Obeticholic acid oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of obeticholic acid.
Drugs List
Therapeutic Indications
Uses
Primary biliary cholangitis in Child-Pugh B or C or decompensated cirrhotic
Primary biliary cholangitis in non-cirrhotic or Child-Pugh Class A
Dosage
Adults
Non-cirrhotic or Child-Pugh Class A Initial dose of 5mg once a day. Patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin after 6 months of treatment and who tolerates treatment, titrate up to 10mg once a day, based on response and tolerability.
Child-Pugh Class B or Class C or decompensated cirrhosis Initial dose of 5mg once a week. Patients who have not achieved adequate reduction in ALP and/or total bilirubin after 3 months of treating and who tolerates treatment, titrate dose up to 5mg twice a week, at least 3 days apart. Subsequently, increase to 10mg twice a week, at least three days apart, based on response and tolerability.
Patients with Hepatic Impairment
All patients treated with obeticholic acid will have certain degree of hepatic impairment (See Dosage; Adult).
Additional Dosage Information
Dose adjustments for patients experiencing severe pruritus Patients experiencing intolerable severe pruritus, temporarily interrupt treatment for 2 weeks and restart at reduced dose.
Non-cirrhotic or Child-Pugh Class A
Patients intolerant to 5mg once a day, reduce to 5mg every other day. Patients intolerant to 10mg once a day, reduce to 5mg once a day. Continue to increase the dose to 10mg once a day as tolerated, to achieve optimal response.
Child-Pugh Class B or Class C or decompensated cirrhosis Patients intolerant to 5mg twice a week, reduce dose to 5mg once a week. Patients intolerant to 10mg twice a week, reduce dose to 10mg once a week. Continue to increase the dose to 10mg twice a week as tolerated, to achieve optimal response.
Contraindications
Children under 18 years
Biliary obstruction
Breastfeeding
Pregnancy
Precautions and Warnings
Moderate hepatic impairment
Reduce dose in patients with moderate hepatic impairment
Severe pruritus: Consider adding bile acid sequestrant or antihistamine
Severe pruritus: Consider dose reduction, dose frequency or interruption
Advise to avoid bile acid sequestrant 4 to 6 hours before or after dose
Perform liver function tests before commencing therapy
Monitor hepatic function regularly
Discontinue treatment if persistent severe pruritus occurs
Pregnancy and Lactation
Pregnancy
Obeticholic acid is contraindicated during pregnancy.
The manufacturer does not recommend using obeticholic acid during pregnancy. At the time of writing there is limited published information regarding the use of obeticholic acid during pregnancy. Potential risks are unknown.
Lactation
Obeticholic acid is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues obeticholic acid or discontinues breastfeeding. The presence of obeticholic acid in human breast milk and the effects on exposed infants are unknown.
Side Effects
Abdominal discomfort
Abdominal pain
Alanine aminotransferase increased
Arthralgia
Aspartate aminotransferase increased
Constipation
Dizziness
Eczema
Fatigue
Oropharyngeal pain
Palpitations
Peripheral oedema
Pruritus
Pyrexia
Rash
Thyroid abnormalities
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: January 2020
Reference Sources
Summary of Product Characteristics: Ocaliva 5mg film-coated tablets. Intercept Pharma Ltd. Revised March 2018
Summary of Product Characteristics: Ocaliva 10mg film-coated tablets. Intercept Pharma Ltd. Revised March 2018
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.