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Entresto

(sacubitril - valsartan)

How does this medication work? What will it do for me?

This is a combination product that contains 2 medications: sacubitril and valsartan. This combination medication is used with other medications to treat heart failure when the heart is unable to pump effectively.

Sacubitril belongs to the class of medications called neutral endopeptidase inhibitors. It prevents the body from forming certain chemicals that cause water and sodium to be reabsorbed by the kidneys. Valsartan belongs to the class of medications called angiotensin II receptor blockers (ARBs), which relax blood vessels, making more room for blood to flow through them. The combination of these medications relaxes the blood vessels and allows the kidneys to remove excess fluid and sodium from the body. These actions make it easier for the heart to pump blood through the body and reduce symptoms of heart failure.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The usual starting dose of sacubitril - valsartan is 1 tablet of 49 mg sacubitril and 51 mg valsartan taken twice a day. Based on the effectiveness of the medication, your doctor will gradually increase the dose to 1 tablet of 97 mg sacubitril and 103 mg valsartan taken 2 times a day.

This medication may be taken with or without food.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

24 mg/26 mg 
Each violet-white, ovaloid, biconvex, film-coated tablet, with beveled edges, unscored, debossed with “NVR” on one side and “LZ” on the other, contains 24.3 mg of sacubitril and 25.7 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide black (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

49 mg/51 mg 
Each pale yellow, ovaloid, biconvex, film-coated tablet, with beveled edges, unscored, debossed with “NVR” on one side and “L1” on the other, contains 48.6 mg of sacubitril and 51.4 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide yellow (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

97 mg/103 mg
Each light pink, ovaloid, biconvex, film-coated tablet, with beveled edges, unscored, debossed with “NVR” on one side and “L11” on the other, contains 97.2 mg of sacubitril and 102.8 mg of valsartan. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, low-substituted hydroxypropylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose and talc; film-coating: hypromellose, iron oxide red (E 172), iron oxide black (E 172), Macrogol 4000, talc, and titanium dioxide (E 171).

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to sacubitril, valsartan, or any ingredients of the medication
  • are experiencing or have recently experienced dizziness or lightheadedness caused by low blood pressure
  • are taking any medication containing an angiotensin-converting enzyme inhibitor (ACEI)
  • have had angioedema (swelling of the face and throat) after taking an ACE inhibitor or angiotensin II receptor blocker (ARB)
  • have diabetes and are taking the medication aliskiren
  • have moderate-to-severe kidney disease and are taking the medication aliskiren
  • have a history of hereditary angioedema or angioedema that appears to occur without a cause
  • are or may become pregnant

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cough
  • dizziness
  • itchiness
  • nausea
  • rash
  • spinning sensation
  • tiredness
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • low blood pressure when rising from a sitting or lying position
  • signs of kidney problems (e.g., decreased urination, nausea, vomiting, swelling of the feet and ankles)
  • signs of low blood pressure such as dizziness, lightheadedness, or fainting
  • signs of too much potassium in the body (e.g., irregular heartbeat, muscle weakness, generally feeling unwell)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction, including angioedema (swelling of face or throat, hives, difficulty breathing)
  • sudden loss of consciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Angioedema: Angioedema is a condition where the deeper layers of the skin around the eyes and lips swell. It can be life-threatening if the swelling is severe enough to cause the throat or tongue to swell and block the airways. The risk of developing angioedema with this medication increases if it is taken with other ARBs (angiotensin receptor blockers) or the any medications in the family of angiotensin-converting enzyme inhibitors (ACEIs).

This condition has been associated with ARBs such as valsartan and may occur with this medication. If you have experienced angioedema in the past with ACEIs or ARBs, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Sacubitril - valsartan may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the first few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. Because this medication can cause dizziness or lightheadedness, do not get up too quickly after you have been sitting or lying for prolonged periods. If you have heart disease (e.g., heart failure, heart attack) or are taking medications that lower blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney problems: Valsartan can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure).

The use of aliskiren with this medication may further increase risk of kidney problems for people already at risk for this problem. If you have reduced kidney function, renal artery stenosis (narrowing of blood vessels in the kidneys), or congestive heart failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have reduced kidney function, you may require lower doses of this medication.

This medication should not be taken by people with severely decreased kidney function.

Liver problems:  Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. People with reduced liver function may need a lower-than-normal dose of valsartan; therefore, it may be necessary to use the components of the combination product separately. If you have reduced liver function or liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with severe liver impairment.

This medication may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Potassium levels: Increases in blood levels of potassium occur for some people who take sacubitril - valsartan. Potassium levels should be monitored by your doctor. If you experience unexplained nausea, fatigue, muscle weakness, or tingling sensations, contact your doctor.

If you have diabetes, severely reduced kidney function, or a high potassium intake in your diet, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Valsartan may cause severe harm to an unborn fetus and should not be used during pregnancy. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.

Breast-feeding: It is not known if sacubitril - valsartan passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between sacubitril - valsartan and any of the following:

  • aldesleukin
  • aliskiren
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • alpha agonists (e.g., clonidine, methyldopa)
  • amifostine
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
  • other angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • anti-psychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzepine, quetiapine, risperidone)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • brimonidine
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • canagliflozin
  • conivaptan
  • ciprofloxacin
  • cyclosporine
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • duloxetine
  • drospirenone
  • eltrombopag
  • eplerenone
  • guanfacine
  • heparin
  • levodopa
  • lithium
  • low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • methylphenidate
  • minoxidil
  • nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
  • non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
  • pentoxifylline
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • potassium supplements
  • ritonavir
  • salt substitutes that contain potassium
  • sodium phosphates
  • "statin" anti-cholesterol medications (e.g., atorvastatin, lovastatin, simvastatin)
  • teriflunomide
  • tolvaptan
  • trimethoprim
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Entresto

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