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Inpefa
sotagliflozin
Adult Dosing .
Dosage forms: TAB: 200 mg, 400 mg
heart failure-associated risk reduction
- [patients with heart failure]
- Dose: 200-400 mg PO qd; Start: 200 mg PO qd, then may incr. dose to 400 mg PO qd after at least 2wk; Info: start tx when hemodynamically stable in patients with decompensated heart failure; give <1h before first meal of the day; do not cut/crush/chew tab; consider holding tx at least 3 days before surgery
- [patients with diabetes mellitus type 2, CKD, or other cardiovascular risk factors]
- Dose: 200-400 mg PO qd; Start: 200 mg PO qd, then may incr. dose to 400 mg PO qd after at least 2wk; Info: give <1h before first meal of the day; do not cut/crush/chew tab; consider holding tx at least 3 days before surgery
renal dosing
- [see below]
- eGFR >90: no adjustment; eGFR 25-90: not defined, caution advised; eGFR <25: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class 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, Child-Pugh Class B-C
- pregnancy 2nd trimester
- pregnancy 3rd trimester
- breastfeeding
- volume depletion
- diabetic ketoacidosis
- caution: elderly patients
- caution: renal impairment
- caution: pregnancy 1st trimester
- caution: hypotension
- caution: ketoacidosis risk
- caution: pancreatic insulin deficiency
- caution: fasting, prolonged
- caution: alcohol abuse
- caution: genital mycotic infection history
Drug Interactions .
Overview
sotagliflozin
SGLT1/SGLT2 inhibitor
- UGT1A9 substrate
- P-gp inhibitor, weak
- fluid/electrolyte loss
- hypoglycemic effects
- hypotensive effects
Contraindicated
- colchicine
Avoid/Use Alternative
- aldesleukin
- apixaban
- bexagliflozin
- canagliflozin
- dabigatran
- dapagliflozin
- empagliflozin
- ensartinib
- ertugliflozin
- lofexidine
- neratinib
- pralsetinib
- relugolix
- repotrectinib
- rivaroxaban
- sirolimus albumin-bound
- sotagliflozin
- topotecan
- venetoclax
Monitor/Modify Tx
- acebutolol
- afatinib
- alfentanil
- alfuzosin
- aliskiren
- alogliptin
- alprostadil intracavernous
- amantadine
- amifostine
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- apomorphine
- apraclonidine ophthalmic
- aprocitentan
- aripiprazole bimonthly injection
- aripiprazole lauroxil
- aripiprazole monthly injection
- aripiprazole oral
- articaine
- asenapine
- atenolol
- atorvastatin
- avanafil
- azilsartan medoxomil
- benazepril
- berberine
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bisoprolol
- bortezomib
- brexpiprazole
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- bumetanide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- butorphanol
- cabergoline
- candesartan cilexetil
- cannabis
- captopril
- cariprazine
- carteolol ophthalmic
- carvedilol
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cilostazol
- clevidipine
- clofarabine
- clomipramine
- clonidine
- clozapine
- codeine
- coenzyme Q-10
- colesevelam
- cyclosporine
- denileukin diftitox
- desflurane
- desipramine
- dexmedetomidine
- dexmedetomidine injection
- digoxin
- dihydrocodeine
- diltiazem
- dinutuximab
- dipyridamole
- doxazosin
- doxepin
- dronabinol
- duloxetine
- edoxaban
- enalapril
- enalaprilat
- enfortumab vedotin
- entacapone
- entrectinib
- eplerenone
- epoprostenol
- esmolol
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethanol injection
- etripamil nasal
- everolimus
- exenatide
- felodipine
- fenoldopam
- fentanyl
- ferumoxytol
- flaxseed
- flibanserin
- fluphenazine
- fosinopril
- foslevodopa
- furosemide
- garlic
- gilteritinib
- glimepiride
- glipizide
- glyburide
- guanfacine
- haloperidol
- hydralazine
- hydrochlorothiazide
- hydrocodone
- hydromorphone
- iloperidone
- iloprost
- imipramine
- indapamide
- insulin
- irbesartan
- iron sucrose
- isocarboxazid
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- labetalol
- landiolol
- levobunolol ophthalmic
- levodopa
- levorphanol
- lidocaine
- linagliptin
- liraglutide
- lisinopril
- lithium
- lixisenatide
- losartan
- loxapine
- lubiprostone
- lumateperone
- lurasidone
- magnesium sulfate
- maraviroc
- mavorixafor
- meperidine
- mepivacaine
- methadone
- methohexital
- methyldopa
- methylene blue injection
- metolazone
- metoprolol
- midazolam
- milrinone
- milsaperidone
- minoxidil
- mirtazapine
- moexipril
- molindone
- morphine
- nadolol
- nalbuphine
- nateglinide
- nattokinase
- naxitamab
- nebivolol
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nimodipine
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- obinutuzumab
- olanzapine
- oliceridine
- olmesartan medoxomil
- opicapone
- opium
- oxazepam
- oxycodone
- oxymorphone
- paliperidone
- palopegteriparatide
- pentamidine
- pentazocine
- pentobarbital
- perindopril
- perphenazine
- phenelzine
- phenobarbital
- phenoxybenzamine
- phentolamine
- pindolol
- pioglitazone
- pramipexole
- pramlintide
- prazosin
- procarbazine
- prochlorperazine
- promethazine
- propafenone
- propofol
- propranolol
- protriptyline
- quetiapine
- quinapril
- quinidine (antiarrhythmic)
- ramipril
- ranolazine
- rasagiline
- remifentanil
- remimazolam
- repaglinide
- riociguat
- risperidone
- ropinirole
- ropivacaine
- rosiglitazone
- rotigotine transdermal
- sacubitril
- safinamide
- saxagliptin
- selegiline
- selegiline transdermal
- semaglutide
- sevoflurane
- sildenafil
- silodosin
- sirolimus
- sitagliptin
- sodium ferric gluconate complex
- sotalol
- sparsentan
- spironolactone
- sufentanil
- tacrolimus
- tadalafil
- tagraxofusp
- talazoparib
- tamsulosin
- tapentadol
- taurine
- telmisartan
- tenofovir alafenamide
- tenofovir disoproxil
- terazosin
- thalidomide
- thioridazine
- thiothixene
- timolol
- timolol ophthalmic
- tizanidine
- tolcapone
- torsemide
- tramadol
- trandolapril
- tranylcypromine
- trazodone
- treprostinil
- triamterene
- trifluoperazine
- trimipramine
- ubrogepant
- valsartan
- vardenafil
- verapamil
- vosoritide
- yohimbe
- ziprasidone
Caution Advised
- darolutamide
- fexinidazole
- glecaprevir
- naldemedine
- nevirapine
- pibrentasvir
- rifampin
- ritonavir
Adverse Reactions .
Serious Reactions
- acute kidney injury
- ketoacidosis
- urosepsis
- pyelonephritis
- Fournier gangrene
- hypotension
Common Reactions
- UTI
- volume depletion
- diarrhea
- hypoglycemia
- dizziness
- genital mycotic infection
Safety/Monitoring .
Monitoring Parameters
volume status at baseline; eGFR at baseline, then as clinically indicated; BP
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use in 2nd and 3rd trimester, weigh risk/benefit in 1st trimester; inadequate human data available; risk of adverse effects on renal development and maturation in 2nd and 3rd trimesters based on animal data at 5x MRHD and drug's mechanism of action; no known risk of teratogenicity in 1st trimester based on animal data at up to 40x MRHD; risk of teratogenicity and fetal abnormalities in 1st trimester based on animal data at 161x MRHD
Lactation
Clinical Summary
avoid use while breastfeeding; no human data available, though possible risk of adverse effects on infant renal development and maturation based on drug's mechanism of action; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for sotagliflozin: glucuronidation; CYP: 3A4 substrate; UGT: 1A9 (primary) substrate
Excretion: for sotagliflozin: urine 57%, feces 37% (primarily unchanged); Half-life: 5-10h
Subclass: SGLT1 Inhibitors, Cardiovascular ; SGLT2 Inhibitors, Cardiovascular
Mechanism of Action
for sotagliflozin: inhibits sodium-glucose cotransporter 1 (SGLT1), reducing glucose and sodium intestinal absorption; inhibits sodium-glucose cotransporter 2 (SGLT2), reducing glucose and sodium renal reabsorption; may reduce cardiac preload and afterload and downregulate sympathetic activity
Formulary .
No Formulary Selected
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