Seladelpar Dosage

Medically reviewed by Drugs.com. Last updated on Oct 29, 2024.

Usual Adult Dose for Primary Biliary Cholangitis

10 mg orally once a day

Comments:

• Accelerated approval was based on the reduction of alkaline phosphatase levels. Improvement of survival or prevention of liver decompensation has not been demonstrated.
• Use should be avoided in patients with complete biliary obstruction. If complete obstruction is suspected, treatment should be interrupted, and the patient should receive treatment as clinically indicated.

Use: For the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults who have had inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

• Mild Liver Dysfunction (Child-Pugh A): No adjustment recommended
• Moderate and Severe Liver Dysfunction (Child-Pugh B or C): Consider discontinuing treatment in any patient that progresses to moderate or severe hepatic dysfunction.
• The safety and efficacy of this drug in patients with decompensated cirrhosis have not been established. The use of this drug is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). Monitor patients with cirrhosis for evidence of decompensation.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer this drug with or without food.
• Administer 4 hours before or 4 hours after taking bile acid sequestrants, or at a greater interval if possible.

Storage requirements:

• Store capsules at 20C to 25C (68F to 77F), with excursions permitted to 15C to 30C (59F to 86F).

Monitoring:

• Laboratory liver tests before and during treatment
• Patients with cirrhosis, for signs of decompensation
• Bone health parameters according to current standards of care

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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