Choliva 10mg Tablet

Uses

Primary biliary cirrhosis

Side Effects of Choliva 10mg Tablet

• Mouth or throat pain
• Fast, irregular, or pounding heartbeat
• Rash
• Dizziness
• Fainting
• Swelling of the hands, feet, ankles, or lower legs
• Joint or muscle pain
• Constipation

Quick Suggestions:

Maintaining a healthy lifestyle is crucial for individuals with Primary Biliary Cholangitis (PBC) to improve their well-being and manage or prevent certain associated symptoms. Upon diagnosis, your doctor might recommend the following:

1. Adopt a low-sodium diet if you experience fluid retention (edema or ascites).
2. Reduce fat consumption if you are overweight or have fatty liver.
3. Stay well-hydrated by drinking plenty of water.
4. Limit or avoid alcohol intake.
5. Minimize stress when possible.
6. Incorporate exercise into your routine, such as walking.
7. Quit smoking.
8. Implement a proper skincare regimen.
9. Schedule regular dental check-ups.

Indication

Obeticholic acid is indicated for primary biliary cholangitis (PBC). It can be used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA for at least 1 year. It can also be used as monotherapy in adults who are unable to tolerate UDCA.

Pharmacology

Obeticholic acid is an agonist of the farnesoid X receptor (FXR), a nuclear receptor found in the liver, intestine, kidney, and adipose tissue. FXR regulates various target genes involved in controlling bile acid synthesis and transport, lipid metabolism, and glucose homeostasis. FXR activation reduces de novo synthesis of bile acids in hepatocytes and increases the transport of bile acids out of hepatocytes, thereby reducing hepatocyte exposure to bile acid.

Dosage & Administration of Choliva 10mg Tablet

Adult Dose
For noncirrhotic or compensated Child-Pugh class A patients:

• Starting dose: 5 mg orally once daily
• Dosage titration: If an adequate response has not been achieved after 3 months at 5 mg/day, and obeticholic acid is being tolerated, increase the dose to 10 mg once daily. The maximum dosage is 10 mg/day.

For Child-Pugh class B or C patients, or those with a prior decompensation event:

• Starting dose: 5 mg orally once weekly
• Dosage titration: If an adequate response has not been achieved after 3 months at 5 mg once weekly, and obeticholic acid is being tolerated, increase the dose to 5 mg twice weekly (at least 3 days apart). The dosage may be titrated to 10 mg twice weekly (at least 3 days apart) based on response and tolerability.

Obeticholic acid may be taken with or without food. If taken concomitantly with a bile-acid binding resin, it should be separated by at least 4 hours.

Interaction

• Bile-acid binding resins may reduce the absorption, systemic exposure, and efficacy of obeticholic acid.
• Coadministration of warfarin and obeticholic acid has been shown to decrease the INR; monitor the INR and adjust the warfarin dose accordingly.
• Coadministration with CYP1A2 substrates (e.g., theophylline, tizanidine) may increase exposure to CYP1A2 substrates, so monitor these substrates with a narrow therapeutic index.
• Avoid concomitant use of inhibitors of the bile salt efflux pump (BSEP) (e.g., cyclosporine); BSEP inhibitors may exacerbate the accumulation of conjugated bile salts in the liver and result in clinical symptoms.

Contraindications

Obeticholic acid is contraindicated in cases of complete biliary obstruction.

Pregnancy & Lactation

The little human data on Obeticholic Acid consumption during pregnancy is insufficient to establish a drug-associated danger. There is no information on Obeticholic Acid's presence in human milk, its effects on breast-fed infants, or its impact on milk production.

Precaution & Warnings:

• Hepatic decompensation and failure, in some cases fatal, have been reported, particularly in patients with decompensated cirrhosis or Child-Pugh Class B or C hepatic impairment when obeticholic acid was dosed more frequently than the recommended starting dosage of 5 mg once weekly.
• Patients should be monitored for liver enzyme elevations and risks of hepatic decompensation.
• A dose-response relationship has been observed for liver-related adverse reactions, including jaundice, worsening ascites, and primary biliary cholangitis flare at doses exceeding 10 mg/day.
• The effect of obeticholic acid on lactation is unknown, and it is unclear if it is distributed in human breast milk.
• Consider the benefits of breastfeeding and the mother's clinical need for the drug along with any potential adverse effects on the breastfed infant.

Storage Conditions

Keep at 15°C to 30°C in a dry, light-protected location. Keep out of children's reach.