Benlysta

Belimumab

Add-on therapy in adults (IV & SC) & childn ≥5 yr (IV only) w/ active, autoantibody-positive SLE w/ a high degree of disease activity (eg, positive anti-dsDNA & low complement) despite standard therapy. In combination w/ background immunosuppressive therapies for the treatment of adult patients w/ active lupus nephritis.

Powd for conc for soln for infusion (IV) Adult SLE & active lupus nephritis Recommended dose: 10 mg/kg IV infusion over 1 hr on days 0, 14 & 28, & at 4-wk intervals thereafter. For active lupus nephritis, use in combination w/ corticosteroids & mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. Childn ≥5 yr SLE Recommended dose: 10 mg/kg IV infusion over 1 hr on days 0, 14 & 28, & at 4-wk intervals thereafter. Soln for inj (SC) Adult SLE Recommended dose: 200 mg SC once wkly. Transition from IV to SC: Administer 1st SC inj 1-4 wk after the last IV dose. Active lupus nephritis Induction therapy: 400 mg SC once wkly for 4 doses, in combination w/ corticosteroids & mycophenolate or cyclophosphamide. Continuing therapy: 200 mg SC once wkly, in combination w/ mycophenolate or azathioprine. Transition from IV to SC: Administer 1st dose of 200-mg SC inj 1-2 wk after the last IV dose. Transition any time after the patient completes the 1st 2 IV doses.

Hypersensitivity.

Not recommended in severe active CNS lupus; HIV; history of, or current, hepatitis B or C; hypogammaglobulinaemia or IgA deficiency; history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant. Concomitant use w/ other B-cell targeted therapy. Infusion &/or hypersensitivity reactions. Increased risk of infections, malignancies & lymphoproliferative disorders. Do not administer live vaccines 30 days prior to or concurrent w/ therapy. Reports of psychiatric disorders (depression, suicidal ideation & behaviour including suicides); progressive multifocal leukoencephalopathy. Patients w/ active or latent TB. Patients w/ severe renal impairment. Women of childbearing potential must use effective contraception during treatment & for at least 4 mth after the last treatment. Pregnancy & lactation. Elderly ≥65 yr. Powd for conc for soln for infusion (IV): Do not administer as IV bolus. Safety & efficacy in childn <5 yr have not been established. Safety & efficacy in childn & adolescents <18 yr w/ severe active lupus nephritis have not been established. Soln for inj (SC): Safety & efficacy in childn & adolescents <18 yr have not been established.

Bacterial infections eg, bronchitis, UTI; diarrhoea, nausea. Gastroenteritis viral, pharyngitis, nasopharyngitis, viral URTI; leucopenia; hypersensitivity reactions; depression; migraine; inj site reactions; pain in extremity; infusion- or inj-related systemic reactions, pyrexia.

On initiation or discontinuation of belimumab, therapeutic monitoring should be considered for patients being treated w/ CYP substrates w/ a narrow therapeutic index (eg, warfarin).

Immunosuppressants

L04AG04 - belimumab ; Belongs to the class of monoclonal antibodies. Used as immunosuppressants.

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