Sacubitril-Valsartan

Sacubitril/Valsartan is a prescription medication used to treat the symptoms of Heart Failure. 

Sacubitril/Valsartan is available under the following different brand names: Entresto.

Adult and Pediatric dosage

Film-coated tablet

• 24mg/26mg
• 49mg/51mg
• 97mg/103mg

Heart Failure

Adult dosage

• Recommended starting dose: 49mg/51 orally twice daily
• Target maintenance dose: After 2-4 weeks, double the dose to 97/103 mg orally twice daily as tolerated

Pediatric dosage

• Younger than 1 year of age: Safety and efficacy not established
• Children older than 1 year of age
  • Adjust the dose every 2 weeks, as tolerated
  • Weight less than 40 kg
    • Starting dose: 1.6 mg/kg orally twice daily
    • Second titration: 2.3 mg/kg orally twice daily
    • Not to exceed 3.1 mg/kg orally twice daily
  • Weight over 40 kg, but less than 50 kg
    • Starting dose: 24/26 mg orally twice daily
    • Second titration: 49/51 mg orally twice daily
    • Not to exceed 72/78 mg (three 24/26 mg tablets) orally twice daily
  • Weight over 50 kg
    • Starting dose: 49/51 mg orally twice daily
    • Second titration: 72/78 mg (three 24/26 mg tablets) orally twice daily
    • Not to exceed 97/103 mg orally twice daily

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Sacubitril/Valsartan include:

• kidney problems, 
• high potassium, 
• dizziness, 
• lightheadedness, and 
• cough

Serious side effects of Sacubitril/Valsartan include:

• hives, 
• difficulty breathing, 
• swelling of your face, lips, tongue, or throat, 
• lightheadedness, 
• extreme tiredness, 
• slow heart rate, 
• weak pulse, 
• muscle weakness, 
• tingly feeling, 
• little or no urination, 
• rapid weight gain, 
• painful or difficulty urination, and
• swelling in your hands, feet or ankles 

Rare side effects of Sacubitril/Valsartan include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them.  Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Sacubitril/Valsartan has severe interactions with at least 11 other drugs. 
• Sacubitril/Valsartan has serious interactions with at least 13 other drugs.
• Sacubitril/Valsartan has moderate interactions with at least 171 other drugs.
• Sacubitril/Valsartan has minor interactions with the following drugs: 
  • agrimony
  • cornsilk
  • entecavir
  • food
  • noni juice
  • octacosanol
  • reishi
  • shepherd’s purse
  • simvastatin 

This information does not contain all possible interactions or adverse effects.  Visit the RxList Drug Interaction Checker for any drugs interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use.  Keep a list of all your medications with you, and share this information with your doctor and pharmacist.  Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to any component 
• History of angioedema related to previous ACE inhibitor or ARB therapy
• Coadministration of neprilysin inhibitors (eg, sacubitril) with ACE inhibitors may increase angioedema risk; do not administer ACE inhibitors within 36 hours of switching to or from sacubitril/valsartan
• Concomitant use with aliskiren in patients with diabetes

Effects of drug abuse

• None

Short-Term Effects

• See “What are Side Effects Associated with Using Sacubitril/Valsartan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sacubitril/Valsartan?”

Cautions

• Can cause fetal harm when administered to a pregnant woman; use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death (see Black Box Warnings)
• Not for use in patients with hereditary angioedema; observe for signs and symptoms of angioedema; if angioedema occurs, discontinue drug immediately, provide appropriate therapy, and monitor for airway compromise
• Sacubitril/valsartan lowers blood pressure and may cause symptomatic hypotension; patients who are volume-depleted or salt-depleted, or those taking diuretics, are at greater risk
• Drug interaction overview
• Dual blockade of the renin-angiotensin-aldosterone system
  • Coadministration with an ACE inhibitor is contraindicated because of the increased risk of angioedema
  • Avoid use with an ARB, because drug contains the angiotensin II receptor blocker valsartan
  • Concomitant use with aliskiren is contraindicated in patients with diabetes
• Potassium-sparing diuretics
  • As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium
• Nonsteroidal anti-inflammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors)
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, concomitant use of NSAIDs, including COX-2 inhibitors, with sacubitril/valsartan may result in worsening of renal function, including possible acute renal failure
  • Effects are usually reversible; monitor renal function periodically
• Lithium
  • Increases in serum lithium concentrations and lithium toxicity have been reported during coadministration of lithium with angiotensin II receptor antagonists; monitor serum lithium levels
  • Monitor renal function and potassium levels in susceptible patients (eg, diabetes, hypoaldosteronism, high-potassium diet, renal artery stenosis); dosage reduction or interruption may be required

Pregnancy and Lactation

• Discontinue as soon as pregnancy detected; during the second and third trimesters of pregnancy, resulting oligohydramnios may cause fetal injury (eg, hypotension, neonatal skull hypoplasia, anuria, reversible and irreversible renal failure) and death
• Neonates with a history of in utero exposure: Direct attention toward support of blood pressure and renal perfusion; exchange transfusions or dialysis may be required
• Unknown if distributed in human breast milk; not recommended
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.