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

Christine,
Since you started your Prolia in September 2022, that means your 4th shot is due next month. So you are in a critical moment where you need to decide if you are proceeding or transitioning off Prolia. Critical because every additional Prolia shot makes it that much harder and more dangerous to stop. For 2 and prob 3 shots, Alendronate should be effective enough as a relay drug to ease off Prolia but for 4 and above, you will need the more potent Reclast infusion(s). And after 4-5 years, even Reclast is not always effective in mitigating the rebound effect.
If you decide to stop Prolia, you should do BTM tests before starting on your relay drug to monitor the effectiveness of the transition. For Alendronate, i have also come across advice to start on the 5th month after the last Prolia shot instead of waiting till the 6th month - something which makes sense to me as resorption activity ramps up very quickly once the Prolia wears off and it could be advantageous to have Alendronate already activated and on hand.
Oh, Prolia does affect the immune system so it may have a hand in your respiratory infections

Jump to this post

Good Morning,
This is my update on my progress following my GP appointment of yesterday.
Today, I will get my Osnuvo medication, and will commence on Saturday morning! Insurance coverage for the drug cost is AOK, and bone density ordered.
On the issue of getting the baseline bloodwork of the CTX and P1NP, I was told that "since my osteoporosis is not a result of metabolic disease, these tests are not necessary." It is felt that my problem is due to the heavy overuse of Prednisone for about 15 years [which stopped 6 years ago when I moved to this part of the country.]
Osnuvo is the approved biosimilar for Forteo, [which my drug insurance company had denied.]
Also, I asked the pharmacist about 'Gemlife' as suggested by my Connect buddy in India. Apparently, this drug is "not for Canada, only for overseas". [there is no doubt a long story of the whys and wherefores on that topic - but that's for another time]
So, I am relieved to be at this point. This was a struggle after being so ill for so long. It seemed a long process of consolidating my doctors and doing the research on all things. This would not have been possible without the wonderful support and high calibre information and suggestions from my 'learned" Connect buddies. I would not have accomplished this without you.
I thank you all so much.
Sending my best to all for continued success on this long road!
Christine

REPLY

@gravity3, you may want to start a new thread since this one is about evenity. There may already be a thread on it, now that I think about it. See below b/c I am not able to delete this post.

REPLY
@gravity3

I took alendronate for 5 years prior to evenity. On my 6th shots of evenity. Thoughts about next med after evenity?

Jump to this post

REPLY
@thisoldewe

Good Morning,
This is my update on my progress following my GP appointment of yesterday.
Today, I will get my Osnuvo medication, and will commence on Saturday morning! Insurance coverage for the drug cost is AOK, and bone density ordered.
On the issue of getting the baseline bloodwork of the CTX and P1NP, I was told that "since my osteoporosis is not a result of metabolic disease, these tests are not necessary." It is felt that my problem is due to the heavy overuse of Prednisone for about 15 years [which stopped 6 years ago when I moved to this part of the country.]
Osnuvo is the approved biosimilar for Forteo, [which my drug insurance company had denied.]
Also, I asked the pharmacist about 'Gemlife' as suggested by my Connect buddy in India. Apparently, this drug is "not for Canada, only for overseas". [there is no doubt a long story of the whys and wherefores on that topic - but that's for another time]
So, I am relieved to be at this point. This was a struggle after being so ill for so long. It seemed a long process of consolidating my doctors and doing the research on all things. This would not have been possible without the wonderful support and high calibre information and suggestions from my 'learned" Connect buddies. I would not have accomplished this without you.
I thank you all so much.
Sending my best to all for continued success on this long road!
Christine

Jump to this post

Hi Christine,
Great to hear that you are finally making progress on exiting Prolia! Many here have had good results from Forteo.
Yes, Connect is wonderful - i just wished i had gone on it before starting my Osteo meds! You will find many discussions on Forteo which will help to guide you as you start on this med
Do continue to keep us updated
All the best to you and everyone here!

REPLY
@formisc

Christine,
Since you started your Prolia in September 2022, that means your 4th shot is due next month. So you are in a critical moment where you need to decide if you are proceeding or transitioning off Prolia. Critical because every additional Prolia shot makes it that much harder and more dangerous to stop. For 2 and prob 3 shots, Alendronate should be effective enough as a relay drug to ease off Prolia but for 4 and above, you will need the more potent Reclast infusion(s). And after 4-5 years, even Reclast is not always effective in mitigating the rebound effect.
If you decide to stop Prolia, you should do BTM tests before starting on your relay drug to monitor the effectiveness of the transition. For Alendronate, i have also come across advice to start on the 5th month after the last Prolia shot instead of waiting till the 6th month - something which makes sense to me as resorption activity ramps up very quickly once the Prolia wears off and it could be advantageous to have Alendronate already activated and on hand.
Oh, Prolia does affect the immune system so it may have a hand in your respiratory infections

Jump to this post

This is an update to my too long saga of "Coming off of Prolia".
After much research and discussion with all specialists and G.P. the dec ision was made to go to Forteo. My drug insurance company, Canada Life would only cover the biosimilar, Osnuvo.
So with great anticipation , I commenced this on Monday evening the 22 April.
Initially, I experienced the expected headache and light-headedness, which can occur during the first "several days".
Yes, I had light headedness, and a slight headache. So, no driving, stayed at home, lots of rest...
Then, on Friday, I was taken out for a light lunch - my first outing.. all was well, until one hour past and the light headed-ness returned and quickly increased until I realised I was in trouble. I was brought home and lay down... but soon I could not raise my head without this symptom, my headache worsened and when the ambulance arrived my blood pressure was also found to be "unstable" [ worst reading was 192/71, with irregular heartbeat- my normal is 110/60 ].
Conclusion from ER: Stop Osnuvo. Commence Sero. See prescribing physician on Monday.
Two things: Important to point out that I often have had weird and extreme reactions to medications. This reaction is "rare". [lucky me!]
Also, in the Patient Education paper, it clearly states "if dizziness or headache increases, to seek medical care immediately".
So now, I will return to the doctor on Monday and will need to start on another drug to prevent re-bound.
So, the story continues.
Thanks again to those who have followed this adventure.

REPLY
@thisoldewe

This is an update to my too long saga of "Coming off of Prolia".
After much research and discussion with all specialists and G.P. the dec ision was made to go to Forteo. My drug insurance company, Canada Life would only cover the biosimilar, Osnuvo.
So with great anticipation , I commenced this on Monday evening the 22 April.
Initially, I experienced the expected headache and light-headedness, which can occur during the first "several days".
Yes, I had light headedness, and a slight headache. So, no driving, stayed at home, lots of rest...
Then, on Friday, I was taken out for a light lunch - my first outing.. all was well, until one hour past and the light headed-ness returned and quickly increased until I realised I was in trouble. I was brought home and lay down... but soon I could not raise my head without this symptom, my headache worsened and when the ambulance arrived my blood pressure was also found to be "unstable" [ worst reading was 192/71, with irregular heartbeat- my normal is 110/60 ].
Conclusion from ER: Stop Osnuvo. Commence Sero. See prescribing physician on Monday.
Two things: Important to point out that I often have had weird and extreme reactions to medications. This reaction is "rare". [lucky me!]
Also, in the Patient Education paper, it clearly states "if dizziness or headache increases, to seek medical care immediately".
So now, I will return to the doctor on Monday and will need to start on another drug to prevent re-bound.
So, the story continues.
Thanks again to those who have followed this adventure.

Jump to this post

@thisoldewe are you jumping off Prolia (3 shots total?) directly to FORTEO?

REPLY

Yes, I did. The Osnuvo commenced when the next Prolia shot should have been taken.

REPLY
@thisoldewe

Yes, I did. The Osnuvo commenced when the next Prolia shot should have been taken.

Jump to this post

Hope you will feel better soon! I’m sure you and your team of doctors will figure out a way of going forward.

Best wishes

REPLY
@thisoldewe

This is an update to my too long saga of "Coming off of Prolia".
After much research and discussion with all specialists and G.P. the dec ision was made to go to Forteo. My drug insurance company, Canada Life would only cover the biosimilar, Osnuvo.
So with great anticipation , I commenced this on Monday evening the 22 April.
Initially, I experienced the expected headache and light-headedness, which can occur during the first "several days".
Yes, I had light headedness, and a slight headache. So, no driving, stayed at home, lots of rest...
Then, on Friday, I was taken out for a light lunch - my first outing.. all was well, until one hour past and the light headed-ness returned and quickly increased until I realised I was in trouble. I was brought home and lay down... but soon I could not raise my head without this symptom, my headache worsened and when the ambulance arrived my blood pressure was also found to be "unstable" [ worst reading was 192/71, with irregular heartbeat- my normal is 110/60 ].
Conclusion from ER: Stop Osnuvo. Commence Sero. See prescribing physician on Monday.
Two things: Important to point out that I often have had weird and extreme reactions to medications. This reaction is "rare". [lucky me!]
Also, in the Patient Education paper, it clearly states "if dizziness or headache increases, to seek medical care immediately".
So now, I will return to the doctor on Monday and will need to start on another drug to prevent re-bound.
So, the story continues.
Thanks again to those who have followed this adventure.

Jump to this post

Hi Christine,

So sorry to hear of your adverse reaction to Osnuvo. I pray you will have success with your next med. As you must be close to or past 6 months since your last Prolia shot, you may want to consider taking an anti-resorptive like Fosamax just to buy some time and stave off any possible rebound effect if there is going to be delay in starting on your next med. Note though that you should check that you do not have GERD issues or any of the contraindications mentioned in the leaflet

REPLY
@thisoldewe

Yes, I did. The Osnuvo commenced when the next Prolia shot should have been taken.

Jump to this post

Hi @thisoldewe i read a pretty good review paper regarding strategies in discontinuation of prolia. Yesterday I hesitated to give you a link for fear of eliciting undue anxiety. After reading @formisc comments today, I’m thinking why not? You could just bring it to your endo for him/her to read. Your current transition to forteo directly may or may not work. This paper mentioned briefly about forteo. You will see Reclast is most used with #%success rate. Here it is:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7796169/

Wish you have a smooth transition.

REPLY
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