Entresto

Entresto is a prescription medication used to treat heart failure. 

It is a single product containing 2 medications: sacubitril and valsartan. Sacubitril belongs to a group of drugs called neprilisyn inhibitors. These work to control blood volume and lower blood pressure. Valsartan belongs to a group of drugs called angiotensin II receptor antagonists, which help blood vessels to relax.

This medication comes in tablet form and is taken typically 2 times a day.

Common side effects of Entresto include low blood pressure, high blood potassium levels, and poor function of the kidneys.

Entresto is a prescription medicine used to treat heart failure in adults. It is used to reduce the risk of death and hospitalization in people with certain types of long-lasting heart failure. Heart failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceutical Corporation

Serious side effects have been reported with Entresto.

Common side effects of Entresto include:

• low blood pressure
• high blood potassium levels
• poor function of the kidneys.

This is not a complete list of Entresto side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you are taking or are planning to take including prescription and non-prescription medicines, vitamins and herbal supplements. Entresto and other medicines may affect each other. Always check with your doctor before starting or stopping any medicines. Especially tell your doctor if you:

• take an angiotensin-converting enzyme (ACE) inhibitor (medicines to lower blood pressure) such as:

• benazepril (Lotensin, Lotensin HCT)
• captopril (Capoten, Capozide)
• enalapril (Vasotec, Vaseretic)
• fosinopril (Monopril, Monopril HCT)
• lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
• moexipril (Univasc, Uniretic)
• quinapril (Accupril, Accuretic, Quinaretic)
• ramipril (Altace)
• trandolapril (Mavik, Tarka)

• take an angiotensin II receptor blockers (ARB)-medicines used to lower blood pressure such as:

• azilsartan (Edarbi)
• candesartan (Atacand)
• irbesartan (Avapro)
• losartan (Cozaar)
• olmesartan (Benicar)
• telmisartan (Micardis, Twynsta)
• valsartan (Diovan)

• have diabetes and take a medicine called aliskiren. Aliskiren like Entresto can lower blood pressure, may increase blood potassium and may cause poor kidney function.  (Aliskiren is in a class of medications called direct renin inhibitors. It works by decreasing certain natural chemicals that tighten the blood vessels, so blood vessels relax and the heart can pump blood more efficiently).  

• take diuretics (water pills) that may increase your blood potassium such as:

• spironolactone (Aldactone)
• triamterene (Dyrenium)
• amiloride (Midamor)

• take nonsteroidal anti-Inflammatory drugs (NSAIDs) including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). NSAIDs and COX-2 inhibitors like Entresto (see side effects) can also cause poor kidney function. NSAIDs and COX-2 inhibitors include:

• ibuprofen (Advil, Motrin)
• naproxen (Aleve, Naprosyn)
• salsalate (Amigesic)
• celecoxib (Celebrex)
• diclofenac (Voltaren)
• etodolac (Lodine)
• indomethacin (Indocin)
• ketoprofen (Orudis)
• ketorolac (Toradol)
• nabumetone (Relafen)
• oxaprozin (Daypro)
• piroxicam (Feldene)
• sulindac (Clinoril)
• tolmetin (Tolectin)

• lithium (Eskalith, Lithobid) - a medicine used to treat and prevent episodes of mania (abnormally excited mood) in people with bipolar disorder (a mood disorder or changes from one's normal mood to an abnormally excited mood). Entresto may cause lithium toxicity. Your doctor would monitor your lithium blood levels with a lab test and may adjust your lithium dose to avoid toxicity. Ensure you do the lab test when prescribed.

This is not a complete list of Entresto drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Entresto. 

• Serious allergic reactions causing swelling of your face, lips, tongue, and throat (angioedema) that may cause trouble breathing and death. Get emergency medical help right away if you have symptoms of angioedema or trouble breathing. Do not take Entresto again if you have had angioedema while taking Entresto. People who are Black and take Entresto may have a higher risk of having angioedema than people who are not Black and take Entresto. People who have had angioedema before taking Entresto may have a higher risk of having angioedema than people who have not had angioedema before taking Entresto.
• Low blood pressure (hypotension). Low blood pressure may be more common if you also take water pills. Call your doctor if you become dizzy or lightheaded, or you develop extreme fatigue.
• Kidney problems. Your doctor will check your kidney function during your treatment with Entresto. If you have changes in your kidney function tests, you may need a lower dose of Entresto or may need to stop taking Entresto for a period of time.
• Increased amount of potassium in your blood. Your doctor will check your potassium blood level during your treatment with Entresto.
  • Tell your doctor if you have diabetes and take a medicine called aliskiren. Aliskiren can also lower blood pressure and may cause increase blood potassium levels and poor kidney function.

Do not take Entresto if you:

• if you are allergic to sacubitril or valsartan or any other ingredients in Entresto. 
• had allergic reactions including swelling of your face, lips, tongue, throat or trouble breathing while taking medicines called an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB). 
• take an ACE inhibitor medicine. Do not take Entresto for at least 36 hours before or after you take an ACE inhibitor medicine. Talk with your doctor or pharmacist before taking Entresto if you are not sure if you take an ACE inhibitor medicine. Consult your doctor or pharmacist before taking Entresto if you are not sure that you are taking an ACE inhibitor medicine.
• have diabetes and take a medicine that contains aliskiren.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Entresto, salt substitutes containing potassium should be avoided because these may cause high levels of potassium in your blood (hyperkalemia).

Contact your doctor immediately if you are experiencing any of the following symptoms of high potassium blood levels: 

• Weakness
• irregular heartbeat
• confusion
• tingling of toes and fingers
• feeling of heaviness in your legs

Before taking Entresto, tell your doctor about all of your medical conditions. Especially tell your doctor if you have:      

• are allergic to Entresto or any of its ingredients (sacubitril and valsartan)
• if you have had any allergic reaction to an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blockers (ARB)
• kidney problems
• liver problems
• If you are pregnant or plan to become pregnant. If you get pregnant while taking Entresto, tell your doctor right away. Entresto can harm or cause death to your unborn baby
• If you are breastfeeding or plan to breastfeed. It is not known if Entrestro passes into breast milk. You and your doctor should decide if you would take Entrestro or breastfeed. You should not do both.
• take a potassium supplements
• take other medicines for high blood pressure or heart problems especially an ACE inhibitor or an ARB
• take potassium-sparing diuretics
• take nonsteroidal anti-Inflammatory drugs (NSAIDs) 
• use lithium (Eskalith, Lithobid)
• use a salt substitutes

Tell your doctor about all the medicines you take including prescription and non­prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you are pregnant or plan to become pregnant.

Entresto can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. If you get pregnant while taking Entresto, tell your doctor right away.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Entresto crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of Entresto. Your doctor and you will decide if the benefits outweigh the risk of using Entresto. You should not do both.

Take Entresto exactly as your doctor tells you to take it.

Entresto comes in tablet form and is taken twice every day. Your doctor may change your dose of Entresto during treatment.

Take Entresto with water.

Do not chew, divide, or break Entresto tablets. Swallow Entresto tablets whole.

If you take too much Entresto (more than is prescribed), call your doctor right away.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Entresto at the same time.

Take Entresto exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Entresto (sacubitril/valsartan) is 49/51 mg twice a day. Your doctor may double the dose of Entresto after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, depending on your response to Entresto.

If you are not taking an ACE inhibitor or ARB or previously taking low doses of either of these medicines or if you have poor kidney function and/or liver function the recommended starting dose of Entresto (sacubitril/valsartan) is 24/26 mg twice a day. Your doctor may double the dose of Entresto after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, depending on your response to Entresto.

If you take too much Entrestro, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

The most common sign and symptoms associated with Entresto overdose is:

Hypotension – Entrestro lowers blood pressure. It is more common if you take a water pill. You may feel very lightheaded or dizzy or develop extreme fatigue. If you experience these seek medical help immediately.

• Store Entresto at room temperature between 68°F to 77°F (20°C to 25°C).
• Protect Entresto tablets from moisture.
• Store Entresto tablets in the original container.
• Keep all appointments with your doctor and the laboratory. Your doctor will order lab tests to check your body's potassium blood levels, kidney function and liver function.
• Keep Entresto and all medicines out of the reach of children.

WARNING: FETAL TOXICITY

• When pregnancy is detected, discontinue Entresto as soon as possible.

• Drugs that act directly on the renin-angiotensin system (assist to regulate the body's blood pressure) can cause injury and death to the developing fetus.