Uperio

Heart failure (NYHA II-IV) in patient w/ reduced ejection fraction (LVEF ≤40%).

100 mg twice daily can be doubled up to 200 mg twice daily every 2-4 wk. Patient not currently taking ACE inhibitor or angiotensin II receptor blocker; w/ systolic BP ≥100-110 mmHg; w/ moderate hepatic impairment or AST/ALT >2x ULN, moderate to severe renal impairment Recommended starting dose: 50 mg twice daily.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ ACE inhibitors, aliskiren in patients w/ type II diabetes or renal impairment (eGFR <60 mL/min/1.73 m²). History of angioedema related to previous ACE inhibitor or ARB therapy. Hereditary or idiopathic angioedema. Severe hepatic impairment, biliary cirrhosis & cholestasis. Pregnancy.

Administer until 36 hr after last dose of ACE inhibitor. Co-administration w/ aliskiren in patients w/ type II diabetes & renal impairment (eGFR <60 mL/min/1.73 m²); w/ angiotensin receptor blocker. Routinely monitor BP when initiating therapy or during dose titration. Temporary down-titration/discontinue treatment if hypotension & angioedema occurs. Correct Na &/or vol depletion prior to treatment. Not recommended for ESRD. Hyperkalemia, renal artery stenosis, B-type natriuretic peptide. Immediately discontinue if angioedema occurs. Monitor serum K in patients w/ risk factors eg, severe renal impairment, DM, hypoaldosteronism or receiving a high K diet or on mineralocorticoid antagonist; renal function. Black patients have increased susceptibility to develop angioedema. BNP is not a suitable biomarker of heart failure in Uperio-treated patients. Patients w/ NYHA functional class IV. May affect ability to drive & use machines. Renal artery stenosis. Hepatic impairment. Females of childbearing potential must use highly effective contraception during & for 1 wk after last dose of Uperio. Discontinue Uperio as soon as pregnancy occur. Not recommended during breastfeeding. Childn <18 yr.

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

Increased risk of angioedema w/ ACE inhibitors. Higher frequency of adverse events eg, hypotension, hyperkalemia & decreased renal function w/ aliskiren. Not to be co-administered w/ angiotensin receptor blocker. Increased C_max of atorvastatin. Greater BP reduction w/ sildenafil or another PDE-5 inhibitor. 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. Reversible increases in serum lithium. Reduce C_max & AUC of furosemide & metformin. May increase systemic exposure to sacubitrilat or valsartan w/ inhibitors of OATP1B1, OATP1B3, OAT3 (eg, rifampin, cyclosporine), OAT1 (eg, tenofovir, cidofovir) or MRP2 (eg, ritonavir).

Angiotensin II Antagonists

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

K