Sparsentan

Source: UK SPC (eMC) for Filspari 200 mg film-coated tablets, §4.2 (https://www.medicines.org.uk/emc/product/100610/smpc). The UK regimen above is for IgA nephropathy. TOLERABILITY-DRIVEN ADJUSTMENT: if patients experience tolerability issues (systolic blood pressure 100 mmHg or less, diastolic blood pressure 60 mmHg or less, worsening oedema, or hyperkalaemia), adjustment of concomitant medicinal products is recommended first, followed by temporary DOWN-TITRATION or discontinuation of sparsentan. When resuming treatment after interruption, repeating the initial dosing schedule may be considered. Interruption of treatment, preceded or not by dose reduction, may be considered based on persisting hypotension or changes in liver function. Sparsentan should be used with caution in patients with systolic BP of 100 mmHg or less and should NOT be uptitrated in those patients. If hypotension persists despite elimination or reduction of other antihypertensive medicines, reduce to the initial starting dose until blood pressure stabilises, and consider dose interruption if symptoms of hypotension persist after 2 weeks of dose reduction. MISSED DOSE: skip the missed dose and take the next dose at the regularly scheduled time; do not take double or extra doses. ELDERLY: no dose adjustment is recommended, but treatment should be initiated at 200 mg once daily for 14 days and the increase to 400 mg once daily performed WITH CAUTION based on tolerability (hypotension is reported more frequently in elderly patients). HEPATIC IMPAIRMENT: no dose adjustment required in mild or moderate impairment (Child-Pugh A or B), but there is limited clinical experience with moderate impairment so use with caution; NOT recommended in severe impairment (Child-Pugh C, not studied). Sparsentan should NOT be initiated in patients with AST/ALT greater than 2 times ULN (limited clinical experience). LIVER MONITORING: elevations in ALT or AST of at least 3 times ULN have been observed; the US label requires measuring serum aminotransferases and total bilirubin prior to initiation and every 3 months during treatment, avoiding initiation if aminotransferases exceed 3 times ULN. US §2.6 dosage adjustment for aminotransferase elevations greater than 3 times ULN: if greater than 3 and up to 8 times ULN, confirm with a repeat measure and if confirmed interrupt treatment, monitoring aminotransferases and bilirubin at least weekly (and INR as needed) until levels return to pretreatment values and the patient is asymptomatic — do NOT resume if ALT/AST is greater than 3 times ULN with total bilirubin greater than 2 times ULN or INR greater than 1.5, or if ALT/AST is greater than 3 times ULN with symptoms (fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia greater than 5%), or if ALT/AST is greater than 5 times ULN for more than 2 weeks; if treatment is resumed, restart at 50% of the recommended dose once daily with reassessment of hepatic enzymes and bilirubin within 3 days. If greater than 8 times ULN, stop treatment PERMANENTLY if no other cause is found. FLUID RETENTION: if it develops, treat with diuretics or increase the dose of existing diuretics BEFORE modifying the sparsentan dose; diuretics can be considered before starting sparsentan in patients with evidence of fluid retention. Sparsentan has not been studied in heart failure — use with caution. PAEDIATRIC: the UK SPC states that safety and efficacy in children below 18 years with IgAN have not yet been established and no data are available, so paedDose is null. The US label separately approves FSGS dosing in patients aged 8 years and older using FIXED WEIGHT-BANDED doses, not a per-kg dose: weighing MORE than 50 kg — start 400 mg once daily for 14 days then increase to 800 mg once daily as tolerated; weighing 50 kg OR LESS — start 200 mg once daily for 14 days then increase to 400 mg once daily as tolerated. US safety and effectiveness in paediatric patients under 8 years with FSGS, and in paediatric patients with IgAN, have not been established. Verify any under-18 use against a children's formulary. US ADMINISTRATION DETAIL (not in the UK text retrieved): swallow tablets whole with water prior to the morning or evening meal, taking the dose before the same meal each day; for patients unable to swallow whole tablets the tablet may be crushed and suspended in half a cup of water and administered immediately (do not store the suspension; administration with other liquids has not been studied and is not recommended). NOTE ON SOURCES: eMC §4.5 was NOT captured in this bundle — the interaction entries below come from UK §4.3/§4.4 plus §7 of the US label (FILSPARI, Travere Therapeutics, label date 2026-04-09) and must be verified against the full SPC. §4.4, §4.8 and the US §5/§6/§7 sections were truncated at the source-fetch limit.