ocaliva

[gwillistexas]

I saw where the FDA issued a warning on ocaliva 12/12, because of serious liver injuries in patients who do not have cirrhosis. This is scary considering that’s the only drug I’ve been able to take and been on it since 2017. Do I wait for my dr to reach out to me or do I go ahead and send a msg?

[DonnaBoll Administrator]

I would for sure send a message. You might even send him the link to the article you saw this info in. I'm not aware of this being discouraged for people not having cirrhosis. I'll see what I can find out.

[gwillistexas in reply to DonnaBoll]

I will. Thank you. Just search fda warning on ocaliva. I happened to see it on my news app.

[IAmTheGlue]

send a message! The FDA pulled the approval on Ocaliva.

I was at the Mayo Clinic last week and they are switching me to one of the two new drugs. Mine will be the one beginning with E. I can’t remember the name off hand.

They told me to continue taking it until my new medication arrives, but I’ve always been a little fearful of it because of the black box warning.

I hope your doctor can get you one of the new meds. 🙏🏻

[gwillistexas in reply to IAmTheGlue]

I’m approved for Livdelzi. Just waiting on the call to set it up.

[IAmTheGlue in reply to gwillistexas]

I would image that will be your replacement then! 😊 People are having amazing results with these new meds. I’m sooooo hopeful. I have not seen anyone with the really negative effects.

[DonnaBoll Administrator in reply to IAmTheGlue]

There have been very good results from the drug Seladelpar.

[gwillistexas in reply to DonnaBoll]

I’m praying I have no issues with it.

[DonnaBoll Administrator in reply to gwillistexas]

Ocaliva or Seladelpar? just be sure to monitor your liver enzymes every 3-6 months. As always, report any new symptom or worsening symptom to your physician.

[gwillistexas in reply to DonnaBoll]

Livdelzi (seladelpar)

[DonnaBoll Administrator in reply to gwillistexas]

several people I know have had wonderful results with it.....clinical trials have been very promising for sure. We have to be so thankful for all the researchers who continue to work in finding new drugs for us.

[gwillistexas in reply to DonnaBoll]

Yes and I’ve read a lot about it and it is promising. I’m just praying I can tolerate the drug. It should be hrrr sometime today and I will start it tomorrow unless my dr says to be off ocaliva a couple days. I was also able to talk with their pharmacist. I had questions about taking my statin. He said there should be no interaction with the two. Not sure how it will affect my thyroid medication. He said levothyroxine is a very sensitive drug so we don’t know if my tsh may be affected with Livdelzi. I’m hopeful 😊

[gwillistexas in reply to gwillistexas]

Meant “here”

[gwillistexas in reply to DonnaBoll]

Talk about fast action. My drug should be here tomorrow.

[butterflyEi in reply to gwillistexas]

I hope it suits your system.

[gwillistexas in reply to butterflyEi]

Thank you. I’ve been praying hard that it will go well. Can’t go back on ocaliva.

[Zillowgreen in reply to DonnaBoll]

Donna, my doctor wants me to go on Livdelzi but I was concerned about the reports of bone fractures in the study since I have osteoporosis. Have you heard any news about fractures with Livdelzi?

[gwillistexas in reply to Zillowgreen]

I also understand your concern about fractures. I have osteoporosis in my right femur neck. But at this point I feel I have no choice but to try Livdelzi. I for one font like being a no choice situation. Of course I could stay on ocaliva but it would be against my drs advice. Keep us posted.

[OrangeTulip]

Hello. I would message your doctor, your concern is understandable, I would feel the same. When they withdrew Ocaliva in England earlier this year, it was because they thought it was not as effective…so your doc. will move you on to another medication. Unfortunately this is going to be a running theme when you have PBC, it’s such an unknown condition, but at leadt we have options!

[gwillistexas in reply to OrangeTulip]

Yes, I’m just waiting on my call to get all set up on Livdelzi. I sent my hep a msg this morning so I’m waiting for his response. Are you doing ok on Iquirvo?

[OrangeTulip in reply to gwillistexas]

I will have bloodwork in January after six months on Iquirvo, I’m still unsure about the medication and the list of side effects…there is minimal information out there on the drug only what Ibsen has put out, so I’m a bit in the unknown. Good-luck and keep us updated.

[gwillistexas in reply to OrangeTulip]

Thank you and you do the same.

[Samanthaann]

Thanks for posting about this.

[gwillistexas in reply to Samanthaann]

You’re welcome

[Turquoise2075]

Thank you for sharing this info. I just found the FDA statement online. I have been on Ocaliva since June last year so it’s a bit concerning. My recent blood test showed my GGT is a bit high for the first time when that’s not normally elevated for me. I don’t know if that could be in any way related to Ocaliva. Raised GGT can be a sign of liver damage. Not sure what to do. My liver specialist is not particularly communicative or pro-active so I would have to try to get a response from him on it. I was a non-responder to Urso and was made very sick by Fenofibrate. But I still wonder if I should be on Urso. He took me off it when he put me on Ocaliva. I’m in Australia and our version of the FDA is the TGA - Therapeutic Goods Administration. I will look out for any statements that may come from them on it.

[gwillistexas in reply to Turquoise2075]

I’ve been on only ocaliva since 2017. I was allergic to URSO and was immediately take off it. I’ve had very good luck with ocaliva until about a year ago. My ALP was increasing. I had my hepatologist check GGT and it was elevated. So he ordered another lab to see if it was from liver or bones. It was liver. All other labs have remained normal since I started ocaliva with the exception of a slightly elevated ast a couple of times. I never had a side effect with ocaliva so in a way I hate to let go of it. But he says it’s time. We tried Iqirvo a few months ago but I wasn’t able to take it and went back on ocaliva. So I’m living on a prayer that I can take Livdelzi with no problems. I’m sorry your dr doesn’t communicate well. I’m blessed with a very good hepatologist. FDA stated they sent notification to all drs do I hope your dr reaches out to you on this. Please let us hear. 🙏🏻

[Turquoise2075 in reply to gwillistexas]

Thank you. I really hope the Livdelzi works well for you. I’ve never had any side effects either from Ocaliva as far as I’m aware. It helped me greatly with cognitive issues which had become debilitating for me but improved greatly after 3 weeks on Ocaliva. I read that it is thought to protect the blood-brain barrier. It might be one of those things that poses a risk to some people but not others, but it’s so hard to know with ourselves if we might be at any risk. My specialist is polite but just doesn’t engage on questions I ask. I’ll see if he reaches out but will soon contact the clinic if I don’t hear anything to confirm if I should stay on or stop Ocaliva. As I’m in Australia me may not get notification from the FDA, so it depends if the TGA here acts on it. All the very best 🙏

[gwillistexas in reply to Turquoise2075]

Thank you. Stay In touch and let me know 😊

[Turquoise2075 in reply to gwillistexas]

Thank you, yes, I will 😊

[Turquoise2075 in reply to gwillistexas]

Hi again, I just thought I’d let you know I emailed my liver specialist and I got a response from him today regarding Ocaliva, given through a female staff member who phoned me. She said that he advised it was fine for me to stay on it and he’ll just keep monitoring me. The reasoning was because I’m not in cirrhosis, which left me wondering has he actually properly read my email and the FDA report? I explained to the woman on the phone it’s now been found to have caused harm to some people not in cirrhosis but she just glossed over that. So the message I’m being given is there’s nothing to worry about. I only see the specialist every 6 months so I just feel a little uneasy that I’m not monitored that regularly. I think I’d rather go back on Urso. Not sure what to do. How are you going with your new med Livdelzi?

[gwillistexas in reply to Turquoise2075]

I’m glad you asked them about it. I’m not sure how I would feel about their response. I’m just thankful my hepatologist was on top of it and took myself and his other patients off it. I’m doing very well with the new drug. No side effects so far. Thank you for checking in. I’ll definitely keep you in my prayers. Please stay in touch. 🙏🏻😊

[Turquoise2075 in reply to gwillistexas]

I meant to say too I’m glad you are doing well with the new drug and there’s no side effects ☺️ I’m pretty sure Livdelzi is not available here, at least not yet. All the best 🙏

[gwillistexas in reply to Turquoise2075]

Thank you.

[gwillistexas in reply to Turquoise2075]

One thing I thought about, can you ask your dr to monitor you maybe at 3 months? 6 months seems a little too long with a drug that has a warning.

[Turquoise2075 in reply to gwillistexas]

Thank you, yes I thought of 3 months instead of 6. To be honest, I feel like I might get dismissed there as well and told there’s no need. I really don’t feel heard. I’m thinking I might contact the Liver Foundation here in Australia for further advice. Our version of the FDA, the Therapeutic Goods Administration, doesn’t seem to have put out any statements on Ocaliva.

[gwillistexas in reply to Turquoise2075]

Yes do that. I read the article again. Says “frequent monitoring “. Researchers said “it is unclear if monitoring will prevent serious liver injury “. Let me know what you find out.

[Turquoise2075 in reply to gwillistexas]

Hmm, that does feel a bit worrying. I’m inclined to stop taking it but will research further and try and get more info. It’s so frustrating I can’t have a helpful discussion with my specialist who is the person I should be able to discuss this with. Anyway, yes, I’ll let you know what I find out. Thanks again 🙏☺️

[gwillistexas in reply to Turquoise2075]

You’re welcome 😊

[Cfay]

My gastro shared the FDA warning about Ocaliva with me during my checkin last month and let me know it would be pulled off market within the next few months- the FDA hadn’t released the general public warning at that time. Oclaliva was added to my treatment when the drug was in Phase 3 of its trial and the URSODIOL wasn’t reducing my counts by itself; it had just been released for the general PBC population with required screening as long-term effects were still being monitored - hence having to report to the specialty pharmacy each time there was a refill request.

I’ve now been on a daily low dose of Livdelzi (still on URSODIOL 2x day)for a month and the itching is not as bad as previously. I live in Maryland (USA) and the new drip is not yet carried by the major pharmacies yet. I was contacted by Orsini Specialty Drugs and they are delivering the drug on a monthly basis. This company will only bill one insurance company (Medicare is my primary) and not my secondary (Cigna), but my co-pay is only $33/month at this point.

[gwillistexas in reply to Cfay]

Good morning and thank you. Orcini contacted me a couple weeks ago. I received my prescription yesterday, so I will start it today. I have Medicare and Cigna as well. Thanks again for reaching out. I will chat with you later😊

[Turquoise2075]

I just thought I'd let you know that I expressed my concerns again to the liver specialist and he said to just stop Ocaliva for 3 months and monitor based on my generally good liver readings. However, I realised I would prefer to go back on Urso to at least know something is helping with bile flow. Even though I was a non-responder to Urso previously, what normalised my liver readings was doing advanced microbiome testing with a naturopath and taking supplements specifically for what was indicated from the tests. My sense is the Urso may not have worked because of the level of gut dysbiosis and intestinal permeability. As further testing has shown significant healing in these areas it may be that Urso has more of a chance of working now. I would rather be on something that potentially helps rather than nothing. I do feel better coming off Ocaliva given the risks. In Australia the newer meds are not available and I had a bad reaction to Fenofibrate. Urso had no side effects for me so it feels safe to be on it again. Thanks again for discussing this topic as it has helped me in working out what to do 🙏

[gwillistexas in reply to Turquoise2075]

I’m happy for you that he allowed you to stop ocaliva. Let us know how you get along.

[Turquoise2075 in reply to gwillistexas]

Thank you, yes, I will let you know.

[gwillistexas in reply to Turquoise2075]

You’re welcome