What is ENTRESTO?

ENTRESTO is a prescription medicine used to reduce the risk of death and hospitalization in adults with long-lasting (chronic) heart failure. ENTRESTO is usually used with other heart failure therapies, in place of an angiotensin-converting enzyme (ACE) inhibitor or other angiotensin II receptor blocker (ARB) therapy.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about ENTRESTO?

ENTRESTO can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant while taking ENTRESTO, tell your doctor right away.

Who should not take ENTRESTO?

Do not take ENTRESTO if you

• are allergic to sacubitril or valsartan or any of the ingredients in ENTRESTO
• have had an allergic reaction including swelling of your face, lips, tongue, throat (angioedema) or trouble breathing while taking a type of medicine called an ACE inhibitor or ARB
• take an ACE inhibitor medicine. Do not take ENTRESTO for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before taking ENTRESTO if you are not sure if you take an ACE inhibitor medicine
• have diabetes and take a medicine that contains aliskiren

What should I tell my doctor before taking ENTRESTO?

Before you take ENTRESTO, tell your doctor about all of your medical conditions, including if you have kidney or liver problems or a history of hereditary angioedema; are pregnant or plan to become pregnant; are breastfeeding or plan to breastfeed. You should either take ENTRESTO or breastfeed. You should not do both.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take potassium supplements or a salt substitute; nonsteroidal anti-inflammatory drugs (NSAIDs); lithium; or other medicines for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren.

What are the possible side effects of ENTRESTO?

ENTRESTO may cause serious side effects including:

• angioedema that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take ENTRESTO again if you have had angioedema while taking ENTRESTO. People who are Black or who have had angioedema and take ENTRESTO may have a higher risk of having angioedema
• low blood pressure (hypotension). Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue
• kidney problems
• increased amount of potassium in your blood

The most common side effects were low blood pressure, high potassium, cough, dizziness, and kidney problems.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088.

ENTRESTO and the ENTRESTO logo are registered trademarks of Novartis AG.