Ocaliva (obeticholic acid) is a prescription medicine used to treat primary biliary cholangitis (PBC). This medicine is sometimes used together with another drug called ursodeoxycholic acid (UDCA).
Primary biliary cholangitis (PBC) is a chronic liver disease that gradually destroys bile ducts in the liver. These ducts deliver bile to the small intestines, to help your body digest fats and nutrients. When PBC destroys these ducts, the bile stays in your liver and damages its cells. This can lead to cirrhosis (scarring of the liver) and liver failure. PBC is a progressive disease that may have no symptoms for many years. Treating PBC can help keep the liver functioning normally.
Ocaliva was
approved by the US Food and Drug Administration (FDA) on an
“accelerated” basis. In clinical studies, some people with PBC
responded to this medicine, but further studies are needed.
It is not known
if taking Ocaliva will improve your chance of survival or improve your symptoms
of PBC.
Before taking this medicine
You should not use Ocaliva if you are
allergic to obeticholic acid, or if you have complete blockage of your bile
ducts.
Tell your
doctor if you have ever had liver disease. Your doctor will perform tests to
make sure you do not have liver conditions that would prevent you from safely
using Ocaliva.
It is not
known whether obeticholic acid will harm an unborn baby. Tell your doctor if
you are pregnant or plan to become pregnant.
It may not be
safe to breast-feed a baby while you are using this medicine. Ask your doctor
about any risks.
Side effects
Get emergency medical help if you have signs of an allergic reaction to Ocaliva: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- severe itching;
- changes in your mental status, confusion, drowsiness, unusual tiredness;
- fever, swelling around your midsection, rapid weight gain;
- right-sided upper stomach pain, nausea, loss of appetite;
- vomiting, diarrhea, weight loss;
- urinating less often, dark urine;
- jaundice (yellowing of the skin or eyes); or
- bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
Common Ocaliva side effects may include:
- itching;
- skin rash, redness, oozing, or crusting;
- fever, dizziness, feeling tired;
- stomach pain, constipation;
- pain in your mouth or throat;
- fast or irregular heart rate;
- swelling in your hands or lower legs;
- joint pain; or
- abnormal thyroid function.
Keywords: Ocaliva; obeticholic acid.
