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Sacubitril / valsartan

Class
Antihypertensives
Subclass
Neprilysin inhibitor / angiotensin receptor blocker combination
Substance name
Sacubitril / valsartan
Brand names
Entresto®
Contains
Valsartan
Sacubitril
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
HF
•
Start at: 49/51 mg PO BID for 2-4 weeks
•
Maintenance: 97/103 mg PO BID
Start at half the usual starting dose in patients not currently taking or previously on low doses an ACEi or an ARB.
HFpEF • Off-label
•
Start at: 49/51 mg PO BID
•
Maintenance: 97/103 mg PO BID
Hypertension in patients with HFpEF • Off-label
•
Start at: 24/26 mg PO BID
•
Maintenance: 97/103 mg PO BID
Indications for use
Labeled indications
Adults
•
Treatment of HF
Off-label indications
Adults
•
Treatment of HFpEF
•
Treatment of hypertension in patients with HFpEF
Safety risks
Boxed warnings
Fetal toxicity
Contraindications
Hypersensitivity to sacubitril/valsartan or its components
Hereditary angioedema
History of angioedema related to previous ACEis or ARBs
Concomitant use of aliskiren in patients with diabetes
Warnings and precautions
Angioedema
•
Use extreme caution in Black patients, as they are at higher risk of angioedema than non-Black patients.
Hypotension
•
Use caution in patients volume or salt depletion and/or receiving high doses of diuretics.
Increased serum lithium levels
•
Use caution in patients taking lithium. Monitor lithium levels.
Increased serum potassium
•
Use caution in patients with risk factors for hyperkalemia, such as severe renal impairment, diabetes, hypoaldosteronism, on potassium-sparing diuretics or a high potassium diet.
Oliguria, renal failure
•
Use caution in patients with renal dysfunction, severe congestive HF, or comcomitant use of NSAIDs. Closely monitor serum creatinine. Down-titrate or interrupt sacubitril/valsartan if a clinically significant decrease in renal function occurs.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor renal function.
eGFR < 30 mL/min/1.73 m²
•
Start at dose of 24/26 mg BID. Monitor renal function. Monitor for hyperkalemia.
Renal replacement therapy
Any modality
•
Dose as in eGFR < 30 mL/min/1.73 m². Monitor renal function. Monitor for hyperkalemia.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Start at dose of 24/26 mg BID.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Do not use. Evidence of fetal harm in humans. Discontinue sacubitril/valsartan when pregnancy is detected.
•
Use of RAAS inhibitors during the second and third trimesters can cause reduced fetal renal function leading to anuria and renal failure, oligohydramnios, fetal lung hypoplasia, and skeletal deformations, including skull hypoplasia, hypotension, and death.
Breastfeeding
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Hypotension, ↑ serum creatinine, ↑ serum potassium
Common 1-10%
•
Anemia, renal failure, cough, dizziness
Unknown frequency
•
Anaphylaxis, angioedema, itching, skin rash
Interactions
Drug(s)
Check Interactions
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