Exported Medicines

Obeticholic Acid

Obeticholic Acid

General Information

Obeticholic Acid is indicated for use to treat primary biliary cholangitis (PBC). PBC is a chronic liver disease that gradually destroys bile ducts in the liver. These ducts deliver the bile to the small intestines. It is 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 or scarring of the liver and liver failure.

This medication may help slow the worsening of primary biliary cholangitis. It also decreases the production of bile in the liver and increases the removal of bile from the liver. This may as well decrease symptoms such as:

  • Itchy skin
  • Tiredness
  • Abdominal pain
  • Dry mouth and eyes

Obeticholic Acid may be used alone or in combination treatment for certain liver disease.  This drug is a synthetically modified bile acid that is a potent agonist of the farnesoid X nuclear (FXR). It is a nuclear receptor with major effects on bile acid synthesis. It is primarily located in tissues that are integral to bile acid metabolism (liver and intestines). Activation of FXR has anti-cholestatic effects. That it prevents the toxic build-up of bile acid in the liver. This was given provisional approval for use in the year 2016 by the Food and Drug Administration (FDA).

This prescription is supplied as tablets for oral use. The available doses for this product are 5 mg and 10 mg. Each tablet contains Obeticholic Acid as an active ingredient. It is a white to off-white powder that is soluble in acetone and methanol. Its solubility in water is pH-dependent.

How does Obeticholic Acid work?

Obeticholic Acid works in a unique way to reduce the production of the bile acids in the liver. It increases the flow of the bile acids out of the liver and may help lessen the damaging build-up of bile acids overall. By decreasing bile acid build-up, Obeticholic Acid helps to lower ALP levels. ALP means Alkaline Phosphate which is an enzyme found in several tissues throughout the body. The highest concentrations of ALP are present in the cells that comprise bone and the liver. Lower ALP is important as it is a marker that may indicate reduced damage to bile ducts.

High ALP can be a sign of liver damage or that your disease is progressing. Lowering your ALP levels can be critical to your liver health. It may lessen the risk of needing a liver transplant.

In studies, almost half of people who took Obeticholic Acid for a year were considered ‘responders’ to treatment. Most people in some studies took Obeticholic Acid in combination with other drugs to treat the condition were considered ‘responders’ if they:

  • Had ALP levels less than 1.67 times the upper limit or normal
  • Saw their ALP levels decrease by at least 15%
  • Kept their bilirubin levels within normal ranges

Talk to your doctor about the importance of lowering your ALP levels. Find out as well if this prescription is right for you.

How to use Obeticholic Acid?

The prescribed dosage is based on your medical condition, age, and response to the treatment. You must take this medication exactly as it is prescribed. For the best benefit from this product, take it regularly. Do not stop taking this medication without the consent of your doctor. It may cause another complication or may worsen your current condition.

The typical initial dose for primary biliary cholangitis (PBC) is 5 mg once a day. In which it can be increased to a maximum of 10 mg a day. Take the tablet by mouth with a full glass of water. You may take each dose with or without food as directed by your doctor. To help you remember, take it at the same time each day. If your doctor has prescribed a once or twice weekly schedule, it may help to mark your calendar.

If you also take certain other drugs to lower your cholesterol, take Obeticholic Acid at least 4 hours before or 4 hours after taking these medicines. These drugs are colestipol or cholestyramine which is a bile acid-binding resin.

If you missed a dose, take it as soon as you remember it. If it is almost time for your next dose, skip the missed dose and follow your regular schedule. Inform your doctor if your condition gets worse or does not improve.

What are the side effects of Obeticholic Acid?

Common side effects of this drug:

  • Fatigue
  • Itching
  • Rash
  • Abdominal pain and discomfort
  • Joint pain
  • Constipation
  • Mouth and throat pain
  • Dizziness
  • Eczema
  • Swelling of the extremities
  • Fever
  • Palpitations
  • Fainting
  • Thyroid function abnormality
  • Tiredness or weakness
  • Skin rash, redness or oozing

If these side effects persist or get worse, call for medical help right away.

Warnings and Precautions

Before taking Obeticholic Acid let your doctor know if:

  • You are allergic to this drug, any other medications, or any of the ingredients of Obeticholic Acid.
  • You have non-prescription or prescription medications, nutritional supplements, vitamins, or herbal products you are taking or plan to take.
  • You have or have ever had high cholesterol or thyroid disease.
  • You are pregnant, planning to become pregnant, or breastfeeding women.
  • If there are any signs of an allergic reaction, call for medical assistance right away.
  • If you become pregnant while taking Obeticholic Acid, call your doctor immediately.
  • Do not share this or any of your prescriptions with others even if they have the same symptoms as yours.
  • You should not use this for the treatment of other conditions.
  • Call your doctor if you have any unusual problems while taking this medication.
  • Keep this medication in the container it came in, tightly closed, and out of reach of children.
  • Store at room temperature far from heat and moisture.
  • In case of emergency or overdose, seek medical assistance right away.

Symptoms of overdose may include:

  • Dark-colored urine
  • Yellowing of the skin or eyes
  • Loss of appetite
  • Nausea and vomiting
  • Pain in the upper right part of the stomach
  • Swelling in the area around the stomach