Sacubitril and valsartan (Oral route)

Pronunciation:

sak-UE-bi-tril, val-SAR-tan

Brand Names:

Entresto

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system may cause fetal injury or death. Discontinue use immediately if pregnancy is detected .

Classifications:

Therapeutic—

Neprilysin Inhibitor/ARB Combination

Pharmacologic—

Angiotensin II Receptor Antagonist

Uses of This Medicine:

Sacubitril and valsartan combination is used together with other medicines to treat chronic heart failure in adults and cut down on the number of hospital visits for heart problems. It is also used to treat symptomatic heart failure in children 1 year of age and older.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sacubitril and valsartan combination in children 1 year of age and older.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sacubitril and valsartan combination in the elderly.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Aliskiren
Benazepril
Captopril
Enalapril
Enalaprilat
Fosinopril
Lisinopril
Moexipril
Perindopril
Quinapril
Ramipril
Sparsentan
Trandolapril
Zofenopril

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Benazepril
Captopril
Cilazapril
Enalapril
Enalaprilat
Fosinopril
Furosemide
Lisinopril
Lithium
Moexipril
Perindopril
Potassium Citrate
Potassium Phosphate
Quinapril
Ramipril
Simeprevir
Spirapril
Tacrolimus
Trandolapril
Trimethoprim
Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac
Acemetacin
Amtolmetin Guacil
Bromfenac
Bufexamac
Celecoxib
Choline Salicylate
Clonixin
Dexibuprofen
Dexketoprofen
Diclofenac
Diflunisal
Dipyrone
Droxicam
Eltrombopag
Etodolac
Etofenamate
Etoricoxib
Felbinac
Fenoprofen
Fepradinol
Feprazone
Floctafenine
Flufenamic Acid
Flurbiprofen
Ibuprofen
Indomethacin
Ketoprofen
Ketorolac
Lornoxicam
Loxoprofen
Lumiracoxib
Meclofenamate
Mefenamic Acid
Meloxicam
Morniflumate
Nabumetone
Naproxen
Nepafenac
Niflumic Acid
Nimesulide
Nimesulide Beta Cyclodextrin
Oxaprozin
Oxyphenbutazone
Parecoxib
Phenylbutazone
Piketoprofen
Piroxicam
Pranoprofen
Proglumetacin
Propionic Acid
Propyphenazone
Proquazone
Rofecoxib
Salicylic Acid
Salsalate
Sodium Salicylate
Sulindac
Tenoxicam
Tiaprofenic Acid
Tolfenamic Acid
Tolmetin
Valdecoxib

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Angioedema caused by ACE inhibitor or ARB therapy, history of or
Patients with diabetes who are also taking aliskiren (Tekturna®)—Should not be used in patients with these conditions.

Kidney disease, severe or
Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine 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.

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

For children who cannot swallow the tablets, your pharmacist will mix this medicine as a liquid suspension. Shake the bottle of suspension well for at least 10 seconds before giving it to your child.

Dosing—

For oral dosage form (tablets):
- For heart failure:
  - For patients taking Entresto® with an ACE inhibitor or ARB:
    - Adults—At first, 1 tablet of 49 milligrams (mg) of sacubitril and 51 mg of valsartan 2 times a day. After 2 to 4 weeks, your doctor may increase your dose as needed and tolerated. However, the dose is usually not more than 1 tablet of Entresto® 97/103 mg two times a day.
    - Children 1 year of age and older and weighing at least 50 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The starting dose is 1 tablet of Entresto® 49/51 mg two times a day. Your doctor will increase your dose every 2 weeks as needed and tolerated. However, the dose is usually not more than 1 tablet of Entresto® 97/103 mg two times a day.
    - Children 1 year of age and older and weighing at least 40 kg to less than 50 kg—Dose is based on body weight and must be determined by your doctor. The starting dose is 1 tablet of Entresto® 24/26 mg two times a day. Your doctor will increase your dose every 2 weeks as needed and tolerated. However, the dose is usually not more than 3 tablets of Entresto® 24/26 mg two times a day.
    - Children 1 year of age and older and weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor. The starting dose is 1.6 mg per kg of body weight two times a day. Your doctor will increase your dose every 2 weeks as needed and tolerated. However, the dose is usually not more than 3.1 mg per kg of body weight two times a day.
    - Children younger than 1 year of age—Use and dose must be determined by your doctor.
  - For patients not currently taking an ACE inhibitor or ARB and for patients previously taking low doses of ACE inhibitor or ARB:
    - Adults—At first, 1/2 tablet of Entresto® 49/51 mg two times a day. After 2 to 4 weeks, your doctor may double your dose as needed and tolerated. However, the dose is usually not more than 1 tablet of Entresto® 97/103 mg two times a day.
    - Children 1 year of age and older and weighing at least 50 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The starting dose is 1/2 tablet of Entresto® 49/51 two times a day. Your doctor will increase your dose every 2 weeks as needed and tolerated. However, the dose is usually not more than 1 tablet of Entresto® 97/103 mg two times a day.
    - Children 1 year of age and older and weighing at least 40 kg to less than 50 kg—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.8 mg per kg of body weight two times a day. Your doctor will increase your dose every 2 weeks as needed and tolerated. However, the dose is usually not more than 3 tablets of Entresto® 24/26 mg two times a day.
    - Children 1 year of age and older and weighing less than 40 kg—Dose is based on body weight and must be determined by your doctor.
    - Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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—

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.

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

Store the mixed oral suspension in room temperature for up to 15 days. Do not refrigerate.

Precautions While Using This Medicine:

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

Using this medicine 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 this medicine, tell your doctor right away.

Do not take this medicine 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 this medicine 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.

Side Effects of This Medicine:

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:

More common: 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

Less common: 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

Rare: 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:

More common: 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.

Last Updated: 11/16/2023

The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites.