Obexa 10

Indications

Obeticholic acid is used to treat primary biliary cholangitis (PBC), a long-term liver disease in which the small bile ducts inside the liver are slowly damaged. It is used together with Ursodeoxycholic acid when that medicine alone has not worked well enough, or on its own in people who cannot take Ursodeoxycholic acid. It is started and monitored by a liver specialist.

How It Works

It acts on a receptor in the liver and gut called FXR, which controls bile acid production. This lowers the amount of bile acid made in the liver and helps bile flow out, reducing damage to liver cells.

Dosage and Administration

As prescribed by the specialist. It is usually started at 5 mg once a day, and the specialist may increase it after about 6 months depending on blood tests and how well it is tolerated. People with cirrhosis need special dosing decided by the specialist. Take with or without food. If you also take a bile acid binder (such as Cholestyramine), take obeticholic acid at least 4 hours before or 4 to 6 hours after it.

Interactions

• Cholestyramine, Colestipol and Colesevelam reduce its absorption; separate the doses as above.
• It can change the effect of Warfarin; the INR (blood clotting test) should be checked.
• It may raise levels of Theophylline and Tizanidine.

Contraindications

• Advanced liver disease with complications (decompensated cirrhosis), such as fluid in the abdomen, vomiting blood or confusion caused by liver failure.
• Complete blockage of the bile ducts.
• Allergy to obeticholic acid or any ingredient of the product.

Side Effects

Common: itching (often in the first months), tiredness, stomach pain, constipation, joint pain, dizziness, sore throat, skin rash and swelling of the hands or feet.

Get urgent medical help for:

• Yellow skin or eyes, or dark urine.
• A swollen abdomen or rapid weight gain.
• Vomiting blood, or black, tar-like stools.
• Confusion, unusual sleepiness or severe pain in the upper right abdomen.
• Severe itching that stops you sleeping or carrying on with daily life.

Pregnancy and Lactation

There is little information on use in pregnancy; it should be avoided unless the specialist decides it is needed. It is not known whether it passes into breast milk; the doctor will help decide between breastfeeding and treatment.

Precautions and Warnings

• Serious liver injury has been reported, mainly in people with cirrhosis and at higher than recommended doses. Regular liver blood tests are essential.
• Tell the specialist at once if itching becomes severe; other medicines may help.
• It can lower HDL (good) cholesterol; cholesterol may be checked.
• Do not take more than the prescribed dose.

Overdose

Higher doses increase the risk of liver problems. Seek medical advice promptly if too much is taken.

Therapeutic Class

Bile acid analogue (FXR agonist) for liver disease.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.