SUBCUTANEOUS (SC)

BENLYSTA(belimumab) PRESCRIBING INFORMATION (Great Britain & Northern Ireland):

Benlysta 200mg solution for injection in pre-filled pen. Refer to Summary of Product Characteristics (SmPC) before prescribing. Benlysta is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein. Indications: Systemic Lupus Erythematosus (SLE) - Add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. Lupus Nephritis (LN) – 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 or LN. First subcutaneous (SC) injection should be supervised by a healthcare professional in a setting qualified to manage hypersensitivity reactions; must provide proper training in SC technique and education about signs and symptoms. Patient or caregiver may administer after HCP deems appropriate. Dose: SLE - 200mg once weekly (not weight dependent) subcutaneous injection to abdomen or thigh, change site each week (see package leaflet for detailed instructions). Consider discontinuation if no improvement after 6 months of treatment of SLE. LN - If initiating with Benlysta 400mg dose (two 200mg injections) once weekly, into thigh or abdomen, for 4 doses, then 200mg once weekly. When 400mg injected at the same site, administer each 200mg injection at least 5cm apart. In patients continuing therapy with belimumab for active LN recommended dose is 200 mg once weekly. In patients with active LN, Benlysta should be used in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. Monitor patient continuously. Missed dose: If dose missed administer as soon as possible, then resume on usual day of administration or start new weekly schedule from day of missed dose administered. Change scheduled dosing day: New dose can be given on newly preferred day; Continue with the new weekly schedule from that day, even if dosing interval temporarily <1 week. Transition from intravenous (IV) to SC: refer to the SmPC. Elderly (≥65 years): Use with caution. Dose adjustment not required. Renal impairment: Dose adjustment not required. Caution in severe impairment. Paediatric population (<18 years): no data. Contraindications: Hypersensitivity to belimumab or any excipients. Warnings and precautions: 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 co-administered with other B cell targeted therapy. Hypersensitivity: Administration may cause hypersensitivity reactions which can be severe and fatal. Interrupt administration and administer appropriate medical therapy. Risk is greatest with first two doses; consider risk for every injection. Advise patients reactions are possible on day of, or several days after administration and inform of potential signs and symptoms and possibility of recurrence. Patients with history of multiple drug allergies or significant hypersensitivity may be at increased risk. Inform patients to seek medical attention if symptoms experienced and provide package leaflet. Delayed-type, non-acute hypersensitivity reactions possible. Infections: Increased risk of infections in adults and children, including opportunistic. 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. Advise patients to contact their healthcare professional if they develop symptoms of infection. Carefully monitor new infections - consider interrupting immunosuppressants including Benlysta until infection resolved. Depression and suicidality: Before treatment assess risk of depression and suicide; monitor during treatment. Advise patients to contact their healthcare professional about new or worsening psychiatric symptoms. If experienced, consider discontinuation. Progressive multifocal leukoencephalopathy (PML): Be alert to symptoms suggestive of 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. Malignancy: Caution when considering Benlysta for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. Interactions: No interaction studies. Risk for indirect reduction of CYP activity cannot be excluded: on initiation or discontinuation of Benlysta, consider therapeutic monitoring for patients on CYP substrates with a narrow therapeutic index, where 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. 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 excreted in breast milk - so recommend to either discontinue Benlysta or breast feeding depending on risk/benefit to mother and child. Fertility: No data. 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, viral upper respiratory tract infection, leucopenia, hypersensitivity reactions, depression, migraine, injection site reactions, pain in extremity, injection-related systemic reactions, pyrexia. Serious: Anaphylactic reactions, suicidal ideation and behaviour. Basic NHS Costs: Temporary supply during COVID-19 pandemic; list price unavailable. Legal category: POM. Marketing authorisation numbers: 4x pre-filled pens-EU/1/11/700/004, PL GB 19494/0271 Marketing authorisation holder: Great Britain: GlaxoSmithKline UK Limited, 980 Great West Road, Bretford, Middlesex, TW8 9GS, United Kingdom. Northern Ireland: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Further information: Freephone: 0800 221 441. Email: customercontactuk@gsk.com.
PI-7775; Date of prep: July 2021.

INTRAVENOUS (IV)

BENLYSTA(belimumab) PRESCRIBING INFORMATION (Great Britain & Northern Ireland):

Benlysta 120mg and 400mg powder for concentrate for solution for intravenous (IV) infusion. Refer to Summary of Product Characteristics (SmPC) before prescribing. Benlysta is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein. Indications: Systemic Lupus Erythematosus (SLE) - Add-on therapy in patients aged ≥5 years with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. Lupus Nephritis (LN) - 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 or LN. IV infusions should be administered by qualified healthcare professional trained to give infusion therapy. Severe or life-threatening hypersensitivity reactions and infusion reactions can occur, including delayed onset or recurrence. Administer in an environment where resources for managing reactions are immediately available. Clinical supervision required for several hours after infusion, following at least first 2 infusions. Make patients aware of potential risk of severe or life-threatening hypersensitivity reactions (day of, or several days after infusion, including signs/symptoms and possibility of recurrence) and provide package leaflet each time Benlysta administered. Instruct patients to seek immediate medical attention if they experience these symptoms. Premedication: An antihistamine, with/without an antipyretic, may be administered before infusion. Dose: SLE or LN - 10 mg/kg intravenously by infusion over 1-hour on days 0, 14 and 28, and at 4-week intervals thereafter. LN: Should be prescribed in combination with corticosteroids and mycophenolate or cyclophosphamide for induction, or mycophenolate or azathioprine for maintenance. Monitor patient continuously. Transition from IV to SC: Refer to SmPC. Administration: 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. SLE: Consider discontinuation if no improvement after 6 months treatment of SLE. Elderly (≥65 years): Use with caution. Dose adjustment not required. Renal impairment: Dose adjustment not required. Caution in severe impairment. Hepatic: no data. Unlikely to require dose adjustment. Paediatric population: SLE (≥5 years) - 10 mg/kg Benlysta on Days 0, 14 and 28, and at 4-week intervals thereafter; no data for <5 years; LN – No data in children/adolescents <18 years old. Contraindications: Hypersensitivity to belimumab or any excipients. Warnings and precautions: 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 co-administered with other B cell targeted therapy. Infusion reactions and hypersensitivity: Administration may cause hypersensitivity or infusion reactions which can be severe and fatal - Interrupt administration and administer appropriate medical therapy. Risk greatest with first two infusions. Patients with history of multiple drug allergies or significant hypersensitivity may be at increased risk. Delayed-type, non-acute hypersensitivity reactions possible. Infections: Increased risk of infections in adults and children - 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. Advise patients to contact their healthcare professional if develop symptoms of infection. Carefully monitor new infections - consider interrupting immunosuppressants including Benlysta, until infection resolved. Depression and suicidality: Before treatment assess risk of depression and suicide; monitor during treatment. Advise patients to contact their healthcare professional about new or worsening psychiatric symptoms. If experienced, consider discontinuation. Progressive multifocal leukoencephalopathy (PML): Be alert to symptoms suggestive of 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. Malignancy: Caution when considering Benlysta for patients with a history of malignancy or when considering continuing treatment in patients who develop malignancy. Interactions: No interaction studies. Risk for indirect reduction of CYP activity cannot be excluded: on initiation or discontinuation of Benlysta, consider therapeutic monitoring for patients on CYP substrates with a narrow therapeutic index, where 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. 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 excreted in breast milk - so recommend to either discontinue Benlysta or breast feeding depending on risk/benefit to mother and child. Fertility: No data. 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, viral upper respiratory tract infection, leucopenia, hypersensitivity reactions, depression, migraine, pain in extremity, infusion-related systemic reactions, pyrexia. Serious: Anaphylactic reaction, suicidal ideation and behaviour. Basic NHS Costs: 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. Legal category: POM. Marketing authorisation numbers: 120mg EU/1/11/700/001, PL GB 19494/0270; 400mg EU/1/11/700/002, PL GB 19494/0272. Marketing authorisation holder: Great Britain: GlaxoSmithKline UK Limited, 980 Great West Road, Bretford, Middlesex, TW8 9GS, United Kingdom. Northern Ireland: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland. Further information from: Freephone: 0800 221 441. Email: customercontactuk@gsk.com.
PI-7775; Date of prep: July 2021.

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to GlaxoSmithKline on 0800 221 441