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Pediatric Lupus Nephritis Now Included in Belimumab Approval

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Peeyush Ghalot
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(Image Courtesy: - GlaxoSmithKline)

Belimumab (Benlysta) is now approved by the Food and Drug Administration (FDA) for paediatric patients with active lupus nephritis who are undergoing conventional medication. These patients range in age from 5 to 17 years old. Belimumab, a B-lymphocyte stimulator (BLyS)-specific inhibitor, is also recommended for the treatment of systemic lupus erythematosus (SLE) patients aged 5 and older who have active disease and are taking their prescribed medications. Based on the extrapolation of efficacy from the intravenous (IV) study in adults with active lupus nephritis and supported by pharmacokinetic data from IV studies in adults with active lupus nephritis and from paediatric patients with SLE, belimumab was approved for use in paediatric patients with lupus nephritis. Children's estimated belimumab exposures were comparable to those of adults with active lupus nephritis. Belimumab side effects are most frequently related with nauseousness, diarrhoea, pyrexia, bronchitis, nasopharyngitis, sleeplessness, pain in extremity, depression, migraine, and pharyngitis. For intravenous usage, Benlysta comes in 5mL and 20mL single-dose vials containing 120mg and 400mg of belimumab, respectively. Additionally, the drug is offered as a single-dose prefilled autoinjector or syringe for subcutaneous administration that has 200mg/mL of belimumab. Benlysta can be given intravenously to individuals 5 years of age and older, or subcutaneously to adults 18 years of age and older.

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