Prescription Required.Why?
Is the active ingredient in the medication.
Obeticholic acid is used to treat primary biliary cholangitis (PBC), a chronic liver disease.
It is also being studied for other liver diseases and conditions.
It is prescribed for adults with PBC who have not responded adequately to other treatments.
Obeniv 5 Tablet (Obeticholic Acid) is a farnesoid X receptor (FXR) agonist. FXR is a nuclear receptor that plays a role in regulating bile acid synthesis and cholesterol metabolism. By activating FXR, obeticholic acid reduces the production of bile acids, which can help to improve liver function in patients with PBC.
Store obeticholic acid tablets at room temperature, between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.
The usual starting dose of obeticholic acid is 5 mg once daily.
Your doctor may adjust your dose based on your response to treatment.
Take obeticholic acid tablets by mouth with a meal.
Do not crush, break, or chew the tablets.
The most common side effects of obeticholic acid are itching, fatigue, and pruritus.
More serious side effects can occur, including liver damage, high cholesterol levels, and gallbladder problems.
It is recommended to avoid alcohol consumption while taking obeticholic acid.
Obeticholic acid may cause dizziness or drowsiness. Do not drive or operate machinery until you know how this medication affects you.
Obeticholic acid should not be used during pregnancy. It is not known if obeticholic acid passes into breast milk. Talk to your doctor about the risks and benefits of taking obeticholic acid if you are pregnant or breastfeeding.
Obeticholic acid is not approved for use in children.
Obeticholic acid is not usually recommended for people with severe kidney disease.
Obeticholic acid is used to treat liver disease. However, it can also cause liver damage. Your doctor will monitor your liver function while you are taking this medication.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205626lbl.pdf
https://www.ncbi.nlm.nih.gov/pubmed/26935411
https://www.uptodate.com/contents/primary-biliary-cholangitis-pbc-treatment
https://www.liverfoundation.org/for-patients/about-liver-disease/primary-biliary-cholangitis-pbc/
