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mechanism of action is Angiotensin 2 Receptor Antagonists [MoA]

Entresto

(Sacubitril And Valsartan)

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Dosage & Administration

* The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103mg orally twice daily. (

2.2 Adult Heart Failure

The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily.

Double the dose of ENTRESTO after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

)
* Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient. (

2.2 Adult Heart Failure

The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily.

Double the dose of ENTRESTO after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.

)

* For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions. (

2.3 Pediatric Heart Failure

For the recommended dosage for pediatric patients aged 1 year and older, refer to Table 1 if using the tablets, or Table 2 if using the oral pellets.

Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Table 1: Recommended Dose and Titration for Pediatric Patients Using Tablets
^†Use of the oral suspension or oral pellets (see Table 2) is recommended in these patients. Recommended mg/kg doses are of the combined amount of both sacubitril and valsartan [see Dosage and Administration (2.4, 2.5)] . ^‡Doses of 72 mg/78 mg can be achieved using three 24 mg/26 mg tablets [see Dosage Forms and Strengths (3)] .
	Titration Step Dose (twice daily)
Weight (kg)	Starting	Second	Final
Less than 40 kg^†	1.6 mg/kg	2.3 mg/kg	3.1 mg/kg
At least 40 kg, less than 50 kg	24 mg/26 mg	49 mg/51 mg	72 mg/78 mg^‡
At least 50 kg	49 mg/51 mg	72 mg/78 mg^‡	97 mg/103 mg

Table 2: Recommended Dose and Titration for Pediatric Patients using ENTRESTO SPRINKLE^†
^†When using capsules, more than one capsule may be needed to achieve recommended doses. Oral pellets are contained within each capsule. Use the entire contents of the capsules to achieve the dose. ^‡Recommended mg/kg doses are of the combined amount of sacubitril and valsartan [see Dosage and administration (2.4)] . ^*For patients 50 kg or more, see Table 1.
	Titration Step Dose (twice daily)
Weight (kg)^*	Starting	Second	Final
Less than 13 (use oral suspension^‡)	1.6 mg/kg	2.3 mg/kg	3.1 mg/kg
13 to less than 19	12 mg/12 mg (Two 6 mg/6 mg capsules)	18 mg/18 mg (Three 6 mg/6 mg capsules)	24 mg/24 mg (Four 6 mg/6 mg capsules)
19 to less than 26	18 mg/18 mg (Three 6 mg/6 mg capsules)	24 mg/24 mg (Four 6 mg/6 mg capsules)	30 mg/32 mg (Two 15 mg/16 mg capsules)
26 to less than 34	24 mg/24 mg (Four 6 mg/6 mg capsules)	30 mg/32 mg (Two 15 mg/16 mg capsules)	45 mg/48 mg (Three 15 mg/16 mg capsules)
34 to less than 50^*	30 mg/32 mg (Two 15 mg/16 mg capsules)	45 mg/48 mg (Three 15 mg/16 mg capsules)	60 mg/64 mg (Four 15 mg/16 mg capsules)

2.4 Preparation of Oral Suspension Using Tablets

ENTRESTO oral suspension can be substituted at the recommended tablet dosage in patients unable to swallow tablets.

ENTRESTO 800 mg/200 mL oral suspension can be prepared in a concentration of 4 mg/mL (sacubitril/valsartan 1.96/2.04 mg/mL). Use ENTRESTO 49/51 mg tablets in the preparation of the suspension.

To make an 800 mg/200 mL (4 mg/mL) oral suspension, transfer eight tablets of ENTRESTO 49/51 mg film-coated tablets into a mortar. Crush the tablets into a fine powder using a pestle. Add 60 mL of Ora-Plus^®into the mortar and triturate gently with pestle for 10 minutes, to form a uniform suspension. Add 140 mL of Ora-Sweet^®SF into mortar and triturate with pestle for another 10 minutes, to form a uniform suspension. Transfer the entire contents from the mortar into a clean 200 mL amber colored PET or glass bottle. Place a press-in bottle adapter and close the bottle with a child resistant cap.

The oral suspension can be stored for up to 15 days. Do not store above 25°C (77°F) and do not refrigerate. Shake before each use.

^*Ora-Sweet SF^®and Ora-Plus^®are registered trademarks of Paddock Laboratories, Inc.

2.5 Preparation and Administration of Oral Pellets

ENTRESTO SPRINKLE are oral pellets contained within capsules. Do not swallow the capsules. Do not chew or crush the oral pellets.

ENTRESTO SPRINKLE can also be substituted in patients unable to swallow tablets.

Use the entire contents of the capsules to achieve the dose.

To administer ENTRESTO oral pellets, open the capsule and sprinkle the full content onto 1 to 2 teaspoons of soft food. Consume the food containing the oral pellets immediately after adding them. Empty capsule shells must be discarded after use and not swallowed. Do not administer ENTRESTO oral pellets via nasogastric, gastrostomy, or other enteral tubes because it may cause obstruction of enteral tubes.

)
* Reduce starting dose to half the usually recommended starting dosage for:

* patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. (

2.6 Dose Adjustment for Patients Not Taking an ACE inhibitor or ARB or Previously Taking Low Doses of These Agents

In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) and for patients previously taking low doses of these agents, start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose every 2 to 4 weeks in adults and every 2 weeks in pediatric patients to follow the recommended dose escalation thereafter

[see Dosage and Administration (2.2, 2.3)]

Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets

[see Dosage and Administration (2.3, 2.4, 2.5)]

)
* patients with severe renal impairment. (

2.7 Dose Adjustment for Severe Renal Impairment

In adults and pediatric patients with severe renal impairment estimated glomerular filtration rate (eGFR less than 30 mL/min/1.73 m²), start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter

[see Dosage and Administration (2.2, 2.3)]

Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets

[see Dosage and Administration (2.3, 2.4, 2.5)]

No starting dose adjustment is needed for mild or moderate renal impairment.

)
* patients with moderate hepatic impairment. (

2.8 Dose Adjustment for Hepatic Impairment

In adults and pediatric patients with moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter

[see Dosage and Administration (2.2, 2.3)]

Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets

[see Dosage and Administration (2.3, 2.4, 2.5)]

No starting dose adjustment is needed for mild hepatic impairment.

Use in patients with severe hepatic impairment is not recommended.

)

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Entresto Prescribing Information

Dosage and Administration (

2.3 Pediatric Heart Failure

For the recommended dosage for pediatric patients aged 1 year and older, refer to Table 1 if using the tablets, or Table 2 if using the oral pellets.

Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Table 1: Recommended Dose and Titration for Pediatric Patients Using Tablets
^†Use of the oral suspension or oral pellets (see Table 2) is recommended in these patients. Recommended mg/kg doses are of the combined amount of both sacubitril and valsartan [see Dosage and Administration (2.4, 2.5)] . ^‡Doses of 72 mg/78 mg can be achieved using three 24 mg/26 mg tablets [see Dosage Forms and Strengths (3)] .
	Titration Step Dose (twice daily)
Weight (kg)	Starting	Second	Final
Less than 40 kg^†	1.6 mg/kg	2.3 mg/kg	3.1 mg/kg
At least 40 kg, less than 50 kg	24 mg/26 mg	49 mg/51 mg	72 mg/78 mg^‡
At least 50 kg	49 mg/51 mg	72 mg/78 mg^‡	97 mg/103 mg

Table 2: Recommended Dose and Titration for Pediatric Patients using ENTRESTO SPRINKLE^†
^†When using capsules, more than one capsule may be needed to achieve recommended doses. Oral pellets are contained within each capsule. Use the entire contents of the capsules to achieve the dose. ^‡Recommended mg/kg doses are of the combined amount of sacubitril and valsartan [see Dosage and administration (2.4)] . ^*For patients 50 kg or more, see Table 1.
	Titration Step Dose (twice daily)
Weight (kg)^*	Starting	Second	Final
Less than 13 (use oral suspension^‡)	1.6 mg/kg	2.3 mg/kg	3.1 mg/kg
13 to less than 19	12 mg/12 mg (Two 6 mg/6 mg capsules)	18 mg/18 mg (Three 6 mg/6 mg capsules)	24 mg/24 mg (Four 6 mg/6 mg capsules)
19 to less than 26	18 mg/18 mg (Three 6 mg/6 mg capsules)	24 mg/24 mg (Four 6 mg/6 mg capsules)	30 mg/32 mg (Two 15 mg/16 mg capsules)
26 to less than 34	24 mg/24 mg (Four 6 mg/6 mg capsules)	30 mg/32 mg (Two 15 mg/16 mg capsules)	45 mg/48 mg (Three 15 mg/16 mg capsules)
34 to less than 50^*	30 mg/32 mg (Two 15 mg/16 mg capsules)	45 mg/48 mg (Three 15 mg/16 mg capsules)	60 mg/64 mg (Four 15 mg/16 mg capsules)

2.5 Preparation and Administration of Oral Pellets

ENTRESTO SPRINKLE are oral pellets contained within capsules. Do not swallow the capsules. Do not chew or crush the oral pellets.

ENTRESTO SPRINKLE can also be substituted in patients unable to swallow tablets.

Use the entire contents of the capsules to achieve the dose.

)

4/2024

ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated:

to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. (
1.1 Adult Heart Failure
ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal.
LVEF is a variable measure, so use clinical judgment in deciding whom to treat
[see Clinical Studies (14.1)]
.
)
for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. (
1.2 Pediatric Heart Failure
ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.
)

The recommended starting dosage for adults is 49 mg/51 mg orally twice daily. The target maintenance dose is 97 mg/103mg orally twice daily. (
2.2 Adult Heart Failure
The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily.
Double the dose of ENTRESTO after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
)
Adjust adult doses every 2 to 4 weeks to the target maintenance dose, as tolerated by the patient. (
2.2 Adult Heart Failure
The recommended starting dose of ENTRESTO is 49/51 mg orally twice-daily.
Double the dose of ENTRESTO after 2 to 4 weeks to the target maintenance dose of 97/103 mg twice daily, as tolerated by the patient.
)

For pediatric patients, see the Full Prescribing Information for recommended dosage, titrations, preparation and administration instructions. (

2.3 Pediatric Heart Failure

For the recommended dosage for pediatric patients aged 1 year and older, refer to Table 1 if using the tablets, or Table 2 if using the oral pellets.

Take the recommended dose orally twice daily. Adjust pediatric patient doses every 2 weeks, as tolerated by the patient.

Table 1: Recommended Dose and Titration for Pediatric Patients Using Tablets
^†Use of the oral suspension or oral pellets (see Table 2) is recommended in these patients. Recommended mg/kg doses are of the combined amount of both sacubitril and valsartan [see Dosage and Administration (2.4, 2.5)] . ^‡Doses of 72 mg/78 mg can be achieved using three 24 mg/26 mg tablets [see Dosage Forms and Strengths (3)] .
	Titration Step Dose (twice daily)
Weight (kg)	Starting	Second	Final
Less than 40 kg^†	1.6 mg/kg	2.3 mg/kg	3.1 mg/kg
At least 40 kg, less than 50 kg	24 mg/26 mg	49 mg/51 mg	72 mg/78 mg^‡
At least 50 kg	49 mg/51 mg	72 mg/78 mg^‡	97 mg/103 mg

Table 2: Recommended Dose and Titration for Pediatric Patients using ENTRESTO SPRINKLE^†
^†When using capsules, more than one capsule may be needed to achieve recommended doses. Oral pellets are contained within each capsule. Use the entire contents of the capsules to achieve the dose. ^‡Recommended mg/kg doses are of the combined amount of sacubitril and valsartan [see Dosage and administration (2.4)] . ^*For patients 50 kg or more, see Table 1.
	Titration Step Dose (twice daily)
Weight (kg)^*	Starting	Second	Final
Less than 13 (use oral suspension^‡)	1.6 mg/kg	2.3 mg/kg	3.1 mg/kg
13 to less than 19	12 mg/12 mg (Two 6 mg/6 mg capsules)	18 mg/18 mg (Three 6 mg/6 mg capsules)	24 mg/24 mg (Four 6 mg/6 mg capsules)
19 to less than 26	18 mg/18 mg (Three 6 mg/6 mg capsules)	24 mg/24 mg (Four 6 mg/6 mg capsules)	30 mg/32 mg (Two 15 mg/16 mg capsules)
26 to less than 34	24 mg/24 mg (Four 6 mg/6 mg capsules)	30 mg/32 mg (Two 15 mg/16 mg capsules)	45 mg/48 mg (Three 15 mg/16 mg capsules)
34 to less than 50^*	30 mg/32 mg (Two 15 mg/16 mg capsules)	45 mg/48 mg (Three 15 mg/16 mg capsules)	60 mg/64 mg (Four 15 mg/16 mg capsules)

2.4 Preparation of Oral Suspension Using Tablets

ENTRESTO oral suspension can be substituted at the recommended tablet dosage in patients unable to swallow tablets.

ENTRESTO 800 mg/200 mL oral suspension can be prepared in a concentration of 4 mg/mL (sacubitril/valsartan 1.96/2.04 mg/mL). Use ENTRESTO 49/51 mg tablets in the preparation of the suspension.

The oral suspension can be stored for up to 15 days. Do not store above 25°C (77°F) and do not refrigerate. Shake before each use.

^*Ora-Sweet SF^®and Ora-Plus^®are registered trademarks of Paddock Laboratories, Inc.

2.5 Preparation and Administration of Oral Pellets

ENTRESTO SPRINKLE are oral pellets contained within capsules. Do not swallow the capsules. Do not chew or crush the oral pellets.

ENTRESTO SPRINKLE can also be substituted in patients unable to swallow tablets.

Use the entire contents of the capsules to achieve the dose.

)

Reduce starting dose to half the usually recommended starting dosage for:
- patients not currently taking an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) or previously taking a low dose of these agents. (
  2.6 Dose Adjustment for Patients Not Taking an ACE inhibitor or ARB or Previously Taking Low Doses of These Agents
  In patients not currently taking an ACE inhibitor or an angiotensin II receptor blocker (ARB) and for patients previously taking low doses of these agents, start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose every 2 to 4 weeks in adults and every 2 weeks in pediatric patients to follow the recommended dose escalation thereafter
  [see Dosage and Administration (2.2, 2.3)]
  .
  Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets
  [see Dosage and Administration (2.3, 2.4, 2.5)]
  .
  )
- patients with severe renal impairment. (
  2.7 Dose Adjustment for Severe Renal Impairment
  In adults and pediatric patients with severe renal impairment estimated glomerular filtration rate (eGFR less than 30 mL/min/1.73 m²), start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter
  [see Dosage and Administration (2.2, 2.3)]
  .
  Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets
  [see Dosage and Administration (2.3, 2.4, 2.5)]
  .
  No starting dose adjustment is needed for mild or moderate renal impairment.
  )
- patients with moderate hepatic impairment. (
  2.8 Dose Adjustment for Hepatic Impairment
  In adults and pediatric patients with moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter
  [see Dosage and Administration (2.2, 2.3)]
  .
  Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets
  [see Dosage and Administration (2.3, 2.4, 2.5)]
  .
  No starting dose adjustment is needed for mild hepatic impairment.
  Use in patients with severe hepatic impairment is not recommended.
  )

ENTRESTO film-coated tablets are supplied as unscored, ovaloid tablets in the following strengths:

ENTRESTO 24/26 mg, (sacubitril 24 mg and valsartan 26 mg) are violet white and debossed with “NVR” on one side and “LZ” on the other side.
ENTRESTO 49/51 mg, (sacubitril 49 mg and valsartan 51 mg) are pale yellow and debossed with “NVR” on one side and “L1” on the other side.
ENTRESTO 97/103 mg, (sacubitril 97 mg and valsartan 103 mg) are light pink and debossed with “NVR” on one side and “L11” on the other side.

ENTRESTO SPRINKLE film-coated oral pellets are contained in a hard capsule in the following strengths:

ENTRESTO SPRINKLE 6/6 mg, (sacubitril 6 mg and valsartan 6 mg) consists of a white colored cap with “04” and a transparent body with “NVR” and both parts with arrows.
ENTRESTO SPRINKLE 15/16 mg, (sacubitril 15 mg and valsartan 16 mg) consists of a yellow colored cap with “10” and a transparent body with “NVR” and both parts with arrows.

Lactation: Breastfeeding not recommended. (
8.2 Lactation
Risk Summary
There is no information regarding the presence of sacubitril/valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. Sacubitril/valsartan is present in rat milk (
see Data
). Because of the potential for serious adverse reactions in breastfed infants from exposure to sacubitril/valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with ENTRESTO.
Data
Following an oral dose (15 mg sacubitril/15 mg valsartan/kg) of [¹⁴C] ENTRESTO to lactating rats, transfer of LBQ657 into milk was observed. After a single oral administration of 3 mg/kg [¹⁴C] valsartan to lactating rats, transfer of valsartan into milk was observed.
)
Severe Hepatic Impairment: Use not recommended. (
2.8 Dose Adjustment for Hepatic Impairment
In adults and pediatric patients with moderate hepatic impairment (Child-Pugh B classification), start ENTRESTO at half the usually recommended starting dose. After initiation, increase the dose to follow the recommended dose escalation thereafter
[see Dosage and Administration (2.2, 2.3)]
.
Note: Initiate pediatric patients weighing 40 to 50 kg who meet this criterion at 0.8 mg/kg twice daily using the oral suspension or oral pellets
[see Dosage and Administration (2.3, 2.4, 2.5)]
.
No starting dose adjustment is needed for mild hepatic impairment.
Use in patients with severe hepatic impairment is not recommended.
,
8.6 Hepatic Impairment
No dose adjustment is required when administering ENTRESTO to patients with mild hepatic impairment (Child-Pugh A classification). Half of the starting dose is recommended in adult and pediatric patients with heart failure and with moderate hepatic impairment (Child-Pugh B classification). The use of ENTRESTO in patients with severe hepatic impairment (Child-Pugh C classification) is not recommended, as no studies have been conducted in these patients
[see Dosage and Administration (2.8)
and
Clinical Pharmacology (12.3)]
.
)

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