Indications and medication precautions for Indian natco version of Ocaliva
Ocaliva is a medication used for specific liver diseases, and its indications and medication precautions must strictly follow clinical guidelines. The following sub items describe their indications and medication precautions to ensure the safety and effectiveness of treatment.
1. Indications
(1) Primary biliary cholangitis (PBC): Suitable for adult patients with insufficient response or intolerance to ursodeoxycholic acid (UDCA), can be used alone or in combination with UDCA.
(2) Non alcoholic steatohepatitis (NASH): Currently in clinical trials and has not been officially approved for this indication.
2. Medication precautions
(1) Liver function monitoring
Liver function needs to be evaluated before treatment, and ALT, AST, and bilirubin levels should be regularly monitored during treatment. When liver function abnormalities occur, the dosage should be adjusted or medication should be suspended.
(2) Dose adjustment
Mild liver dysfunction patients do not need to adjust the dosage. Moderate liver dysfunction (Child Pugh B grade) should start with lower doses and be closely monitored. Severe liver dysfunction (Child Pugh C grade) is contraindicated.
(3) Medication for special populations
Pregnant women are prohibited from using it, and women of childbearing age should take effective contraceptive measures. Breastfeeding women should weigh the pros and cons. Elderly patients do not need to adjust their dosage, but close monitoring is necessary.
(4) Drug interactions
The combination of resin drugs with bile acids can reduce the absorption of obeticolic acid, and should be taken at least 4 hours apart. Combined use with strong CYP3A4 inhibitors may increase exposure to obeticolic acid.
(5) Adverse reaction management
Common adverse reactions include itching, fatigue, and abdominal pain. Severe itching may require reducing or suspending medication. If severe liver function damage occurs, the medication should be stopped immediately.
(6) Other precautions
During the treatment period, it is necessary to maintain a low-fat diet. Missing medication does not require supplementation, please take the medication according to the original plan next time. Medications should be stored at room temperature to avoid moisture and high temperatures.
Disclaimer：《Indications and medication precautions for Indian natco version of Ocaliva》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！