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

Interactions
PK
Renal impairment
References

Tezepelumab

Generic name
Tezepelumab
Brand name
ATC Code
R03DX11

Pharmacokinetics in children

Based on population pharmacokinetic analysis, there was no clinically meaningful age-related difference in the pharmacokinetics of tezepelumab between adults and adolescents aged 12 to 17 years. The following pharmacokinetic parameters are known: (SmPC Tezspire)

Tmax 3 - 10 days (following a single subcutaneous administration)
Bioavailability (F) 77%
Cl 0,17 L/d*
Vd, central 3,9 L*
Vd, peripheral 2,2 L*
T1/2 26 days

* based on population pharmacokinetic analysis for a 70 kg individual

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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

Adjuvant treatment in severe asthma
  • Subcutaneous
    • ≥ 12 years
      • 210 mg/dose once every 4 weeks.

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Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

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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 adolescents 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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Xanthines
R03DA04
Leukotriene receptor antagonists
R03DC03
Other systemic drugs for obstructive airway diseases
R03DX09
R03DX05

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Reference

  1. AstraZeneca AB, SmPC Tezspire (EU/1/22/1677/001) Rev4. 19-4-2023, www.ema.europa.eu

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Changes

Changes