Sacubitril (sak-UE-bi-tril), Valsartan (val-SAR-tan)

Treats chronic heart failure.

Brand Name(s):

Entresto, Entresto Sprinkle

When This Medicine Should Not Be Used:

How to Use This Medicine:

Pellet, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• For children who are unable to swallow the tablets, your pharmacist will mix this medicine as a liquid suspension. Shake the bottle of suspension well before each use.
• Entresto® Sprinkle oral pellets:
  • The Entresto® Sprinkle contains oral pellets inside of a capsule. The capsule must be opened and the pellets sprinkled on soft food (including applesauce, yogurt, or pudding). Do not swallow the empty capsule shells. Do not chew or crush the oral pellets.
  • In a small bowl or cup, place 1 to 2 teaspoonfuls of soft food.
  • Hold the capsule upright, with the colored cap on top, over the soft food. Gently pinch the middle of the capsule and pull slightly on the top with your other hand to separate the 2 ends of the capsule. Be careful not to spill the contents while opening the capsule.
  • Empty all of the pellets onto the food. Check the capsule to make sure that you did not miss any oral pellets. Tap the capsule to remove any remaining oral pellets.
  • Give or take the mixture right away.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. You may store the mixed oral liquid at room temperature for up to 15 days. Do not refrigerate.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take this medicine with aliskiren if you have diabetes.
• Do not take this medicine together with an ACE inhibitor medicine or within 36 hours of switching from or to an ACE inhibitor.
• Some foods and medicines can affect how sacubitril/valsartan works. Tell your doctor if you are using any of the following:
  • Lithium
  • Diuretic (water pill, including amiloride, spironolactone, triamterene)
  • Other medicines to treat high blood pressure or heart problems
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
• Ask your doctor before you use any medicine, supplement, or salt substitute that contains potassium.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, liver disease, or diabetes.
• This medicine may cause the following problems:
  • Angioedema (swelling of the face, lips, tongue, or throat or trouble breathing)
  • Kidney problems
  • Hyperkalemia (too much potassium in your blood)
• This medicine could lower your blood pressure, especially if you also take a diuretic (water pill). Stand or sit up slowly if you feel dizzy or lightheaded.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, weakness, uneven heartbeat, trouble breathing, numbness in your hands, feet, or lips
• Decrease in how much or how often you urinate, bloody or cloudy urine, lower back or side pain
• Lightheadedness, dizziness, or fainting

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088