Maybe I shouldn’t post OCALIVA side effects. I’m hoping everyone here knows them

[SunnyXXOO]

MEDICATION GUIDE OCALIVA (o-CAL-eh-vah) (obeticholic acid) tablets

What is the most important information I should know about OCALIVA?

If you have primary biliary cholangitis (PBC) with advanced cirrhosis, you may need a lower dose of OCALIVA.

• Before you start OCALIVA, and during your treatment with OCALIVA, your healthcare provider will do tests to check

your liver. These tests will help your healthcare provider decide how much OCALIVA you should take and how often

you should take it.

• If you have worsening liver problems, your dose of OCALIVA may be changed, stopped for a period of time, or stopped

completely by your healthcare provider.

OCALIVA can cause serious side effects including:

Worsening of liver problems, liver failure, in some cases leading to death, have happened in people with PBC with advanced liver cirrhosis when OCALIVA was taken more often than recommended.

• Tell your healthcare provider right away if you have any of the following symptoms of worsening liver problems during treatment with OCALIVA:

• Tell your healthcare provider right away if you have any of the following symptoms during treatment with OCALIVA and they are severe or do not go away:

o swelling of your stomach-area from a build-up of fluid o yellowing of your skin or the whites of your eyes

o black, tarry, or bloody stools

o coughing up or vomiting blood, or your vomit looks like

“coffee grounds”

o mental changes such as confusion, sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality

o stomach-area pain

o nausea, vomiting, or diarrhea o loss of appetite or weight loss o new or worsening fatigue

o weakness

o fever and chills

o light-headedness

o less frequent urination

What is OCALIVA?

OCALIVA is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone in adults who cannot tolerate UDCA.

It is not known if taking OCALIVA will improve your chance of survival or improve your symptoms of PBC.

It is not known if OCALIVA is safe and effective in children.

Do not take OCALIVA if you:

• have a complete blockage of the bile ducts in your liver or gall bladder.

Before taking OCALIVA, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if OCALIVA will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if OCALIVA passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take OCALIVA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. OCALIVA can affect the way certain medicines work. Certain other medicines may affect the way OCALIVA works.

How should I take OCALIVA?

• Take OCALIVA exactly as your healthcare provider tells you to.

• Do not take more OCALIVA than your healthcare provider tells you to.

• Take OCALIVA with or without food.

• If you take a bile acid binding resin, take OCALIVA at least 4 hours before or 4 hours after you take your bile acid binding resin. If this is not possible, space the time between taking OCALIVA and your bile acid binding resin as far apart as possible.

• If you take too much OCALIVA, call your healthcare provider or get emergency medical help right away.

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What are the possible side effects of OCALIVA? OCALIVA can cause serious side effects, including:

• See “What is the most important information I should know about OCALIVA?”

• Severe itching (pruritus). Itching is a common side effect of OCALIVA and can sometimes become severe (intense itching or itching over much of your body). Severe itching can cause discomfort, problems sleeping, and problems doing daily activities and usually needs to be treated. Tell your healthcare provider if you get severe itching or if your itching gets worse.

• Lower HDL-C (“good” cholesterol). OCALIVA can lower high levels of HDL-C. Your healthcare provider will check your cholesterol levels during your treatment with OCALIVA.

The most common side effects of OCALIVA include:

These are not all the possible side effects of OCALIVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• tiredness

• stomachpainanddiscomfort • rash

• jointpain

• mouthandthroatpain

• dizziness

• constipation

• swelling in your hands, ankles, or

feet

• fast or irregular heartbeat

• fever

• changes in how your thyroid gland

works

• dryness, irritation, redness,

crusting or drainage of the skin (eczema)

How should I store OCALIVA?

• Store OCALIVA at room temperature between 68°F to 77°F (20°C to 25°C). Keep OCALIVA and all medicines out of the reach of children.

General information about the safe and effective use of OCALIVA.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use OCALIVA for a condition for which it was not prescribed. Do not give OCALIVA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about OCALIVA that is written for health professionals.

What are the ingredients in OCALIVA?

Active ingredient: obeticholic acid

Inactive ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate

Film coating: Opadry II (Yellow) containing polyvinyl alcohol-part hydrolyzed, titanium dioxide, macrogol (polyethylene glycol 3350), talc, iron oxide yellow

Distributed by: Intercept Pharmaceuticals, Inc., New York, NY 10001 OCALIVA is a registered trademark of Intercept Pharmaceuticals, Inc. For more information, go to OCALIVA.com or call 1-844-782-4278.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Issued: January 2018

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[gwillistexas]

Well aware. Anyone who is given OCA should surely have all this info included in their prescription. With all due respect, if we read side effects on any medication, none of them are good. I don’t like taking OCA but I have no other choice at the moment. I agree people should be aware, but I really don’t understand the reason for this post other than to put fear in someone who may be faced with having to take it. What about side effects of Urso? No doubt it has its share. Let’s post that. People’s liver conditions may have worsened on it as well simply because they are/were nonresponders.

[SunnyXXOO in reply to gwillistexas]

No fake news here!!!!

[gwillistexas in reply to SunnyXXOO]

I don’t think anyone took it as fake news Sunny. It’s always smart for us to be knowledgeable but we have to follow our drs & do what’s seemingly in our best interest, that’s all. 😊 if we’re going to reject their orders then why bother. We’re doing the best we know how with this crazy disease.

[gwillistexas in reply to gwillistexas]

Let me add, anyone who is familiar with OCA, knows it’s not fake. I have all info you posted , as well as anyone else who takes this drug. There’s really no benefit in this conversation continuing on side effects of OCA. I’m pretty sure we all get it. 😊

[ninjagirlwebb in reply to gwillistexas]

In the US, any time you get a prescription filled, a pamphlet or fact sheet is given to the patient with the meds. Anyone who wants to know can read that pamphlet & any questions can be directed to the pharmacist or your own doctor. I am sure they would be more than happy to address any concerns.

Additionally, if your healthcare provider refuses to have a discussion with you about those concerns, you are better off with a new doctor or pharmacist.

[Hidden in reply to gwillistexas]

I agree with you! Better for me at thistime to take an extensively regulated drug from a qualified prescriber than an unregulated, possibly mind-altering substance that would lessen my ability to reach a rational decision. I'm thankful that Ocaliva and Urso exist. Why would anyone expect Big Pharma not to make a profit? That's how new drugs are researched and developed? It cost billions to research and test drugs and bring them to the market and the tooth-fairy isn't going to do it?

[gwillistexas in reply to Hidden]

Intercept does have a large profit. But, OCA is very expensive as anyone who takes it knows. The lowest price I could find where I live was $6,530 for 1 month rx. No one can pay those prices. Most have had to ask for assistance & Interconnect Services saved me on that. So, Intercept making profit on that drug is well earned. I agree with you😊

[EileenUSA]

Hi Sunny,

I want to assume that you had good intentions with this post but I am struggling to see that. Those of us with PBC face difficult decisions regarding treatments and each of us must weigh and be effected by pros and cons of decisions made.

I know you are an advocate for alternative treatments but I don't think scaring people about medications they have chosen to take with the hope of slowing down their disease is a very positive contribution here.

I get that you believe you have "found the cure" but many of us here have made our own educated choices to deal with our disease and that includes pharmaceuticals.

Please respect that.

[Caseymayr1102 in reply to EileenUSA]

Hi Eileen,

If that's scaring you, then do not read it. It's really no different than the info you can find on the medication. Drs hand over scripts and many times I've been told there's no side effects, only to find out that's not true. For many, it's being informed that matters most. I'd rather know these things and then make an educated decision, rather than blindly doing what my Dr says. This to me, was just another piece of knowledge. If Sunny has found alternatives that work, that's fantastic & sign me up. I believe in research & knowing the facts. I also am open and believing in alternative medicine. It's good to be open to trying whatever will get me to my healthiest. It's guided me well as I deal with PBC, lupus, & breast cancer.

To me, this was helpful in knowing more about the medication.

I say let's be as informed as possible. Let's not get scared, let's get educated so we can be our own advocate for good health.

Take care,

Jules

[EileenUSA in reply to Caseymayr1102]

Hi Jules,

I acknowledge that the tone of my post might not be the greatest. Regarding use of word "scaring".

I know many on here who are using OCA and they see it as a chance to slow progress and prevent damage to liver. And of course they should be fully aware of the risks. I know that they (the ones I *know*) didn't sign up to take this new drug without understanding what they were getting in to.

My heart goes out to all who are making tough decisions as to best course to take for quality of life and management of this crazy disease we have. I do apologize if my post is seen as discouraging input.

[SunnyXXOO in reply to Caseymayr1102]

‘‘This is truely not a scare tactic”

Spot in Jules !!!

I wonder if everyone truly know how these drugs work.

I wonder how many people really know and understand BIG PHARMA.

I wonder if everyone here understands that pharmaceuticals companies and hospital are in cahoots.

I wonder how many people are aware that their physicians can not lean toward or say anything about Integrative or Function Medicine (hospital policy).

I hoping everyone knows their body and what it needs. It is so important that everyone here is up to snuff (knowledgeable) with this horrible autoimmune (Dis-ease), knowing is crucial.

It is a individual choice how they manager illness, I get that.

Functional Medicine does work, but works slowly, take time to get to the root of the problem.

Yes, functional and intergrative medicine can be expensive but there are less expensive ways to use it.

I totally respect and honour everyone’s decisions.

I think the the importance of knowledge, research, studies is HUGH!!!!

Some people here think I’m being negative, it’s for the good of all people in this forum. This illness is not all rosey and prettty, it is all negative, but, we stay positive, graceful through out your journey. Teach, teach others what you know of importance.

This earth is like one big schoolroom,

We’re all here to teach each other.

I believe there is a reason for everything that happens, we are learning and teaching at the same time. Some of the time it really hard to figure why this is happening, but believe me there is a reason for everything the happens on this earth.

Love, Peace, Graditude, and Light

SunnyXXOO

[AutoimmunetoStars in reply to EileenUSA]

Finally, someone acknowledges that people already know the side effects! While I never had this drug, I did take several TNF drugs. People would go into forums with people that can't get off those drugs for more reasons than 1. It sounds helpful, but it isn't. I know what its like not to be on those drugs when I did flare. It was hell. Even though it might've been the trigger for my problems rn, I do not regret my use of TNF inhibitors. Because I needed them.

Idk, I agree with you completely, even if its not the same drug. I do agree with Sunny though, there are alternatives and I can respect that. I've seen some people with UC do good on alternatives, but I never was one of those. (Tried, could not get off drugs) Some people have that work, but others don't. It varies just like any other drug that's commercial made.

[SunnyXXOO in reply to EileenUSA]

Important info!!! I have PBC stage 4 (transplant material) also. I have good days and bad days just like everyone else.

I try to treat my liver problem with respect and stay out of its way, I also try to stay POSITIVE and Grateful and handle myself with Grace.

I am very informed with what is going on with my body, that’s because it is my business to know everything about my PBC.

I am sorry if I offended you, but everything I post is the truth and everyone should know every detail about there illness and what is good and what is bad.

I am also non-responder of URSO, Western Medicine does not agree with me, just makes me sicker. My Specialist are all on board with me.

Yes, I’m in the healthcare field and I have a lot of school behind me, but that doesn’t make me any different than you or anybody else.

I’m sorry to announce cold hard fact!

Love, Peace, Graditude, and Light

SunnyXXOO

[kimphoebe]

Wow sunny

Think you listed everything people who already know who are taking ocaliva. With every medication there will always be a list of side effects but people have to make up their own minds weather to take it or not. I'm currently on a clinical trial for pbc because I'm a nonresponder to uso. With this trial at the mo there is no list of side effects but I am doing it firstly to help myself and others. I'm still thinking why you needed to put this post up. This site is ment for to help other people not cause stress.

[EileenUSA in reply to kimphoebe]

Kim,

I just wanted to send you a hug and good wishes and prayers for you and the others who are in the trial with you. Praying you have some positive results.

[kimphoebe in reply to EileenUSA]

Thankyou Eileen

For your kind words

Kimphoebe xx

[Lawyers]

It sounds like a typical TV commercial for any of new drugs. Side effects soundxworse than disease. Love the baby boomer songs they use. At least here in the US. Love big pharma!

[gwillistexas in reply to Lawyers]

Lawyers...true. If we take OCA we should keep up with all updates because it is still in trials. It has proven a benefit for so many people. Drs have a great responsibility to stay on top of monitoring labs, etc. As long as they do that & pay attention & recognize a problem, we as patients should be safe. As you probably know, there were problems with drs not prescribing correctly which caused serious problems for some. Intercept Pharmaceuticals alerts all prescribing physicians and it’s up to those drs to pay attention. 😊

[mrspeffer]

Oh, the beauty in personal choice. I was asked to try OCA as i am allergic to URSO. I made the choice to read the side effects, and thought, based on my reaction to similar meds, ...not anything I'm interested in. My Hep agreed that since my scans were normal, that taking it just to lower numbers was not worth it for me. To all of you who are having success with this or any other drug, hat's off to you. I read on here how many have decreased LFT's and those that are having no changes. I believe we all have to come to a crossroads where we make decisions based on the information we have. The consequences of those choices are ours to own too. I just keep hearing the old tune by Joan Osborne "what if the cure is worse than the disease". Thank you to all of you who freely shared your thoughts, experience and opinions here. Makes for good morning reading...Be well

[EileenUSA in reply to mrspeffer]

So true- what you write.

And just to be clear- I have an open mind to non-Western approaches and have used them ( 40 years ago I was getting acupuncture treatments from a Chinese Medicine dr in Chinatown) Since it was illegal to practice acupuncture back then- you had to know a secret word to tell the shopkeeper who would then lead you to the back room for your treatment! Wild times.

I have used other energy treatments, supplements, yoga (spent time at an ashram back in the 80s-old hippie here.. lol)

All this just to say that I am taking URSO and hope that it helps slow progress down, and I also have worked hard on my diet and my mental stress levels etc.

No I don't think Pharma (or Western medicine) has the "answer" to everything- but I have benefited from it with some other very serious health problems I had. I am grateful for that too.

[Ottley3]

I think that everyone on this board who is taking ocaliva are aware of the side effects and many of us are feeling them - but as it’s the only fda approved second line of defense against PBC - it is the best available choice to many in this group for long term survival. Thanks for trying to help?

[Karaliz in reply to Ottley3]

And you are very fortunate it is approved in the USA. Here in Australia there is no sign of it becoming available. I am on it as part of the long term safety extension arm of the trial but other Aussies who would benefit from it are unable to access it.

Karaliz

[Shulsey]

Hello, I agree with the fact that every medication has the side effects on it. I've been taking Ocaliva for two years with zero side effects. Only great numbers coming back from my bloodwork since I've started it. I also take the Urso with it every day & have nothing but praise about it. It has helped me more than anything else.

Stay Strong❣️

Shannon

Stage 4 PBC

Stage F4 cirrhosis, & varicies