Belimumab (Lupus Nephritis)

Source: UK SPC (eMC) for Benlysta 120 mg powder for concentrate for solution for infusion, section 4.2 (https://www.medicines.org.uk/emc/product/4679/smpc). The SPC gives the SAME regimen for SLE and for active lupus nephritis: 'In patients with SLE or active lupus nephritis, the recommended dose regimen is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.' COMBINATION REQUIREMENT IN LUPUS NEPHRITIS: in patients with active lupus nephritis, belimumab should be used IN COMBINATION with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. INITIATION AND SUPERVISION: treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE, and infusions administered by a qualified healthcare professional trained to give infusion therapy, in an environment where resources for managing severe or life-threatening hypersensitivity and infusion reactions are immediately available. Patients should remain under clinical supervision for a prolonged period (several hours) following at least the first 2 infusions, because acute hypersensitivity symptoms have been reported several hours after the infusion and clinically significant reactions have recurred after initial appropriate treatment. The package leaflet should be provided to the patient each time belimumab is administered. PREMEDICATION: an antihistamine, with or without an antipyretic, may be administered before the infusion. INFUSION MANAGEMENT: the infusion rate may be slowed or interrupted if an infusion reaction develops, and must be discontinued immediately for a potentially life-threatening adverse reaction. REVIEW: the patient's condition should be evaluated continuously; in SLE, discontinuation should be considered if there is no improvement in disease control after 6 months of treatment (the SPC states no equivalent 6-month rule for lupus nephritis). TRANSITION FROM INTRAVENOUS TO SUBCUTANEOUS — LUPUS NEPHRITIS: the first dose of 200 mg subcutaneous injection should be administered 1 to 2 weeks after the last intravenous dose, and this transition should occur any time after the patient completes the first 2 intravenous doses. (For SLE the first subcutaneous injection is given 1 to 4 weeks after the last intravenous dose.) ELDERLY: data in patients 65 years and over are limited; use with caution, but dose adjustment is not required. HEPATIC IMPAIRMENT: no specific studies conducted; patients with hepatic impairment are unlikely to require dose adjustment. PAEDIATRIC — READ CAREFULLY: the 10 mg/kg regimen captured in paedDose below is licensed for SLE in children aged 5 years and older ONLY. For LUPUS NEPHRITIS the safety and efficacy in children and adolescents below 18 years have NOT been established and no data are available, so the paediatric figure below must NOT be applied to lupus nephritis. Verify any paediatric use against a children's formulary. SOURCE LIMITATION: eMC section 4.5 was NOT captured in this bundle — the interactions entry below comes from section 7 of the US label (openFDA/DailyMed) and must be checked against the UK SPC. Sections 4.4 and 4.8 were truncated at the fetch limit (the section 4.8 frequency table was cut off at its first row).

SLE ONLY, children aged 5 years and older: 'The recommended dose regimen for children aged 5 years and older is 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter.' Safety and efficacy in children below 5 years of age have NOT been established and no data are available. LUPUS NEPHRITIS: safety and efficacy in children and adolescents below 18 years with severe active lupus nephritis have NOT been established and no data are available — this per-kg figure must not be extrapolated to the lupus nephritis indication that this page covers. Verify against a children's formulary.