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

Interactions
PK
Renal impairment
References

Mepolizumab

Generic name
Mepolizumab
Brand name
ATC Code
R03DX09

Pharmacokinetics in children

The following mean (95% CI) pharmacokinetic parameters were calculated using a population kinetics model (Gupta 2019):

Normalized for bodyweight 27 kg 50 kg 70 kg
Dose 40 mg 100 mg 100 mg
Cmax (mg/l) 10.2 (9.5 – 10.9) 16.3 (15.0 – 17.6) 12.8 (11.2 – 14.4)
t½ (days) 0.09 (0.08 – 0.09) 0.15 (0.13 – 0.16) 0.20 (0.16 – 0.23)
Cl/F (l/day) 23.6 (21.9 – 25.3) 21.8 (19.6 – 24.1) 21.0 (17.6 – 24.3)

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

On-label

Licensed use Licensed use

Registration Status Title

Ernstig eosinofiel astma:
6 tot 12 jaar: 40 mg mg SC 1 x per 4 weken
12 tot 18 jaar: 100 mg SC 1 x per 4 weken

 

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Available formulations

Poeder voor inj.vlst. 100 mg

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Dosages

Ernstig refractair eosinofiel astma
  • Subcutaneous
    • 6 years up to 12 years
      • 40 mg/dose once every 4 weeks.
Eosinophilic granulomatosis met polyangiitis (EGPA)
  • Subcutaneous
    • 12 years up to 18 years
      • 300 mg/dose once every 4 weeks.
    • 6 years up to 12 years and < 40 kg
      • 100 mg/dose once every 4 weeks.
    • 6 years up to 12 years and ≥ 40 kg
      • 200 mg/dose once every 4 weeks.
    • 12 years up to 18 years
      [1]
      • 300 mg/dose once 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 safety profile in children is similar to that of adults.

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

Adult Side Effects

Zeer vaak (> 10%): hoofdpijn.

Vaak (1-10%): neusverstopping, faryngitis, ondersteluchtweginfectie. Pijn in bovenbuik. Urineweginfectie. Rugpijn. Eczeem, systemische allergische reacties, systemische toedieningsreacties (zoals huiduitslag, overmatig blozen, spierpijn), lokale reacties (pijn, roodheid, zwelling, jeuk, branderigheid) op de injectieplaats, koorts.

Zelden (0,01-0,1%): anafylaxe.

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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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Xanthines
R03DA04
Leukotriene receptor antagonists
R03DC03
Other systemic drugs for obstructive airway diseases
R03DX05
R03DX11

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References

  1. GlaxoSmithKline Trading Services Limited, SmPC Nucala(EU/1/15/1043/001) Rev 19; 16-07-2924, www. geneesmiddeleninformatiebank.nl
  2. Gupta et al, Subcutaneous mepolizumab in children aged 6 to 11 years with severe eosinophilic asthma., Pediatr Pulmonol., 2019, Dec 54(12), 1957-67

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Changes

Changes