sacubitril + valsartan


Novartis Healthcare


Novartis Healthcare
Concise Prescribing Info
Per 50 mg FC tab Sacubitril 24.3 mg, valsartan 25.7 mg. Per 100 mg FC tab Sacubitril 48.6 mg, valsartan 51.4 mg. Per 200 mg FC tab Sacubitril 97.2 mg, valsartan 102.8 mg
Reduce the risk of CV mortality & morbidity in adult patients w/ systolic heart failure (NYHA class II-IV, LVEF ≤40%). In combination w/ other heart failure therapies (eg, β-blockers, diuretics & mineralocorticoid antagonists) as appropriate in place of an ACE inhibitor or angiotensin II receptor blocker (ARB).
Dosage/Direction for Use
Starting dose: 100 mg bid. Double the dose at 2-4 wk to the target dose of 200 mg bid as tolerated by the patient. Patient not currently taking an ACE inhibitor or an ARB Start at 50 mg bid & slow dose titration (doubling every 3-4 wk). Patient w/ systolic BP ≥100-110 mmHg, moderate (eGFR 30-60 mL/min/1.73 m2) & severe (eGFR <30 mL/min/1.73 m2) renal impairment, moderate hepatic impairment (Child-Pugh B) Starting dose: 50 mg bid.
May be taken with or without food.
Hypersensitivity to sacubitril or valsartan. Concomitant use w/ ACE inhibitors. History of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Aliskiren-containing medicinal products in patients w/ DM or renal impairment (eGFR <60 mL/min/1.73 m2). Severe hepatic impairment, biliary cirrhosis & cholestasis. Pregnancy (2nd & 3rd trimester).
Special Precautions
Dual blockade of renin-angiotensin-aldosterone system (RAAS). Not to be administered w/ an ACE inhibitor; aliskiren in type 2 diabetes; angiotensin receptor blocker. Avoid concomitant use w/ aliskiren in patients w/ renal impairment (eGFR <60 mL/min/1.73 m2). Monitor BP; serum K; renal function. Discontinue if hypotension; angioedema occurs. Correct Na- &/or vol-depletion before starting treatment. Severe renal impairment. Hyperkalemia. Drugs known to raise K levels eg, K-sparing diuretics, K supplements. Prior & known history of angioedema. Black patients. Patients w/ renal artery stenosis; NYHA functional class IV; moderate hepatic impairment (Child-Pugh B class) or w/ AST/ALT values <2x the upper limit of the normal range. Not suitable w/ B-type natriuretic peptide as biomarker of heart failure. Pregnancy & lactation.
Adverse Reactions
Hyperkalemia, hypotension, renal impairment. Cough, dizziness, diarrhea, anemia, fatigue, renal failure, hypokalemia, headache, syncope, asthenia, nausea, orthostatic hypotension, gastritis, vertigo, hypoglycemia.
Drug Interactions
Concomitant use w/ aliskiren, ACE inhibitors; angiotensin receptor blocker; OATP1B1 & OATP1B3 substrates (eg, statins), PDE5 inhibitors (eg, sildenafil), lithium, furosemide, metformin, K-sparing diuretics including mineral corticoid antagonists (eg, spironolactone, triamterene, amiloride) K supplements, or salt substitutes containing K, NSAIDs including selective cyclooxygenase-2 inhibitors, nitrates, inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampin, cyclosporine) or MPR2 (eg, ritonavir).
ATC Classification
C09DX04 - valsartan and sacubitril ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.
Entresto FC tab 50 mg
Entresto FC tab 100 mg
Entresto FC tab 200 mg
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