WARNING

Entresto (sacubitril/valsartan) is a medication used to treat heart failure with reduced ejection fraction. While it can be effective, there are potential risks associated with its use:

• Hypotension (low blood pressure): Entresto can cause a drop in blood pressure, especially in the initial stages of treatment, which may lead to dizziness or fainting.
• Hyperkalemia (high potassium levels): Entresto can cause an increase in potassium levels in the blood, which may lead to complications such as irregular heartbeats or muscle weakness.
• Renal impairment: It may worsen kidney function, particularly in patients with pre-existing renal impairment or those taking other medications that affect the kidneys.
• Angioedema: In rare cases, Entresto can cause swelling of the face, lips, tongue, or throat, which can be severe and require immediate medical attention.
• Hypersensitivity reactions: Some individuals may experience allergic reactions to Entresto, including rash, itching, or difficulty breathing.
• Fetal toxicity: Entresto is contraindicated during pregnancy as it may harm the fetus. Women of childbearing age should use effective contraception while taking this medication.
• Interaction with other medications: Entresto may interact with other drugs, particularly potassium-sparing diuretics or potassium supplements, leading to an increased risk of hyperkalemia.

It’s important for patients to discuss their medical history and any other medications they are taking with their healthcare provider before starting Entresto to minimize the risks and ensure safe and effective treatment. Regular monitoring of blood pressure, kidney function, and potassium levels is typically recommended during treatment.

Why is this medication prescribed?

Entresto (sacubitril/valsartan) is prescribed primarily for the treatment of heart failure with reduced ejection fraction (HFrEF). It is specifically indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with symptomatic chronic heart failure and reduced ejection fraction.

The combination of sacubitril and valsartan in Entresto works through two mechanisms: sacubitril inhibits the enzyme neprilysin, which increases levels of beneficial peptides, while valsartan is an angiotensin II receptor blocker (ARB) that blocks the effects of angiotensin II, leading to vasodilation and decreased blood pressure.

Entresto is typically used in patients who remain symptomatic despite treatment with standard therapy, such as ACE inhibitors, beta-blockers, or aldosterone antagonists.

How should this medicine be used?

As for how Entresto should be used:

• Starting dose: The recommended starting dose is usually one tablet of Entresto containing 49 mg of sacubitril and 51 mg of valsartan, taken twice daily.
• Titration: The dosage may be increased after 2 to 4 weeks to the target maintenance dose of one tablet containing 97 mg of sacubitril and 103 mg of valsartan, taken twice daily, depending on tolerability.
• Administration: Entresto tablets should be swallowed whole with or without food.
• Missed doses: If a dose is missed, patients should take the next dose at the usual time; double doses should not be taken to make up for missed doses.
• Special populations: Dose adjustments may be necessary in patients with renal impairment or hepatic impairment.
• Monitoring: Patients should be monitored regularly for signs of hypotension, hyperkalemia, and renal function during treatment with Entresto.

It’s crucial for patients to follow their healthcare provider’s instructions carefully regarding the use of Entresto to maximize its benefits and minimize the risk of adverse effects. Additionally, they should inform their healthcare provider about any other medications, supplements, or medical conditions they have before starting Entresto.

Other uses for this medicine

Apart from its primary use in heart failure, there may be other potential uses for Entresto being explored in clinical research. Some of these include:

• Hypertension: Entresto may be studied for its potential to manage hypertension (high blood pressure).
• Renal Protection: Research suggests that Entresto might have benefits in protecting renal function, particularly in patients with chronic kidney disease and heart failure.

What special precautions should I follow?

As for special precautions to follow when taking Entresto:

• Pregnancy and breastfeeding: Entresto is contraindicated during pregnancy as it may harm the fetus. Women of childbearing potential should use effective contraception during treatment with Entresto. It’s also not recommended for use while breastfeeding.
• Kidney function: Entresto can cause a decline in kidney function, especially in patients with pre-existing renal impairment or those taking other medications affecting the kidneys. Regular monitoring of kidney function is essential during treatment.
• Potassium levels: Entresto may increase potassium levels in the blood, which can lead to hyperkalemia. It should be used cautiously in patients at risk of hyperkalemia, such as those with kidney impairment or those taking potassium-sparing diuretics or potassium supplements. Regular monitoring of potassium levels is recommended.
• Hypotension: Entresto can cause low blood pressure, especially during the initiation of treatment or dose adjustments. Patients should be monitored for symptoms of hypotension, such as dizziness or fainting. Adjustments to concomitant medications may be necessary.
• Angioedema: Rare cases of angioedema (swelling of the face, lips, tongue, or throat) have been reported with Entresto. Patients should be advised to seek medical attention immediately if they experience symptoms of angioedema.
• Hypersensitivity reactions: Some individuals may experience allergic reactions to Entresto, such as rash, itching, or difficulty breathing. If any signs of hypersensitivity occur, patients should discontinue Entresto and seek medical attention.
• Interactions: Entresto may interact with other medications, including potassium-sparing diuretics, potassium supplements, nonsteroidal anti-inflammatory drugs (NSAIDs), and lithium. Patients should inform their healthcare provider about all medications and supplements they are taking before starting Entresto.
• Liver function: Entresto should be used with caution in patients with hepatic impairment, as it has not been extensively studied in this population. Liver function tests may be monitored during treatment.

It’s essential for patients to discuss their medical history and any concerns with their healthcare provider before starting Entresto to ensure safe and effective treatment. Compliance with healthcare provider instructions, including dosage adjustments and monitoring, is crucial for optimal management of heart failure and minimizing the risk of adverse effects.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with taking Entresto. However, it’s important to maintain a balanced diet and avoid excessive intake of foods high in potassium, as Entresto can increase potassium levels in the blood. If you have concerns about your diet or potassium intake, discuss them with your healthcare provider or a registered dietitian.

What should I do if I forget a dose?

If you miss a dose of Entresto, take it as soon as you remember, unless it is close to the time for your next dose. In that case, skip the missed dose and take your next dose at the scheduled time. Do not double up on doses to make up for a missed one. If you are unsure about what to do, contact your healthcare provider or pharmacist for guidance. Consistent adherence to your prescribed dosing schedule is important for achieving optimal treatment outcomes.

What side effects can this medication cause?

Entresto (sacubitril/valsartan) can cause various side effects, although not everyone experiences them. Common side effects of Entresto may include:

• Hypotension (low blood pressure): This can cause dizziness, lightheadedness, or fainting, especially when standing up quickly.
• Hyperkalemia (high potassium levels): Entresto can increase potassium levels in the blood, which may lead to symptoms such as weakness, palpitations, or irregular heartbeats.
• Renal impairment: Some patients may experience a decline in kidney function while taking Entresto, particularly those with pre-existing kidney disease or other medications affecting the kidneys.
• Cough: Entresto may cause a persistent dry cough in some individuals, similar to other medications that affect the renin-angiotensin system.
• Angioedema: Although rare, Entresto can cause swelling of the face, lips, tongue, or throat, which can be severe and require immediate medical attention.
• Hypersensitivity reactions: Some people may experience allergic reactions to Entresto, such as rash, itching, or difficulty breathing.
• Fatigue: Feeling tired or fatigued is a common side effect of Entresto.
• Headache: Some patients may experience headaches while taking Entresto.
• Diarrhea: Entresto can occasionally cause diarrhea as a side effect.
• Dizziness: Feeling dizzy or experiencing vertigo is another potential side effect of Entresto.

It’s essential to report any side effects you experience while taking Entresto to your healthcare provider. They can help determine whether the side effect is significant and whether any adjustments to your treatment plan are necessary. Additionally, some side effects may diminish over time as your body adjusts to the medication.

What should I know about storage and disposal of this medication?

Storage and disposal:

• Storage: Store Entresto tablets at room temperature away from moisture, heat, and light. Keep the medication in its original packaging and out of reach of children and pets.
• Disposal: Dispose of unused or expired Entresto tablets properly according to local regulations or guidelines. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist or local waste disposal facility for guidance on proper disposal methods.

In case of emergency/overdose

• Seek medical attention: In case of an overdose or if you suspect you have taken too much Entresto, seek immediate medical assistance or contact your local poison control center. Do not attempt to treat the overdose yourself.
• Symptoms: Symptoms of an Entresto overdose may include severe hypotension (low blood pressure), dizziness, fainting, increased potassium levels (hyperkalemia), and other adverse effects. Prompt medical intervention is necessary to address these symptoms and prevent complications.

What other information should I know?

• Follow-up appointments: Attend all scheduled follow-up appointments with your healthcare provider while taking Entresto. These visits are essential for monitoring your response to the medication, adjusting your dosage if needed, and addressing any concerns or side effects.
• Medication interactions: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Entresto. Certain medications, such as potassium-sparing diuretics, potassium supplements, and certain antihypertensive drugs, can increase the risk of side effects or complications when taken concomitantly with Entresto.
• Lifestyle modifications: Your healthcare provider may recommend certain lifestyle modifications to complement your treatment with Entresto, such as maintaining a healthy diet, limiting alcohol consumption, quitting smoking, and engaging in regular exercise. Follow these recommendations to optimize the effectiveness of your treatment and improve your overall health.
• Emergency medical information: Carry emergency medical identification (e.g., a wallet card or bracelet) indicating that you are taking Entresto in case of a medical emergency.

By following these guidelines and staying informed about the storage, disposal, emergency procedures, and other important information related to Entresto, you can help ensure safe and effective treatment.