Ocaliva
Liver Cirrhosis, Biliary, ursodiol, ursodiol
Treatment
4 FDA approvals
4 Active Studies for Ocaliva
Treatment for
Liver Cirrhosis, Biliary
What is Ocaliva
Obeticholic acid
The Generic name of this drug
Treatment Summary
Obeticholic acid is a medication used to treat primary biliary cirrhosis (PBC), a progressive and chronic condition that can lead to liver failure. It was approved for this use in 2016 and is usually used in combination with ursodeoxycholic acid. In 2021, the FDA updated its prescribing information to warn against its use in patients with advanced cirrhosis due to a risk of liver failure. Obeticholic acid is currently being considered for FDA approval to treat non-alcoholic liver steatohepatitis (NASH). If approved, it will be available for this use in 2020.
Ocaliva
is the brand name
Ocaliva Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Ocaliva
Obeticholic acid
2016
2
Approved as Treatment by the FDA
Obeticholic acid, also known as Ocaliva, is approved by the FDA for 4 uses which include Primary Biliary Cholangitis and ursodiol .
Primary Biliary Cholangitis
Used to treat Primary Biliary Cholangitis in combination with Ursodeoxycholic acid
ursodiol
Used to treat Inadequate response to UDCA (ursodeoxycholic acid) in combination with Ursodeoxycholic acid
Liver Cirrhosis, Biliary
Used to treat Primary Biliary Cholangitis in combination with Ursodeoxycholic acid
ursodiol
Effectiveness
How Ocaliva Affects Patients
Obeticholic acid is thought to help reduce inflammation and scarring of the liver caused by Primary Biliary Cirrhosis. However, it is not yet known if taking this drug improves the survival rate of those affected.
How Ocaliva works in the body
Primary biliary cirrhosis is an autoimmune disorder that damages the bile ducts and liver. Obeticholic acid is a drug used to combat this condition by decreasing the amount of bile in the liver. It does this by binding to a receptor in the liver and intestinal cells, called the farnesoid X receptor. This process helps reduce inflammation and cirrhosis of the liver caused by too much bile.
When to interrupt dosage
The advised measure of Ocaliva is contingent upon the determined condition, including ursodiol, Primary Biliary Cholangitis and ursodiol. The quantity of dosage fluctuates, corresponding to the technique of delivery (e.g. Tablet, film coated - Oral or Tablet) specified in the following table.
Condition
Dosage
Administration
Liver Cirrhosis, Biliary
5.0 mg, , 10.0 mg
Oral, Tablet, film coated, , Tablet, film coated - Oral, Tablet, Tablet - Oral
ursodiol
5.0 mg, , 10.0 mg
Oral, Tablet, film coated, , Tablet, film coated - Oral, Tablet, Tablet - Oral
ursodiol
5.0 mg, , 10.0 mg
Oral, Tablet, film coated, , Tablet, film coated - Oral, Tablet, Tablet - Oral
Warnings
Ocaliva has four contraindications, therefore it should not be utilized if you are suffering from any of the conditions in the subsequent table.
Ocaliva Contraindications
Condition
Risk Level
Notes
complete biliary obstruction
Do Not Combine
Hypertension, Portal
Do Not Combine
Fibrosis
Do Not Combine
Fibrosis
Do Not Combine
There are 20 known major drug interactions with Ocaliva.
Common Ocaliva Drug Interactions
Drug Name
Risk Level
Description
Zolmitriptan
Minor
The metabolism of Zolmitriptan can be decreased when combined with Obeticholic acid.
(R)-warfarin
Moderate
The therapeutic efficacy of (R)-warfarin can be decreased when used in combination with Obeticholic acid.
(S)-Warfarin
Moderate
The therapeutic efficacy of (S)-Warfarin can be decreased when used in combination with Obeticholic acid.
6-O-benzylguanine
Moderate
The metabolism of 6-O-benzylguanine can be decreased when combined with Obeticholic acid.
8-azaguanine
Moderate
The metabolism of 8-azaguanine can be decreased when combined with Obeticholic acid.
Ocaliva Toxicity & Overdose Risk
The highest amount of obeticholic acid recorded in a healthy person is 500 mg, with 250 mg given over 12 days. Side effects of taking obeticholic acid include itching and increased liver enzymes. Taking more than the recommended dose could lead to further liver damage, fluid buildup, worsening of existing bile duct conditions, and jaundice. If someone overdoses on obeticholic acid, they should be monitored closely and given supportive care.
Ocaliva Novel Uses: Which Conditions Have a Clinical Trial Featuring Ocaliva?
11 active experiments are being conducted to investigate the potential of Ocaliva to ameliorate Primary Biliary Cholangitis, ursodiol and ursodiol-related ailments.
Condition
Clinical Trials
Trial Phases
Liver Cirrhosis, Biliary
4 Actively Recruiting
Phase 3, Phase 2
ursodiol
0 Actively Recruiting
ursodiol
0 Actively Recruiting
Patient Q&A Section about ocaliva
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How long do you take Ocaliva?
"The recommended dosage for OCALIVA is 5 mg orally once daily for 3 months, with an increase to 10 mg once daily if tolerated and based on response. Starting with a dosage of 10 mg once daily is not recommended, as it increases the risk of pruritus."
Answered by AI
What is Ocaliva used for?
"Ocaliva is a medication used to treat primary biliary cholangitis, a rare and chronic liver disease. Ocaliva has been shown to improve a certain blood test that is used to measure liver problems. It is available in 5 mg and 10 mg tablets."
Answered by AI
What is obeticholic acid used for?
"Obeticholic acid is used to either treat primary biliary cholangitis on its own, or in combination with ursodiol. This is for people who cannot take ursodiol or were not treated successfully with it in the past."
Answered by AI
Is Ocaliva a specialty drug?
"A specialty pharmacy is a pharmacy that specializes in particular types of medication, as opposed to your local pharmacy which carries a more general range of drugs. A specialty pharmacy would coordinate the delivery of a drug like OCALIVA® (obeticholic acid), which is a specialized medication."
Answered by AI