Ocaliva 10 

Presentation:Ocaliva 10 is available as yellow, 8 mm x 7 mm triangular film-coated tablets, debossed with 'INT' on one side and '10' on the other side.Each tablet contains 10 mg of obeticholic acid.While "Ocaliva" is a brand name, in Bangladesh, alternative brands containing obeticholic acid 10 mg are available from local manufacturers.

Indications:Ocaliva (Obeticholic Acid) is indicated for the treatment of primary biliary cholangitis (PBC) in adults, either: 

• In combination with ursodeoxycholic acid(UDCA) in adults with an inadequate response to UDCA. 
• As monotherapy in adults unable to tolerate UDCA. 

Prior to initiating treatment, the physician should determine if the patient has decompensated cirrhosis, a prior decompensation event, or compensated cirrhosis with evidence of portal hypertension, as Ocaliva is contraindicated in these conditions. 

Dosage and Administration:Ocaliva 10 tablets should be taken orally once daily, with or without food.For patients taking bile acid binding resins (such as cholestyramine, colestipol, or colesevelam), Ocaliva should be administered at least 4 to 6 hours before or 4 to 6 hours after taking the bile acid binding resin, or at as great an interval as possible. 

The recommended starting dose is 5 mg once daily for the first 6 months. After 6 months, for patients who have not achieved an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin and who are toleratingOcaliva, the dose may be increased to 10 mg once daily.The maximum recommended dose is 10 mg once daily. 

For patients experiencing severe intolerability due to pruritus, the dose may be reduced to 5 mg every other day or 5 mg once daily. The dose may also be temporarily interrupted for up to 2 weeks followed by restarting at a reduced dose. 

Side Effects: The most commonly reported side effects are:

• Pruritus (itching)
• Fatigue

Other common side effects may include:

• Abdominal pain and discomfort 
• Rash 
• Arthralgia (joint pain) 
• Oropharyngeal pain (pain in the middle part of the throat) 
• Dizziness 
• Constipation 
• Peripheral oedema (swelling of legs, feet, arms, or hands) 
• Palpitations (fast or irregular heartbeat) 
• Pyrexia (fever) 
• Thyroid function abnormality 
• Eczema 

Serious side effects may include worsening of liver problems or liver failure.Patients should immediately inform their doctor if they experience symptoms such as swelling of the stomach area from fluid build-up, yellowing of the skin or eyes, black, tarry or bloody stools, coughing up or vomiting blood, mental changes, new or worsening fatigue, weakness, fever and chills, light-headedness, or less frequent urination. Severe pruritus may also occur. 

Precautions: Ocaliva (Obeticholic Acid) is contraindicated in patients with: 

• Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event. 
• Compensated cirrhosiswith evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia). 
• Complete biliary obstruction. 
• Known hypersensitivity to obeticholic acid or any of the excipients. 

Caution should be exercised in patients with compensated cirrhosis, concomitant hepatic disease, and severe intercurrent illness. Liver function tests should be monitored regularly during treatment.

Ocaliva may interact with certain medications, including bile acid binding resins, warfarin, and CYP1A2 substrates with a narrow therapeutic index (e.g., theophylline, tizanidine).The INR should be monitored and the warfarin dose adjusted accordingly if co-administered. Concomitant use with inhibitors of the bile salt efflux pump (BSEP) should be avoided.

Use in Pregnancy and Lactation: There is no experience using Ocaliva in pregnancy. As a precautionary measure, it is not recommended for use during pregnancy. It is unknown whether obeticholic acid is excreted in human breast milk. A decision should be made whether to discontinue breastfeeding or discontinue Ocaliva therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Storage:This medicinal product does not require any special storage conditions.Store in the original bottle to protect from moisture. Keep out of the sight and reach of children. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 

Important Note: This information is for general knowledge and informational purposes only, and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication. They can assess your individual medical condition and provide the most appropriate advice.