Entresto

Per 50 mg FC tab 24.3 mg sacubitril & 25.7 mg valsartan (as sacubitril valsartan Na salt complex). Per 100 mg FC tab 48.6 mg sacubitril & 51.4 mg valsartan (as sacubitril valsartan Na salt complex). Per 200 mg FC tab 97.2 mg sacubitril & 102.8 mg valsartan (as sacubitril valsartan Na salt complex)

Treatment of symptomatic chronic heart failure (NYHA class II-IV) in adult w/ reduced ejection fraction to reduce the risk of CV death & hospitalization due to heart failure.

Starting dose: 100 mg bd. Double the dose at 2-4 wk to the target dose of 200 mg bd, as tolerated by the patient. Patient w/ moderate renal impairment (eGFR 30-60 mL/min/1.73 m²) or severe renal impairment (eGFR <30 mL/min/1.73 m²) Initially 50 mg bd. Patient w/ moderate hepatic impairment (Child-Pugh B) or w/ AST/ALT >2 times ULN Initially 50 mg bd.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ ACE inhibitors. Must not be administered until 36 hr after discontinuing ACE inhibitor therapy. Known history of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Concomitant use w/ aliskiren-containing medicinal products in patients w/ DM or renal impairment (eGFR <60 mL/min/1.73 m²). Severe hepatic impairment, biliary cirrhosis & cholestasis. 2nd & 3rd trimester of pregnancy.

Dual blockade of the renin-angiotensin-aldosterone system through combined use of ACE inhibitors, ARBs or aliskiren. Do not co-administer w/ an ACE inhibitor or an ARB. Not recommended w/ direct renin inhibitors eg, aliskiren. Reports of symptomatic hypotension & angioedema. May be associated w/ decreased renal function & increased risk of hyperkalaemia. Monitor serum K especially in patients who have risk factors for hyperkalaemia. Do not initiate treatment in patients w/ serum K level >5.4 mmol/L or w/ systolic BP <100 mmHg. May increase blood urea & serum creatinine levels in patients w/ bilateral or unilateral renal artery stenosis. Caution in patients w/ NYHA class IV; renal impairment; moderate hepatic impairment (Child-Pugh B) or w/ AST/ALT >2 times ULN. Not recommended in patients w/ ESRD. B-type natriuretic peptide is not a suitable biomarker of heart failure in patients treated w/ Entresto. Minor influence on the ability to drive & use machines. Not recommended during the 1st trimester of pregnancy or during breast-feeding. Safety & efficacy in childn & adolescents <18 yr have not been established.

Hyperkalaemia; hypotension; renal impairment. Anaemia; hypokalaemia, hypoglycaemia; dizziness, headache, syncope; vertigo; orthostatic hypotension; cough; diarrhoea, nausea, gastritis; renal failure; fatigue, asthenia.

Increased risk of angioedema w/ ACE inhibitors. Potentially higher frequency of adverse events w/ aliskiren or another ARB. Increased systemic exposure of OATP1B1 & OATP1B3 substrates eg, statins. Greater BP reduction w/ sildenafil or other PDE5 inhibitor. Increased serum K & creatinine w/ K-sparing diuretics (triamterene, amiloride), mineralocorticoid antagonists (eg, spironolactone, eplerenone), K supplements, salt substitutes containing K or other agents (eg, heparin). Increased risk of worsening of renal function w/ NSAIDs in elderly patients, vol-depleted patients (including those on diuretic therapy), or patients w/ compromised renal function. Potential reversible increases in serum lithium conc & toxicity. Reduced C_max & AUC of furosemide & metformin. Increased systemic exposure of sacubitril active metabolite & valsartan w/ inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampicin, ciclosporin), OAT1 (eg, tenofovir, cidofovir) or MRP2 (eg, ritonavir).

Other Cardiovascular Drugs

C09DX04 - valsartan and sacubitril ; Belongs to the class of angiotensin II receptor blockers (ARBs), other combinations. Used in the treatment of cardiovascular disease.

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