Ocaliva (obeticholic acid)

100 % legal and regulated
Secured logistics globally
24/7 track & trace delivery
Safe payment by bank transfer or credit card

We are registered as an independent intermediary for medicines with the Dutch Ministry of Health

Ocaliva (obeticholic acid)

How to buy Ocaliva: You can order Ocaliva (obeticholic acid) via TheSocialMedwork if the drug has not been approved and/or is not available in the patient's country. TheSocialMedwork - helping patients and doctors access the latest approved medicines and at the lowest price possible worldwide.

Manufacturer Intercept Pharmaceuticals
Disease Primary Biliary Cholangitis (PBC)
Indication Primary biliary cholangitis (PBC)
Mode of Action Farnesoid X receptor (FXR) agonist
Approval Status EMA approved (EU); FDA approved (USA)
CAS Number 459789-99-2
HS Code 29372900
Strength 10 mg, 5 mg

Who is obeticholic acid for?

Obeticholic acid is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA [1].

Recommended dose

Complete information about obeticholic acid dosage and administration can be found here: [1][4].
The recommended therapy consists of:
  • Starting Dosage: the recommended starting dosage of obeticholic acid is 5 mg orally once daily in adults who have not achieved an adequate response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA.
  • Dosage Titration: if adequate reduction in ALP and/or total bilirubin has not been achieved after 3 months of obeticholic acid 5 mg once daily and the patient is tolerating obeticholic acid, increase dosage to 10 mg once daily.
  • Maximum Dosage: 10 mg once daily.
For the management of patients with intolerable pruritus or hepatic impairment see full prescribing information [1].
Correct dosing is of the utmost importance. The FDA (Food and Drugs Administration, USA) warns that incorrect dosing in some patients with moderate to severe decreases in liver function may result in an increased risk of serious liver injury and death [5].
Consult your treating doctor for personalised dosing.

What is obeticholic acid and how does it work?

Obeticholic acid is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA; or as monotherapy in adults unable to tolerate UDCA [1]. PBC is a chronic or long-lasting disease that causes the small bile ducts in the liver to become inflamed, damaged and ultimately destroyed. This causes bile to remain in the liver, damaging liver cells over time and resulting in cirrhosis, or scarring of the liver. As cirrhosis progresses and the amount of scar tissue in the liver increases, the liver loses its ability to function. Obeticholic acid, given orally, binds to the farnesoid X receptor (FXR)—a receptor found in the nucleus of cells in the liver and intestines. FXR is a key regulator of bile acid metabolic pathways. Obeticholic acid increases bile flow from the liver and suppresses bile acid production in the liver, thus reducing the exposure of the liver to toxic levels of bile acids [2].

What is obeticholic acid's approval status?

Obeticholic acid was approved by
  • FDA (USA) on May 27, 2016 [2]
  • EMA (EU) on December 12, 2016 [3]
for the treatment of patients with primary biliary cholangitis (PBC).
The approval is based on a 12-months trial involving 216 patients with PBC who were taking UDCA for at least 12 months and were on a stable dosage for at least 3 months; or patients who were unable to tolerate UDCA and did not receive it for at least 3 months. All patients had a level of Alkaline phosphatase (ALP — an enzyme fundamental for metabolism within the liver) at least 1.67 times higher than normal (with normal being 118 U/ L for females and 124 U / L for males); or had a level of bilirubin (a brownish yellow substance produced when the liver breaks down old red blood cells and found in bile) higher than normal but less than twice as normal (with normal being 1.1 mg/ dL for females and 1.5 mg / dL for males). Patients received either obeticholic acid 10 mg for 12 months, or obeticholic acid 5 mg for the first 6 months with the option of an escalation to 10 mg for the last 6 months, or placebo. When possible patients took UDCA [1].
Patients were considered responders if after 12 months their ALP was less than 1.67 times the normal and decreased of at least 15 %, and if their bilirubin wasless or equal the normal level. At 12 months the responders on Ocaliva 10 mg were 48 % (95 % CI = 36 - 60), those on Ocaliva 5 mg with possibility to increase the dosage to 10 mg were 46 % (95 % CI = 34 - 58), and those on placebo were 10 % (95 % CI = 4 - 19) [1].
The most common side effects are tiredness and itching [3].
[1] Summary of Product Characteristics [FDA]: Ocaliva (obeticholic acid), Intercept Pharmaceuticals, May 2016.
[2] FDA News Release: FDA approves Ocaliva for rare, chronic liver disease, 31/05/2016.
[3] EMA. Human Medicines: Ocaliva (obeticholic acid), 19/12/2016, cited on 18/04/2017.
[4] Summary of Product Characteristics [EMA]: Ocaliva (obeticholic acid), Intercept Pharma Ltd., Dec. 2016.
[5] FDA. FDA Drug Safety Communication: FDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease, 21/09/2017.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.

How can we help?

★ ★ ★ ★ ★

We've received requests for support from patients and doctors in over 120 countries, and delivered medicines to 6 continents. They've given us a 5 star rating for our service. Read what our friends from around the world are saying...

"My experience has been excellent. TheSocialMedwork were totally knowledgeable about the medicine I was looking for, and how to get it delivered to me quickly and easily. I UNCONDITIONALLY recommend TSM to anyone, it is truly a world-class organisation."

— Charles, USA

"During the transaction process I was very well informed by TheSocialMedwork team. They have put so much effort to ensure the best service was offered to me. Moreover the medicine I ordered was imported two weeks earlier. I highly recommend TheSocialMedwork."

— Tomasz, Poland

"I hope you know how needed you are and what it means to get a prompt, succinct and helpful reply. You are our hero. You have given us realistic hope in obtaining needed drugs in a timely way."

— Regina, US

"TheSocialMedwork were so helpful in getting the right medication to me, expediting its delivery, and keeping in touch. They simply can't do enough to help you. I would not hesitate to recommend TheSocialMedwork to anybody. Lovely people."

— Stephen, UK

"Totally awesome! Keep up the great work you're doing!"

— Dee, Australia

"When the doctor tells you that there are no treatments left to try, search further - there may be new treatments in other countries."

— Charlotte, The Netherlands

"TheSocialMedwork's professional capabilities, kindness and patience deserve our gratitude and respect."

— Haoyu, China

"My daughter died at the age of 21 because she couldn't get the treatment that might have saved her life. Now TheSocialMedwork might be able to help people like Abigail to get the best treatment."

— Frank, Virginia, USA

"The team is highly professional, friendly and will take care of everything. More options for doctor and patients. This service is transparent, unique and necessary. Keep it up!"

— Pa Tric, Germany

"Excellent communication and clarifications given every time when requested. They also provide fantastic support and updates from the start till the end of the process of the medicine provisioning."

— Milos, Serbia & Montenegro

Registered with the Dutch Ministry of Health as an independent intermediary, Registration number 6730 BEM
Registered as a USA Delaware LLC.

Our service uses cookies.