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

Interactions
PK
Renal impairment
References

Omalizumab

Generic name
Omalizumab
Brand name
ATC Code
R03DX05

Pharmacokinetics in children

No information

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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

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Dosages

Improving asthma control in severe persistent asthma
  • Subcutaneous
    • 6 years up to 18 years
        • The dose and dosing frequency are determined by the total IgE serum concentration measured before the start of the treatment, and by the bodyweight – see table below.
        • Treatment by a paediatric specialist (pulmonologist) who has experience with the use of omalizumab for this indication.

        DOSAGE REGIMEN (dosage in mg/dose)
        Pay attention to the difference in dosing frequency(every 4 weeks versus every 2 weeks)
        X = no data available for dosage recommendation

        initial
        value
        of IgE        		≥20-
        25 kg        		>25-
        30kg        		>30-
        40kg        		>40-
        50kg        		>50-
        60kg        		>60-
        70kg        		>70-
        80kg        		>80-
        90kg        		>90-
        125kg        		>125-
        150 kg
        ≥30-100 75
        mg/
        4 weeks        		 75
        mg/
        4 weeks        		 75
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks
        >100-200 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks
        >200-300 150
        mg/
        4 weeks        		 150
        mg/
        4 weeks        		 225
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks
        >300-400 225
        mg/
        4 weeks        		 225
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks
        >400-500 225
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks
        >500-600 300
        mg/
        4 weeks        		 300
        mg/
        4 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X
        >600-700 300
        mg/
        4 weeks        		 225
        mg/
        2 weeks        		 450
        mg/
        4 weeks        		 600
        mg/
        4 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 X X
        >700-800 225
        mg/
        2 weeks        		 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X
        >800-900 225
        mg/
        2 weeks        		 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X
        >900-1000 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X
        >1000
        -1100        		 225
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X X
        >1100
        -1200        		 300
        mg/
        2 weeks        		 300
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X X
        >1200
        -1300        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 450
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 X X X X X X
        >1300
        -1500        		 300
        mg/
        2 weeks        		 375
        mg/
        2 weeks        		 525
        mg/
        2 weeks        		 600
        mg/
        2 weeks        		 X X X X X X
Chronic urticaria
  • Subcutaneous
    • 6 years up to 12 years

      • There are only a few case descriptions available about the use of omalizumab in chronic urticaria in children. Properly substantiated dose recommendations can therefore not be given. A description of the cases therefore follows:

        • 300 mg every 2 weeks: 10-year-old girl [Netchiporouk 2015]
        • 300 mg every 4 weeks: 8-year-old boy [Viswanathan 2013]
        • 150 mg every 2 weeks: 10-year-old boy [Uysal 2014]
        • 150 mg every 4 weeks: 7 and 10-year-old [Sussman 2014], 4 and 5-year-old girls [Netchiporouk 2015]

        When the urticaria goes into remission, the dose is reduced.
        Treatment by a paediatric allergologist or pediatric dermatologist who has experience with using omalizumab for this indication.

    • 12 years up to 18 years
      • 300 mg/dose every 4 weeks.

      • Treatment by a paediatric allergologist or pediatric dermatologist who has experience with the use of omalizumab for this indication.

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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

< 12 years:
Very common (> 10%): , fever.

Common (1-10%): headaches; epigastric distress.

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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
R03DX11

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References

  1. Novartis Europharm Limited., SPC Xolair( EU/1/05/319/002-4) 14-4-2015, www.geneesmiddeleninformatiebank.nl
  2. Sussman G et al. , Real-life experiences with omalizumab for the treatment of chronic urticarial. , Ann Allergy Asthma Immunol., 2014, Feb;112(2):, 170-4
  3. Uysal P et al. J , An algorithm for treating chronic urticaria with omalizumab: dose interval should be individualized. , Allergy Clin Immunol., 2014, Mar;133(3):, 914-5.e2
  4. Viswanathan RK et al. 2013, Retrospective analysis of the efficacy of omalizumab in chronic refractory urticarial., Allergy Asthma Proc., 2013, Sep-Oct;34(5):, 446-52
  5. Netchiporouk E et al., Management of pediatric chronic spontaneous and physical urticaria patients with omalizumab: case series., Pediatr Allergy Immunol., 2015, Sep;26(6), 585-8
  6. Sussman G et al., Real-life experiences with omalizumab for the treatment of chronic urticarial., Ann Allergy Asthma Immunol., 2014, Feb;112(2):, 170-4
  7. Uysal P et al. J, An algorithm for treating chronic urticaria with omalizumab: dose interval should be individualized., Allergy Clin Immunol., 2014, Mar;133(3):, 914-5.e2

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Changes

Changes