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← Return to Evenity - My Email to FDA
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Osteoporosis & Bone Health | Last Active: Sep 23 4:11pm | Replies (73)
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Additional response from the FDA. They take our questions seriously.
___________________
Dear Norma,
Thank you for your follow-up email.
The Review Division, who received your email, provided the information below:
Please note that drug exposure changes due to weight is always part of the FDA review. For the romosozumab trials, patients weighing 100 lbs and less were included in the trials, so we did review the safety of the drug in that population.
Best regards,
TNC
Pharmacist
Division of Drug Information
Center for Drug Evaluation and Research
Tel: 855-543-DRUG (855-543-3784)
druginfo@fda.hhs.gov
Replies to "Additional response from the FDA. They take our questions seriously. ___________________ Dear Norma, Thank you for..."
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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!