SACUBITRIL Drug Interactions: What You Need to Know

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Drug Interactions (FDA Label)

INTERACTIONS

Avoid concomitant use with aliskiren in patients with estimated glomerular filtration rate (eGFR) less than 60. ( 7.1 )
Potassium-sparing diuretics: May lead to increased serum potassium. ( 7.2 )
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): May lead to increased risk of renal impairment. ( 7.3 )
Lithium: Increased risk of lithium toxicity. ( 7.4 )

7.1 Dual Blockade of the Renin-Angiotensin-Aldosterone System Concomitant use of sacubitril and valsartan tablets with an ACE inhibitor is contraindicated because of the increased risk of angioedema [see Contraindications ( 4 )] . Avoid use of sacubitril and valsartan tablets with an ARB, because sacubitril and valsartan tablets contains the angiotensin II receptor blocker valsartan. The concomitant use of sacubitril and valsartan tablets with aliskiren is contraindicated in patients with diabetes [see Contraindications ( 4 )] . Avoid use with aliskiren in patients with renal impairment (eGFR less than 60 mL/min/1.73 m²).

7.2 Potassium-Sparing Diuretics As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions ( 5.5 )].

7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Including Selective

Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with sacubitril and valsartan tablets may result in worsening of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically.

7.4 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use with sacubitril and valsartan tablets.

Contraindications

Sacubitril and valsartan tablets are contraindicated:

in patients with hypersensitivity to any component
in patients with a history of angioedema related to previous ACE inhibitor or ARB therapy [see Warnings and Precautions ( 5.2 )]
with concomitant use of ACE inhibitors. Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions (7.1)]
with concomitant use of aliskiren in patients with diabetes [see Drug Interactions (7.1 )]
Hypersensitivity to any component. ( 4 )
History of angioedema related to previous ACEi or ARB therapy. ( 4 )
Concomitant use with ACE inhibitors. ( 4 , 7.1 )
Concomitant use with aliskiren in patients with diabetes. ( 4 , 7.1 )

Related Warnings

AND PRECAUTIONS Observe for signs and symptoms of angioedema and hypotension. ( 5.2 , 5.3 ) Monitor renal function and potassium in susceptible patients. ( 5.4 , 5.5 )

5.1 Fetal Toxicity Sacubitril and valsartan tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, consider alternative drug treatment and discontinue sacubitril and valsartan tablets. However, if there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system, and if the drug is considered lifesaving for the mother, advise a pregnant woman of the potential risk to the fetus [see Use in Specific Populations ( 8.1 )] .

5.2 Angioedema Sacubitril and valsartan tablets may cause angioedema [see Adverse Reactions ( 6.1 )] . If angioedema occurs, discontinue sacubitril and valsartan tablets immediately, provide appropriate therapy, and monitor for airway compromise. Sacubitril and valsartan tablets must not be re-administered. In cases of confirmed angioedema where swelling has been confined to the face and lips, the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1,000 (0.3 mL to 0.5 mL) and take measures necessary to ensure maintenance of a patent airway. Sacubitril and valsartan tablets have been associated with a higher rate of angioedema in Black than in non-Black patients. Patients with a prior history of angioedema may be at increased risk of angioedema with sacubitril and valsartan tablets [see Adverse Reactions ( 6.1 )] . Sacubitril and valsartan tablets must not be used in patients with a known history of angioedema related to previous ACE inhibitor or ARB therapy [see Contraindications ( 4 )] . Sacubitril and valsartan tablets should not be used in patients with hereditary angioedema.

5.3 Hypotension Sacubitril and valsartan tablets lowers blood pressure and may cause symptomatic hypotension [see Adverse Reactions ( 6.1 )] . Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. Correct volume or salt depletion prior to administration of sacubitril and valsartan tablets or start at a lower dose. If hypotension occurs, consider dose adjustment of diuretics, concomitant antihypertensive drugs, and treatment of other causes of hypotension (e.g., hypovolemia). If hypotension persists despite such measures, reduce the dosage or temporarily discontinue sacubitril and valsartan tablets. Permanent discontinuation of therapy is usually not required.

5.4 Impaired Renal Function As a consequence of inhibiting the renin-angiotensin-aldosterone system (RAAS), decreases in renal function may be anticipated in susceptible individuals treated with sacubitril and valsartan tablets [see Adverse Reactions ( 6.1 )] . 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 ACE inhibitors and angiotensin receptor antagonists has been associated with oliguria, progressive azotemia and, rarely, acute renal failure and death. Closely monitor serum creatinine, and down-titrate or interrupt sacubitril and valsartan tablets in patients who develop a clinically significant decrease in renal function [see Use in Specific Populations ( 8.7 ) and Clinical Pharmacology ( 12.3 )] . As with all drugs that affect the RAAS, sacubitril and valsartan tablets may increase blood urea and serum creatinine levels in patients with bilateral or unilateral renal artery stenosis. In patients with renal artery stenosis, monitor renal function.

5.5 Hyperkalemia Through its actions on the RAAS, hyperkalemia may occur with sacubitril and valsartan tablets [see Adverse Reactions ( 6.1 )] . Monitor serum potassium periodically and treat appropriately, especially in patients with risk factors for hyperkalemia such as severe renal impairment, diabetes, hypoaldosteronism, or a high potassium diet. Dosage reduction or interruption of sacubitril and valsartan tablets may be required [see Dosage and Administration ( 2.7 )] .

5.6 Risk of Allergic Reactions Due to Tartrazine The 97 mg/103 mg tablets contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

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