Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Ocaliva (Obeticholic-acid).
Cholesterol: Ocaliva (Obeticholic-acid) can cause a decrease in the amount of HDL ("good cholesterol"), which can contribute to increased risk of heart disease. If you have or are at risk of developing heart disease, discuss with your doctor how Ocaliva (Obeticholic-acid) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ocaliva (Obeticholic-acid), and whether any special monitoring is needed.
Itchiness: Itchiness is a common effect of taking obeticholic acid. It usually decreases in severity over time. If itchiness becomes widespread or intense, contact your doctor.
Liver function: Liver disease or reduced liver function may cause Ocaliva (Obeticholic-acid) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Ocaliva (Obeticholic-acid) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ocaliva (Obeticholic-acid), and whether any special monitoring is needed.
Obeticholic acid can cause further decreases in liver function and produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking Ocaliva (Obeticholic-acid). If you have severe changes in liver function, your doctor may recommend that you take a lower dose of Ocaliva (Obeticholic-acid) or stop taking it altogether.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Pregnancy: Ocaliva (Obeticholic-acid) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Ocaliva (Obeticholic-acid), contact your doctor immediately.
Breast-feeding: It is not known if obeticholic acid passes into breast milk. If you are a breast-feeding mother and are taking Ocaliva (Obeticholic-acid), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Ocaliva (Obeticholic-acid) have not been established for children less than 16 years old.