Drug reference
Adjunctive therapy in patients with active, autoantibody- positive systemic lupus erythematosus with a high degree of disease activity despite standard therapy ▶BY INTRAVENOUS INFUSION ▶Adult: 10 mg/kg every 2 weeks for 3 doses, then 10 mg/kg every 4 weeks, review treatment if no response within 6 months
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Do not initiate until active infections controlled . history or development of malignancy. predisposition to infection
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NICE decisions ▶Belimumab for treating active autoantibody-positive systemic lupus erythematosus (June 2016) NICE TA397 Belimumab (Benlysta ®) is recommended as an add-on treatment option in adults with active autoantibody- positive systemic lupus erythematosus, only if all of the following criteria apply: . there is evidence for serological disease activity (defined as positive anti-double-stranded DNA and low complement) and a Safety of Estrogen in Lupus National Assessment – Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score of greater than or equal to 10 despite standard therapy; . treatment with belimumab is continued after 24 weeks only if the SELENA-SLEDAI score has improved by 4 points or more; . the manufacturer provides belimumab with the discount agreed in the patient access scheme; and . under the conditions specified in the NICE managed access agreement documentation. Patients whose treatment was started before this guidance was published should continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta397 Scottish Medicines Consortium (SMC) decisions SMC No. 775/12 The Scottish Medicines Consortium has advised (May 2017) that belimumab (Benlysta ®) is accepted for restricted use within NHS Scotland as adjunctive therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity despite standard therapy, and who have evidence of serological disease activity and a Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA- SLEDAI) score of 10 or greater. This advice is contingent upon the continuing availability of the Patient Access Scheme in NHS Scotland or a list price that is equivalent or lower.
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MHRA/CHM ADVICE: BELIMUMAB (BENLYSTA ®): INCREASED RISK OF SERIOUS PSYCHIATRIC EVENTS SEEN IN CLINICAL TRIALS (APRIL 2019) Clinical trials show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients with systemic lupus erythematosus on belimumab. Healthcare professionals should assess patients for these risks before starting treatment, monitor for new or worsening signs of these risks during treatment, and advise patients to seek immediate medical attention if new or worsening symptoms occur.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Depression. diarrhoea. fever. hypersensitivity. increased risk of infection. infusion related reaction. leucopenia. migraine. nausea. pain in extremity ▶Uncommon Angioedema. skin reactions. suicidal tendencies ▶Frequency not known Progressive multifocal leukoencephalopathy (PML). self-injurious behaviour. vomiting SIDE-EFFECTS, FURTHER INFORMATION Infusion-related side-effects are reported commonly, including severe or life-threatening hypersensitivity and infusion reactions. Premedication with an antihistamine, with or without an antipyretic may be considered.
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Manufacturer advises adequate contraception during treatment and for at least 4 months after last dose.
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Avoid unless essential.
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Avoid—present in milk in animal studies.
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Caution in severe impairment—no information available.
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Delay in the onset of acute hypersensitivity reactions has been observed; patients should remain under clinical supervision for several hours following at least the first 2 infusions.
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For intravenous infusion (Benlysta ®), give intermittently in Sodium chloride 0.9%; reconstitute with water for injections (120 mg in 1.5 mL, 400 mg in 4.8 mL) to produce a solution containing 80 mg/mL; gently swirl vial for 60 seconds, then allow to stand; swirl vial (without shaking) for 60 seconds every 5 minutes until dissolved; dilute requisite dose with infusion fluid to a final volume of 250 mL and give over 1 hour.
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There can be variation in the licensing of different medicines containing the same drug. Powder for solution for infusion ▶Benlysta (GlaxoSmithKline UK Ltd) A Belimumab 120 mg Benlysta 120mg powder for concentrate for solution for infusion vials | 1 vial P £121.50 (Hospital only) Belimumab 400 mg Benlysta 400mg powder for concentrate for solution for infusion vials | 1 vial P £405.00 (Hospital only) IMMUNOSUPPRESSANTS › PURINE SYNTHESIS INHIBITORS
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10 mg/kg every 2 weeks for 3 doses, then
First-line fragment. Read the complete Indications and Dose section above.
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