Sacubitril and valsartan (oral route)

Brand Name

US Brand Name

Entresto

Entresto Sprinkle

Description

Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalization. This medicine is also used to treat children with symptomatic heart failure.

Valsartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, valsartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

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

This product is available in the following dosage forms:

Tablet
Pellet

Before Using

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.

Pediatric

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.

Geriatric

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

Breastfeeding

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.

Drug Interactions

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
Cilazapril
Enalapril
Enalaprilat
Fosinopril
Lisinopril
Moexipril
Perindopril
Quinapril
Ramipril
Sparsentan
Spirapril
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.

Asciminib
Atrasentan
Azilsartan
Azilsartan Medoxomil
Candesartan
Ceftobiprole Medocaril
Cyclosporine
Darolutamide
Elexacaftor
Eltrombopag
Eprosartan
Furosemide
Irbesartan
Lithium
Losartan
Olmesartan
Potassium Citrate
Potassium Phosphate
Sacubitril
Simeprevir
Tacrolimus
Telmisartan
Trimethoprim
Valsartan
Voclosporin

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
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

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.

Proper Use

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 leaflet and patient instructions . Read and follow the instructions carefully. Ask your doctor if you have any questions.

For children who are unable to swallow the tablets, your pharmacist will mix this medicine as a liquid suspension. Shake the bottle of suspension well before each use.

To use the Entresto® Sprinkle oral pellets:

The Entresto® Sprinkle contains oral pellets inside of a capsule. The capsule must be opened and the pellets sprinkled on soft food (including applesauce, yogurt, or pudding). Do not swallow the empty capsule shells. Do not chew or crush the oral pellets.
In a small bowl or cup, place 1 to 2 teaspoonfuls of soft food.
Hold the capsule upright, with the colored cap on top, over the soft food. Gently pinch the middle of the capsule and pull slightly on the top with your other hand to separate the 2 ends of the capsule. Be careful not to spill the contents while opening the capsule.
Empty all of the pellets onto the food. Check the capsule to make sure that you did not miss any oral pellets. Tap the capsule to remove any remaining oral pellets.
Give or take the mixture right away.

Dosing

For heart failure:
- For oral dosage form (tablets):
  - Adults—At first, one tablet 2 times a day. Each tablet contains 49 milligrams (mg) sacubitril and 51 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 97 mg sacubitril and 103 mg valsartan 2 times a day.
  - Children 1 year of age and older weighing 40 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor.
    - Weighing 50 kilograms (kg) or more—At first, one tablet 2 times a day. Each tablet contains 49 milligrams (mg) sacubitril and 51 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 97 mg sacubitril and 103 mg valsartan 2 times a day.
    - Weighing 40 kg to less than 50 kg—At first, one tablet 2 times a day. Each tablet contains 24 mg sacubitril and 26 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 72 mg sacubitril and 78 mg valsartan 2 times a day.
    - Weighing less than 40 kg—Use of oral liquid or oral pellets is recommended.
  - Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For oral dosage form (pellets):
  - Children 1 year of age and older weighing less than 50 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
    - Weighing 34 kilograms (kg) to less than 50 kg—At first, 2 capsules 2 times a day. Each capsule contains 15 milligrams (mg) sacubitril and 16 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 60 mg sacubitril and 64 mg valsartan 2 times a day.
    - Weighing 26 kg to less than 34 kg—At first, 4 capsules 2 times a day. Each capsule contains 6 mg sacubitril and 6 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 45 mg sacubitril and 48 mg valsartan 2 times a day.
    - Weighing 19 kg to less than 26 kg—At first, 3 capsules 2 times a day. Each capsule contains 6 mg sacubitril and 6 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 30 mg sacubitril and 32 mg valsartan 2 times a day.
    - Weighing 13 kg to less than 19 kg—At first, 2 capsules 2 times a day. Each capsule contains 6 mg sacubitril and 6 mg valsartan. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 24 mg sacubitril and 24 mg valsartan 2 times a day.
    - Weighing less than 13 kg—Use of oral liquid is recommended.
  - Children younger than 1 year of age—Use and dose must be determined by your doctor.
- For oral dosage form (suspension):
  - Children younger than 1 year of age weighing less than 13 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. At first, 1.6 mg per kilogram (mg/kg) of body weight 2 times a day. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 3.1 mg/kg of body weight 2 times a day.

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.

You may store the mixed oral liquid at room temperature for up to 15 days. Do not refrigerate.

Precautions

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 breastfeed during treatment with this medicine.

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

This medicine may cause a serious allergic reaction, including angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have large or hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals.

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 feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

This medicine may cause a serious kidney problem. Check with your provider right away if you have agitation, confusion, decreased urine output, depression, dizziness, headache, hostility, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of the face, ankles, or hands, or unusual tiredness or weakness.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your provider right away if you have any of the following symptoms: abdominal or stomach pain, confusion, trouble breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness of the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

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

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

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
stomach pain
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

Incidence not known

Chest tightness
cough
difficulty swallowing
hives, itching, skin rash
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
trouble breathing

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.

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