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Filspari
sparsentan
Black Box Warnings .
Appropriate Use
available only through restricted distribution program (Filspari REMS) due to risk of hepatotoxicity; prescribers, patients, and pharmacies must enroll at 1-833-513-1325 or www.filsparirems.com
Hepatotoxicity
AST/ALT incr. >3x ULN in up to 3.5% of patients, including cases confirmed with rechallenge; endothelin receptor antagonists have caused elevated AST/ALT, hepatotoxicity, and liver failure; monitor AST/ALT and bilirubin before tx start, then q3mo; interrupt tx and closely monitor if AST/ALT >3x ULN; avoid use if AST/ALT >3x ULN at baseline since monitoring for hepatotoxicity may be more difficult and patients may be at increased risk for serious hepatotoxicity
Embryo-Fetal Toxicity
contraindicated in pregnancy due to risk of fetal harm; obtain negative pregnancy test before tx start; avoid pregnancy by using effective contraception before tx start, during tx, and x2wk after D/C; D/C ASAP if pregnancy detected
Adult Dosing .
Dosage forms: TAB: 200 mg, 400 mg
Restricted Distribution in US
- [1-833-513-1325 or www.filsparirems.com for more info]
IgA nephropathy, primary
- [400 mg PO qd]
- Start: 200 mg PO qd x14 days; Info: for patients with disease progression risk; see pkg insert for dose adjustments based on AST/ALT; give before meals; consider retitrating from 200 mg PO qd if tx interrupted
focal segmental glomerulosclerosis
- [<50 kg]
- Dose: 400 mg PO qd; Start: 200 mg PO qd x14 days; Info: to decr. proteinuria in patients without nephrotic syndrome; see pkg insert for dose adjustments based on AST/ALT; give before meals; consider retitrating from 200 mg PO qd if tx interrupted
- [>50 kg]
- Dose: 800 mg PO qd; Start: 400 mg PO qd x14 days; Info: to decr. proteinuria in patients without nephrotic syndrome; see pkg insert for dose adjustments based on AST/ALT; give before meals; consider retitrating from 400 mg PO qd if tx interrupted
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: avoid use
Peds Dosing .
- Dosage forms: TAB: 200 mg, 400 mg
Restricted Distribution in US
- [1-833-513-1325 or www.filsparirems.com for more info]
focal segmental glomerulosclerosis
- [8 yo and older, <50 kg]
- Dose: 400 mg PO qd; Start: 200 mg PO qd x14 days; Info: to decr. proteinuria in patients without nephrotic syndrome; see pkg insert for dose adjustments based on AST/ALT; give before meals; consider retitrating from 200 mg PO qd if tx interrupted
- [8 yo and older, >50 kg]
- Dose: 800 mg PO qd; Start: 400 mg PO qd x14 days; Info: to decr. proteinuria in patients without nephrotic syndrome; see pkg insert for dose adjustments based on AST/ALT; give before meals; consider retitrating from 400 mg PO qd if tx interrupted
renal dosing
- [see below]
- eGFR >30: no adjustment; eGFR <30: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A, B, or C: avoid use