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Entresto Sprinkle
sacubitril/ valsartan
Black Box Warnings .
Fetal Toxicity
fetal/neonatal morbidity/mortality may occur when drugs that act directly on the renin-angiotensin system are used in pregnancy; D/C drug ASAP once pregnancy detected
Adult Dosing .
Adult dosing is currently unavailable or not applicable for this drug.
Peds Dosing .
- Dosage forms: PELLET: 6 mg/6 mg per cap, 15 mg/16 mg per cap
heart failure, symptomatic with left ventricular systolic dysfunction
- [patients converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, 13-18.9 kg]
- Dose: 24 mg/24 mg PO bid; Start: 12 mg/12 mg PO bid x2wk, then 18 mg/18 mg PO bid x2wk, then 24 mg/24 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, 19-25.9 kg]
- Dose: 30 mg/32 mg PO bid; Start: 18 mg/18 mg PO bid x2wk, then 24 mg/24 mg PO bid x2wk, then 30 mg/32 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, 26-33.9 kg]
- Dose: 45 mg/48 mg PO bid; Start: 24 mg/24 mg PO bid x2wk, then 30 mg/32 mg PO bid x2wk, then 45 mg/48 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, 34-49.9 kg]
- Dose: 60 mg/64 mg PO bid; Start: 30 mg/32 mg PO bid x2wk, then 45 mg/48 mg PO bid x2wk, then 60 mg/64 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from low dose ACE inhibitor or ARB tx, 1 yo and older, 13-18.9 kg]
- Dose: 24 mg/24 mg PO bid; Start: 6 mg/6 mg PO bid x2wk, then 12 mg/12 mg PO bid x2wk, then 18 mg/18 mg PO bid x2wk, then 24 mg/24 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from low dose ACE inhibitor or ARB tx, 1 yo and older, 19-25.9 kg]
- Dose: 30 mg/32 mg PO bid; Start: 9 mg/9 mg PO bid x2wk, then 18 mg/18 mg PO bid x2wk, then 24 mg/24 mg PO bid x2wk, then 30 mg/32 mg PO bid; Info: must open cap, but do not chew/crush pellet; may use oral suspension preparation from tab form for start dose; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from low dose ACE inhibitor or ARB tx, 1 yo and older, 26-33.9 kg]
- Dose: 45 mg/48 mg PO bid; Start: 12 mg/12 mg PO bid x2wk, then 24 mg/24 mg PO bid x2wk, then 30 mg/32 mg PO bid x2wk, then 45 mg/48 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients converting from low dose ACE inhibitor or ARB tx, 1 yo and older, 34-49.9 kg]
- Dose: 60 mg/64 mg PO bid; Start: 15 mg/16 mg PO bid x2wk, then 30 mg/32 mg PO bid x2wk, then 45 mg/48 mg PO bid x2wk, then 60 mg/64 mg PO bid; Info: must open cap, but do not chew/crush pellet; for patients converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [patients currently not receiving ACE inhibitor or ARB tx, 1 yo and older, 13-18.9 kg]
- Dose: 24 mg/24 mg PO bid; Start: 6 mg/6 mg PO bid x2wk, then 12 mg/12 mg PO bid x2wk, then 18 mg/18 mg PO bid x2wk, then 24 mg/24 mg PO bid; Info: must open cap, but do not chew/crush pellet
- [patients currently not receiving ACE inhibitor or ARB tx, 1 yo and older, 19-25.9 kg]
- Dose: 30 mg/32 mg PO bid; Start: 9 mg/9 mg PO bid x2wk, then 18 mg/18 mg PO bid x2wk, then 24 mg/24 mg PO bid x2wk, then 30 mg/32 mg PO bid; Info: must open cap, but do not chew/crush pellet; may use oral suspension preparation from tab form for start dose
- [patients currently not receiving ACE inhibitor or ARB tx, 1 yo and older, 26-33.9 kg]
- Dose: 45 mg/48 mg PO bid; Start: 12 mg/12 mg PO bid x2wk, then 24 mg/24 mg PO bid x2wk, then 30 mg/32 mg PO bid x2wk, then 45 mg/48 mg PO bid; Info: must open cap, but do not chew/crush pellet
- [patients currently not receiving ACE inhibitor or ARB tx, 1 yo and older, 34-49.9 kg]
- Dose: 60 mg/64 mg PO bid; Start: 15 mg/16 mg PO bid x2wk, then 30 mg/32 mg PO bid x2wk, then 45 mg/48 mg PO bid x2wk, then 60 mg/64 mg PO bid; Info: must open cap, but do not chew/crush pellet
renal dosing
- [patients converting from usual dose ACE inhibitor or ARB tx]
- eGFR <30: decr. usual start dose by 50%, then incr. dose q2wk following usual dose escalation
- HD/PD: not defined
- [all other patients]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [patients converting from usual dose ACE inhibitor or ARB tx]
- Child-Pugh Class B: decr. usual start dose by 50%, then incr. dose q2wk following usual dose escalation; Child-Pugh Class C: avoid use
- [all other patients]
- Child-Pugh Class C: avoid use
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- angioedema history, ACE inhibitor-associated
- angioedema history, ARB-associated
- angioedema, hereditary
- pregnancy
- breastfeeding
- hepatic impairment, Child-Pugh Class C
- caution: hepatic impairment, Child-Pugh Class B (patient converting from usual dose ACE inhibitor or ARB tx)
- caution: renal artery stenosis
- caution: renal impairment
- caution: volume depletion
- caution: hyponatremia
- caution: hyperkalemia risk
- caution: hypotension
- caution: post-MI
Drug Interactions .
Overview
sacubitril
neprilysin inhibitor
- OATP1B1 inhibitor, weak
- OATP1B3 inhibitor, weak
- angioedema
- vasodilator agent
valsartan
ARB
- MRP2 substrate
- OATP1B1 substrate
- OATP1B3 substrate
- angiotensin II Type 1 antagonist
- antihypertensive agent
- decreases renal perfusion/fxn
- hyperkalemia
- hypoglycemic effects
Contraindicated
- aliskiren
- benazepril
- captopril
- enalapril
- enalaprilat
- fosinopril
- grazoprevir
- isocarboxazid
- lisinopril
- moexipril
- perindopril
- quinapril
- ramipril
- sparsentan
- trandolapril
Avoid/Use Alternative
- aldesleukin
- amikacin
- amiloride
- angiotensin II
- aripiprazole lauroxil
- atrasentan
- azilsartan medoxomil
- brincidofovir
- candesartan cilexetil
- celecoxib
- clofarabine
- cyclosporine
- diclofenac
- diclofenac topical
- diflunisal
- drospirenone (contraceptive)
- drospirenone (hormone replacement)
- elagolix
- eplerenone
- etodolac
- fenoprofen
- flurbiprofen
- heparin
- ibuprofen
- indomethacin
- irbesartan
- ketoprofen
- ketorolac
- landiolol
- lofexidine
- losartan
- meclofenamate
- mefenamic acid
- meloxicam
- nabumetone
- naproxen
- nilotinib
- olmesartan medoxomil
- oxaprozin
- piroxicam
- potassium acid phosphate
- potassium bicarbonate
- potassium chloride
- potassium citrate
- potassium iodide
- potassium phosphate
- spironolactone
- sulindac
- tacrolimus
- telmisartan
- tolmetin
- tolvaptan
- triamterene
- trimethoprim
- valsartan
- voclosporin
- zavegepant
Monitor/Modify Tx
- abiraterone acetate
- acebutolol
- acyclovir
- adefovir dipivoxil
- albuterol
- albuterol inhaled
- alfentanil
- alfuzosin
- almotriptan
- alprostadil intracavernous
- amantadine
- amifostine
- amikacin inhaled
- amitriptyline
- amlodipine
- amoxapine
- amphetamine
- amphotericin
- anthrax immune globulin
- apomorphine
- apraclonidine ophthalmic
- aprocitentan
- arformoterol inhaled
- aripiprazole bimonthly injection
- aripiprazole monthly injection
- aripiprazole oral
- armodafinil
- articaine
- asciminib
- asenapine
- aspirin
- atenolol
- atogepant
- atomoxetine
- atorvastatin
- atropine ophthalmic
- auranofin
- avanafil
- axitinib
- balsalazide
- benzphetamine
- berberine
- betamethasone
- betaxolol
- betaxolol ophthalmic
- bethanechol
- bevacizumab
- bexagliflozin
- bismuth subsalicylate
- bisoprolol
- bortezomib
- botulism immune globulin
- brexpiprazole
- brigatinib
- brimonidine ophthalmic
- brimonidine topical
- bromocriptine
- budesonide
- bumetanide
- bupivacaine
- bupivacaine liposomal
- buprenorphine
- bupropion
- butorphanol
- cabergoline
- cabozantinib
- caffeine
- caffeine citrate
- canagliflozin
- cannabis
- capecitabine
- carboplatin
- carfilzomib
- cariprazine
- carteolol ophthalmic
- carvedilol
- chloroprocaine
- chlorothiazide
- chlorpromazine
- chlorthalidone
- cidofovir
- cilostazol
- cisplatin
- clevidipine
- clindamycin
- clomipramine
- clonidine
- clozapine
- cocaine
- codeine
- coenzyme Q-10
- colistimethate
- copanlisib
- copper histidinate
- corticotropin
- cortisone
- creatine
- cyclophosphamide
- cytomegalovirus immune globulin
- danazol
- dapagliflozin
- darbepoetin alfa
- darolutamide
- decitabine
- deferasirox
- deferoxamine
- deflazacort
- denileukin diftitox
- desflurane
- desipramine
- desmopressin
- desvenlafaxine
- dexamethasone
- dexmedetomidine
- dexmedetomidine injection
- dexmethylphenidate
- dextroamphetamine
- diazoxide
- diethylpropion
- dihydrocodeine
- dihydroergotamine
- diltiazem
- dinutuximab
- dipyridamole
- doxapram
- doxazosin
- doxepin
- dronabinol
- droxidopa
- duloxetine
- eletriptan
- eluxadoline
- empagliflozin
- entacapone
- entrectinib
- ephedra
- ephedrine injection
- ephedrine oral
- epinephrine
- epinephrine inhaled
- epoetin alfa
- epoprostenol
- eptinezumab
- erenumab
- ergotamine
- ertugliflozin
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethanol injection
- ethinyl estradiol (contraceptive)
- etrasimod
- etripamil nasal
- felodipine
- fenfluramine
- fenoldopam
- fentanyl
- ferumoxytol
- finerenone
- fingolimod
- flaxseed
- flibanserin
- flucytosine
- fludrocortisone
- fluphenazine
- formoterol inhaled
- foscarnet
- foslevodopa
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- furosemide
- gadobenate dimeglumine
- galcanezumab
- ganciclovir
- garlic
- gentamicin
- gilteritinib
- glimepiride
- glipizide
- glyburide
- guanfacine
- haloperidol
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocodone
- hydrocortisone
- hydromorphone
- hydroxocobalamin IV
- ibrutinib
- ibuprofen lysine
- ifosfamide
- iloperidone
- iloprost
- imipramine
- immune globulin
- indapamide
- insulin
- iodixanol
- iohexol
- iomeprol
- iopamidol
- iopromide
- iothalamate meglumine
- ioversol
- iron sucrose
- isoflurane
- isosorbide dinitrate
- isosorbide mononitrate
- isradipine
- ketamine
- labetalol
- lanreotide
- leflunomide
- lenvatinib
- levalbuterol inhaled
- levobunolol ophthalmic
- levodopa
- levomilnacipran
- levorphanol
- levothyroxine
- licorice
- lidocaine
- liothyronine
- lisdexamfetamine
- lithium
- lomustine
- lopinavir/ritonavir
- lorlatinib
- loxapine
- lubiprostone
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- luspatercept
- lutetium Lu 177 vipivotide tetraxetan
- magnesium citrate
- magnesium salicylate
- magnesium sulfate
- maraviroc
- meperidine
- mepivacaine
- mesalamine
- mesalamine rectal
- methadone
- methamphetamine
- methohexital
- methotrexate
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylene blue injection
- methylergonovine
- methylphenidate
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- metoprolol
- midazolam
- midodrine
- milnacipran
- milrinone
- milsaperidone
- minoxidil
- mirabegron
- mirtazapine
- mitomycin
- modafinil
- molindone
- momelotinib
- morphine
- nadolol
- nalbuphine
- naphazoline ophthalmic
- naratriptan
- nateglinide
- nattokinase
- naxitamab
- nebivolol
- neomycin
- niacin (vitamin B3)
- nicardipine
- nifedipine
- nimodipine
- niraparib
- nisoldipine
- nitric oxide
- nitrite
- nitroglycerin
- nitroprusside
- nortriptyline
- nusinersen
- obinutuzumab
- olanzapine
- oliceridine
- olodaterol inhaled
- olsalazine
- opicapone
- opium
- osilodrostat
- oxaliplatin
- oxazepam
- oxycodone
- oxymetazoline nasal
- oxymetazoline ophthalmic
- oxymetazoline topical
- oxymorphone
- oxytocin
- ozanimod
- paliperidone
- palopegteriparatide
- pamidronate
- paromomycin
- pazopanib
- pemetrexed
- penicillamine
- pentamidine
- pentazocine
- pentobarbital
- pentostatin
- pentoxifylline
- perphenazine
- pexidartinib
- phendimetrazine
- phenelzine
- phenobarbital
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- pindolol
- pitavastatin
- plazomicin
- polyethylene glycol
- polyethylene glycol/electrolytes
- polymyxin B
- ponatinib
- ponesimod
- pralsetinib
- pramipexole
- pravastatin
- prazosin
- prednisolone
- prednisone
- pretomanid
- procarbazine
- prochlorperazine
- promethazine
- propafenone
- propofol
- propranolol
- protriptyline
- pseudoephedrine
- quetiapine
- ramucirumab
- rasagiline
- regorafenib
- remifentanil
- remimazolam
- repaglinide
- Rho(D) immune globulin
- rifampin
- rimegepant
- riociguat
- ripretinib
- risperidone
- ritonavir
- rituximab
- rizatriptan
- ropeginterferon alfa-2b
- ropinirole
- ropivacaine
- rotigotine transdermal
- sacubitril
- safinamide
- salmeterol inhaled
- salsalate
- selegiline
- selegiline transdermal
- selpercatinib
- sevoflurane
- sildenafil
- silodosin
- siponimod
- sirolimus
- sitagliptin
- sodium ferric gluconate complex
- sorafenib
- sotagliflozin
- sotalol
- streptomycin
- streptozocin
- sufentanil
- sulfate bowel prep
- sumatriptan
- sunitinib
- tadalafil
- tagraxofusp
- tamsulosin
- tapentadol
- taurine
- telavancin
- temsirolimus
- tenofovir alafenamide
- tenofovir disoproxil
- terazosin
- terbutaline
- teriflunomide
- testosterone
- tetrahydrozoline ophthalmic
- thalidomide
- thioridazine
- thiothixene
- thyroid
- timolol
- timolol ophthalmic
- tiopronin
- tivozanib
- tizanidine
- tobramycin
- tobramycin inhaled
- tolcapone
- torsemide
- tramadol
- trametinib
- tranylcypromine
- trazodone
- treprostinil
- triamcinolone
- trifluoperazine
- trimipramine
- ubrogepant
- vaccinia immune globulin
- vadadustat
- valacyclovir
- valganciclovir
- vamorolone
- vancomycin
- vandetanib
- vardenafil
- vasopressin
- venlafaxine
- verapamil
- vericiguat
- vilanterol inhaled
- viloxazine
- vosoritide
- willow bark
- yohimbe
- ziprasidone
- ziv-aflibercept
- zoledronic acid
- zolmitriptan
Caution Advised
- bosentan
- eltrombopag
- glecaprevir
- pregabalin
- verteporfin
- voxilaprevir
Adverse Reactions .
Serious Reactions
- hypersensitivity reaction
- anaphylaxis
- angioedema
- bullous dermatitis
- hypotension, severe
- hyperkalemia
- renal impairment
- renal failure
- neutropenia
- thrombocytopenia
- hepatitis
- rhabdomyolysis
Common Reactions
- hypotension
- Cr incr.
- hyperkalemia
- cough
- Hgb decr.
- Hct decr.
- dizziness
- renal failure
- hypotension, orthostatic
Safety/Monitoring .
Monitoring Parameters
BUN/Cr at baseline, then periodically; electrolytes; BP
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; if must use, monitor amniotic fluid and fetus closely; risk of fetal and neonatal harm, including intrauterine growth restriction, oligohydramnios, renal failure, and death, in 2nd and 3rd trimesters based on human data and drug's mechanism of action
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 sacubitril: minimal; CYP450: minimal; for valsartan: liver; CYP450: 2C9 substrate
Excretion: for sacubitril: urine 52-68%, feces 37-48%; Half-life: 11.5h; for valsartan: feces 86%, urine 13% (10% unchanged); Half-life: 9.9h
Subclass: Angiotensin Receptor Blockers (ARBs) ; Neprilysin Inhibitors
Mechanism of Action
for sacubitril: prodrug converted to active metabolite, which inhibits neprilysin, decreasing natriuretic peptide degradation; for valsartan: selectively antagonizes angiotensin II AT1 receptors
Formulary .
No Formulary Selected
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