FXR 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 | Beacon pharmaceuticals plc |
| Also available as |
Indications
- Treatment of primary biliary cholangitis (PBC) in adult patients without cirrhosis
- Treatment of PBC in adult patients with compensated cirrhosis without evidence of portal hypertension
- Monotherapy in patients unable to tolerate ursodeoxycholic acid (UDCA)
Mode of Action
- Obeticholic acid is an agonist for Farnesoid X Receptor (FXR)
- Decreases intracellular hepatocyte concentrations of bile acids
- Increases transport of bile acids out of hepatocytes
- Limits the overall size of the circulating bile acid pool
- Promotes choleresis to reduce hepatic exposure to bile acids
Pharmacodynamics
- Increased concentrations of FGF-19
- Reduction in concentrations of cholic acid and chenodeoxycholic acid
Dosage & Administration
- Recommended dosage regimen for PBC patients without cirrhosis or with compensated cirrhosis
- Monitoring for biochemical response, tolerability, and progression of PBC
- Management of patients with intolerable pruritus on Obeticholic acid
Interactions
- Bile Acid Binding Resins
- Warfarin
- CYP1A2 Substrates with Narrow Therapeutic Index
- Inhibitors of Bile Salt Efflux Pump
Contraindications
- Decompensated cirrhosis
- Compensated cirrhosis with evidence of portal hypertension
- Complete biliary obstruction
Side Effects
- Pruritus
- Fatigue
- Stomach pain and discomfort
- Rash
- Arthralgia
- Oropharyngeal pain
- Dizziness
- Constipation
- Abnormal thyroid function
- Eczema
Pregnancy & Lactation
- Limited available human data on the use of obeticholic acid during pregnancy
- No information on the presence of obeticholic acid in human milk
- Consideration of the developmental and health benefits of breastfeeding
Precautions & Warnings
- Hepatic Decompensation and Failure in PBC Patients with Cirrhosis
- Severe Pruritus
- Reduction in HDL-C
Use in Special Populations
- Pediatric Use
- Geriatric Use
- Hepatic Impairment
Overdose Effects
- Dose-dependent increase in the incidence of hepatic adverse reactions
- Supportive care administered as appropriate in case of overdosage
Therapeutic Class
- Farnesoid X Receptor Agonists
Storage Conditions
- Store below 30°C in a dry place
- Protect from light
- Keep out of children’s reach