OBETICHOLIC ACID

Obeticholic acid belongs to a class of drugs called gastrointestinal agents developed by the U.S. Food And Drug Administration and initially approved in the year 2016, for treating primary biliary cholangitis (PBC).

Obeticholic acid helps to treat primary biliary cholangitis (PBC). This chronic liver disease can be caused by inflammation and damage to the small bile ducts in the liver, which leads to reduced bile flow, liver damage, and serious scarring (fibrosis).

Obeticholic acid is available in the form of tablets with doses 5mg and 10mg. Your physician will decide the correct dosage and duration based on age, body weight, and disease condition. Only stop taking the medicine if your doctor advises you to stop.

The side effects known to occur commonly during the treatment with Obeticholic acid are tiredness, stomach pain, discomfort, constipation, joint pain, mouth, and throat pain, dizziness, fast or irregular heartbeat, fever, dryness, irritation, or redness of the skin, rash, swelling of ankles, hands, or feet, and thyroid hormone irregularity. Some serious side effects also include worsening of liver problems ( white of the eyes or yellowing of skin, black, tarry or bloody stools, coughing up or vomiting blood, confusion, slurred speech, mood swings), severe itching, and lower HDL-C (good cholesterol).

This drug is contraindicated in individuals with known hypersensitivity or allergy to any other ingredients in the medicine. The levels of certain medications, such as theophylline (used to aid breathing) and tizanidine (used to relieve muscle stiffness and restriction), may increase when taken with Obeticholic acid. Your doctor may need to monitor the levels of these medications in your blood and adjust their dosages if necessary. Medications like cholestyramine, colestipol, and colesevelam, which are used to lower blood cholesterol levels, may reduce the effectiveness of this drug. If you are taking these medicines, your doctor will advise you to take this medication at least 4 to 6 hours before or after taking the bile acid-binding resin to allow sufficient time for their separate absorption. The use of this drug is not recommended in children or adults.

Before taking Obeticholic acid, it is necessary to consult with your physician if you have any concerns about complete blockage of bile ducts in your gallbladder or worsening liver health. Your physician will conduct regular blood tests to monitor your liver function. Itching may occur as a side effect of this drug, and in some cases, it may become severe (intense itching over much of the body). If you experience difficult-to-tolerate itching, your doctor may prescribe additional medications to manage it or adjust your dosage. This drug is not recommended for use during pregnancy due to the lack of sufficient data and experience with its use in pregnant women. As a precautionary measure, pregnant individuals should avoid taking this drug.

Inform your physician if you are taking any medicines to lower blood cholesterol levels. Certain cholesterol-lowering medications can interact with Obeticholic acid and may affect their effectiveness or increase the risk of side effects. Your physician must be aware of all the medications you are taking to make appropriate adjustments to your treatment plan if necessary.

Almac Pharma Services (Ireland) Limited, Electronic medicines compendium (EMC), [Revised on Aug 2022] [ Accessed on 24th August 2023], https://www.medicines.org.uk/emc/files/pil.2561.pdf Intercept Pharmaceutical Inc, US Food and Drug Administration, [ Revised on Jan 2018] [Accessed on 24th August 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207999s003lbl.pdf Bertram G. Katzung, Lange's Basic and Clinical Pharmacology, Drugs Used in treating Gastrointestinal Diseases, 14th Edition, 2018, 1112.