Entresto (sacubitril and valsartan)

What are the Indications for Entresto?

In adults, Entresto is indicated for the treatment of chronic heart failure to improve symptoms and reduce the risk of hospitalization and death.

In children aged 1 year of age and older, Entresto is indicated for symptomatic heart failure.

Entresto is not recommended if you are allergic to it or any of its ingredients.

How is Entresto used?

Storage

Entresto should be stored at room temperature between 68° – 77°F(20° – 25°) in a tightly closed container, away from light and moisture.

Keep Entresto out of reach of children and pets.

Instruction

Entresto should be taken by mouth with or without food twice daily. Swallow the tablets whole. Do not crush, chew, or split tablets.

Dosage

Entresto is available in tablet form in the following strengths:

• 24 mg/26 mg
• 49 mg/51 mg
• 97 mg/103 mg

If the tablet cannot be swallowed whole, the pharmacy will compound the medication into liquid form. The recommended starting dose of Entresto is dependent on age and weight (for patients under 18 years of age).

18 years and older: The recommended starting dose is 49/51 mg (sacubitril/valsartan) twice daily. After 2-4 weeks, the dose may be increased to 97/103 mg twice daily, depending on your tolerance.

1 – 17 years of age: The recommended starting dose is based on weight.

• Body weight less than 40 kg (88 lb): The starting dose is 1.6 mg twice daily. After 2 weeks, if tolerated, increase the dose to 2.3 mg.
• Body weight 40 – 50 kg (110 lb): The starting dose is 24/26 mg twice daily. After 2 weeks, if tolerated, increase the dose to 49/51 mg.
• Body weight more than 50 kg: The starting dose is 49/51 mg twice daily. After 2 weeks, if tolerated, increase the dose to 72/78 mg.

Side Effects

It’s important to understand that although Entresto is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Entresto, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Entresto, side effects may go away.

Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own:

• Cough
• Dizziness
• Low blood pressure
• Kidney problems
• High levels of potassium in the blood

Serious Side Effects

Severe adverse reactions while using Entresto can occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Severe allergic reaction: severe rash or itching, swelling in the face, lips, tongue, or throat, rapid heartbeat, fainting or dizziness, or problems breathing or swallowing.
• Angioedema: swelling of the face, lips, tongue, or throat

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Entresto, tell your doctor or pharmacist:

• If you are allergic to any medications such as Entresto
• If you have a history of angioedema or have a family history of angioedema
• If you have kidney problems
• If you have liver problems
• If you are pregnant or expect to become pregnant
• If you are breastfeeding or plan to breastfeed

Hyperkalemia

Taking Entresto can cause high levels of potassium in the blood, which can be dangerous, especially if you have pre-existing kidney disease or take medications that increase potassium levels. Your doctor will monitor you for signs of hyperkalemia, and check your potassium levels regularly.

Hypotension

Taking Entresto can cause low blood pressure, especially if you are dehydrated or have salt depletion. Look for signs of hypotension and avoid activities that may cause a sudden drop in your blood pressure, such as standing up quickly.

Renal Impairment

Taking Entresto can cause a worsening of kidney function, especially if you have pre-existing kidney disease or are taking medications that affect the kidneys. Your doctor should assess your kidney function before starting treatment with Entresto and continue to monitor your kidney for signs of renal impairment while taking Entresto.

Pregnant or Planning to Become Pregnant

Using Entresto during pregnancy can severely harm your unborn child and may result in death. If you are pregnant or become pregnant while taking Entresto, contact your doctor immediately.

Breastfeeding

It is not known if Entresto passes into breast milk. If you are breastfeeding or considering breastfeeding while taking Entresto, talk to your doctor for the best course of action before taking Entresto.

Interactions & Contraindications

Before using Entresto, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Ace Inhibitors

Taking Entresto with an ACE inhibitor can increase the risk of angioedema. Do not take Entresto until you’ve consulted with your doctor to determine if change of therapy is needed.

Non-steroid Anti-inflammatory Drugs (NSAID)

Taking Entresto with NSAIDs can reduce the effectiveness of Entresto and increase your risk of renal impairment. Consult with your doctor to determine if change of therapy is needed.

Lithium

Taking Entresto with Lithium can increase the levels of lithium in the blood, leading to toxic side effects. Consult with your doctor to determine if change of therapy is needed.

Potassium-sparing Diuretics

Taking Entresto with potassium-sparing diuretic medications can increase potassium levels in the blood and increase your risk of hyperkalemia. Consult with your doctor to determine if change of therapy is needed.