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

Interactions
PK
Renal impairment
References

Belimumab

Generic name
Belimumab
Brand name
ATC Code
L04AG04

Pharmacokinetics in children

The pharmacokinetic parameters are based on a pharmacokinetic population analysis of 25 patients from a phase II pharmacokinetic study in pediatric patients with SLE who received subcutaneous belimumab and the Phase II study in pediatric patients with SLE who received intravenous belimumab.

The average steady-state concentration after subcutaneous administration in children is comparable to that of subcutaneous administration in adults (200 mg SC) and intravenous administration in children (10 mg/kg IV).
Simulated PK parameters at steady state:

  Age category Dose

 Cmax (µg/ml)
SC 5-18 years; ≥ 50 kg 200 mg/dose 1x/week 124
5-18 years; 30–<50 kg 200 mg/dose every 10 days 114
5-18 years; 15–<30 kg 200 mg/dosis every 2 weekd 119
IV 12-18 jaar 10 mg/kg 317
5-12 jaar 10 mg/kg 305

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Available formulations

No information is present at this moment.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Dosages

Systemic lupus erythematodes (SLE) that does not respond to the conventional therapy
  • Intravenous
    • ≥ 5 years
      • 10 mg/kg/dose on day 0,14 and 28 and every 4 weeks afterwards.
      • Duration of treatment:

        If no improvement occurs after 6 months of treatment, consider discontinuing treatment.

        • Infuse over 1 hour
        • Administration of belimumab can lead to serious or life-threatening hypersensitivity and infusion reactions. Clinically monitor the patient a few hours after administration. Before intravenous infusion, an antihistamine, with or without an antipyretic, can be given prophylactically.
  • Subcutaneous
    • 5 years up to 18 years and 15 up to 30 kg
      • 200 mg/dose every 2 weeks.
    • 5 years up to 18 years and 30 up to 50 kg
      • 200 mg/dose every 10 days.
    • 5 years up to 18 years and ≥ 50 kg
      • 200 mg/dose once per week.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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

Infections have also been reported as the most common side effect in children.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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.

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Interactions

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

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

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
L04AC22
L04AC07
L04AC05
Calcineurin inhibitors
L04AD01
L04AD02
Sphingosine-1-phosphate (S1P) receptor modulators
L04AE01
Janus-associated kinase (JAK) inhibitors
L04AF02
L04AF02
L04AF08
L04AF01
Mammalian target of rapamycin (mTOR) kinase inhibitors
L04AH02
L04AH01
Complement inhibitors
L04AJ01
L04AJ02
Dihydroorotate dehydrogenase (DHODH) inhibitors
L04AK02

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

References

  1. GlaxoSmithKline (Ireland) Limited, SmPC Benlysta (EU/1/11/700/001) 25-10-2019, www.geneesmiddeleninformatiebank.nl
  2. GlaxoSmithKline (Ireland) Limited, SmPC Benlysta (EU/1/11/700/001) Rev 39; 7-10-2025, www.ema.europa.eu

A second drug has not been selected yet.
Press ‘drugs’ followed with and select second drug from list to add the second drug to the comparison.

Changes

Changes