tic impairment (Child-Pugh Class B): Initiate therapy with sacubitril 24 mg/valsartan 26 mg PO twice daily. Double the dose every 2—4 weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg PO twice daily, as tolerated.
Severe hepatic impairment: Use not recommended.
Renal Impairment
eGFR >/= 30 mL/min/1.73 m2: No dosage adjustment needed.
eGFR < 30 mL/min/1.73 m2: Initiate therapy with sacubitril 24 mg/valsartan 26 mg PO twice daily. Double the dose every 2—4 weeks to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg PO twice daily, as tolerated.
Hemodialysis
Due to high protein binding, sacubitril; valsartan is unlikely to be removed by hemodialysis.
ADMINISTRATION
Oral Administration
Oral Solid Formulations
Administer tablets twice daily, with or without food.
STORAGE
Entresto:
- Protect from moisture
- Store at 77 degrees F; excursions permitted to 59-86 degrees F
- Store in original container
CONTRAINDICATIONS / PRECAUTIONS
General Information
Sacubitril; valsartan is contraindicated in patients with hypersensitivity to any component of the product.
ACE-inhibitor induced angioedema, angioedema, Black patients
Sacubitril; valsartan is contraindicated in patients with a history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema. Angioedema was reported during clinical trials of sacubitril; valsartan. Black patients and patients with a prior history of angioedema may be at increased risk of angioedema with sacubitril; valsartan.
Hypotension, hypovolemia
Use sacubitril; valsartan with caution in patients with hypovolemia and in patients who exhibit signs of hypotension. Sacubitril; valsartan lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system including patients who are volume or salt depleted (e.g., those treated with diuretics) are at an increased risk of developing hypotension. Correct volume depletion prior to initiating of therapy.
Renal artery stenosis, renal failure
Sacubitril; valsartan may decrease renal function in patients whose renal function depends upon the activity of the renin-angiotensin-aldosterone system (e.g., patients with severe congestive heart failure). Treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and reduce the dose or interrupt sacubitril; valsartan in patients who develop a clinically significant decrease in renal function. Similar to other drugs that affect the renin-angiotensin-aldosterone system, sacubitril; valsartan may increase blood urea and serum creatinine concentrations in patients with bilateral or unilateral renal artery stenosis. Monitor renal function in patients with renal artery stenosis.
Diabetes mellitus, hyperkalemia, renal impairment
Sacubitril; valsartan therapy may result in hyperkalemia and should be used cautiously in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes mellitus, hypoaldosteronism, or a high potassium diet. Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia. Dosage reduction or interruption of sacubitril; valsartan th |
