Sacubitril

Heart Failure in Adults

Sacubitril is used to treat adults with chronic heart failure to reduce the risk of death from cardiovascular causes and to lower the chances of being hospitalized. It is typically prescribed for patients whose heart muscle is weak and cannot pump blood effectively, a condition often referred to as heart failure with reduced ejection fraction.

Heart Failure in Children

This medication is also used to treat symptomatic heart failure in children and adolescents aged 1 year and older. It helps manage the symptoms of heart failure and improves heart function in pediatric patients.

Combination Therapy

Sacubitril is not available as a single-ingredient medication. It is always used in a fixed-dose combination with valsartan, which belongs to a class of drugs called angiotensin II receptor blockers (ARBs). This combination is often used as a replacement for other types of heart or blood pressure medications, such as ACE inhibitors or other ARBs, to better manage heart failure symptoms and outcomes.

Typical Use Cases

Doctors may prescribe this medication for patients who:

• Have chronic heart failure that is getting worse.
• Need to reduce the risk of sudden hospitalization due to heart failure symptoms.
• Are children at least 1 year old with heart failure symptoms.

How Sacubitril Works

Sacubitril is a type of medicine called a neprilysin inhibitor. It is used to treat heart failure, usually in combination with another medication called valsartan. This combination helps the heart pump blood more effectively to the rest of the body.

The medication works by targeting an enzyme in the body called neprilysin. This enzyme is responsible for breaking down certain natural substances (peptides) that help keep blood vessels open and manage fluid levels. When sacubitril blocks this enzyme, the levels of these helpful substances increase.

Higher levels of these natural substances provide several benefits for patients with heart failure:

• Blood vessel relaxation: They help blood vessels widen, which lowers blood pressure and reduces the workload on the heart.
• Fluid management: They signal the kidneys to pass more salt and water into the urine, which reduces swelling and fluid buildup.
• Heart protection: They may help prevent harmful changes to the structure of the heart muscle over time.

By improving blood flow and reducing fluid retention, sacubitril helps decrease the risk of hospitalization and complications related to heart failure.

Common Side Effects

Some people may experience mild side effects while taking this medication. These often include:

• Dizziness or lightheadedness
• Cough
• Fainting

Serious Side Effects

While less common, some side effects require immediate medical attention. Contact a healthcare provider right away if you experience:

• Signs of an allergic reaction or angioedema, such as swelling of the face, lips, tongue, or throat
• Difficulty breathing or swallowing
• Signs of high potassium levels, such as muscle weakness or a slow, irregular heartbeat
• Signs of kidney problems, such as a change in the amount of urine or swelling in the legs and feet
• Severe low blood pressure

This is not a complete list of all possible side effects. Consult a healthcare professional for medical advice regarding any new or worsening symptoms.

Fetal Toxicity

Drugs that act on the renin-angiotensin system can cause injury and death to a developing fetus. Use of this medication should be discontinued as soon as pregnancy is detected.

Angioedema and Allergic Reactions

Sacubitril may cause angioedema, a serious swelling of the face, lips, tongue, and throat that can cause airway obstruction. This risk is higher in patients with a history of angioedema and in Black patients. This medication must not be taken within 36 hours of taking an ACE inhibitor, as this increases the risk of angioedema.

Contraindications

This medication should not be used by individuals who:

• Have a known hypersensitivity to any component of the drug.
• Are taking aliskiren and have diabetes.
• Have a history of angioedema related to previous ACE inhibitor or ARB therapy.

Hypotension

Low blood pressure (hypotension) may occur, particularly in patients who are volume-depleted or taking diuretics. Monitoring of blood pressure is often necessary during treatment initiation or dose adjustments.

Kidney Function and Potassium Levels

Treatment may lead to decreased kidney function or high levels of potassium in the blood (hyperkalemia). Regular monitoring of serum creatinine and potassium levels is typically recommended, especially in patients with pre-existing kidney disease or those taking other medications that increase potassium.

Pregnancy

Sacubitril is used in combination with valsartan, a drug that can cause severe harm or death to a developing fetus. The risk of fetal injury is highest when the medication is taken during the second and third trimesters of pregnancy. If you become pregnant while taking this medication, you should contact your healthcare provider immediately to discuss discontinuing the drug as soon as possible. It is important to talk with a clinician about safer treatment options if you are pregnant or planning to become pregnant.

Breastfeeding

It is currently unknown if sacubitril passes into human breast milk. Because of the potential for serious adverse reactions in a nursing infant, breastfeeding is generally not recommended while using this medication. Patients should consult with their healthcare provider to discuss the risks and benefits of breastfeeding versus continuing the medication.

Available Dosage Forms

Sacubitril is most commonly available as a combination medication containing both sacubitril and valsartan. It is supplied in the following oral forms:

• Oral Tablets: These are film-coated tablets intended to be swallowed whole.
• Oral Pellets: This form consists of granules provided in a capsule. The capsule is designed to be opened so the pellets can be sprinkled onto soft food or administered through a feeding tube for patients who have difficulty swallowing tablets.

Strengths

The combination of sacubitril and valsartan is available in several fixed-dose strengths. These strengths are generally categorized into low, medium, and high doses to allow healthcare providers to adjust the dosage based on the patient's needs and tolerance. The tablets and pellets are formulated with specific ratios of the two active ingredients to ensure consistent delivery of the medication.

FDA Approval Status

Sacubitril was approved by the U.S. Food and Drug Administration (FDA) in 2015. It is not available as a standalone medication; it is only approved for use in a fixed-dose combination with valsartan.

Approved Indications

The combination of sacubitril and valsartan is approved for the following uses:

• To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with chronic heart failure.
• To treat symptomatic heart failure in pediatric patients aged one year and older.

In adults, the medication is primarily used for patients with chronic heart failure whose heart does not pump blood effectively, though it may also be used in certain other heart failure cases depending on the patient's clinical status.

Boxed Warning

The FDA has issued a boxed warning for this medication regarding fetal toxicity. Drugs that act directly on the renin-angiotensin system can cause injury and death to a developing fetus. Treatment must be discontinued as soon as pregnancy is detected.

Factors Influencing Cost

The price of sacubitril and valsartan can vary significantly based on several factors:

• Insurance Coverage: Most commercial insurance plans and Medicare Part D plans cover this medication. However, the out-of-pocket cost depends on the specific plan's formulary, deductible, and copayment tiers.
• Generic Availability: Generic versions of the sacubitril and valsartan combination have received regulatory approval. Generic medications typically cost less than brand-name versions.
• Pharmacy Choice: Prices may differ between retail pharmacies, mail-order pharmacies, and independent drugstores. Some pharmacies may offer discount programs or lower cash prices.

Financial Assistance Programs

For patients who have difficulty affording their prescription, several options may be available:

• Manufacturer Savings Cards: Patients with commercial insurance may be eligible for savings cards provided by the manufacturer to reduce monthly copays.
• Patient Assistance Programs: Some programs provide the medication at a reduced cost or for free to individuals who meet specific income requirements or who do not have insurance.
• State and Local Programs: Some state pharmaceutical assistance programs help seniors or low-income individuals pay for prescription drugs.

It is advisable to contact your insurance provider or speak with a pharmacist to determine the exact cost and explore available financial assistance options.