Obeliva 5 mg (Tablet)
Unit Price: ৳ 30.00 (1 x 30: ৳ 900.00)
Strip Price: ৳ 900.00
Medicine Details
| Category | Details |
|---|---|
| Generic | Obeticholic acid |
| Company | Everest pharmaceuticals ltd |
| Also available as |
Indications
- Treatment of primary biliary cholangitis in adult patients
- Use in combination with ursodeoxycholic acid (UDCA)
- Monotherapy for patients unable to tolerate UDCA
Mechanism of Action
- Agonist for Farnesoid X Receptor (FXR)
- Regulation of bile acid, inflammatory, fibrotic and metabolic pathways
- Decreases intracellular hepatocyte concentrations of bile acids
Pharmacodynamics
- Increase in concentrations of FGF-19
- Reduction in concentrations of cholic acid and chenodeoxycholic acid
Cardiac Electrophysiology
- No clinically relevant QT interval prolongation
Recommended Dosage Regimen
- Start with 5 mg once daily for the first 3 months
- Increase to 10 mg once daily if inadequate biochemical response
Monitoring
- Biochemical response
- Tolerability
- Progression of PBC
Pruritus Management
- Addition of antihistamine or bile acid-binding resin
- Reduce dosage or temporarily interrupt dosing
Interaction with Bile Acid Binding Resins
- Take Obeliva at least 4 hours before or after the resin
Interaction with Warfarin
- Monitor INR and adjust warfarin dosage as needed
Interaction with CYP1A2 Substrates
- Increased exposure to concomitant drugs
Interaction with BSEP Inhibitors
- Monitor serum transaminases and bilirubin
Contraindications
- Decompensated cirrhosis
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Common Side Effects
- Pruritus
- Fatigue
- Stomach pain and discomfort
- Rash
- Arthralgia
- Oropharyngeal pain
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy
- Limited human data
- No developmental abnormalities observed in animal studies
Lactation
- Unknown presence in human milk
- Consider maternal clinical need and potential effects on infant
Hepatic Decompensation and Failure
- Reported in PBC patients with cirrhosis
- Median time to onset of decompensation
- Hepatotoxicity observed in clinical trials
Severe Pruritus
- Incidence in patients on Obeliva 10mg arm
- Clinical evaluation and management strategies
Reduction in HDL-C
- Dose-dependent reductions from baseline
- Monitor changes in serum lipid levels
Use in Special Populations
- Pediatric use not established
- Geriatric use
- Hepatic impairment precautions
Overdose Effects
- Dose-dependent increase in hepatic adverse reactions
- Careful observation and supportive care
Therapeutic Class
- Farnesoid X Receptor Agonists
Storage Conditions
- Store below 30°C
- Dry place
- Protect from light
- Keep out of children’s reach