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

Interactions
PK
Renal impairment
References

Spesolimab

Generic name
Spesolimab
Brand name
ATC Code
L04AC22

Pharmacokinetics in children

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

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Available formulations

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Dosages

Prevention of flares from generalized pustular psoriasis (GPP)
  • Subcutaneous
    • 12 years up to 18 years and ≥ 40 kg
      • Initial dose: Loading dose: 600 mg/dose, once only.
      • Maintenance dose: 300 mg/dose once every 4 weeks.
    • 12 years up to 18 years and 30 up to 40 kg
      • Initial dose: Loading dose: 300 mg/dose, once only.
      • Maintenance dose: 150 mg/dose once every 4 weeks.
Flares of generalized pustular psoriasis (GPP)
  • Intravenous
    • 12 years up to 18 years and ≥ 40 kg
      • 900 mg/dose, once only.
      • If symptoms persist, repeat 1× if necessary, 1 week after initial dose.

    • 12 years up to 18 years and 30 up to 40 kg
      • 450 mg/dose, once only.
      • If symptoms persist, repeat 1× if necessary, 1 week after initial dose.

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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

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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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Selective immunosuppressants
L04AA24
L04AA32
L04AA13
L04AA02
L04AA06
L04AA31
L04AA04
L04AA44
Other immunosuppressants
L04AX01
L04AX03
Tumor necrosis factor alpha (TNF-alpha) inhibitors
L04AB04
L04AB01
L04AB06
L04AB02
Interleukin inhibitors
L04AC03
L04AC02
L04AC08
L04AC13
L04AC19
L04AC10
L04AC07
L04AC05
Calcineurin inhibitors
L04AD01
L04AD02
Sphingosine-1-phosphate (S1P) receptor modulators
L04AE01
Janus-associated kinase (JAK) inhibitors
L04AF02
L04AF02
L04AF08
L04AF01
Monoclonal antibodies
L04AG04
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ01
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

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Reference

  1. Boehringer Ingelheim International GmbH, SmPC Spevigo EU/1/22/1688/001 Rev 1, 10-10-2024, www.geneesmiddelinformatiebank.nl

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Changes

Changes