nd examination should be performed to assess the intra-amniotic environment, and fetal testing may be appropriate, based on week of gestation. Patients and physicians should be aware that oligohydramnios may not appear until after the fetus has sustained irreversible injury. If oligohydramnios is observed, consider alternative drug treatment. Closely observe neonates and infants with histories of in utero exposure to sacubitril; valsartan for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, blood pressure and renal perfusion support may be required, as well as exchange transfusion or dialysis to reverse hypotension and/or support decreased renal function.
DEA CLASS
Rx
DESCRIPTION
Oral product for heart failure containing a neprilysin inhibitor (sacubitril) and an angiotensin II receptor blocker (valsartan)
Usually administered in conjunction with other heart failure therapies in place of an ACE inhibitor or other angiotensin II receptor blocker (ARB)
Not for concomitant use with ACE inhibitor or patients with history of angioedema related to previous ACE inhibitor or ARB therapy
COMMON BRAND NAMES
Entresto
HOW SUPPLIED
Entresto Oral Tab: 24-26mg, 49-51mg, 97-103mg
DOSAGE & INDICATIONS
To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II—IV) and reduced ejection fraction.
NOTE: Sacubitril; valsartan is usually administered in conjunction with other heart failure therapies in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin II receptor blocker (ARB).
Oral dosage
Adults
Sacubitril 49 mg/valsartan 51 mg tablet PO twice daily for patients who were being treated with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB). After 2—4 weeks, increase the dose to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg PO twice daily, as tolerated. For patients not taking an ACE inhibitor or ARB or taking low doses of these agents, initiate therapy with sacubitril 24 mg/valsartan 26 mg PO twice daily. Double the dose every 2—4 weeks, as tolerated, to the target maintenance dose of sacubitril 97 mg/valsartan 103 mg PO twice daily. NOTE: Sacubitril/valsartan is contraindicated with concomitant use of an ACE inhibitor. If switching from an ACE inhibitor to sacubitril/valsartan, allow 36 hours between administration of the 2 drugs. In a double-blind trial comparing enalapril and sacubitril; valsartan in patients with Class II-IV heart failure and an ejection fraction of </= 40%, sacubitril; valsartan was superior to enalapril in reducing the risk of the combined endpoint of cardiovascular death or hospitalization for heart failure (HR 0.80, 95% CI 0.73—0.87, p < 0.001). Sacubitril; valsartan also reduced the risk of hospitalization for heart failure by 21% (p < 0.001) and significantly decreased the symptoms and physical limitations of heart failure (p = 0.001).
MAXIMUM DOSAGE
Adults
Sacubitril 97 mg PO and valsartan 103 mg PO twice daily.
Geriatric
Sacubitril 97 mg PO and valsartan 103 mg PO twice daily.
Adolescents
Safety and efficacy have not been established.
Children
Safety and efficacy have not been established.
Infants
Not indicated.
Neonates
Not indicated.
DOSING CONSIDERATIONS
Hepatic Impairment
Mild hepatic impairment: No dosage adjustment needed.
Moderate hepa |
