®
Entresto
(Sacubitril /Valsartan)
Objectives
01
02
03
Indication and the
Class
Mechanism of
Action
Dosing and Dose
Adjustment
04
05
Side Effects and
Contraindications
Monitoring
Parameters
06
Patient
Education
About Entersto ®
Indication
o It was approved by the US Food and Drug Administration (FDA) in
2015 to reduce the risk of death and hospitalization in heart failure
patients' class II-IV
Class of the Drug
o Angiotensin receptor neprilysin inhibitor (ARNI)
Dosing
Adult dosing:
Patients who previously taking a moderate to high dose ACE inhibitor or
angiotensin II receptor blocker:
Initial: Sacubitril 49 mg/valsartan 51 mg BID. Double the dose as tolerated after 2 to 4
weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg BID
o Patients who previously taking low doses of an ACE inhibitor or ARB or
not currently taking an ACE inhibitor or an ARB:
Initial: Sacubitril 24 mg/valsartan 26 mg BID. Double the dose as tolerated every 2 to 4
weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg BID
o
Dose Adjustment
Adult dose adjustment:
Renal Impairment:
o eGFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
o eGFR <30 mL/minute/1.73 m2: Initial: Sacubitril 24 mg/valsartan 26 mg twice
daily.
Hepatic Impairment:
o Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
o Moderate impairment (Child-Pugh class B): Initial: Sacubitril 24 mg/valsartan
26 mg twice daily.
o Severe impairment (Child-Pugh class C): Use not recommended
Dosing
Pediatrics dosing:
Patients previously taking a moderate to high dose ACE inhibitor or ARB:
40 to <50 kg: Sacubitril 24 mg/valsartan 26 mg BID; titrate dose in 2 weeks to sacubitril 49
mg/valsartan 51 mg BID, then 2 weeks later to sacubitril 72 mg/valsartan 78 mg BID
≥50 kg: Sacubitril 49 mg/valsartan 51 mg BID; titrate dose in 2 weeks to sacubitril 72
mg/valsartan 78 mg BID, then 2 weeks later to sacubitril 97 mg/valsartan 103 mg BID
Patients not currently taking an ACE inhibitor or an ARB or previously taking low doses of
an ACE inhibitor or ARB:
>50 kg: Sacubitril 24 mg/valsartan 26 mg BID; titrate dose in 2 weeks to sacubitril 49
mg/valsartan 51 mg BID, then 2 weeks later to sacubitril 72 mg/valsartan 78 mg (three 24/26 mg
tablets) BID, then 2 weeks later to sacubitril 97 mg/valsartan 103 mg BID.
Dose Adjustment
Pediatric dose adjustment:
Renal Impairment:
o Mild to moderate impairment (eGFR ≥30 mL/minute/1.73 m2): No dosage adjustment
necessary.
o Severe impairment (eGFR <30 mL/minute/1.73 m2): Initial: Reduce the usual starting dose by
50%, then follow the recommended dose escalation to titrate dose
Hepatic Impairment:
o Mild impairment: No dosage adjustment necessary
o Moderate impairment: Reduce the usual starting dose by 50%, then follow the recommended
dose escalation to titrate dose
o Severe impairment: Use not recommended
Side Effects
Hyperkalemia
Angioedema
Increased Serum
Creatinine
Hypotension
Cough
Dizziness
Contraindications
Hypersensitivity
to the drug
components
History of
angioedema
Concomitant use
of other ReninAngiotensinAldosterone
System (RAAS)
Medications
Pregnancy and
breast feeding
Monitoring
Parameters
o
o
o
o
BP
Serum creatinine level
Potassium level
Sign & symptoms of angioedema
Black Box Warning
Fetal toxicity: Drugs that act directly on the renin-angiotensin system
can cause injury and death to the developing fetus.
Patient Education
You should not take
this drug within 36
hrs. of switching
from ACEI drugs
Take with or without
food. Stored at room
temperature
01
02
A liquid (suspension)
can be made if you
cannot swallow pills
03
04
Take a missed dose as soon as
remember, but if it close to the
time for your next dose, skip it
(DONOT take 2 doses at the
same dose
References
1. Lexicomp: Evidence-Based Drug Treatment
Information.
2. HIGHLIGHTS OF PRESCRIBING INFORMATION.
Accessdata.fda.gov.
Thank you
Do you have any questions?