WARNING

Valsartan and sacubitril are medications used to treat heart conditions. Valsartan is an angiotensin II receptor blocker (ARB), and sacubitril is a neprilysin inhibitor. They are often combined in a single medication called sacubitril/valsartan.

While these medications can be effective in managing heart-related issues, they also come with potential risks and side effects. It’s essential to note that individual responses to medications can vary, and not everyone will experience these side effects. Some potential risks associated with valsartan and sacubitril include:

• Hypotension (Low Blood Pressure): Both medications can cause a drop in blood pressure, especially when first starting the treatment or when the dosage is increased. This can lead to dizziness, lightheadedness, or fainting.
• Hyperkalemia (High Potassium Levels): Valsartan can increase potassium levels in the blood. High levels of potassium can be dangerous and may lead to heart rhythm abnormalities.
• Renal Impairment: These medications may affect kidney function, especially in individuals with pre-existing kidney issues. Regular monitoring of kidney function is typically recommended.
• Angioedema: This is a rare but serious side effect that involves swelling of the deeper layers of the skin, often around the eyes and lips. It can be life-threatening if it affects the throat.
• Cough: Some people may experience a persistent cough as a side effect of these medications.
• Altered Blood Glucose Levels: Valsartan may affect blood glucose levels, and individuals with diabetes should monitor their blood sugar carefully.
• Interaction with Other Medications: Both medications can interact with other drugs, so it’s crucial to inform your healthcare provider about all the medications and supplements you are taking.
• Pregnancy Risk: Valsartan and sacubitril may cause harm to an unborn baby, so they are generally not recommended during pregnancy. If pregnancy is detected, alternative medications may be considered.

It’s important to consult with a healthcare professional before starting or discontinuing any medication. They can provide personalized advice based on your medical history and specific health conditions. If you experience any concerning side effects while taking these medications, it’s essential to seek prompt medical attention.

Why is this medication prescribed?

Valsartan and sacubitril are medications that are commonly prescribed together in a single fixed-dose combination known as sacubitril/valsartan. This combination medication is primarily used for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults.

The combination of sacubitril and valsartan is designed to target different pathways involved in the progression of heart failure. By combining these two medications, the hope is to achieve greater therapeutic benefits than using either drug alone. This medication has been shown in clinical trials to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with HFrEF.

How should this medicine be used?

The combination medication sacubitril/valsartan is available in tablet form and is taken orally. It’s important to follow your healthcare provider’s instructions and the information provided on the prescription label. Here are some general guidelines on how sacubitril/valsartan is typically used:

• Dosage: The dosage will depend on your specific medical condition and response to treatment. Your healthcare provider will determine the appropriate dose for you. The typical starting dose is one tablet containing sacubitril 49 mg/valsartan 51 mg (often referred to as the 50/50 dose) twice daily. The dosage may be adjusted based on your tolerance and response to the medication.
• Administration: Take sacubitril/valsartan regularly and at the same time(s) every day. The tablets can be taken with or without food. Swallow the tablet whole with water. Do not crush or chew the tablets.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double up on doses to make up for a missed one.
• Precautions: Inform your healthcare provider about all the medications you are currently taking, including prescription, over-the-counter drugs, and herbal supplements, as they may interact with sacubitril/valsartan. It’s important to have regular check-ups and follow-up appointments with your healthcare provider to monitor your response to the medication and adjust the dosage if needed. Report any unusual side effects or symptoms to your healthcare provider promptly.
• Special Populations: Sacubitril/valsartan is not recommended during pregnancy. It can harm an unborn baby, so effective contraception is essential for women of childbearing age. It is also not recommended for breastfeeding mothers.

Always follow your healthcare provider’s recommendations and guidelines. If you have any questions or concerns about how to take sacubitril/valsartan, do not hesitate to contact your healthcare provider for clarification.

Other uses for this medicine

Valsartan and sacubitril, typically prescribed together as sacubitril/valsartan, are primarily used for the treatment of heart failure with reduced ejection fraction (HFrEF). As of last update, this remains the primary approved use. However, it’s essential to note that medical guidelines and approved uses may evolve, so it’s advisable to consult with a healthcare professional or refer to the most recent medical literature for the latest information.

What special precautions should I follow?

Special Precautions for Valsartan and Sacubitril:

• Pregnancy and Breastfeeding: Valsartan and sacubitril are generally contraindicated during pregnancy due to potential harm to the fetus. Effective contraception is recommended. It’s not recommended for use while breastfeeding, as the medications may pass into breast milk.
• Angioedema: Individuals with a history of angioedema related to previous ACE inhibitor or ARB therapy should use sacubitril/valsartan with caution.
• Renal Impairment: Regular monitoring of renal function is essential, especially in patients with pre-existing kidney conditions. Dosage adjustments may be necessary based on kidney function.
• Hypotension: Sacubitril/valsartan can cause low blood pressure, especially during the initiation of treatment or dosage adjustments. Patients should be advised to rise slowly from a sitting or lying position to minimize the risk of dizziness or fainting.
• Hyperkalemia: Monitoring of potassium levels is important, as sacubitril/valsartan may increase potassium levels in the blood. Patients should avoid excessive consumption of potassium-rich foods or supplements.
• Interactions with Other Medications: Inform your healthcare provider about all medications, including prescription, over-the-counter, and herbal supplements, as they may interact with sacubitril/valsartan.
• Discontinuation: Discontinuing sacubitril/valsartan abruptly may lead to an increase in symptoms of heart failure. Dosage adjustments should be made under the guidance of a healthcare professional.

Always follow your healthcare provider’s instructions regarding the use of sacubitril/valsartan, and promptly report any unusual or severe side effects. If you have specific health concerns or conditions, your healthcare provider can provide tailored advice based on your individual medical history.

What special dietary instructions should I follow?

• Potassium-Rich Foods: Avoid excessive consumption of potassium-rich foods (e.g., bananas, oranges, spinach) and potassium supplements unless specifically advised by your healthcare provider. High potassium levels can be a concern when taking sacubitril/valsartan.
• Salt Intake: Your healthcare provider may recommend dietary changes to manage sodium (salt) intake. Reduced salt intake can help manage blood pressure and fluid balance.

What should I do if I forget a dose?

• If you forget to take a dose of sacubitril/valsartan, take it as soon as you remember.
• If it is almost time for your next scheduled 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 unsure about what to do, contact your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Valsartan and sacubitril, especially when used together in the combination medication sacubitril/valsartan, can cause various side effects. It’s important to note that not everyone will experience these side effects, and the severity can vary from person to person. Common side effects and potential adverse reactions include:

• Hypotension (Low Blood Pressure): Dizziness, lightheadedness, or fainting may occur, especially when standing up quickly. This is more likely to happen when initiating treatment or adjusting the dosage.
• Hyperkalemia (High Potassium Levels): Elevated levels of potassium in the blood can lead to symptoms such as weakness, fatigue, or irregular heartbeats.
• Renal Impairment: Changes in kidney function, especially in individuals with pre-existing kidney issues.
• Angioedema: Swelling of deeper layers of the skin, often around the eyes and lips. This is a rare but serious side effect that can be life-threatening if it affects the throat.
• Cough: While less common with ARBs compared to ACE inhibitors, a persistent cough can still occur.
• Altered Blood Glucose Levels: Valsartan may affect blood glucose levels, and individuals with diabetes should monitor their blood sugar carefully.
• Impaired Renal Function: Sacubitril can increase blood urea nitrogen (BUN) and serum creatinine levels, indicating potential renal impairment.
• Decreased Hemoglobin and Hematocrit: Some individuals may experience a decrease in hemoglobin and hematocrit levels.
• Dizziness and Fatigue: These can be common side effects, especially when starting the medication.
• Elevated Blood Uric Acid: Sacubitril may increase blood uric acid levels, which could be a concern for individuals with gout.

It’s essential to contact your healthcare provider if you experience any severe or persistent side effects. Additionally, if you notice signs of an allergic reaction, such as difficulty breathing, swelling, or severe rash, seek emergency medical attention.

This list is not exhaustive, and individual responses to medications can vary. Your healthcare provider can provide more detailed information based on your medical history and help weigh the potential benefits against the risks of these medications. They will also guide you on what symptoms to monitor and when to seek medical attention.

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

Storage and Disposal of Valsartan and Sacubitril:

• Storage:
  • Store sacubitril/valsartan at room temperature, away from moisture and heat.
  • Keep the medication in its original container, and close the bottle tightly after each use.
• Disposal:
  • Dispose of unused or expired medications properly. Follow local regulations for medication disposal.
  • Do not flush medications down the toilet unless instructed to do so. Check with your local pharmacy or health department for guidance on safe disposal methods, such as medication take-back programs.

In case of emergency/overdose

In case of emergency or overdose, seek medical attention immediately. Contact your local poison control center at 1-800-222-1222 or go to the nearest emergency room. Symptoms of overdose may include severe dizziness, fainting, or extreme fatigue.

What other information should I know?

• Regular Monitoring: Your healthcare provider may schedule regular check-ups to monitor your response to sacubitril/valsartan. This may include blood pressure checks, kidney function tests, and electrolyte monitoring.
• Dietary Considerations: Maintain a consistent and balanced diet, and avoid excessive intake of potassium-rich foods or supplements. Follow any dietary recommendations provided by your healthcare provider.
• Medication Interactions: Inform your healthcare provider about all medications, including prescription, over-the-counter, and herbal supplements, as they may interact with sacubitril/valsartan.
• Missed Dose: If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double up on doses.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of sacubitril/valsartan with your healthcare provider. It is generally not recommended during pregnancy and breastfeeding.
• Allergic Reactions: If you experience signs of an allergic reaction, such as difficulty breathing, swelling, or severe rash, seek emergency medical attention.

Always follow your healthcare provider’s instructions and inform them of any concerns or changes in your health. They can provide personalized guidance based on your medical history and help manage your medication effectively. If you have specific questions about sacubitril/valsartan or its use, consult with your healthcare provider or pharmacist for the most accurate and up-to-date information.