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

Interactions
PK
Renal impairment
References

Lanadelumab

Generic name
Lanadelumab
Brand name
ATC Code
B06AC05

Pharmacokinetics in children

After subcutaneous administration of 150 mg every 4 weeks (2 to 6 years) and 150 mg every 2 weeks (6 to 12 years), overall exposure (i.e. Cavg,ss) to lanadelumab was similar in adult and adolescent (12 to 18 years) 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

Routine prevention of angio-oedema episodes
  • Subcutaneous
    • 2 years up to 18 years and 10 up to 20 kg
      • 150 mg/dose every 4 weeks.
      • In case of insufficient effect, the dose may be increased to 150 mg every 3 weeks. 

    • 2 years up to 18 years and 20 up to 40 kg
      • 150 mg/dose every 2 weeks.
      • In case of stably attack-free disease, the dose may be decreased to 150 mg every 4 weeks. 

    • 2 years up to 18 years and ≥ 40 kg
      • 300 mg/dose every 2 weeks.
      • In case of stably attack-free disease, the dose may be decreased to 300 mg every 4 weeks. 

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Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

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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 side effect profile in children does not differ from that in adults.

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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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Enzymes
B06AA03
Drugs used in hereditary angioedema
B06AC04
B06AC02

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References

  1. Takeda Pharmaceuticals International AG Ireland Branch , SmPC Takhzyro (EU EU/1/18/1340/001) Rev 12; 22-11-2023 , www.ema.europa.eu
  2. Takeda Pharmaceuticals International AG Ireland Branch, SmPC Takhzyro (EU EU/1/18/1340/001) Rev 12; 22-11-2023, www.ema.europa.eu

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Changes

Changes