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PRESCRIBING INFORMATION (EU): BENLYSTA▼ (belimumab) is available as 120mg and 400mg powder for concentrate for solution for intravenous (IV) infusion and 200mg solution for subcutaneous (SC) injection in pre-filled pen or syringe. Refer to Summary of Product Characteristics (SmPC) before prescribing. Benlysta is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein. Indication:Systemic Lupus Erythematosus (SLE): Add-on therapy in adult patients 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. Intravenous infusion only can be used in SLE patients aged ≥5 years. Active lupus nephritis: Treatment of adult patients with active lupus nephritis in combination with background immunosuppressive therapies. Dosage & administration: Treatment should be initiated and supervised by qualified physician experienced in diagnosis and treatment of SLE. Infusions should be administered by qualified healthcare professional trained to give infusion therapy. Severe or life-threatening hypersensitivity reactions and infusion reactions can occur, possibly after several hours and can recur after initial treatment of symptoms. Administer in an environment where resources for managing reactions are available. Clinical supervision required for several hours after infusion, following at least first 2 infusions. Make patients aware of potential risk of hypersensitivity reactions (day of, or several days after infusion, including signs/symptoms and recurrence) and provide package leaflet each time Benlysta administered. Premedication: An antihistamine, with/without an antipyretic, may be administered. Dose (intravenous infusion): 10 mg/kg intravenously by infusion over 1- hour on days 0, 14 and 28, and at 4-week intervals thereafter. Monitor patient continuously. Reconstitute and dilute before use (see SmPC for instructions); infuse over 1-hour (not bolus). Infusion rate may be slowed/interrupted if patient develops an infusion reaction. Discontinue if patient experiences potentially life- threatening adverse reaction. Dose (pre-filled pen): 200 mg subcutaneously once weekly (not weight dependent) to abdomen or thigh, in adult patients only; change site each week. In Active lupus nephritis 400 mg dose (two 200 mg injections) once weekly for 4 doses, then 200 mg once weekly. In patients continuing therapy with belimumab for active lupus nephritis recommended dose is 200 mg once weekly. For transitioning from intravenous to subcutaneous administration, refer to the SmPC. In patients with active lupus nephritis, Benlysta should be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. Consider discontinuation if no improvement after 6 months of treatment of SLE. Elderly (≥65 years): Use with caution. Dose adjustment not required. Renal impairment: Caution in severe impairment. Paediatric population: The safety and efficacy of Benlysta in children and adolescents aged below 18 years with severe active LN have not been established. For SLE - no data for <5-year-olds. Contraindications: Hypersensitivity to belimumab or any excipients. Warnings and precautions (see SmPC for details): Record tradename and batch number. Not recommended in: severe active central nervous system lupus; HIV; history of/current hepatitis B or C; hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl); history of major organ transplant or hematopoietic stem cell/marrow transplant or renal transplant. Caution: If Benlysta co-administered with other B cell targeted therapy and patients with history of malignancy or who develop malignancy whilst receiving treatment. Infusion reactions and hypersensitivity: Administration may cause hypersensitivity or infusion reactions which can be severe and fatal. Interrupt administration and administer appropriate medical therapy. Delayed-type, non-acute hypersensitivity reactions (e.g. rash, nausea, fatigue, myalgia, headache, facial oedema) possible. Infections: Increased risk of infections - younger children may be at increased risk. Fatal infections (e.g. pneumonia and sepsis) occurred more frequently in patients receiving Benlysta; consider pneumococcal vaccination prior to initiation. Do not initiate with active serious infections (including serious chronic); Exercise caution and assess risk/benefit in patients with history of recurrent infection. Carefully monitor new infections - consider interrupting Benlysta. Depression and suicidality: Before treatment assess risk of depression and suicide in patient; closely monitor during treatment – consider discontinuation if new or worsening psychiatric symptoms. Progressive multifocal leukoencephalopathy (PML): Monitor for new or worsening signs/symptoms – refer to neurologist if suspected; suspend further dosing until excluded. Immunisation: Do not give live vaccines 30 days before, or concurrently with Benlysta. Interactions: No interaction studies. A risk for indirect reduction of CYP activity possible: on initiation or discontinuation of Benlysta, therapeutic monitoring should be considered for patients on CYP substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g. warfarin). Pregnancy and lactation: Women of childbearing potential must use effective contraception during and at least 4 months after last treatment. Limited data on use in pregnant women. Benlysta should not be used during pregnancy unless potential benefit justifies potential risk to foetus. Not known if Benlysta is excreted in human milk or absorbed after ingestion. Maternal IgG is secreted in breast milk so recommended to either discontinue Benlysta or breast feeding depending on risk/benefit to mother and child. Undesirable effects: See SmPC for full list. Very common (≥1/10): Bacterial infections (e.g. bronchitis, urinary tract infection), diarrhoea, nausea. Common (≥1/100 to <1/10): Gastroenteritis viral, pharyngitis, nasopharyngitis, herpes zoster, viral upper respiratory tract infections, leucopenia, injection site reactions (s.c. only), hypersensitivity reactions, depression, migraine, pain in extremity, infusion-related systemic reactions, pyrexia. Serious: Anaphylactic reactions, progressive multifocal leukoencephalopathy, malignancies, fatal infections, suicidal ideation and behaviour. Paediatric population: no new safety signals in ≥12-year olds; limited data in <12 year olds, see SmPC for information on infections. Basic NHS cost: Available as 120mg and 400mg vials containing white/off-white powder for reconstitution to provide 80mg/ml belimumab. 1 x 120mg vial, £121.50, 1 x 400mg vial, £405.00. Pre-filled pen: temporary supply during COVID-19 pandemic; list price unavailable. Legal category: POM Marketing authorisation numbers: 120mg EU/1/11/700/001; 400mg EU/1/11/700/002. EU/1/11/700/003 (1 pre-filled pen); EU/1/11/700/004 (4 pre-filled pens); EU/1/11/700/006 (1 pre-filled syringe); EU/1/11/700/007 (4 pre-filled syringes). Marketing authorisation holder: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Further information from:Freephone: 0800 221 441. Email: firstname.lastname@example.org
PI-7933; Date of prep: May 2021.
Adverse events should be reported. For UK, reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store. For Germany, adverse events should be reported to Paul-Ehrlich-Institut: www.pei.de or on +49 6103770. Adverse events should also be reported to GlaxoSmithKline on +44 800 221 441 or, for Germany, to https://de.gsk.com, or on +49 800 122 33 55. If you are professionally active in another country, adverse events should be reported to the appropriate health authority in your country.
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