Active Ingredient: Sparsentan
Sparsentan is indicated for the treatment of adults with primary immunoglobulin A nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 200 milligrams sparsentan, once daily, over the duration of 14 days. Afterwards, oral, 400 milligrams sparsentan, once daily.
Sparsentan treatment should be initiated at a dose of 200 mg once daily for 14 days and then increased to a maintenance dose of 400 mg once daily, dependent upon tolerability.
If patients experience tolerability issues (systolic blood pressure [SBP] ≤100 mmHg, diastolic blood pressure ≤60 mmHg, worsening edema, or hyperkalaemia), adjustment of concomitant medicinal products, followed by temporary down–titration or discontinuation of sparsentan is recommended.
When resuming treatment with sparsentan after interruption, repeating the initial dosing schedule may be considered. Interruption of treatment preceded, or not by dose reduction of sparsentan, may be considered based on persisting hypotension or changes in liver function.
If a dose is missed, the dose should be skipped and the next dose is to be taken at the regularly scheduled time. Double or extra doses should not be taken.
No dose adjustment is recommended in elderly patient. In elderly patients sparsentan treatment should be initiated at a dose of 200 mg once daily for 14 days. The increase to a maintenance dose of 400 mg once daily should be performed with caution, based on tolerability.
Sparsentan can be taken with or without food.
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