Dosage and Administration of Ocaliva in Laos and Special Population Medication
Ocaliva is a farnesol X receptor agonist primarily used for the treatment of primary biliary cholangitis (PBC). The following provides detailed instructions on usage, dosage, and medication for special populations to assist in rational clinical drug use.
1. Usage and dosage
(1) Initial dose: The recommended initial dose is 5mg orally, once daily.
(2) Dose adjustment: After 3 months of treatment, if the tolerance is good and ALP/bilirubin does not meet the standard, it can be increased to 10mg once daily.
(3) Medication time: It is recommended to take it at a fixed time, either before or after meals.
(4) Omission treatment: If one dose is missed, there is no need to take a replacement dose, and the next dose will continue according to the original plan.
2. Medication for special populations
(1) Pregnancy period
Animal studies have shown embryotoxicity, and it is contraindicated for pregnant women. Effective contraceptive measures should be taken during the medication period for women of childbearing age.
(2) Lactation period
It is not yet clear whether obeticolic acid is secreted into human milk. During lactation, the necessity of treatment should be balanced, and it is recommended to suspend breastfeeding.
(3) Children's use
The safety and efficacy of using it for patients under 18 years old have not been established and is not recommended.
(4) Elderly medication
Patients over 65 years old do not need to adjust their dosage, but close monitoring of liver function is necessary.
(5) Liver dysfunction
Child Pugh Class A patients do not require dose adjustment; Child Pugh B grade should start at 5mg once a week; Child Pugh Class C is prohibited.
(6) Renal insufficiency
Mild to moderate renal dysfunction does not require dose adjustment; Data on severe renal impairment (eGFR<30mL/min/1.73m ²) is limited and should be used with caution.
3. Precautions
(1) Liver function needs to be evaluated before treatment, and ALT, AST, and bilirubin levels should be regularly monitored during treatment.
(2) When combined with bile acid conjugated resin drugs, they should be taken at least 4 hours apart.
(3) Common adverse reactions include itching, fatigue, and abdominal pain. In severe cases, medication should be reduced or suspended.
Disclaimer：《Dosage and Administration of Ocaliva in Laos and Special Population Medication》Edited and sorted by Seagull Pharmacy's editors. Please contact us in time if there is any infringement. In addition, the suggestions for drug usage, dosage and disease mentioned in the article are only for medical staff's reference, and can not be used as any basis for medication！