Belimumab
Generic name
Belimumab
Brand name
ATC Code
L04AG04
- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
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 |
dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
Available formulations
No information is present at this moment.
Dosages
| Systemic lupus erythematodes (SLE) that does not respond to the conventional therapy |
|---|
|
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.
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.
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.
Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
IMMUNOSUPPRESSANTS
This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.
| 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 | ||
References
- GlaxoSmithKline (Ireland) Limited, SmPC Benlysta (EU/1/11/700/001) 25-10-2019, www.geneesmiddeleninformatiebank.nl
- GlaxoSmithKline (Ireland) Limited, SmPC Benlysta (EU/1/11/700/001) Rev 39; 7-10-2025, www.ema.europa.eu
Changes
Therapeutic Drug Monitoring
Overdose
