical-answers/what-happens-when-you-stop-evenity-3577578/
I was told that Evenity continues to "mineralize" for two months.
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1 Reaction@windyshores, thanks for your response. There had already been 17 romosozumab related ONJ cases reported to the FDA Pharmaceutical Adverse Events Database by Sept. 2021. From the studies I have read, it *appears so far that Evenity carries about the same ONJ risk as oral bisphosphonates. It's still a small risk for most, but for someone like me who needs an oral bone graft, it is definitely a risk. Also, a study of the data on the FDA site revealed that ONJ risk from Evenity was found to have the earliest onset of all the osteoporosis drugs at 169.5 days into treatment, which is surprising. I know that systemic clearance occurs at 0.38mL/kg/hr-but I need a pharmacist to figure out what that means for me!
@marymj7 I was wondering how the risk could be high with a drug that was only approved for one year, when the risk with bisphosphonates is (allegedly) after 3-5 years. But the mechanism of sclerostin inhibition is so different from the mechanism of other anti-resorptives.
I wrote somewhere on this forum about the side effects that came as a surprise once bone drugs were on the market: bisphosphonates and atypical fractures/jaw necrosis, Prolia and rebound, and Evenity raising P1NP for only a couple of weeks- all surprises. On the positive side, actual post-marketing experience with Forteo and Tymlos showed on bone cancers.
I wonder if this early ONJ risk with Evenity was expected by researchers and marketers. It is so new. Medwatch/FDA is helpful. Thank you for sharing this! I did Evenity for 120 days but now Reclast- we'll see...I have one problem tooth!
Hope pharmacist, doctor and dentist can work together to make sure your oral surgery is safe!
@windyshores Thanks so much. It helps just having someone to chat with about this. I will post again if/when things become clearer for my situation. I hope your problem tooth can be saved instead of extracted so you won't have to worry.