Entresto

Uses

What is Entresto® (sacubitril and valsartan) used for?

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 certain people 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 usually given together with other blood pressure medications.

How should I take Entresto® (sacubitril and valsartan)?

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.

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

How do I store Entresto® (sacubitril and valsartan)?

Entresto® is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Entresto® in the bathroom or the freezer. There may be different brands of Entresto® that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Entresto® down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Entresto® (sacubitril and valsartan)?

Before using this drug, tell your doctor if:

• You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
• You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
• You have allergy with any of active or inactive ingredients of Entresto® or other medications.
• You have any other illnesses, disorders, or medical conditions.

You should not use Entresto® 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)
• 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 (Amturnide, Tekturna, Tekamlo, Valturna).

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:

• Liver disease
• Diabetes
• If you are on a low-salt-diet
• 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.

Is it safe during pregnancy or breastfeeding?

There isn’t enough information about the safety of using Entresto® during pregnancy and breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Entresto®.

Side effects

What side effects can occur from Entresto® (sacubitril and valsartan)?

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

Common side effects may include:

• Dizziness
• Cough

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Entresto® (sacubitril and valsartan)?

Entresto® may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Products that may interact with this drug are:

• Aliskiren
• Lithium
• Any other heart or blood pressure medicines
• A diuretic or “water pill’
• Medicine or mineral supplements that contain potassium
• NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others

Does food or alcohol interact with Entresto® (sacubitril and valsartan)?

Entresto® may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Entresto® (sacubitril and valsartan)?

Entresto® may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using Entresto® (sacubitril and valsartan).

What is the dose of Entresto® (sacubitril and valsartan) for an adult?

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

What is the dose of Entresto® (sacubitril and valsartan) for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Entresto® (sacubitril and valsartan) available?

Entresto® is available in the following dosage forms and strengths:

• Tablet, film coated: sacubitril 24mg, valsartan 26mg

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Entresto®, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.