Dupilumab

Generic name
Dupilumab
Brand name
ATC Code
D11AH05
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

After correction for body weight, no age-related pharmacokinetic differences were observed in adolescents and children 6-12 years with atopic dermatitis. In children aged 6 months to 5 years old, clearance increased with age, but this is taken into account in the recommended dosage schedule. 

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

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Moderate to severe constitutional eczema
  • Subcutaneous
    • ≥ 12 years and < 60 kg
      • Initial dose: 400 mg/dose, once only.
      • Maintenance dose: 200 mg/dose every 2 weeks.

      • If no improvement in symptoms has occurred after 16 weeks, discontinuation of treatment should be considered.

    • ≥ 12 years and ≥ 60 kg
      • Initial dose: 600 mg/dose, once only.
      • Maintenance dose: 300 mg/dose every 2 weeks.

      • If no improvement in symptoms has occurred after 16 weeks, discontinuation of treatment should be considered.

    • 6 years up to 12 years and 15 up to 60 kg
      • Initial dose: 300 mg/dose on day 1 and day 15.
      • Maintenance dose: 300 mg/dose every 4 weeks. if indicated the dose may be increased to 200 mg/dose every 2 weeks.
        • First maintenance dose 4 weeks after day 15
        • If no improvement in symptoms has occurred after 16 weeks, discontinuation of treatment should be considered.
    • 6 months up to 6 years and 5 up to 15 kg
      • 200 mg/dose once a month.
    • 6 months up to 6 years and 15 up to 30 kg
      • 300 mg/dose once a month.
Eosinophilic asthma with type 2 inflammation, as an adjuvant
  • Subcutaneous
    • 6 years up to 12 years and ≥ 60 kg
      • 200 mg/dose every 2 weeks.

      • In  comorbid constitutional eczema: use dose for eczema.

    • ≥ 12 years
      • Initial dose: 400 mg/dose, once only.
      • Maintenance dose: 200 mg/dose every 2 weeks.

      • In combination with oral corticosteroids or with comorbid constitutional eczema: starting dose 600 mg once and then 300 mg every 2 weeks.

    • 6 years up to 12 years and 15 up to 30 kg
      • 300 mg/dose Every 2 weeks.

      • In combination  with comorbid constitutional eczema: use dose for eczema.

    • 6 years up to 12 years and 30 up to 60 kg
      • 200 mg/dose every 2 weeks. ALTERNATIVELY: 300 mg/dose every 4 weeks..

      • In comorbid constitutional eczema: use dose for eczema.

    • 6 years up to 12 years and ≥ 60 kg
      [1]
      • 200 mg/dose every 2 weeks.

      • In  comorbid constitutional eczema: use dose for eczema.
Eosinophilic esophagitis
  • Subcutaneous
    • 1 year up to 18 years and ≥ 40 kg
      • 300 mg/dose once a week.
    • 1 year up to 18 years and 30 up to 40 kg
      • 300 mg/dose once every 2 weeks.
    • 1 year up to 18 years and 15 up to 30 kg
      • 200 mg/dose once every 2 weeks.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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 observed safety profile is comparable to that of adults.

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 in children

Cases of enterobiasis have been reported in children aged 6 to 12 years with moderate to severe asthma. In intestinal worm infections, dupilumab may adversely affect the immune system response; therefore, treat existing intestinal worm infections prior to initiation of treatment. Stop dupilumab if a worm infection occurs during treatment that does not respond well to treatment. 

Interactions

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

OTHER DERMATOLOGICAL PREPARATIONS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Other dermatologicals
D11AX
Agents for dermatitis, excluding corticosteroids
D11AH08
D11AH02
D11AH01
D11AH07
OTHER DERMATOLOGICALS
D11AX

Reference

  1. Sanofi Aventis, SmPC Dupixent (EU/1/17/1229/001-020) Rev 39, 06-01-2025, www.geneesmiddelinformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose