Belimumab


Concise Prescribing Info
Indications/Uses
Adjunctive therapy in active, autoantibody-positive SLE.
Dosage/Direction for Use
Adult : IV Initial: 10 mg/kg via infusion over 60 minutes every 2 weeks for 3 doses, then at 4-week intervals thereafter. SC 200 mg via injector device once weekly. Discontinue if no improvement within 6 months of therapy.
Dosage Details
Intravenous
Systemic lupus erythematosus
Adult: As adjunctive therapy in patient with active, autoantibody-positive cases: Initially, 10 mg/kg via infusion over 60 minutes every 2 weeks for 3 doses, then at 4-week intervals thereafter. Discontinue if no improvement within 6 months of therapy.

Subcutaneous
Systemic lupus erythematosus
Adult: As adjunctive therapy in patient with active, autoantibody-positive cases: 200 mg via injector device once weekly. Discontinue if no improvement within 6 months of therapy.
Reconstitution
IV infusion: Add 1.5 or 4.8 mL of sterile water for injection to a vial containing 120 mg or 140 mg, respectively. Gently swirl for 60 seconds every 5 minutes up to 30 minutes until powder has dissolved. Do not shake. Further dilute appropriate volume in 250 mL of NaCl 0.45%, or lactated Ringer’s solution by removing and discarding equal amount of the reconstituted solution to be added. Mix by gentle inversion.
Contraindications
Administration of live vaccines.
Special Precautions
Patient with severe or chronic infections, history of malignancy. Not recommended for use in patient with severe active lupus nephritis and or severe active CNS lupus, HIV, history or current hepatitis B or C, hypogammaglobulinaemia, history of major organ transplant or haematopoietic stem cell/marrow transplant or renal transplant.
Adverse Reactions
Significant: Risk of malignancy, anxiety depression, mood changes insomnia.
Blood and lymphatic system disorders: Leucopenia.
Gastrointestinal disorders: Nausea, diarrhoea, viral gastroenteritis.
General disorders and administration site conditions: Injection site reactions (e.g. pain, pruritus, erythema, induration, pruritus, haematoma), fever.
Immune system disorders: Hypersensitivity reactions.
Musculoskeletal and connective tissue disorders: Limb pain.
Nervous system disorders: Migraine.
Respiratory, thoracic and mediastinal disorders: Bronchitis, nasopharyngitis, upper respiratory tract infection, pharyngitis.
Potentially Fatal: Anaphylaxis, infusion reactions, severe or chronic infections. CV disease, suicidality, progressive multifocal leucoencephalopathy.
MonitoringParameters
Monitor for new or worsening of depression, suicidal ideation or other mood changes; hypersensitivity/infusion reactions, infections.
Drug Interactions
Potentially Fatal: May enhance the adverse/toxic effect of live vaccines.
Action
Description: Belimumab is a monoclonal antibody that inhibits the binding of B-lymphocyte stimulator protein required to receptors on B-lymphocytes, thereby preventing B-lymphocytes survival and reducing the activity of B-cell mediated immunity and auto-immune response.
Pharmacokinetics:
Absorption: Bioavailability: 74% (SC). Time to peak plasma concentration: 2.6 days (SC).
Distribution: Volume of distribution: 5 L.
Excretion: Terminal elimination half-life: 19.4 days (IV); 18.3 days (SC).
Storage
Store between 2-8°C. Do not freeze. Protect from light. Avoid exposure to heat.
MIMS Class
ATC Classification
L04AA26 - belimumab ; Belongs to the class of selective immunosuppressive agents. Used to induce immunosuppression.
References
Anon. Belimumab. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 06/04/2018.

Anon. Belimumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/04/2018.

Benlysta Injection, Powder, Lyophilized for Solution; Benlysta Solution (Human Genome Sciences, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 06/04/2018.

Buckingham R (ed). Belimumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/04/2018.

Joint Formulary Committee. Belimumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/04/2018.

Disclaimer: This information is independently developed by MIMS based on Belimumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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