Product Details

BENLYSTA(BELIMUMAB 400MG)20ML

Manufacturer: Glaxo Smith Kline

MFG#: 49401-0102-01

NDC: 49401-0102-01

PID: 666739

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Additional Information

Product NameBenlysta (Belimumab 400 mg) 20 ml
ApplicationImmunosuppressive Agent
Generic Drug NameBelimumab
Mechanism of ActionInhibits B-lymphocyte stimulator (BLyS) to reduce autoantibody production and B-cell activity
Strength400 mg
TypeIntravenous
Volume20 mL
Administration Schedule10 mg/kg IV at weeks 0, 2, and 4, then every 4 weeks
Common Side EffectsNausea, diarrhea, fever, infusion reactions, infections
Serious ReactionsHypersensitivity, anaphylaxis, progressive multifocal leukoencephalopathy (PML)
Container TypeSingle-Use Vial
Storage RequirementsRequires Refrigeration (2°C to 8°C / 36°F to 46°F)
UsesTreatment of systemic lupus erythematosus (SLE) and lupus nephritis

Description

Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. By inhibiting BLyS, a cytokine essential for the survival of B cells, Benlysta reduces autoantibody production and modulates the immune response.

The injection is supplied as a sterile, preservative-free, lyophilized powder in a single-dose glass vial with a rubber stopper and a flip-off seal. Each 20 mL vial contains 400 mg of belimumab, which must be reconstituted with sterile water for injection and further diluted in 0.9% sodium chloride before intravenous administration. 

Benlysta is administered via intravenous infusion over one hour. The recommended dosing regimen for SLE consists of 10 mg/kg at weeks 0, 2, and 4, followed by maintenance doses every four weeks. For lupus nephritis, it is given at the same frequency but can be combined with corticosteroids and other immunosuppressive agents.

Frequently Asked Questions (FAQs)

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BENLYSTA(BELIMUMAB 400MG)20ML is manufactured by Glaxo Smith Kline.

You can purchase BENLYSTA(BELIMUMAB 400MG)20ML on our website at https://injx.pipelinemedical.com/product/detail/benlysta-pr-400mg-pf-spd-649447