Sacubitril and valsartan

Sacubitril and valsartan is a combination medicine that is used in adults with chronic heart failure. Sacubitril and valsartan lowers the risk of being hospitalized when symptoms get worse and reduces the risk of death from heart failure.

Sacubitril and valsartan is also used to treat symptomatic heart failure in children who are at least 1 year old.

Sacubitril and valsartan may also be used for purposes not listed in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Your dose may change if you switch to a different strength or form of sacubitril and valsartan. Avoid medication errors by using the medicine exactly as stated on the label or as prescribed by your doctor.

Sacubitril and valsartan is usually taken twice a day with or without food. You may need to take more than one capsule or tablet to get the full dose. Follow your doctor's instructions.

Doses for children and teenagers are based on weight. Your child's dose may change if they gain or lose weight.

Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

If you cannot swallow a tablet whole, a pharmacist can create a liquid suspension. Inform the doctor if the person taking this medicine has trouble swallowing the tablet.

Shake the oral suspension (liquid) well. Measure a dose using the measuring device provided (not a kitchen spoon).

The oral pellets are inside the capsule. Do not swallow the capsule whole, and do not chew or crush the oral pellets inside the capsule. The capsule must be opened before taking the oral pellets. Do not swallow the empty capsule shell after opening.

To take the oral pellets, open the capsule and sprinkle the contents onto 1 to 2 teaspoons of soft food, like applesauce, yogurt, or pudding. Swallow the mixture right away after adding the pellets.

Do not give the oral pellets through a feeding tube. The pellets may clog the tube.

Your doctor will need to check your progress regularly. Your blood and kidney function may need to be tested often.

Store at room temperature away from moisture and heat. Dispose of any oral suspension not used within 15 days after it is mixed. Do not store the oral suspension in a refrigerator.

Do not use if you are pregnant. Stop using sacubitril and valsartan and tell your doctor right away if you become pregnant.

If you have diabetes, do not take sacubitril and valsartan with any medication that contains aliskiren (a blood pressure medicine).

Tell your doctor about all your other medicines. Some drugs should not be used with sacubitril and valsartan.

You should not use this medicine if you are allergic to sacubitril or valsartan or if you have ever had a severe allergic reaction to similar medicines such as:

• an ACE inhibitor--benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, perindopril, quinapril, ramipril, trandolapril; or
• an ARB--azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan.

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

If you have diabetes, do not take sacubitril and valsartan with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking sacubitril and valsartan with aliskiren if you have kidney disease.

Tell your doctor if you have or have ever had:

• diabetes;
• low blood pressure;
• low levels of aldosterone (hypoaldosteronism);
• hereditary angioedema;
• if you are dehydrated;
• if you are on a low-salt diet;
• if you are on a high-potassium diet; or
• severe liver or kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Sacubitril and valsartan can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Sacubitril and valsartan may cause serious side effects. Call your doctor right away if you have:

• feeling like you might pass out;
• high blood potassium—nausea, weakness, tingling feeling, chest pain, irregular heartbeats, loss of movement; or
• kidney problems—swelling, urinating less, feeling tired or short of breath.

Common side effects of sacubitril and valsartan may include:

• kidney problems;
• high potassium levels in your blood;
• dizziness, feeling like you might pass out; 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.

Take the medicine as soon as you can, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

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

Do not take potassium supplements or use salt substitutes, unless your doctor has instructed you to.

Tell your doctor about all your other medicines, especially:

• lithium;
• a diuretic or "water pill" that may increase blood potassium such as spironolactone, triamterene, or amiloride;
• heart or blood pressure medication;
• 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 affect sacubitril and valsartan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.