Ocaliva 10 mg (Obeticholic Acid Tablet) 10mg

Ocaliva 10 mg is an FXR agonist used to treat primary biliary cholangitis (PBC).

• Primary biliary cholangitis (PBC): Used in adults with an inadequate response to UDCA or who are unable to tolerate UDCA.
• Primary biliary cholangitis (PBC) in combination with UDCA: For adults who have not responded adequately to UDCA after at least 12 months.
• Primary biliary cholangitis (PBC) as monotherapy: For adults who cannot tolerate UDCA.

• Obeticholic acid is a selective agonist of the farnesoid X receptor (FXR), which reduces hepatic bile acid synthesis and promotes bile flow. It targets and binds to FXR expressed in the liver and intestine, decreasing the production of bile in the liver and increasing the removal of bile from the liver. This action helps to lower hepatic exposure to bile acids and modulate inflammatory, fibrotic, and metabolic pathways.

Ocaliva 10 mg may cause side effects, which can be categorized as common or serious.

Common Side Effects

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Itching (pruritus)
• Fatigue
• Dizziness
• Fever
• Chills
• Less frequent urination

Serious or Rare Side Effects

• Liver damage, sometimes serious enough to require liver transplantation or cause death, especially in patients with cirrhosis.
• Yellowing of the skin or eyes (jaundice)
• Dark urine
• Black tarry stools
• Coughing up or vomiting blood
• Swelling in and around the stomach area
• Confusion
• Slurred speech
• Anxiety
• Mood swings
• Changes in personality

Ocaliva 10 mg should be used with caution and certain precautions should be observed.

• Liver function monitoring: Use cautiously in patients with cirrhosis. Ocaliva may worsen liver function and lead to hepatic failure. Discontinue if signs of decompensation occur.
• Cirrhosis: Contraindicated in patients with decompensated cirrhosis, a prior decompensation event, or compensated cirrhosis with evidence of portal hypertension.
• Pregnancy: The safety of Ocaliva during pregnancy is unknown. Consult a healthcare provider before use.
• Breastfeeding: The safety of Ocaliva during breastfeeding is unknown. Consult a healthcare provider before use.
• Bile acid binding resins: Take Ocaliva at least 4 to 6 hours before or after taking bile acid binding resins.
• Store at 20°C to 25°C (68°F to 77°F): Keep in the original pack, protect from moisture.

Ocaliva 10 mg may interact with other medications, which can be categorized as major or moderate.

Major Interactions (Avoid)

• Bile acid binding resins: Take Ocaliva at least 4 to 6 hours before or after taking bile acid binding resins.
• CYP1A2 substrates: Obeticholic acid may increase the exposure of CYP1A2 substrates, potentially leading to adverse effects.
• CYP2B6 substrates: Obeticholic acid may increase the exposure of CYP2B6 substrates, potentially leading to adverse effects.

Moderate Interactions (Monitor Closely)

• CYP3A4 substrates: Obeticholic acid may increase the exposure of CYP3A4 substrates, potentially leading to adverse effects.
• CYP2C8 substrates: Obeticholic acid may increase the exposure of CYP2C8 substrates, potentially leading to adverse effects.
• CYP2C9 substrates: Obeticholic acid may increase the exposure of CYP2C9 substrates, potentially leading to adverse effects.