Entresto contains a combination of sacubitril and valsartan. Sacubitril is a blood pressure medicine. It works by increasing the levels of certain proteins in the body that can dilate (widen) blood vessels. This helps lower blood pressure by reducing sodium levels.

Valsartan is an angiotensin II receptor blocker (sometimes called an ARB). Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Entresto is used in adults with chronic heart failure. This medicine helps lower the risk of needing to be hospitalized when symptoms get worse, and helps lower the risk of death from heart failure.

Entresto is also used to treat heart failure in children who are at least 1 year old.

Entresto is usually given together with other heart medications.

Do not use Entresto if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Entresto can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you have diabetes, do not use Entresto together with any medication that contains aliskiren (Tekturna, Tekamlo).

Take Entresto exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Entresto with or without food. Take the medicine at the same time each day.

Sacubitril and valsartan doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

If you cannot swallow a tablet whole, a pharmacist can make an oral suspension (liquid). Tell the doctor if the person taking this medicine has trouble swallowing the tablet.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Store Entresto in the original container at room temperature away from moisture and heat. Throw away any oral suspension not used within 15 days after it was mixed. Do not keep the oral suspension in a refrigerator.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: Sacubitril 49 mg-Valsartan 51 mg orally twice a day

Maintenance dose: Sacubitril 97 mg-Valsartan 103 mg orally twice a day

Comments:
-Increase to the target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily) after 2 to 4 weeks, as tolerated.
-A starting dose of sacubitril 24 mg-valsartan 26 mg twice a day is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) and for patients previously taking low doses of these agents. Double the dose every 2 to 4 weeks to the target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily), as tolerated.

Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic New York Heart Association (NYHA) Class II to IV heart failure and reduced ejection fraction; usually administered in conjunction with other heart failure therapies or in place of an ACE inhibitor or other ARB.

You should not use Entresto if you are allergic to sacubitril or valsartan (Diovan), or if you have ever had a severe allergic reaction to a blood pressure medication such as:

• an ACE inhibitor - benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril (Lotensin, Vasotec, Prinivil, Accupril, Mavik, and others); or

• an ARB - azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan (Atacand, Avapro, Benicar, Diovan, Edarbi, Micardis, Teveten, and others).

You should not take Entresto within 36 hours before or after you have taken any ACE inhibitor medication.

If you have diabetes, do not use Entresto together with any medication that contains aliskiren such as Tekturna or Tekamlo.

You may also need to avoid taking Entresto with aliskiren if you have kidney disease.

To make sure Entresto is safe for you, tell your doctor if you have ever had:

• liver disease;

• diabetes;

• hereditary angioedema;

• if you are on a low-salt-diet; or

• if you are dehydrated.

Do not use Entresto if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Entresto can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

It is not known whether sacubitril and valsartan passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using Entresto.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking Entresto, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of Entresto.

Get emergency medical help if you have signs of an allergic reaction to Entresto: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Also call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• extreme tiredness;

• high potassium - slow heart rate, weak pulse, muscle weakness, tingly feeling; or

• kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common Entresto side effects may include:

• kidney problems;

• high potassium;

• dizziness, feeling light-headed; or

• cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• aliskiren;

• lithium;

• any other heart or blood pressure medicines;

• a diuretic or "water pill";

• medicine or mineral supplements that contain potassium; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with sacubitril and valsartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.