Choliva 5 

Presentation: Each tablet of Choliva 5 contains Obeticholic Acid 5 mg. Choliva 5 is a product of UniMed UniHealth Pharmaceuticals Ltd. in Bangladesh and is usually available in blister packs. The tablets are typically peach-colored and shield-shaped with markings on one side.

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

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

PBC is a chronic liver disease characterized by the gradual destruction of the bile ducts in the liver. Choliva helps to improve liver function by reducing bile acid production and increasing bile acid removal from the liver, thereby reducing the toxic effects of bile acid in the liver.

Dosage and Administration: The recommended starting dosage of Choliva is 5 mg orally once daily for the first 3 months. After the first 3 months, if an adequate reduction in alkaline phosphatase (ALP) and/or total bilirubin has not been achieved and the patient is tolerating Choliva, the dosage may be increased to a maximum of 10 mg once daily.

Choliva tablets can be taken with or without food. If taking a bile acid-binding resin (such as cholestyramine, colestipol, or colesevelam), take Choliva at least 4 hours before or 4 hours after taking the bile acid-binding resin, or at as great an interval as possible.  

Side Effects: The most common side effects reported with Choliva include:

• Pruritus (itching)
• Fatigue
• Abdominal pain and discomfort

Other common side effects may include:  

• Rash  
• Arthralgia (joint pain)  
• Oropharyngeal pain (pain in the middle part of the throat)  
• Dizziness  
• Constipation  
• Abnormal thyroid function  
• Eczema (inflammation of the skin)
• Reduced high-density lipoprotein cholesterol (HDL-C)

Serious side effects, including worsening liver function and hepatic decompensation, have been reported, particularly in patients with cirrhosis. It is important to contact your doctor immediately if you experience symptoms such as yellowing of the skin or eyes, dark urine, black tarry stools, vomiting blood, swelling in the abdomen, confusion, or changes in mental status.

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

• Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event.  
• Compensated cirrhosis who have 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 severe liver disease other than PBC. Choliva may interact with certain medications, including bile acid-binding resins and warfarin. Patients should inform their doctor of all medications they are taking. Liver function tests should be monitored during treatment.

Use in Pregnancy and Lactation: There is limited data on the use of Obeticholic Acid in pregnant women. Choliva should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. It is not known whetherObeticholic Acid is excreted in human milk. Caution should be exercised when administering Choliva to a breastfeeding woman.

Storage: Store Choliva tablets according to the instructions on the product packaging, usually at room temperature. Keep out of reach of children.

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.