Sacubitril and valsartan

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Sacubitril is a blood pressure medicine. It works by increasing the levels of certain proteins in the body that can dilate (widen) blood vessels. This helps lower blood pressure by reducing sodium levels.

Valsartan is an angiotensin II receptor blocker (sometimes called an ARB). Valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Sacubitril and valsartan is a combination medicine used in certain people with chronic heart failure. This medicine helps lower the risk of needing to be hospitalized when symptoms get worse, and helps lower the risk of death from heart failure.

Sacubitril and valsartan is usually given together with other blood pressure medications.

Sacubitril and valsartan may also be used for purposes not listed in this medication guide.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking sacubitril and valsartan, unless your doctor has told you to.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of sacubitril and valsartan.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: Sacubitril 49 mg-Valsartan 51 mg orally twice a day

Maintenance dose: Sacubitril 97 mg-Valsartan 103 mg orally twice a day

Comments:
-Increase to the target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily) after 2 to 4 weeks, as tolerated.
-A starting dose of sacubitril 24 mg-valsartan 26 mg twice a day is recommended for patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) and for patients previously taking low doses of these agents. Double the dose every 2 to 4 weeks to the target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily), as tolerated.

Use: To reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic New York Heart Association (NYHA) Class II to IV heart failure and reduced ejection fraction; usually administered in conjunction with other heart failure therapies or in place of an ACE inhibitor or other ARB.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Take sacubitril and valsartan exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

sacubitril and valsartan comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Dosing

Tell your doctor if you have ever had any unusual or allergic reaction to sacubitril and valsartan or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

• For oral dosage form (tablets):
  • For heart failure:
    • Adults— At first, one tablet two times a day. Your doctor may increase your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of sacubitril and valsartan, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your or your child's progress at regular visits to make sure that sacubitril and valsartan is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using sacubitril and valsartan while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using sacubitril and valsartan, tell your doctor right away.

Do not take sacubitril and valsartan for at least 36 hours before or after you take an ACE inhibitor medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position or if you have been taking a diuretic (water pill). Make sure you know how you react to sacubitril and valsartan before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Ask your doctor before you use medicines, supplements, or salt substitutes that contain potassium.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain
• blurred vision
• confusion
• difficult breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular heartbeat
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• sweating
• unusual tiredness or weakness
• weakness or heaviness of the legs

• Bloody urine
• decreased frequency or amount of urine
• increased thirst
• loss of appetite
• lower back or side pain
• swelling of the face, fingers, or lower legs
• weight gain

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cough
• dizziness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate impairment (Child-Pugh class B): Initial: Sacubitril 24 mg and valsartan 26 mg twice daily

Severe impairment (Child-Pugh class C): Use not recommended (has not been studied).

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue sacubitril/valsartan as soon as possible.

Applies to sacubitril / valsartan: oral tablet

Along with its needed effects, sacubitril / valsartan may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sacubitril / valsartan:

• Abdominal or stomach pain
• blurred vision
• confusion
• difficult breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• irregular heartbeat
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• sweating
• unusual tiredness or weakness
• weakness or heaviness of the legs

• Bloody urine
• decreased frequency or amount of urine
• increased thirst
• loss of appetite
• lower back or side pain
• swelling of the face, fingers, or lower legs
• weight gain

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

Some side effects of sacubitril / valsartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Cough
• dizziness

Mild to moderate renal dysfunction: No adjustment recommended

Severe renal dysfunction (estimated GFR less than 30 mL/min/1.73 m2): Sacubitril 24 mg-Valsartan 26 mg orally twice a day; double dose every 2 to 4 weeks to target maintenance dose (sacubitril 97 mg-valsartan 103 mg twice daily), as tolerated.

US BOXED WARNING:
-FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.