Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Sacubutril + valsartan

Generic name
Sacubutril + valsartan
Brand name
ATC Code
C09DX04

Pharmacokinetics in children

The pharmacokinetic profile of sacubitril/valsartan in pediatric patients is similar to that of adult patients.

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dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Cardiac failure
  • Oral
    • Granules
      • ≥ 1 year and < 40 kg
        • Initial dose: 3.2 mg/kg/day in 2 doses. Halve the starting dose if an ACE inhibitor or angiotensin II antagonist has not been used previously or has been used at a low dose..
        • Maintenance dose: Increase dosage based on tolerability every 2-4 weeks until target dosage of 6.2 mg/kg/day in 2 doses.
        • Directions for administration:

          The granules are administered by opening the capsule and sprinkling the contents on a small amount of soft food (1 to 2 teaspoons). Food containing granules should be ingested immediately.  The capsule/empty shells should not be swallowed. 

    • Tablet
      • ≥ 1 year and 40 up to 50 kg

        • Starting dose: sacubitril/valsartan 24 mg/26 mg 2 times daily. Halve the starting dose if an ACE inhibitor or angiotensin II antagonist has not been used previously or has been used at a low dose.
          Maintenance dosage: increase starting dosage based on tolerability every 2-4 weeks to target dosage of sacubitril/valsartan 72 mg/ 78 mg 2 times daily.

      • ≥ 1 year and ≥ 50 kg

        • Starting dose: sacubitril/valsartan 49 mg/ 51 mg 2 times daily. Halve the starting dose if an ACE inhibitor or angiotensin II antagonist has not been used previously or has been used at a low dose.
          Maintenance dosage: increase starting dosage based on tolerability every 2-4 weeks to target dosage of sacubitril/valsartan 97 mg/ 103 mg 2 times daily.

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Renal impaiment in children > 3 months

eGFR: < 60 ml/min/1.73 m²:

≥ 1 year and < 50 kg: start 0.8 mg/kg body weight 2x daily, then increase to standard starting dose and then increase dose to target dose every 2-4 weeks based on tolerability.

≥ 1 year and ≥ 50 kg: start sacubitril/valsartan 24/26 mg 2x daily, then increase to standard starting dose and then increase to target dose every 2-4 weeks based on tolerability.

Source: SmPc Entresto

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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The safety profile of  in pediatric patients is similar to that of adult patients.

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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

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Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

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Reference

  1. Novartis Europharm Limited, SmPC Entresto (EU/1/15/1058/001) Rev 19, 08-12-2023, www.ema.europa.eu

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Changes

Changes