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

Interactions
PK
Renal impairment
References

Tralokinumab

Generic name
Tralokinumab
Brand name
ATC Code
D11AH07

Pharmacokinetics in children

No information available (source: SmPC Adtralza)

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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

Atopic dermatitis
  • Subcutaneous
    • 12 years up to 18 years
      • Initial dose: 600 mg/dose, once only.
      • Maintenance dose: 300 mg/dose every 2 weeks.
        • In stable disease activity after 16 weeks, the dose may be decreased to 300 mg 1x every 4 weeks;
        • If no response has occurred after 16 treatment weeks, discontinuation of treatment should be considered.

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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 12 years and older was generally similar to that of adults. However conjunctivitis was less common in adolescents.

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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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References

  1. LEO Pharma A/S, SmPC Adtralza (EU/1/21/1554/001) Rev 4; 29-11-2023 , www.ema.europa.eu
  2. LEO Pharma A/S, SmPC Adtralza (EU/1/21/1554/001) Rev 4; 29-11-2023, www.ema.europa.eu

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Changes

Changes