An estimated five million Americans are currently living with a type of heart disease called congestive heart failure, which affects people of all age groups.
People with congestive heart failure are more likely to be hospitalized as their symptoms worsen, but a new medication, called Entresto, manufactured by Novartis Pharmaceuticals Corporation,, offers hope for some people with the condition.
Entresto features a new medication, called sacubitril, that is only found in Entresto and works differently from other medications to treat congestive heart failure.
What Is Entresto?
Entresto was first approved for medical use in the United States by the Food and Drug Administration (FDA) in 2015, which means that the drug is still manufactured under its original patent and no generic versions are available.
Sacubitril is a medication that is unique to Entresto, and it belongs to a class of drugs called neprilysin inhibitors.
Valsartan is a common drug used for the treatment of various heart conditions; it belongs to a class of drugs called angiotensin II receptor blockers, or ARBs.
It is commonly prescribed alongside other heart failure medications such as beta blockers and in place of an ACE inhibitor.
What Is Entresto Used to Treat?
Entresto is a chronic heart failure therapy, also known as congestive heart failure.
Entresto specifically treats a type of heart failure that occurs when the heart becomes enlarged and is too weak to sufficiently pump blood out to the body, i.e. reduced ejection fraction.
When a person experiences heart failure and doesn’t pump enough blood, blood and other fluids begin to back up inside the lungs, abdomen, liver, and lower body, which can contribute to increased risk of cardiovascular death.
There are four different stages of congestive heart failure, including:
- Class I: No symptoms are experienced, and the condition can be managed through medication, lifestyle changes, and monitoring.
- Class II: Experience shortness of breath, fatigue, and heart palpitations during normal physical activity, but feel fine during rest. The condition can still be managed through medication, lifestyle changes, and monitoring.
- Class III: Even mild physical activity can cause shortness of breath, fatigue, and heart palpitations, but still feel ok at rest. Treatment options are limited and can be complex.
- Class IV: Symptoms are present even at rest, and physical activity is impossible. No remaining treatment options are available.
How Does Entresto Work?
Entresto is a unique prescription drug for the treatment of heart failure, as it contains two active ingredients that each work in different ways.
Entresto is the first and only FDA-approved medication that helps to increase the heart’s ability to pump blood through the body in patients who have a certain type of chronic heart failure in which the heart is enlarged and too weak to properly pump blood from systolic dysfunction.
Valsartan is an ARB that works by keeping the blood vessels open and preventing them from narrowing, which helps to lower blood pressure and improve blood flow.
Sacubitril is a new medication that is only found in Entresto. Sacubitril is another blood pressure medicine that elevates the levels of some proteins in the body which have been found to help widen the blood vessels.
This action causes blood pressure to lower by reducing sodium levels.
As a result of these two actions, Entresto is able to help lower the risk of hospitalization and reduce the risk of death in people with a certain type of chronic heart failure.
Entresto is also used to treat heart failure in children who are at least 12 months of age.
What Is the Cost of Entresto?
As a relatively new medication, no generic forms of Entresto are available.
As such, there is no direct competition for the medication, which keeps prices high. The manufacturer also offers a co-pay card for patients with commercial insurance that do not have coverage for Entresto or who cannot afford their current prescription.
The co-pay card is not available for patients who have Medicare, Medicaid, or insurance through any other state or federal program.
Patient support programs are also available from the manufacturer but may have certain income and medical requirements that will prevent some patients from qualifying.
Are There Any Risks Associated with Entresto?
Taking Entresto can be helpful for many patients, but use of the drug is not without risk, even at a low dose. Risks associated with Entresto include:
- All patients, regardless of their current kidney health, should have their kidney function and potassium levels monitored periodically while taking Entresto, as the medication can cause kidney problems even in people who have never experienced issues with kidney function.
- People of African-American descent and those who have already experienced angioedema (swelling of the facial areas and airways) unrelated to ACE inhibitor administration are considered more likely to experience an allergic reaction to Entresto.
- Entresto can cause severe injury and death of the fetus in pregnant women who take the medication during the second and third trimesters of pregnancy. Women who become pregnant while taking Entresto should immediately stop use of the drug unless the medication is deemed to be a lifesaving benefit for the mother, who should be advised of risks to the fetus. Birth defects that are caused by the use of Entresto during pregnancy include:
- Reduced fetal renal function
- Fetal lung hypoplasia
- Skeletal deformations, including skull hypoplasia
- It is more common to experience low blood pressure when taking Entresto, and people taking water pills are more likely to experience low blood pressure.
- Entresto can cause increased levels of potassium in the blood, so your doctor should check your potassium level during treatment with Entresto.
What Dose of Entresto Do I Take?
The prescribing information recommended dosage for Entresto will depend on the condition being treated, the age of the patient, and several other factors.
Entresto is available in tablet form in three different strengths of its main ingredients, sacubitril and valsartan, including a starting dose of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg.
When taken for heart failure in adults, most patients will start taking Entresto at a dose of 49 mg/51 mg of sacubitril/valsartan taken twice per day.
The target maintenance dose for most patients is 97 mg/103 mg taken twice per day and is typically reached after two to four weeks. However, some patients may be able to begin taking the higher dose more quickly, while others may need more time, depending on their tolerance of the drug.
When Entresto is taken for pediatric heart failure in patients aged one year and older, the dosage varies by weight. Children take the recommended dose of Entresto twice daily, and patients typically have their dosages adjusted once every two weeks.
Pediatric patients weighing less than 40 kg start at a dose of 1.6 mg/kg and gradually increase their dosages to 2.3 mg/kg and 3.1 mg/kg, respectively.
Pediatric patients weighing at least 40 kg but less than 50 kg will begin taking the 24 mg/26 mg dose, then step up to the 49 mg/51 mg dose, ultimately reaching 72 mg/78 mg.
Pediatric patients who weigh over 50 kg start at a dose of 49 mg/51 mg, then increase to a dose of 72 mg/78 mg and finally to 97 mg/103 mg.
What Are the Side Effects of Entresto?
Side effects associated with Entresto are categorized as either common or serious.
Common side effects associated with Entresto include:
- Low blood pressure/symptomatic hypotension (especially in patients with an activated renin-angiotensin-aldosterone system)
- High potassium
- Kidney problems
- Serious allergic reaction, as indicated by swelling of the face, lips, tongue, and throat
- Low blood pressure or hypotension
- Kidney problems, as evidenced by a change in the amount of urine produced
- Increased potassium levels in the blood (hyperkalemia)
Who Should Not Take Entresto?
If you are allergic to any of the ingredients in Entresto, including sacubitril or valsartan, you should not take Entresto. Patients with a history of any of the following also should not take Entresto:
- Angioedema (swelling of the face/lips tongue/throat) or difficulty breathing while taking medications called ACE inhibitors or ARBs
- Currently taking an ACE inhibitor (angiotensin-converting enzyme inhibitor) medicine due to potential for drug interaction with concomitant use
- Have diabetes and are currently taking a medication that contains Aliskiren
Patients who have current hepatic or renal impairment, acute renal failure, are pregnant or planning to become pregnant (as the drug may transfer to the unborn baby), are breastfeeding or planning to breastfeed, or who have a history of angioedema or hereditary angioedema should speak to their doctor before taking Entresto.
Patients who are breastfeeding must either stop breastfeeding or stop feeding Entresto due to the medication’s tendency to pass through breast milk to a nursing infant.
Entresto can interact with certain prescription and over the counter medications, as well as vitamins and herbal supplements.
It is important to give your pharmacist and doctor a complete record of everything you’re taking, particularly as it pertains to potassium supplements, salt substitutes, nonsteroidal anti-inflammatory drugs (NSAIDs), medications for high blood pressure or heart problems, lithium, ACE inhibitors, ARBs, or aliskiren.
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