Benlysta 400 mg powder f

Benlysta 120 mg powder for concentrate for solution for infusion.

Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml.

Benlysta 400 mg powder for concentrate for solution for infusion.

Each vial contains 400 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per ml.

Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian ) by recombinant DNA technology

Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy

Benlysta treatment should be initiated and supervised by a qualified sician experienced in the diagnosis and treatment of SLE. Benlysta infusions should be administered by a qualified healthcare professional trained to give infusion therapy.

Administration of Benlysta may result in severe or life-threatening hypersensitivity reactions and infusion reactions. Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered. Recurrence of clinically significant reactions after initial appropriate treatment of symptoms has also been observed . Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available. Patients should remain under clinical supervision for a prolonged period of time (for several hours), following at least the first 2 infusions, taking into account the possibility of a late onset reaction.

Patients treated with Benlysta should be made aware of the potential risk of severe or life-threatening hypersensitivity and the potential for delayed onset or recurrence of symptoms. The package leaflet should be provided to the patient each time Benlysta is administered