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FDA approves expanded indication of ENTRESTO®

ENTRESTO® (sacubitril/valsartan) was granted an expanded indication by the FDA.

ENTRESTO is now approved to reduce the risk of cardiovascular death and heart failure hospitalization in more adult patients with chronic heart failure (CHF). Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. The label also states LVEF is a variable measure and recommends using clinical judgment in deciding whom to treat. This label expansion is based on efficacy and safety evidence observed in PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with guideline-defined heart failure with preserved ejection fraction (HFpEF). The greatest benefit in the study was shown in patients with LVEF below normal.

We are committed to continuing our work with the heart failure community as the needs of people with HF evolve, ensuring you have the information needed to answer questions as they arise. Here are more details on the available programs and resources developed to educate and support patients taking ENTRESTO and their caregivers.

  1. This website offers educational and supports resources that families or patients with HF may need while using ENTRESTO to manage their heart failure

  2. ENTRESTO® Central: Patient support program that provides financial guidance and assistance for patients considering ENTRESTO as a form of HF treatment. The program outlines treatment costs associated with federal and commercial insurance, offers patients a free one-month trial of ENTRESTO, and sponsors $10 co-pay cards for commercially insured patients.


ENTRESTO is a prescription medicine used to treat adults with long-lasting (chronic) heart failure to help reduce the risk of death and hospitalization. ENTRESTO works better when the heart cannot pump a normal amount of blood to the body.


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 during treatment with ENTRESTO, tell your doctor right away.

Do not take ENTRESTO if you:

  1. are allergic to any of the ingredients in ENTRESTO

  2. 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 angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)

  3. take an ACE inhibitor medicine. Do not take ENTRESTO for at least 36 hours before or after you

  4. take an ACE inhibitor medicine. Talk with your doctor or pharmacist before taking ENTRESTO if

  5. you are not sure if you take an ACE inhibitor medicine

  6. have diabetes and take a medicine that contains aliskiren

Before taking ENTRESTO:

Tell your doctor about all of your medical conditions, including if you:

  1. have a history of hereditary angioedema

  2. have kidney or liver problems

  3. 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:

  1. Swelling of your face, lips, tongue and throat (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

  2. People who are Black or who have had angioedema and take ENTRESTO may have a higher risk of having angioedema

  3. low blood pressure (hypotension), which may be more common if you take water pills.

  4. Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue

  5. kidney problems

  6. increased amount of potassium in your blood (hyperkalemia)

The most common side effects were:

  1. low blood pressure

  2. high potassium

  3. cough

  4. dizziness

  5. kidney problems

Please see ENTRESTO full Prescribing Information including Boxed WARNING.


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