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Entresto
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 .
Dosage forms: TAB: 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg
heart failure, chronic
- [pts converting from usual dose ACE inhibitor or ARB tx]
- Dose: 97 mg/103 mg PO bid; Start: 49 mg/51 mg PO bid x2-4wk, then 97 mg/103 mg PO bid; Info: for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts converting from low dose ACE inhibitor or ARB tx]
- Dose: 97 mg/103 mg PO bid; Start: 24 mg/26 mg PO bid x2-4wk, then 49 mg/51 mg PO bid x2-4wk, then 97 mg/103 mg PO bid; Info: for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts currently not receiving ACE inhibitor or ARB tx]
- Dose: 97 mg/103 mg PO bid; Start: 24 mg/26 mg PO bid x2-4wk, then 49 mg/51 mg PO bid x2-4wk, then 97 mg/103 mg PO bid
renal dosing
- [pts converting from usual dose ACE inhibitor or ARB tx]
- eGFR <30: start 24 mg/26 mg bid, then incr. dose q2-4wk following usual dose escalation
- HD/PD: not defined
- [all other pts]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [pts converting from usual dose ACE inhibitor or ARB tx]
- Child-Pugh Class B: start 24 mg/26 mg bid, then incr. dose q2-4wk following usual dose escalation; Child-Pugh Class C: avoid use
- [all other pts]
- Child-Pugh Class C: avoid use
Peds Dosing .
- Dosage forms: TAB: 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg
heart failure, symptomatic w/ left ventricular systolic dysfxn
- [pts converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, <40 kg]
- Dose: 3.1 mg/kg/dose PO bid; Start: 1.6 mg/kg/dose PO bid x2wk, then 2.3 mg/kg/dose PO bid x2wk, then 3.1 mg/kg/dose PO bid; Info: see pkg insert for suspension preparation; mg/kg doses are of combined amount of sacubitril and valsartan; for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, 40-50 kg]
- Dose: 72 mg/78 mg PO bid; Start: 24 mg/26 mg PO bid x2wk, then 49 mg/51 mg PO bid x2wk, then 72 mg/78 mg PO bid; Info: for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts converting from usual dose ACE inhibitor or ARB tx, 1 yo and older, >50 kg]
- Dose: 97 mg/103 mg PO bid; Start: 49 mg/51 mg PO bid x2wk, then 72 mg/78 mg PO bid x2wk, then 97 mg/103 mg PO bid; Info: for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts converting from low dose ACE inhibitor or ARB tx, 1 yo and older, <40 kg]
- Dose: 3.1 mg/kg/dose PO bid; Start: 0.8 mg/kg/dose PO bid x2wk, then 1.6 mg/kg/dose PO bid x2wk, then 2.3 mg/kg/dose PO bid x2wk, then 3.1 mg/kg/dose PO bid; Info: see pkg insert for suspension preparation; mg/kg doses are of combined amount of sacubitril and valsartan; for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts converting from low dose ACE inhibitor or ARB tx, 1 yo and older, 40-50 kg]
- Dose: 72 mg/78 mg PO bid; Start: 0.8 mg/kg/dose PO bid x2wk, then 24 mg/26 mg PO bid x2wk, then 49 mg/51 mg PO bid x2wk, then 72 mg/78 mg PO bid; Info: see pkg insert for suspension preparation for start dose; mg/kg doses are of combined amount of sacubitril and valsartan; for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts converting from low dose ACE inhibitor or ARB tx, 1 yo and older, >50 kg]
- Dose: 97 mg/103 mg PO bid; Start: 24 mg/26 mg PO bid x2wk, then 49 mg/51 mg PO bid x2wk, then 72 mg/78 mg PO bid x2wk, then 97 mg/103 mg PO bid; Info: for pts converting from ACE inhibitor, start 36h after ACE inhibitor tx D/C
- [pts currently not receiving ACE inhibitor or ARB tx, 1 yo and older, <40 kg]
- Dose: 3.1 mg/kg/dose PO bid; Start: 0.8 mg/kg/dose PO bid x2wk, then 1.6 mg/kg/dose PO bid x2wk, then 2.3 mg/kg/dose PO bid x2wk, then 3.1 mg/kg/dose PO bid; Info: see pkg insert for suspension preparation; mg/kg doses are of combined amount of sacubitril and valsartan
- [pts currently not receiving ACE inhibitor or ARB tx, 1 yo and older, 40-50 kg]
- Dose: 72 mg/78 mg PO bid; Start: 0.8 mg/kg/dose PO bid x2wk, then 24 mg/26 mg PO bid x2wk, then 49 mg/51 mg PO bid x2wk, then 72 mg/78 mg PO bid; Info: see pkg insert for suspension preparation for start dose; mg/kg doses are of combined amount of sacubitril and valsartan
- [pts currently not receiving ACE inhibitor or ARB tx, 1 yo and older, >50 kg]
- Dose: 97 mg/103 mg PO bid; Start: 24 mg/26 mg PO bid x2wk, then 49 mg/51 mg PO bid x2wk, then 72 mg/78 mg PO bid x2wk, then 97 mg/103 mg PO bid
renal dosing
- [pts converting from usual dose ACE inhibitor or ARB tx, <50 kg]
- eGFR <30: start 0.8 mg/kg/dose bid, then incr. dose q2wk following usual dose escalation
- HD/PD: not defined
- [pts converting from usual dose ACE inhibitor or ARB tx, >50 kg]
- eGFR <30: start 24 mg/26 mg bid, then incr. dose q2wk following usual dose escalation
- HD/PD: not defined
- [all other pts]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [pts converting from usual dose ACE inhibitor or ARB tx, <50 kg]
- Child-Pugh Class B: start 0.8 mg/kg/dose bid, then incr. dose q2wk following usual dose escalation; Child-Pugh Class C: avoid use
- [pts converting from usual dose ACE inhibitor or ARB tx, >50 kg]
- Child-Pugh Class B: start 24 mg/26 mg bid, then incr. dose q2wk following usual dose escalation; Child-Pugh Class C: avoid use
- [all other pts]
- Child-Pugh Class C: avoid use