| Initial U.S. Approval: 2011
BENLYSTA (belimumab) is a human IgG1γ monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). Belimumab has a molecular weight of approximately 147 kDa. Belimumab is produced by recombinant DNA technology in a mammalian cell expression system.
BENLYSTA is supplied as a sterile, white to off-white, preservative-free, lyophilized powder for intravenous infusion. Upon reconstitution with Sterile Water for Injection, USP, [see Dosage and Administration] each single-use vial delivers 80 mg/mL belimumab in 0.16 mg/mL citric acid, 0.4 mg/mL polysorbate 80, 2.7 mg/mL sodium citrate, and 80 mg/mL sucrose, with a pH of 6.5.
| CLINICAL PHARMACOLOGY
Mechanism of Action
BENLYSTA is a BLyS-specific inhibitor that blocks the binding of soluble BLyS, a B-cell survival factor, to its receptors on B cells. BENLYSTA does not bind B cells directly, but by binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.
| INDICATIONS AND USAGE
BENLYSTA ® (belimumab) is indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy.
Limitations of Use
BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab.
| WARNINGS AND PRECAUTIONS
| ADVERSE REACTIONS
Common adverse reactions (≥5 %) in clinical trials were: nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, and pharyngitis.
To report SUSPECTED ADVERSE REACTIONS, contactHuman Genome Sciences, Inc. at 1-877-423-6597or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
| DOSAGE AND ADMINISTRATION
The recommended dosage regimen is 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter. Reconstitue, dilute and administer as an intravenous infusion only, over a period of 1 hour. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The infusion must be discontinued immediately if the patient experiences a serious hypersensitivity reaction [see Contraindications, Warnings and Precautions].
Preparation of Solutions
| DOSAGE FORMS AND STRENGTHS
Single-use vials of belimumab lyophilized powder for injection:
BENLYSTA is a sterile, preservative-free lyophilized powder for reconstitution, dilution, and intravenous infusion provided in single-use glass vials with a latex-free rubber stopper and a flip-off seal. Each 5-mL vial delivers 120 mg of belimumab. Each 20-mL vial delivers 400 mg of belimumab.
Store vials of BENLYSTA refrigerated between 2° to 8°C (36° to 46°F). Vials should be protected from light and stored in the original carton until use. Do not freeze. Avoid exposure to heat. Do not use beyond the expiration date.
| Package Insert data:
BENLYSTA is a registered trademark of Human Genome Sciences, Inc., used under license by GlaxoSmithKline.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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