Ocaliva 10 mg (Tablet)
Unit Price: ৳ 55.00 (3 x 10: ৳ 1,650.00)
Strip Price: ৳ 550.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Biopharma limited |
| Also available as |
Title
- Choliva
Categories
- Medicine
- Therapeutic Class: Farnesoid X Receptor Agonists
Description
- Choliva is indicated for the treatment of adult patients with primary biliary cholangitis (PBC) without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension. Either in combination with ursodeoxycholic acid (UDCA) with an inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA.
- Obeticholic acid is an agonist for Farnesoid X Receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
- The recommended dosage of Obeticholic acid for PBC patients without cirrhosis or with compensated cirrhosis who do not have evidence of portal hypertension, who have not achieved an adequate biochemical response to an appropriate dosage of UDCA for at least 1 year or are intolerant to UDCA follows below: Start with a dosage of 5 mg once daily for the first 3 months. After the first 3 months, for patients who have not achieved an adequate reduction in ALP and/or total bilirubin and who are tolerating Obeticholic acid increase to a maximum dosage of 10 mg once daily.
Indications
- Treatment of primary biliary cholangitis (PBC) in adult patients without cirrhosis or with compensated cirrhosis without evidence of portal hypertension
- Combination therapy with ursodeoxycholic acid (UDCA) with inadequate response to UDCA or as monotherapy in patients unable to tolerate UDCA
Mechanism of Action
- Obeticholic acid is an agonist for Farnesoid X Receptor (FXR), a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic and metabolic pathways.
Pharmacodynamics
- Administration of Obeticholic acid 10 mg once daily was associated with a 173% increase in concentrations of FGF-19, an FXR-inducible enterokine involved in bile acid homeostasis from baseline to Month 12.
- Concentrations of cholic acid and chenodeoxycholic acid were reduced 2.7 micromolar and 1.4 micromolar respectively from baseline to Month 12.
Cardiac Electrophysiology
- At a dose of 10 times the maximum recommended dose, Obeticholic acid does not prolong the QT interval to any clinically relevant extent.
Dosage & Administration
- Determine if the patient has decompensated cirrhosis or evidence of portal hypertension before initiating Obeticholic acid.
- Start with a dosage of 5 mg once daily for the first 3 months. After the first 3 months, increase to a maximum dosage of 10 mg once daily for patients not achieving adequate reduction in ALP and/or total bilirubin while tolerating Obeticholic acid.
- Routinely monitor patients during Obeticholic acid treatment for biochemical response, tolerability, and progression of PBC.
Interaction
- Bile Acid Binding Resins such as cholestyramine adsorb and reduce bile acid absorption, potentially reducing the absorption, systemic exposure, and efficacy of Ocaliva.
- Co-administration of Ocaliva and warfarin may decrease the International Normalized Ratio (INR).
- Ocaliva may increase the exposure to concomitant drugs that are CYP1A2 substrates.
Contraindications
- Decompensated cirrhosis (e.g., Child-Pugh Class B or C) or a prior decompensation event
- Compensated cirrhosis with evidence of portal hypertension (e.g., ascites, gastroesophageal varices, persistent thrombocytopenia)
- Complete biliary obstruction
Side Effects
- Most common side effects include: Pruritus, Fatigue, Stomach pain and discomfort. Other common side effects include rash, joint pain, oropharyngeal pain, dizziness, constipation, abnormal thyroid function, and eczema.
Pregnancy & Lactation
- Limited human data on the use of obeticholic acid during pregnancy are not sufficient to inform a drug-associated risk.
- No information is available on the presence of obeticholic acid in human milk or its effects on the breastfed infant or milk production.
Precautions & Warnings
- Hepatic decompensation and failure have been reported with Ocaliva treatment in PBC patients with cirrhosis, sometimes fatal or resulting in liver transplant.
- Severe pruritus was reported in a substantial percentage of patients and clinical evaluation should be considered for patients with new onset or worsening severe pruritus.
- Reduction in HDL-C levels may occur in patients with PBC during treatment.
Use in Special Populations
- The safety and effectiveness of Ocaliva in pediatric patients have not been established.
- Of the patients in clinical trials who received the recommended dosage, 20% were 65 years of age or older. No overall differences in safety or effectiveness were observed for older individuals, but greater sensitivity of some older individuals cannot be ruled out.
- Hepatic decompensation and failure have been reported with Ocaliva treatment in PBC patients with cirrhosis.
Overdose Effects
- PBC patients who received Ocaliva at higher than recommended dosages experienced a dose-dependent increase in hepatic adverse reactions, including elevations in liver biochemical tests, ascites, jaundice, and portal hypertension.
Storage Conditions
- Store below 30°C in a dry place and protect from light. Keep out of children's reach.