Entresto

Entresto

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sacubitril valsartan Na salt complex
Indications/Uses
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 other angiotensin II receptor blocker.
Dosage/Direction for Use
Target dose: 200 mg bid. Recommended starting dose: 100 mg bid. Double the dose every 2-4 wk to the target dose. Patients not currently taking ACE inhibitor or angiotensin II receptor blocker 50 mg bid. Severe renal impairment (eGFR <30 mL/min/1.73 m2), moderate hepatic impairment (Child-Pugh B classification) Initially 50 mg bid.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ ACE inhibitors & aliskiren in patients w/ type 2 diabetes. Do not administer until 36 hr after discontinuation of ACE inhibitor therapy. Known history of angioedema related to previous ACE inhibitor or angiotensin II receptor blocker therapy; hereditary angioedema. Pregnancy.
Special Precautions
Severe renal (eGFR <30 mL/min/1.73 m2) & hepatic (Child-Pugh C classification) impairment. Concomitant use w/ angiotensin II receptor blockers & ACE inhibitors, K-sparing diuretics & K supplements; aliskiren in type 2 diabetic patients. Do not initiate until 36 hr after taking the last dose of ACE inhibitor therapy, & when Entresto is discontinued, ACE inhibitor therapy must not be initiated until 36 hr after the last dose. Hypotension. Correct Na &/or vol depletion prior to initiation of treatment. Monitoring of serum K in patients w/ severe renal impairment, DM, hypoaldosteronism or receiving high K diet. Immediately discontinue use, & appropriate therapy & monitoring should be provided if angioedema occurs. Patients w/ prior or known history of angioedema related to previous ACE inhibitor or angiotensin II receptor blocker therapy or hereditary angioedema; Black patients. Renal artery stenosis; monitor renal function. Women of childbearing potential should use contraception during therapy & 1 wk after last dose. Pregnancy & lactation. Ped patients <18 yr.
Adverse Reactions
Hyperkalemia; hypotension; renal impairment. Hypokalemia; dizziness, headache; vertigo; syncope, orthostatic hypotension; cough; diarrhoea, nausea; renal failure; fatigue, asthenia.
Drug Interactions
Increased risk of angioedema w/ ACE inhibitors. Aliskiren, & angiotensin II receptor blockers due to angiotensin II receptor blocking activity of Entresto. May increase the systemic exposure of OATP1B1 & OATP1B3 substrates eg, statins. Increase Cmax & AUC of atorvastatin. Greater BP reduction w/ sildenafil. Increased serum K & serum creatinine w/ K-sparing diuretics (eg, triamterene, amiloride), mineralocorticoid antagonists (eg, spironolactone, eplerenone), K supplements or salt substitutes containing K. Increased risk of worsening of renal function w/ NSAIDs including COX-2 inhibitors. May increase serum conc & toxicity of lithium. May increase systemic exposure w/ rifampin, cyclosporine or 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.
Presentation/Packing
Form
Entresto FC tab 100 mg
Packing/Price
2 × 14's
Form
Entresto FC tab 200 mg
Packing/Price
8 × 7's
Form
Entresto FC tab 50 mg
Packing/Price
2 × 14's
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