Prolia black box warning?

Posted by cpd54 @cpd54, Feb 21 6:36am

FYI,
https://m.youtube.com/watch?v=sZPSWZocbJw

*Moderator Note*

Dr. Susan Brown is listed as a medical anthropologist and certified Nutritionist. Medical anthropology is the study of how health and illness are shaped, experienced, and understood in the context of cultural, historical, and political forces. Dr. Brown is the author of Better Bones and also a retailer. The boxed warning on Prolia specifically focused on the risk to patients with kidney disease and those on dialysis. 

When making treatment and medication choices, it is highly recommended to speak with an endocrinologist.

Additional reading - https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-revises-labeling-amgens-drug-treat-bone-loss-2024-01-19/

Interested in more discussions like this? Go to the Osteoporosis & Bone Health Support Group.

@formisc

That sounds like a great plan! As mentioned earlier, if you do not want to commit to a prescription of Alendronate yet, you could just try a couple of weeks to gauge your reaction, if any. But remember to do the blood tests first. Oh, you may also want to consider bringing forward your DXA so that you can separate the effect of Prolia and your subsequent relay drug on bone density

Reclast is the more potent drug and is most often quoted for use as a relay drug for getting off Prolia esp after 4 (per Dr McCormick, 3) or more shots of Prolia. But i was wary of putting in 1 year's dose at 1 go so i opted for weekly Alendronate where timing is also less of an issue. If you do end up deciding on Reclast, there is a lot of advice on this forum on how to minimise any side-effects like drinking lots of water. Also, windyshores (search under "Members") mentioned that she would ask for a 20% test dosage first so i am not sure if that is something your doctor would consider or agree to
All the best to you and please do keep us updated!

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Hello formisc,
So sorry, I had answered under the wrong classification, so best to re-write this !
So here is my update from my 13 March appointment.
Apparently, my rhuematologist sent my GP a letter suggesting stopping the Prolia due to on-going infections and respiratory history [which is long] and to start Forteo. Should mention my rhuemy is also an internal medicine specialist.
To stress the point of on-going chest infections since the start of Prolia, I took ill again on 03 March, with ER treatment required.[Was seen by another respirologist there, who concurred with my regular respirologist].
I am now home and after a regime of 3 antibiotics and my regular antibiotic, I am improving ! Once back to 'normal' I will commence Forteo. [I am set for another round of pulmonary function tests after another 3 weeks and respirologist appointments, which will occur before the Forteo shot commences].
Apparently, Forteo has less infection complications and is indicated for steroid induced osteoporosis. Looks like the better choice.
I have yet to get my baseline bloodwork, but will do so when feeling a bit better.
Again thanks to you and others for your expertise and wonderful support in this - you were the trigger to get this 'ball rolling'.
Your happy Connect Buddy!

REPLY

Hi Christine,

I did read your update in the other thread but it was very kind of you to post it here as well. I think you are making a good decision to go off Prolia esp given its negative impact on your immune system. As others have mentioned, the usual follow-up from Prolia is a bisphosphonate like Reclast or Fosamax and Prolia may reduce the effectiveness of an anabolic like Forteo but as you have not been on Prolia for very long, there should still be some efficacy in using Forteo. I am surprised that your rheumatologist suggested Forteo rather than a bisphosphonate as a relay drug but he/she may have her reasons. It means however, that it is even more important to monitor closely your BTMs to ensure that any possible rebound from Prolia is controlled.

I note that you have further tests and respiratory appointments before you commence on Forteo. If these end up delaying your commencement of Forteo beyond 6 months from your last Prolia shot, you may wish to consider checking with your rheumatologist if you could just take a week or two of Fosamax/Alendronate as a temporary measure to mitigate any possible rebound effect.

All the best for a speedy recovery from your chest infection and do take care and keep us updated.

REPLY
@thisoldewe

Hello formisc,
So sorry, I had answered under the wrong classification, so best to re-write this !
So here is my update from my 13 March appointment.
Apparently, my rhuematologist sent my GP a letter suggesting stopping the Prolia due to on-going infections and respiratory history [which is long] and to start Forteo. Should mention my rhuemy is also an internal medicine specialist.
To stress the point of on-going chest infections since the start of Prolia, I took ill again on 03 March, with ER treatment required.[Was seen by another respirologist there, who concurred with my regular respirologist].
I am now home and after a regime of 3 antibiotics and my regular antibiotic, I am improving ! Once back to 'normal' I will commence Forteo. [I am set for another round of pulmonary function tests after another 3 weeks and respirologist appointments, which will occur before the Forteo shot commences].
Apparently, Forteo has less infection complications and is indicated for steroid induced osteoporosis. Looks like the better choice.
I have yet to get my baseline bloodwork, but will do so when feeling a bit better.
Again thanks to you and others for your expertise and wonderful support in this - you were the trigger to get this 'ball rolling'.
Your happy Connect Buddy!

Jump to this post

Sorry, i must have tapped on "Comment" instead of "Reply"

REPLY
@formisc

Hi Christine,

I did read your update in the other thread but it was very kind of you to post it here as well. I think you are making a good decision to go off Prolia esp given its negative impact on your immune system. As others have mentioned, the usual follow-up from Prolia is a bisphosphonate like Reclast or Fosamax and Prolia may reduce the effectiveness of an anabolic like Forteo but as you have not been on Prolia for very long, there should still be some efficacy in using Forteo. I am surprised that your rheumatologist suggested Forteo rather than a bisphosphonate as a relay drug but he/she may have her reasons. It means however, that it is even more important to monitor closely your BTMs to ensure that any possible rebound from Prolia is controlled.

I note that you have further tests and respiratory appointments before you commence on Forteo. If these end up delaying your commencement of Forteo beyond 6 months from your last Prolia shot, you may wish to consider checking with your rheumatologist if you could just take a week or two of Fosamax/Alendronate as a temporary measure to mitigate any possible rebound effect.

All the best for a speedy recovery from your chest infection and do take care and keep us updated.

Jump to this post

Hi formisc,
Although I have not been told, I am surmising Forteo is the better choice due to lower immune problems and in the past [before I moved to this part of the country] I was treated with truck loads of prednisone, over many years!
The blood work is for CTX, P1NP, Calcium, Vitamin D, and PTH. Will be booked before starting the Forteo and after I am clear of this infection. [ I know that a course of Prednisone would get me over this last bump quickly, but we don't touch that anymore!]

REPLY
@cella65

Has anyone gone off prolia. I have had 1 shot of prolia and can’t imagine continuing this drug. Fosamax was no better if not worse. At 78 I can’t see spending the rest of my life such misery.

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Talk to an md before going off. Spontaneous fractures can happen when people go off cold Turkey.

REPLY
@thisoldewe

Hi formisc,
Although I have not been told, I am surmising Forteo is the better choice due to lower immune problems and in the past [before I moved to this part of the country] I was treated with truck loads of prednisone, over many years!
The blood work is for CTX, P1NP, Calcium, Vitamin D, and PTH. Will be booked before starting the Forteo and after I am clear of this infection. [ I know that a course of Prednisone would get me over this last bump quickly, but we don't touch that anymore!]

Jump to this post

Thanks, Christine.

As far as i know, bisphosphonates like Fosamax/Alendronate and Reclast do not affect the immune system unlike Prolia so a possible option would be to transition to one of these anti-resorptives for a short term before starting on Forteo. Personally, i opted for Alendronate as i was not comfortable with the idea of a 12m dose in one go but some choose Reclast because of GERD concerns.

It would be good to specifically discuss the management of any possible Prolia rebound with your doctor as i worry that this and spontaneous fractures could be under-reported and under-estimated.

Oh, on your proposed blood work, those are great choices. The other thing i would include is albumin as it may indicate if your calcium reading needs to be corrected.

REPLY

Well, seems I have hit another bump in the road. Although, on the up side, today, I got some of the bloodwork taken... but not the CTX or the P1NP. These two must be ordered by a specialist.. Turns out the specialist is on an extended vacation, and won't be back until 15 April. [I left a message anyway] And there is no word on the bone density tests either.
Today, I was to speak with the pharmacist, but the prescription has not been written yet by the G.P. !
So the pharmacist wants to wait until we know what drug we are going with - makes sense. I assume the G.P. is waiting for the specialist to return to get the other blood work orders and still waiting for the insurance okay for the Forteo, or other generics.
It is different in Canada; there are long wait lists and things do seem to move slower than what I see in some Connect accounts.
So the progress is at a slow point, without any immediate hope of change. I do have my original Prolia appointment with the G.P. for 18 April. [I did not cancel it, just in case of delays] I will not be getting the Prolia - that is a 'for certain'! -- but, I will take all suggestions with me for the talk on ' what happens now' with the G.P. Clearly, Fosamax, or other like drug, will be necessary if there are still delays in the progress. I agree with your thoughts on Reclast; I have too many sensitive reactions to medications. [no, did not want me to take anything earlier. And no, not getting an endocrinologist referral either]
.... these are reasons why patience is such a difficult attribute to develop!!
This is feeling like a soap opera, but I will let you know just how this all works out! Thanks for listening!

REPLY
@thisoldewe

Well, seems I have hit another bump in the road. Although, on the up side, today, I got some of the bloodwork taken... but not the CTX or the P1NP. These two must be ordered by a specialist.. Turns out the specialist is on an extended vacation, and won't be back until 15 April. [I left a message anyway] And there is no word on the bone density tests either.
Today, I was to speak with the pharmacist, but the prescription has not been written yet by the G.P. !
So the pharmacist wants to wait until we know what drug we are going with - makes sense. I assume the G.P. is waiting for the specialist to return to get the other blood work orders and still waiting for the insurance okay for the Forteo, or other generics.
It is different in Canada; there are long wait lists and things do seem to move slower than what I see in some Connect accounts.
So the progress is at a slow point, without any immediate hope of change. I do have my original Prolia appointment with the G.P. for 18 April. [I did not cancel it, just in case of delays] I will not be getting the Prolia - that is a 'for certain'! -- but, I will take all suggestions with me for the talk on ' what happens now' with the G.P. Clearly, Fosamax, or other like drug, will be necessary if there are still delays in the progress. I agree with your thoughts on Reclast; I have too many sensitive reactions to medications. [no, did not want me to take anything earlier. And no, not getting an endocrinologist referral either]
.... these are reasons why patience is such a difficult attribute to develop!!
This is feeling like a soap opera, but I will let you know just how this all works out! Thanks for listening!

Jump to this post

Hi Christine,

Sorry to hear about the slight hiccup. If it gets nearer to your scheduled Prolia shot on 18 April and you still do not have your next medication, it would be really worth considering taking a Fosamax/Alendronate to buy you some time. There's just too much risk to go off Prolia without a relay drug to mitigate any rebound effect. Please continue to keep us updated.
All the best

REPLY

gravity, I only just saw your reply. I've notice a few people being prescribed Forteo after Evenity. It makes sense to me because Evenity works as an antiresporptive in the later part of treatment. Felicia Cosman recommends an antiresorptive after Evenity specifically alendronate which would be a repeat for you because it is more effective than Prolia, which I would never recommend.
https://www.dovepress.com/getfile_article_fulltext.php?filename=article_fulltext%2Fs127000%2F127568/img/DDDT-127568-F03.jpg

REPLY
@formisc

Hi Christine,

Sorry to hear about the slight hiccup. If it gets nearer to your scheduled Prolia shot on 18 April and you still do not have your next medication, it would be really worth considering taking a Fosamax/Alendronate to buy you some time. There's just too much risk to go off Prolia without a relay drug to mitigate any rebound effect. Please continue to keep us updated.
All the best

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Yes forming, I will not be leaving that appointment (18) without answers and my prescription of Fosamax!!!
Thanks for the guidance!

REPLY
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