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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
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 .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- hepatic impairment
- ALT or AST >3x ULN
- breastfeeding
- pregnancy
- caution: patients of childbearing potential
- caution: renal impairment, chronic
- caution: renal artery stenosis
- caution: CHF, severe
- caution: volume depletion
- caution: hypotension risk
Drug Interactions .
Overview
sparsentan
endothelin antagonist; angiotensin II antagonist
- CYP3A4 substrate
- CYP2B6 inducer, weak
- CYP2C9 inducer, weak
- CYP2C19 inducer, weak
- P-gp inhibitor, weak
- BCRP inhibitor
- angiotensin II Type 1 antagonist
- gastric pH sensitive
- hyperkalemia
- hypotensive effects
- nephrotoxicity
Contraindicated
- aliskiren
- ambrisentan
- aprocitentan
- atrasentan
- azilsartan medoxomil
- bosentan
- candesartan cilexetil
- cidofovir
- colchicine
- irbesartan
- losartan
- macitentan
- olmesartan medoxomil
- sparsentan
- telmisartan
- valsartan
Avoid/Use Alternative
- adagrasib
- aldesleukin
- alpelisib
- amikacin
- amikacin inhaled
- amiloride
- angiotensin II
- apalutamide
- apixaban
- atazanavir
- benazepril
- bumetanide
- butalbital
- captopril
- carbamazepine
- ceritinib
- chloramphenicol
- cimetidine
- cladribine oral
- clarithromycin
- clofarabine
- cobicistat
- dabigatran
- dexlansoprazole
- enalapril
- enalaprilat
- encorafenib
- ensartinib
- enzalutamide
- esomeprazole
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- famotidine
- foscarnet
- fosinopril
- fosphenytoin
- ganciclovir
- gentamicin
- idelalisib
- itraconazole
- ivosidenib
- ketoconazole
- lansoprazole
- levoketoconazole
- lisinopril
- lofexidine
- lonafarnib
- lopinavir/ritonavir
- lumacaftor/ivacaftor
- mannitol
- mavacamten
- meperidine
- methotrexate
- mifepristone
- mitotane
- moexipril
- nefazodone
- nelfinavir
- neratinib
- nizatidine
- norgestimate (contraceptive)
- omeprazole
- oxaliplatin
- pantoprazole
- pazopanib
- pentamidine
- pentobarbital
- perindopril
- phenobarbital
- phenytoin
- polymyxin B
- posaconazole
- potassium chloride
- potassium phosphate
- pralsetinib
- primidone
- quinapril
- rabeprazole
- ramipril
- relugolix
- repotrectinib
- ribociclib
- rifabutin
- rifampin
- ritonavir
- rivaroxaban
- sirolimus albumin-bound
- St. John's wort
- streptomycin
- streptozocin
- tacrolimus
- tenofovir disoproxil
- tipranavir
- tobramycin
- tobramycin inhaled
- topotecan
- trandolapril
- tucatinib
- valganciclovir
- venetoclax
- vonoprazan
- voriconazole
Monitor/Modify Tx
- acebutolol
- acyclovir
- adefovir dipivoxil
- afatinib
- alectinib
- alfentanil
- alfuzosin
- allopurinol
- alprostadil intracavernous
- aluminum hydroxide
- amantadine
- amifostine
- amitriptyline
- amlodipine
- amoxapine
- amphotericin
- anthrax immune globulin
- apomorphine
- apraclonidine ophthalmic
- aprepitant
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- articaine
- asenapine
- aspirin
- atenolol
- atorvastatin
- auranofin
- avacopan
- avanafil
- axitinib
- balsalazide
- berberine
- berotralstat
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bevacizumab
- bexagliflozin
- bisoprolol
- bleomycin
- bortezomib
- botulism immune globulin
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- butorphanol
- cabergoline
- cabozantinib
- calcium carbonate
- canagliflozin
- cannabis
- capecitabine
- carboplatin
- carfilzomib
- cariprazine
- carteolol ophthalmic
- carvedilol
- celecoxib
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cilostazol
- ciprofloxacin
- cisplatin
- clevidipine
- clindamycin
- clofazimine
- clomipramine
- clonidine
- clozapine
- codeine
- coenzyme Q-10
- colistimethate
- conivaptan
- copper histidinate
- creatine
- crizotinib
- cyclophosphamide
- cyclosporine
- cytomegalovirus immune globulin
- danazol
- dapagliflozin
- darunavir
- decitabine
- deferasirox
- deferoxamine
- denileukin diftitox
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- diclofenac
- diclofenac topical
- diflunisal
- digoxin
- dihydrocodeine
- diltiazem
- dinutuximab
- dipyridamole
- doxazosin
- doxepin
- dronabinol
- dronedarone
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- duloxetine
- duvelisib
- edoxaban
- empagliflozin
- enfortumab vedotin
- entacapone
- entrectinib
- eplerenone
- epoprostenol
- ertugliflozin
- erythromycin
- esmolol
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethanol injection
- etodolac
- etripamil nasal
- everolimus
- fedratinib
- felodipine
- fenoldopam
- fenoprofen
- fentanyl
- ferumoxytol
- finerenone
- flaxseed
- flibanserin
- fluconazole
- flucytosine
- fluphenazine
- flurbiprofen
- fluvastatin
- fosamprenavir
- foslevodopa
- furosemide
- garlic
- gilteritinib
- grapefruit
- guanfacine
- haloperidol
- heparin
- hydralazine
- hydrochlorothiazide
- hydrocodone
- hydromorphone
- hydroxocobalamin IV
- ibuprofen
- ibuprofen lysine
- ifosfamide
- iloperidone
- iloprost
- imatinib
- imipramine
- immune globulin
- indapamide
- indomethacin
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- irinotecan
- iron sucrose
- isavuconazonium
- isocarboxazid
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- ketoprofen
- ketorolac
- labetalol
- landiolol
- lapatinib
- lefamulin
- lenacapavir
- lenvatinib
- letermovir
- levobunolol ophthalmic
- levodopa
- levorphanol
- lidocaine
- lifileucel
- lithium
- lomustine
- loxapine
- lubiprostone
- lumateperone
- lurasidone
- lutetium Lu 177 vipivotide tetraxetan
- magnesium carbonate
- magnesium citrate
- magnesium hydroxide
- magnesium oxide
- magnesium salicylate
- magnesium sulfate
- maraviroc
- mavorixafor
- meclofenamate
- mefenamic acid
- meloxicam
- mepivacaine
- mesalamine
- mesalamine rectal
- methadone
- methohexital
- methyldopa
- methylene blue injection
- metolazone
- metoprolol
- midazolam
- milrinone
- milsaperidone
- minoxidil
- mirtazapine
- mitomycin
- mitoxantrone
- molindone
- morphine
- nabumetone
- nadolol
- nalbuphine
- naproxen
- nattokinase
- naxitamab
- nebivolol
- neomycin
- netupitant
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nilotinib
- nimodipine
- nirogacestat
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- nusinersen
- obinutuzumab
- olanzapine
- oliceridine
- olsalazine
- opicapone
- opium
- oxaprozin
- oxazepam
- oxycodone
- oxymorphone
- paliperidone
- palopegteriparatide
- pamidronate
- paromomycin
- pemetrexed
- penicillamine
- pentazocine
- pentostatin
- perphenazine
- phenelzine
- phenoxybenzamine
- phentolamine
- pindolol
- piroxicam
- pitavastatin
- plazomicin
- polyethylene glycol
- polyethylene glycol/electrolytes
- potassium acid phosphate
- potassium bicarbonate
- potassium citrate
- potassium iodide
- pramipexole
- pravastatin
- prazosin
- procarbazine
- prochlorperazine
- promethazine
- propafenone
- propofol
- propranolol
- protriptyline
- quetiapine
- quinidine (antiarrhythmic)
- ramucirumab
- ranolazine
- rasagiline
- remifentanil
- remimazolam
- Rho(D) immune globulin
- rilzabrutinib
- riociguat
- risperidone
- rituximab
- ropeginterferon alfa-2b
- ropinirole
- ropivacaine
- rosuvastatin
- rotigotine transdermal
- sacubitril
- safinamide
- salsalate
- selegiline
- selegiline transdermal
- sevoflurane
- sildenafil
- silodosin
- simvastatin
- sirolimus
- sitagliptin
- sodium bicarbonate
- sodium citrate
- sodium ferric gluconate complex
- sodium zirconium cyclosilicate
- sotagliflozin
- sotalol
- spironolactone
- succinylcholine
- sufentanil
- sulfate bowel prep
- sulindac
- sunitinib
- tadalafil
- tagraxofusp
- talazoparib
- tamsulosin
- tapentadol
- taurine
- telavancin
- temsirolimus
- tenofovir alafenamide
- terazosin
- thalidomide
- thioridazine
- thiothixene
- timolol
- timolol ophthalmic
- tiopronin
- tivozanib
- tizanidine
- tolcapone
- tolmetin
- tolvaptan
- torsemide
- tramadol
- tranylcypromine
- trazodone
- treprostinil
- triamterene
- trifluoperazine
- trimethoprim
- trimipramine
- ubrogepant
- vaccinia immune globulin
- valacyclovir
- vancomycin
- vardenafil
- verapamil
- voclosporin
- vosoritide
- warfarin
- willow bark
- yohimbe
- ziprasidone
- ziv-aflibercept
- zoledronic acid
- zonisamide
Caution Advised
- bupropion
- carisoprodol
- darolutamide
- glecaprevir
- naldemedine
- nevirapine
- pibrentasvir
- seladelpar
- sulfasalazine
- velpatasvir
Adverse Reactions .
Serious Reactions
- acute kidney injury
- hypotension
- hyperkalemia
Common Reactions
- hyperkalemia
- hypotension
- edema, peripheral
- dizziness
- anemia
- acute kidney injury
- ALT or AST elevated
- eGFR decr.
Safety/Monitoring .
Monitoring Parameters
AST/ALT, bilirubin before tx start, then q3mo; pregnancy test before tx start; Cr; K
Pregnancy/Lactation .
Pregnancy
Clinical Summary
contraindicated during pregnancy; inadequate human data available; risk of fetal harm, including craniofacial malformations, skeletal abnormalities, decr. fetal wt, and embryo-fetal death based on animal data at 10x MRHD
Individuals of Reproductive Potential
obtain negative pregnancy test before tx start; avoid pregnancy by using effective contraception before tx start, during tx, and x2wk after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid use while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for sparsentan: liver; CYP450: 3A (primary) substrate
Excretion: for sparsentan: feces 80% (9% unchanged), urine 2% (minimally unchanged); Half-life: 9.6h
Subclass: Endothelin and Angiotensin II Receptor Antagonists
Mechanism of Action
for sparsentan: selectively antagonizes endothelin type A receptor and angiotensin II type 1 receptor
Formulary .
No Formulary Selected
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