Tymlos Side effects

@osteopatient2026 Yup. Tymlos is my last drug option, before defaulting to Reclast (due to previously failed treatment meds' severe side effects). My reduced dose on Tymlos is driven 100% by inability to tolerate the side effects. My provider wanted me to stop this drug, but it is my last hope of building bone and leaves only Reclast as the next step. Side effects are challenging enough that I could raise the white flag at any minute. I just think it's terrible that Reclast does not provide providers any guidance whatsoever regarding lower dose ootions. We see way too often on this site that doctors, including mine, did not even know the pen could be titrated. My provider is against my off-label lower dose and will not provide any titrating guidance whatsoever. However, she is allowing me to continue, because she knows I'm in a difficult situation with no remaining options...and she is worried about my reacting to Reclast. Just not understanding why Reclast won't put out an official statement that would say something along the lines of suporting dose reductions (with likely less effectiveness), based on clinical trials AND at the discretion of the physician. Some reduced-dose folks on this site have reported incredible gains. For some of us, we're in a position that some improvement sure as heck beats no chance of any at all.

From a financial standpoint, Radius is still getting their full amount of money from me, even though I'm throwing away half the pen each month. Why wouldn't they want to continue with patients like me, who may be able to tolerate the lower doses, but whose doctors won't allow it, because there's no guidance from Radius? I spoke to a pharmacist, who has been involved with development phone calls with Radius, and even he doesn't understand why they don't put out this information and create a lower volume cartridge for those of us who can't tolerate the full 80 mcg. We all know the research in this entire area is lagging terribly. And expecting changes anytime soon it's just not realistic. Sad.

@cathyf31 I tried to get info from Radius about going off-label on doseage as my side effect is fatigue and bone pain at 80 mcg. I found I can tolerate 70 mcg and live with the fatigue and the bone pain is not present at the lower dose. Radius had no comment at all about lower dosing. I also spoke with my endo who had no comment either. I think she did not want to provide an opinion, perhaps worried about liability? However, at 108 lbs. and 5'5", the 80 mcg dose creates considerable side effect discomfort. And 10 months after starting Tymlos in October and 9 months after I actually began monitoring bone markers in November, I had a 300% increase in P1NP on the lower dose.

@willowmena Yes, I think it's beyond sad (horrible) that Radius is unable/unwilling to allow any of it employees to comment on any dosage outside of the FDA-approved 80 mcg (which data supported 80 mcg as the biggest bang for the buck with respect to effectiveness). This does not help people like you and me, who cannot tolerate the side effects at full dose. My health provider also will provide zero comments or guidance on any dosage adjusting or titrating. It would be so helpful for rmRadius to simply print one comment that states, "At the discretion of the physician, doses can be adjusted in an attempt to mitigate side effects, with an understanding that maximum benefits will likely not be achieved compared to the full dose. " (Duh). We understand we likely will have reduced gains, but if we can't tolerate the medicine and otherwise have to stop, we would have zero gains.

Not long ago, somebody shared a link to some clinical trial information on Tymlos. It is the only place in print I have ever seen a mention of reduced doses, specifically 20 mcg and 40 mcg in Phase 2. I will take a screenshot and attach a snippet of the information. I actually shared this with my provider, who originally until I shared with her, did not know that the pen was even adjustable. I do find it interesting that her quiet position that requires me to navigate my own waters, due to the severity of my side effects, is allowing me to continue to use the medication though (although still preferring I stop). At the beginning, she pushed back hard and I did not think that I would be abke to continue. We are both very concerned with my only next step (Reclast), so maybe that is why I've been allowed to continue.

I did speak with a Radius employee, who gave me a recommendation to have my provider call in and speak to a Science Liaison at Radius to see if that individual would be willing to share the data and potential benefits about the lower doses. My provider called multiple times, but never received a return call. Terrible. I also spoke to a specialty pharmacist who had been involved in previous Radius calls and agrees 100% that Radius should release that data and even produce a smaller-sized cartridge for the lower doses, so the extra medicine is just not thrown away after 30 days. He said that he would diligently work to try and get on with another call with Radius. Sadly, we can all see the painfully slow and dangerous pace of improvement in the world of osteoporosis.

@cathyf31 I wonder what other information they have managed to withhold or conceal. Approx 80% of the male rats developed bone cancer when administered high doses of the meds. I don't trust the "standard" dose to be safe for everyone.

@willowmena Our bodies can definitely respond differently to the meds, but Inam thankful they exist and have helped many people avoid fractures and move out of the osteoporosis range. Hoping for the best. Good luck!!

@lori62yb it takes 2 months to get over the sides effects. Then like magic it disappears. Titrate up starting with a lower dose. I had to go back and do that (with my doctors permission of course). Just finishing 2 years. After I adjusted it all flew by.

@willowmena
we really don't have to worry about developing cancer like those rats.
I also find it a little suspect that the 40mcg results aren't published except in press releases.
But Radius did design a flexible pen, not accidentally, I suspect, because this pen design is more expensive to manufacture than a flat dose devise would be.
I've heard of Radius reps recommending titrated dosage and even explaining how to achieve them (only on Connect).
I often suspect that phone representatives in most companies are undertrained.
There could be a legal (FDA) problem in advising because the drug wasn't tested in the ways we want, need to use them.