B Lymphocyte Stimulator-directed Antibody Interactions

B Lymphocyte Stimulator-specific Inhibitor

Lupus Erythematosus, Systemic

<section class="Section" data-sectioncode="34089-3"><a name="inv-5782a7b3-13da-49b6-9bd6-254f7f71def8"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>Belimumab is a human IgG1λ 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 murine cell (NS0) expression system.Intravenous Infusion<dl><dt>•</dt><dd>BENLYSTA (belimumab) for injection is a sterile, white to off-white, preservative‑free, lyophilized powder in a single-dose vial for reconstitution and dilution prior to intravenous infusion. BENLYSTA for injection is supplied as 120 mg per vial and 400 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.5 mL and 4.8 mL, respectively) to obtain a concentration of 80 mg/mL [see Dosage and Administration (<a href="#inv-610dcc19-f33d-401d-8f40-451c0fd9ec64">2.2</a>)]. After reconstitution, each vial allows for withdrawal of 1.5 mL (120 mg) or 5 mL (400 mg). Each mL delivers 80 mg belimumab, citric acid (0.16 mg), polysorbate 80 (0.4 mg), sodium citrate (2.7 mg), and sucrose (80 mg), with a pH of 6.5.</dd></dl>The vial stoppers are not made with natural rubber latex.Subcutaneous InjectionBENLYSTA (belimumab) injection is a sterile, preservative-free, clear to opalescent, and colorless to pale yellow solution for subcutaneous use. It is supplied in a 1-mL single-dose prefilled autoinjector with a fixed 27-gauge, half-inch needle or in a 1-mL single-dose prefilled syringe with a fixed 27-gauge, half-inch needle with a needle guard. Each 1 mL delivers 200 mg belimumab, L-arginine hydrochloride (5.3 mg), L-histidine (0.65 mg), L-histidine monohydrochloride (1.2 mg), polysorbate 80 (0.1 mg), and sodium chloride (6.7 mg), with a pH of 6.0.The autoinjectors and prefilled syringes are not made with natural rubber latex.</section>

BENLYSTA

belimumab

Benlysta

belimumab 120 MG Injection

belimumab 120 MG Injection [Benlysta]

belimumab 400 MG Injection

belimumab 400 MG Injection [Benlysta]

1 ML belimumab 200 MG/ML Auto-Injector

1 ML belimumab 200 MG/ML Auto-Injector [Benlysta]

1 ML belimumab 200 MG/ML Prefilled Syringe

1 ML belimumab 200 MG/ML Prefilled Syringe [Benlysta]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Report Adverse Event

Prescribing Information

Medication Guide

Submit MSL Request 

Pharmacy List

How to Order Benlysta

Coverage Authorization Request

Coverage Authorization Appeals

Benlysta Gateway - Provider Portal

Benlysta Gateway Enrollment Form 

Enroll in Patient Savings Program 

Formulary Information

Reimbursment Information

Other HCP Resources 

Other HCP Resources: Webinars 

About Benlysta

Patient Stories

FAQs: Lupus & Lupus Nephritis

Side Effects 

Discussion Guide

Benlysta Cares Support Program 

Instructions for Use - Autoinjector: Lupus & Lupus Nephritis 

Receiving Benlysta IV

Taking Benlysta (At Home Administration)