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Switched from Tacrolimus to Belatacept

Posted by 2gallonhabit @2gallonhabit, Nov 20, 2023

Hi all. I'm just shy of my one year kidney transplant anniversary. At my four month appointment I asked my doctor if I'd be a candidate to switch from Tacrolimus to Belatacept (I'd done the research and knew that I was). The reason I asked was because despite Tacrolimus being the "gold standard" (combined with Mycophenolate Mofetil) for anti-rejection medications, it comes with side effects. Mine included significant GI issues, hair loss and steadily increasing blood glucose levels. Also, I was concerned with the nephrotoxic effects of the drug (ever notice that as your dosage goes up, your creatinine goes up as well?).

I started the Belatacept infusions at the beginning of July and am loving the change. My hair stopped falling out and started growing back. My blood glucose levels returned to normal. My GI issues are gone. But more importantly, I saw an 0.24 decrease in my creatinine levels and an 11 point increase in my eGFR.

Everyone's experience is different but check it out with your doctor if you're interested in learning more. I'm only 56 so I want to keep this kidney has healthy as possible for as long as possible.

Take care.

Vicki

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2gallonhabit | @2gallonhabit | 3 days ago
In reply to @caretakermom "@2gallonhabit My husband received his kidney txplant at Mayo Clinic Az in March 2022, at 62..." + (show)
Profile picture for caretakermom @caretakermom

@2gallonhabit

My husband received his kidney txplant at Mayo Clinic Az in March 2022, at 62 years old. When I asked the txplant coordinator about Belatacept (during the first year post txplant), she said that it can cause brain damage - she did not elaborate. That was the first time I ever heard anything bad about it because online the it was all positive comments..
At the time, I was quite active in reading online posts about alternatives to the usual transplant meds. Like you, I have heard that these meds can cause nephrotoxicity over time. All of the online feebacks regarding Belatcept were positive and so I was very surprised about the nurse's comment.
My husband recently developed a severe case of anemia and we think the culprit is one of his transplant meds(Everolimus). Hematologist/oncologist ran tests howing no hemolysis, all labs consistent with bone marrow suppression. Mayo Az said to get a bone marrow biopsy to show it's working well ()this will point to the Everolimus as the cause of the anemia).
We have a local/home neph and Mayo Az txplant center is out-of-state. We are working with home neph who is in actual contact with the Mayo Az txplant team. We are not sure if they're going to restart Everolimus, once anemia is recovered, or change of medication. If the latter, not sure what to change to because he has already tried Mycophenolate/Myfortic during the first year - did not work because too overly suppressive causing CMV reccurence. Everolimus worked well until this past March when dose had to be increased to meet trough range. So I'm thinking of asking if Belatacept could be an option. I have not done any "research" regarding whether my husband would be a good candidate but would willing to try anything to save his graft.
There is also the question of whether insurance would cover Belatacept which is an expensive therapy(so is Everolims compaared to the other ones). We have Anthem PPO commerical/employer health insurance because husband is still working full-time.

Questions:
How long did it take for your insurance to approve it? Do you have to get prior authorization once a month when you get your infusion? Do you get your infusion at the transplant center?

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@caretakermom Thanks for the info - sounds like a "rare" side effect per drug.com - https://www.drugs.com/sfx/belatacept-side-effects.html - but still real concern. Obviously I'm not a doctor but I believe that since your husband is CMV positive, the Belatacept approval *may* be more difficult. If I remember correctly, the studies focused on Epstein-Barr positive / CMV negative patients (also I think BK virus negative as well?). I believe I read that our immunosuppressed status makes it more risky as CMV and BK may move from dormant to active status.

As for prior authorization, I don't believe there was much of an issue (I was on UHC commercial insurance at the time). My infusion center - Palmetto Infusions (I think they're mainly East Coast/Southern, but growing) took care of all the paperwork and approvals. My understanding is that it goes under your medical benefits, not your drug plan, since it requires you to go to a facility. There's also a manufacturer's discount program that can help with out of pocket.

Oh. Since I had moved from Minnesota to Florida after my transplant, the transplant center gave me the option of a couple of locations near me so I just chose one and got started.

REPLY
1 reply
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caretakermom | @caretakermom | 3 days ago
In reply to @2gallonhabit "@caretakermom Thanks for the info - sounds like a "rare" side effect per drug.com - https://www.drugs.com/sfx/belatacept-side-effects.html..." + (show)
Profile picture for 2gallonhabit @2gallonhabit

@caretakermom Thanks for the info - sounds like a "rare" side effect per drug.com - https://www.drugs.com/sfx/belatacept-side-effects.html - but still real concern. Obviously I'm not a doctor but I believe that since your husband is CMV positive, the Belatacept approval *may* be more difficult. If I remember correctly, the studies focused on Epstein-Barr positive / CMV negative patients (also I think BK virus negative as well?). I believe I read that our immunosuppressed status makes it more risky as CMV and BK may move from dormant to active status.

As for prior authorization, I don't believe there was much of an issue (I was on UHC commercial insurance at the time). My infusion center - Palmetto Infusions (I think they're mainly East Coast/Southern, but growing) took care of all the paperwork and approvals. My understanding is that it goes under your medical benefits, not your drug plan, since it requires you to go to a facility. There's also a manufacturer's discount program that can help with out of pocket.

Oh. Since I had moved from Minnesota to Florida after my transplant, the transplant center gave me the option of a couple of locations near me so I just chose one and got started.

Jump to this post

@2gallonhabit

I appreciate your response.

It is not at all rare for patients taking Everolimus to develop anemia according to our UCLA hematologist/oncologist. You can however say it's uncommon for a patient taking such a small dose(as compared to cancer patients) to develop such severe anemic case. As with every drug, the tolerance is individual to each patient. Our UCLA hematologist/oncologist has many cancer patients also on this drug and he has seen many such anemic cases. In fact, the first thing he said was "I can tell you right now it's the Everolimus" that's causing the anemia. He ordered a bunch of tests to show consistency in bone marrow suppression(supposedly by Everolimus), including lab FLOW tests to show it's not leukemia, or lymphoma so that's a good thing. But the bone marrow biopsy will definitely show whether or not bone marrow is working properly.

Unfortuantely we were not checking hubby's CBC the same time we checked trough levels(usually monthly). We checked CBC 4 months after increasing the Everolimus dose, exactly the same period of when he was last seen by home neph(who said to increase dose to meet trough range). Perhaps hubby's anemia became (gradually)severe because we did not deal with it right away?? We will certainly talk to our neph about it at next office visit.

When our home neph reached out to Mayo Az, they totally discount Everolimus as the cause initially and was told to check for Parvo Virus. Home neph ordered Parvo PCR (from Quest) - negative, UCLA hematologist ordered Parvo too - also negative. Actually, the UCLA lab tested for both types of Parvo Viruses and both negative. UCLA hematologist said to get off Everolimus completely to recover from anemia!! This can take weeks or months. His next CBC test is coming Wed, needs to be done same day but prior to bone marrow biopsy.

We will discuss what to do about hubby's txplant medicine regiment at next office visit on 09/01. Hopefully by then hubby recovers from anemia. Meantime, the Everolimus is being replaced by prednisone and hubby continues Tacrolimus as his current txplant regimen. I would really like for hubby to get off prednisone if at all possible,

We were told by Mayo Az that my husband's donor was CMV positive, but I don't know if the deceased donor had BK, or Epstein-Barr - Mayo Az does not release much medical history of donors. Mayo Az had expected for my husband to deal with CMV but they did not think that it would recur over and over. Each time CMV cleared and the Myfortic dose adjusted back to hubby's the CMV would recur. After the ups and downs of dealing with CMV for about 6 months, Mayo Az finally switched to Everolimus.

Are you saying you think CMV, BK, Epstein-Barr negative in the donor is one of the requirements for Belatacept? You mentioned you got a live-donor, is this someone you know who you can get full medical history? Unfortunately Mayo Az will not disclose much medical history of our deceased donor(HIPPA??) - only to that patient was CMV positive.

Just wondering - since your move to Florida, is your transplant now under the care of a different team? If so, are you comfortable about the change? Side note: our home neph(he's not transplant neph) is interfacing with Mayo Az. We were told by Mayo Az to go thru home neph for all issues. I guess Mayo Az does not really want to deal directly with former transplant patients(beyond 3 years).

REPLY
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2gallonhabit | @2gallonhabit | 3 days ago

Up until now, I've been flying back to Rochester for my annual checkups. I recently spoke to my doctor about transferring post-transplant care to the Florida campus and am told that their protocols are similar to Minnesota. Fingers crossed that the experience is as wonderful as it has been with Rochester. Funny you should mention that - Florida mentioned to my doctor that I need to get a local nephrologist here so the warm and fuzzy bubble may be about to burst... Thanks for the heads up.

Apologies for the confusion re: the alphabet soup. I know i was CMV negative and I believe one of my criteria for my live donor match was that they needed to be CMV negative as well. Other than that, the studies I read said that the recipient needed to be positive for Epstein Barr. In regards to BK, Mayo has tested me yearly and it hasn't reared its ugly head (my brother - who received his kidney transplant six months before me - has had BK two? times since his transplant) - so I don't think it's lying dormant in me (I think? they can test for that).

So really the only thing I know for sure re: my donor is that they were CMV negative. And since BK hasn't shown up, I can only assume they were negative for BK as well.

REPLY
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caretakermom | @caretakermom | 2 days ago
In reply to @amkaplin "Dealing with the medication and side effects is challenging. I started on Tac, but was having..." + (show)
Profile picture for amkaplin @amkaplin

Dealing with the medication and side effects is challenging. I started on Tac, but was having hallucinations. I was put on Bela about 4 years ago. I gained a lot of weight. I was subsequently taken off the Bela by another nephrologist and put on Everolimus. My doctor reduced my Mychrophenolate by 250 mgs. because I was pre diabetic. After 5 years, My kidney is doing well.

Jump to this post

@amkaplin
Hi there,

I was going thru this thread and saw your post which caught my attention because you mentioned Everolimus.

My husband was switched to Everolimus from Myfortic - over-immune and causes CMV recurrence during 1st year post transplant. The regimen for him has been since Dec '22 was Tac and Everolimus and has done well until an increase of Everolimus dose, to meet trough range, that started in Mar '26. He has developed anemia which got progressively worse. We discovered his hemoglobin dropped by 30% at office visit with home neph this past July, about 4 months after previous check up in Mar. Saw GI doctor - no internal bleeding. Next saw UCLA hematologist/oncologist ran tests showing no hemolysis and the labs consistent with bone marrow suppression (very likely by Everolimus). Labs not showing leukemia or lymphoma either. Mayo Az suggested bone marrow biopsy which have been scheduled for next Wed.

They've taken him off Everolimus so that he can recover from anemia and replaced with prednisone which is a horrible drug for him. He is type 2 diabetic pre-transplant and the prednisone jacks up his blood sugar greatly. Hematologist says may take a while to recover from anemia. Our next appointment with home neph is not till 09/01 and we'll have to talk changing transplant regimen. I'm very concerned about whether they(home neph with conultation with Mayo Az) can find something that works well for hubby. Will bring up with home neph but I don't think Bela is an alternative therapy because hubby is NOT EBV-seropositive nor is he is CMV negative, based on studies.

Anyways, there is a lot more involved but questions for you: do you have any side effects with Everolimus and if you don't mind sharing what are your daily doses? Have you ever had to adjust your Everolimus dose from time to time? What is your Everolimus trough level and is it individually tailored to your medical profile? Mayo Az likes it to be 4 - 7. Looking forward to your response. TIA!

REPLY
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geomusser | @geomusser | 2 days ago
In reply to @caretakermom "@2gallonhabit My husband received his kidney txplant at Mayo Clinic Az in March 2022, at 62..." + (show)
Profile picture for caretakermom @caretakermom

@2gallonhabit

My husband received his kidney txplant at Mayo Clinic Az in March 2022, at 62 years old. When I asked the txplant coordinator about Belatacept (during the first year post txplant), she said that it can cause brain damage - she did not elaborate. That was the first time I ever heard anything bad about it because online the it was all positive comments..
At the time, I was quite active in reading online posts about alternatives to the usual transplant meds. Like you, I have heard that these meds can cause nephrotoxicity over time. All of the online feebacks regarding Belatcept were positive and so I was very surprised about the nurse's comment.
My husband recently developed a severe case of anemia and we think the culprit is one of his transplant meds(Everolimus). Hematologist/oncologist ran tests howing no hemolysis, all labs consistent with bone marrow suppression. Mayo Az said to get a bone marrow biopsy to show it's working well ()this will point to the Everolimus as the cause of the anemia).
We have a local/home neph and Mayo Az txplant center is out-of-state. We are working with home neph who is in actual contact with the Mayo Az txplant team. We are not sure if they're going to restart Everolimus, once anemia is recovered, or change of medication. If the latter, not sure what to change to because he has already tried Mycophenolate/Myfortic during the first year - did not work because too overly suppressive causing CMV reccurence. Everolimus worked well until this past March when dose had to be increased to meet trough range. So I'm thinking of asking if Belatacept could be an option. I have not done any "research" regarding whether my husband would be a good candidate but would willing to try anything to save his graft.
There is also the question of whether insurance would cover Belatacept which is an expensive therapy(so is Everolims compaared to the other ones). We have Anthem PPO commerical/employer health insurance because husband is still working full-time.

Questions:
How long did it take for your insurance to approve it? Do you have to get prior authorization once a month when you get your infusion? Do you get your infusion at the transplant center?

Jump to this post

@caretakermom
Hi Caretakermon

I expect that there is a lot about all this that Mayo is not telling us. I am a kidney donor and a caretaker as well. My wife got a transplant July 11, 2018 and has been up and down ever since (in all fairness much more up than down). She has been on the standard Tacrolimus, CellCept and prednisone all 8 years and has had issues. She has been losing sodium for years. She has been hospitalized numerous times with critically low sodium and they keep putting her in the SIADH basket, which has not seemed helpful for her. Limiting water intake does keep her from losing sodium but it also causes large spikes in Tacrolimus, potassium and many other things. Her lab work is pretty much laughable (if it wasn't so sad) almost every value is marker as "outside the range".

Now it seems that we have reached a turning point as she has something like 30% scarring of her kidney (likely from Tacrolimus - but no one at Mayo will admit that). Her GFR bounces between 20 some odd and less than 15 depending on the day and her level of compliance with their 1.5 L water restriction and she is still seeing substantial leg swelling late in the day. We are meeting with her Nephrologist at Mayo again next week and are hoping that we can get her onboard for the transition to Belatacept but it's kind of like jumping out of a plane for us. We have been asking about a change of medication for years, but her doctor has been strongly resistant for reasons we don't understand (and she can't explain).

Does anyone know why the Mayo staff is so reluctant to change patients to Belatacept? We understood there was a supposedly shortage of Belatacept during COVID but now I hear it is compounded at Mayo in Phoenix. Since the Mayo Specialty Pharmacy in Rochester no longer handles the standard trio (Tacro, CellCept, and pred) does that mean that Mayo is "transitioning" too? It's a real puzzle to us. The stories of how well so many are doing on Bellacept is encouraging but I am afraid the transition at this point will be very risky.

REPLY
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caretakermom | @caretakermom | 2 days ago
In reply to @geomusser "@caretakermom Hi Caretakermon I expect that there is a lot about all this that Mayo is..." + (show)
Profile picture for geomusser @geomusser

@caretakermom
Hi Caretakermon

I expect that there is a lot about all this that Mayo is not telling us. I am a kidney donor and a caretaker as well. My wife got a transplant July 11, 2018 and has been up and down ever since (in all fairness much more up than down). She has been on the standard Tacrolimus, CellCept and prednisone all 8 years and has had issues. She has been losing sodium for years. She has been hospitalized numerous times with critically low sodium and they keep putting her in the SIADH basket, which has not seemed helpful for her. Limiting water intake does keep her from losing sodium but it also causes large spikes in Tacrolimus, potassium and many other things. Her lab work is pretty much laughable (if it wasn't so sad) almost every value is marker as "outside the range".

Now it seems that we have reached a turning point as she has something like 30% scarring of her kidney (likely from Tacrolimus - but no one at Mayo will admit that). Her GFR bounces between 20 some odd and less than 15 depending on the day and her level of compliance with their 1.5 L water restriction and she is still seeing substantial leg swelling late in the day. We are meeting with her Nephrologist at Mayo again next week and are hoping that we can get her onboard for the transition to Belatacept but it's kind of like jumping out of a plane for us. We have been asking about a change of medication for years, but her doctor has been strongly resistant for reasons we don't understand (and she can't explain).

Does anyone know why the Mayo staff is so reluctant to change patients to Belatacept? We understood there was a supposedly shortage of Belatacept during COVID but now I hear it is compounded at Mayo in Phoenix. Since the Mayo Specialty Pharmacy in Rochester no longer handles the standard trio (Tacro, CellCept, and pred) does that mean that Mayo is "transitioning" too? It's a real puzzle to us. The stories of how well so many are doing on Bellacept is encouraging but I am afraid the transition at this point will be very risky.

Jump to this post

@geomusser

Hi @geomusser ,

I'm sorry to hear your wife is not feeling well. Did she get her kidney transplant from Mayo Az and do you live locally to the transplant center? Did you advocate Belatacept infusion or did her nephrologist recommend the switch? If she is a good candidate for Belataceot go for it. I have heard mostly positive things, though that is an individualized experience. But at this point, I don't think you have anything to lose?

Unfortunately my hubby would not be a good candidate for Bela. His donor kidney is CMV+ and I do not think he has the EBV antibody. I believe at a minimum the patient has to meet these 2 criteria to be a good candidate. I will bring it up to our home neph, though he would probably defer to the transplant nephrologist.

On regular follow-ups, does your wife see the Mayo transplant nephrologist or do you have a home/local one? Did you ever question the nephrologist why they put her on prednisone? That's what is causing blood sugar mayhem now for my husband. I'm praying that this is only temporarily and that they would remove it from his regimen once we find out what my hubby's immunosuppressants situation is. It is very frustrating for us because we have to work with our home neph, who has to consult with the Mayo transplant nephrologist - we don't have direct access to the Mayo transplant nephrologists.

I'm seeing posts from patients saying they are on a reduced dose of immunosuppressant drugs. For my husband, Mayo out right rejected that when our home neph called to consult with them. He said Mayo Az is "not happy" with the lower Everolimus dose which is tolerable by hubby. We would be perfectly happy if Mayo Az would allow my hubby to restart Everolimus but only at a level that is tolerated by his body(which is different in every patient). We'll have to wait until 09/01 office visit with our local neph to get more information.

Please update us on whether you're able to get Mayo to switch to Balatacept infusion. Would be interesting to hear their reasons for/against it.

REPLY
1 reply
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benedict66066 | @benedict66066 | 1 day ago
In reply to @caretakermom "@geomusser Hi @geomusser , I'm sorry to hear your wife is not feeling well. Did she..." + (show)
Profile picture for caretakermom @caretakermom

@geomusser

Hi @geomusser ,

I'm sorry to hear your wife is not feeling well. Did she get her kidney transplant from Mayo Az and do you live locally to the transplant center? Did you advocate Belatacept infusion or did her nephrologist recommend the switch? If she is a good candidate for Belataceot go for it. I have heard mostly positive things, though that is an individualized experience. But at this point, I don't think you have anything to lose?

Unfortunately my hubby would not be a good candidate for Bela. His donor kidney is CMV+ and I do not think he has the EBV antibody. I believe at a minimum the patient has to meet these 2 criteria to be a good candidate. I will bring it up to our home neph, though he would probably defer to the transplant nephrologist.

On regular follow-ups, does your wife see the Mayo transplant nephrologist or do you have a home/local one? Did you ever question the nephrologist why they put her on prednisone? That's what is causing blood sugar mayhem now for my husband. I'm praying that this is only temporarily and that they would remove it from his regimen once we find out what my hubby's immunosuppressants situation is. It is very frustrating for us because we have to work with our home neph, who has to consult with the Mayo transplant nephrologist - we don't have direct access to the Mayo transplant nephrologists.

I'm seeing posts from patients saying they are on a reduced dose of immunosuppressant drugs. For my husband, Mayo out right rejected that when our home neph called to consult with them. He said Mayo Az is "not happy" with the lower Everolimus dose which is tolerable by hubby. We would be perfectly happy if Mayo Az would allow my hubby to restart Everolimus but only at a level that is tolerated by his body(which is different in every patient). We'll have to wait until 09/01 office visit with our local neph to get more information.

Please update us on whether you're able to get Mayo to switch to Balatacept infusion. Would be interesting to hear their reasons for/against it.

Jump to this post

@caretakermom @amkaplin @geomusser
First off let me say how sorry I am about the real physical and then emotional struggle dealing with your immunosuppression regimens. Hasan Khumash, Mayo Phoenix, is doing or has completed a research study with Belatacept. https://www.mayo.edu/research/clinical-trials/cls-20318351 (Sorry, I just can't find a date for this study so I don't know how old it is.)
And so I don't know any more about the outcomes of the study or if it is even finished. This is just to say that Mayo/Phoenix doesn't appear to be ignoring the topic. From what I can read, if you are EBV negative then Belatacept is just not an option at all. I'm still trying to sift through the CMV Donor positive/Recipient negative situation. I don't know if Belatacept could still be tried under those CMV conditions. For myself, I am going to at least try to open the conversation. Of course I absolutely want to be open to the expertise of my Mayo docs. I also don't want this quality of life for all of my remaining years. Best wishes to all.

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