Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Seladelpar Gilead is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
The recommended dose of seladelpar is 10 mg once daily.
If a dose of seladelpar is missed, the patient should take the subsequent dose at the next scheduled time point. A double dose should not be taken to make up for the missed dose.
Limited data exists in elderly patients. No dose adjustment is required for elderly patients (see section 5.2).
No dose adjustment of seladelpar is required for patients with mild, moderate and severe renal impairment (see section 5.2).
Patients with end-stage renal disease on dialysis have not been studied. No dose recommendation can be provided for this group.
No dose adjustment is required in PBC patients with mild hepatic impairment (Child-Pugh A).
Safety and efficacy of seladelpar have not been established in PBC patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Consider discontinuing seladelpar if the patient progresses to moderate hepatic impairment. Use is not recommended in patients with severe hepatic impairment (see sections 4.4 and 5.2).
There is no relevant use of seladelpar in the paediatric population in the treatment of PBC.
Oral use. The capsules can be taken with or without food.
PBC patients who received 5 times the recommended dose or 20 times the recommended dose of seladelpar experienced an increase in liver transaminases, muscle pain, and/or elevations in creatine phosphokinase, which resolved upon seladelpar discontinuation. Dose dependent increases in serum creatinine were also observed.
There is no specific treatment for overdose with seladelpar. General supportive care of the patient is indicated, as appropriate. If indicated, elimination of unabsorbed medicinal product should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because seladelpar is highly bound to plasma proteins, haemodialysis should not be considered.
4 years.
Do not store above 30°C.
Seladelpar Gilead hard capsules are packaged in a high density polyethylene bottle closed with a polypropylene child resistant cap containing an induction seal. Each bottle contains 30 capsules.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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