Belimumab

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.

• BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus.

• BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab. Previous anaphylaxis to belimumab.contraindicated

• See Full Prescribing Information for complete preparation and administration information. ( 2.1 , 2.2 , 2.3 ) • Intravenous dosage for active SLE or lupus nephritis: o 10 mg/kg at 2‑week intervals for the first 3 doses and at 4‑week intervals thereafter. o Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. ( 2.2 ) o Consider prophylactic premedication for infusion reactions and hypersensitivity reactions. ( 2.1 , 2.2 ) • Subcutaneous dosage for active SLE or lupus nephritis: ( 2.3 ) a Prefilled syringe has not been studied in children less than 18 years of age. b The 400-mg dose requires administration of two 200‑mg injections. Indication Adults (Autoinjector or Prefilled Syringe) Pediatric Patients 5 Years of Age and Older (Weight ‑ Based Dosing) (Autoinjector Only) a Active SLE 200 mg once weekly • ≥40 kg: 200 mg once weekly • 15 kg to less than 40 kg: 200 mg once every 2 weeks Active Lupus Nephritis 400 mg b once weekly for 4 doses, followed by 200 mg once weekly • ≥40 kg: 400 mg b once weekly for 4 doses, followed by 200 mg once weekly • 15 kg to less than 40 kg: 200 mg once weekly for 4 doses, followed by 200 mg once every 2 weeks 2.1 Important Administration Instructions BENLYSTA may be administered intravenously or subcutaneously [see Dosage and Administration ( 2.2 , 2.3 )]. Vials are intended for intravenous use only (not for subcutaneous use) and autoinjectors and prefilled syringes are intended for subcutaneous use only (not for intravenous use).

• Serious Infections: Serious and sometimes fatal infections have occurred in patients receiving immunosuppressive agents, including BENLYSTA. Use with caution in patients with severe or chronic infections. Consider interrupting therapy with BENLYSTA if patients develop a new infection during treatment with BENLYSTA. ( 5.1 ) • Progressive Multifocal Leukoencephalopathy (PML): Evaluate patients with new-onset or deteriorating neurological signs and symptoms for PML. If PML is suspected, immunosuppressant therapy, including BENLYSTA, must be suspended until PML has been excluded. If PML is confirmed, immunosuppressant therapy, including BENLYSTA, must be discontinued. ( 5.1 ) • Hypersensitivity Reactions, including Anaphylaxis: Serious and fatal reactions have been reported. ( 5.2 ) • Depression and Suicidality: Depression and suicidality were reported in trials with BENLYSTA. Assess for depression and risk of suicide before treatment with BENLYSTA and monitor during treatment. Instruct patients to contact their healthcare provider if new or worsening depression, suicidal thoughts, or other mood changes occur. ( 5.3 ) • Immunization: Live vaccines should not be given concurrently with BENLYSTA. ( 5.5 ) 5.1 Serious Infections Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA.

The following serious adverse reactions are described below and in the Warnings and Precautions section: • Serious Infections [see Warnings and Precautions ( 5.1 )] • Hypersensitivity Reactions, including Anaphylaxis [see Warnings and Precautions ( 5.2 )] • Depression and Suicidality [see Warnings and Precautions ( 5.3 )] • Malignancy [see Warnings and Precautions ( 5.4 )] Common adverse reactions (≥5%): nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection site reactions (subcutaneous administration). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-877-423-6597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Intravenous Administration in Adult Subjects with Active SLE The data described in Table 2 reflect exposure to BENLYSTA administered intravenously plus standard therapy compared with placebo plus standard therapy in 2,133 adult subjects with active SLE in 3 controlled trials (Trials 1, 2, and 3). Subjects received BENLYSTA plus standard therapy at doses of 1 mg/kg (n = 673), 4 mg/kg (n = 111; Trial 1 only), or 10 mg/kg (n = 674), or placebo plus standard therapy (n = 675) intravenously over a 1‑hour period on Days 0, 14, 28, and then every 28 days.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that evaluates pregnancy outcomes in women with lupus exposed to BENLYSTA during pregnancy. Healthcare professionals are encouraged to refer patients and pregnant women are encouraged to enroll themselves by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/benlysta-belimumab/ . Risk Summary Available data on use of BENLYSTA in pregnant women, from observational studies, published case reports, and postmarketing surveillance, are insufficient to determine whether there is a drug-associated risk for major birth defects or miscarriage. There are risks to the mother and fetus associated with SLE (see Clinical Considerations ) . Monoclonal antibodies, such as belimumab, are actively transported across the placenta during the third trimester of pregnancy and may affect immune response in the in utero-exposed infant (see Clinical Considerations ) . In an animal combined embryo-fetal and pre- and post-natal development study with monkeys that received belimumab by intravenous administration, there was no evidence of fetal harm with exposures approximately 9 times (based on intravenous administration) and 20 times (based on subcutaneous administration) the exposure at the maximum recommended human dose (MRHD).

Metabolism

Intravenous Infusion in Adults Systemic Lupus Erythematosus: The pharmacokinetic parameters displayed in Table 3 are based on population parameter estimates from 563 adult subjects with active SLE who received BENLYSTA 10 mg/kg . Table 3.

There is limited experience with overdosage of belimumab. Two doses of up to 20 mg/kg have been given intravenously to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg.

• Mar 9, 2011BLABLA125370Human Genome Sciences Inc.
• Jul 20, 2017BLABLA761043Glaxosmithkline Llc

1. 1Product Dose Omission Issue4,96016%
2. 2Systemic Lupus Erythematosus3,85813%
3. 3Fatigue2,0336.6%
4. 4Drug Ineffective1,8185.9%
5. 5Pain1,7395.6%
6. 6Headache1,5415.0%
7. 7Wrong Technique In Device Usage Process1,4774.8%
8. 8Nausea1,4764.8%
9. 9Malaise1,4074.6%
10. 10Arthralgia1,3494.4%
11. 11Injection Site Pain1,3354.3%
12. 12Product Complaint1,2604.1%
13. 13Off Label Use1,0653.5%
14. 14Condition Aggravated9693.1%
15. 15Pyrexia9653.1%

The 10 most recently updated of 108 ClinicalTrials.gov registrations naming Belimumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• PRESERVE: LUPKYNIS in Combination With Belimumab, Obinutuzumab or Anifrolumab in Patients With Lupus Nephritis
  Recruiting · Phase 4 · Interventional · 150 enrolled · Aurinia Pharmaceuticals Inc.
  NCT07611214updated 2026-06-12
• Trial of Belimumab in Early Lupus
  Recruiting · Phase 4 · Interventional · 30 enrolled · Northwell Health
  NCT03543839updated 2026-06-12
• A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
  Recruiting · Phase 4 · Interventional · 350 enrolled · GlaxoSmithKline
  NCT06411249updated 2026-06-03
• Belimumab With Rituximab for Primary Membranous Nephropathy
  Recruiting · Phase 2 · Interventional · 58 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT03949855updated 2026-05-19
• BENLYSTA® Special Drug Use Investigation
  Completed · Observational · 1,514 enrolled · GlaxoSmithKline
  NCT03370263updated 2026-05-18
• Open-label Study of Belimumab Plus Standard Therapy in Chinese Pediatric Participants With Active Systemic Lupus Erythematosus (SLE)
  Completed · Phase 4 · Interventional · 67 enrolled · GlaxoSmithKline
  NCT04908865updated 2026-05-11
• A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE) Participants, Healthy Chinese, and Japanese Participants and CTD-ILD Participants
  Recruiting · Phase 1 · Interventional · 142 enrolled · GlaxoSmithKline
  NCT06576271updated 2026-04-29
• Belimumab in Autoimmune Hepatitis
  Recruiting · Phase 2 · Interventional · 48 enrolled · University Health Network, Toronto
  NCT06381453updated 2026-04-24
• Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)
  Recruiting · Phase 1 · Interventional · 20 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT04097561updated 2026-04-20
• Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation
  Completed · Phase 1 · Interventional · 10 enrolled · Washington University School of Medicine
  NCT03207958updated 2026-04-20

Frequently asked questions

How does Belimumab work?

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.

What is Belimumab used for?

According to FDA labeling, Belimumab carries indications including: BENLYSTA is indicated for the treatment of patients 5 years of age and older with: • Active systemic lupus erythematosus (SLE) who are receiving standard therapy, and • Active lupus nephritis who are receiving standard therapy. Limitations of Use The efficacy of BENLYSTA has not been evaluated in patients with severe active central nervous system (CNS) lupus.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Belimumab?

Belimumab is classified as Monoclonal antibodies, B Lymphocyte Stimulator-specific Inhibitor, B Lymphocyte Stimulator-directed Antibody Interactions, Decreased B Lymphocyte Activation.

What are the brand names for Belimumab?

Belimumab is marketed under brand names including Benlysta.

What are the contraindications for Belimumab?

Belimumab labeling lists contraindications including: BENLYSTA is contraindicated in patients who have had anaphylaxis with belimumab. Previous anaphylaxis to belimumab.. Always consult the full prescribing information and a clinician.