Belimumab: uses, dosing, side effects & brands
Belimumab is a b lymphocyte stimulator-specific inhibitor sold in the U.S. under one brand, for systemic lupus erythematosus. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- B Lymphocyte Stimulator-Specific Inhibitor
- Treats (across its forms)
- Systemic Lupus Erythematosus
- Available as
- Injectable · Solution
- Sold as
- Benlysta
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How belimumab is dosed
From the FDA label for Benlysta (application BLA761043). Other belimumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Belimumab side effects
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 )] • Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis [see Warnings and Precautions ( 5.3 )] • Depression and Suicidality [see Warnings and Precautions ( 5.4 )] • Malignancy [see Warnings and Precautions ( 5.5 )] 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…
Who shouldn’t take belimumab
BENLYSTA is contraindicated in patients with a prior history of: • Anaphylaxis with belimumab [see Warnings and Precautions ( 5.2 )]. • Stevens-Johnson syndrome or toxic epidermal necrolysis with belimumab [see Warnings and Precautions ( 5.3 )]. Previous anaphylaxis, Stevens‑Johnson syndrome, or toxic epidermal necrolysis as a reaction to belimumab. ( 4 )
Belimumab drug interactions
Formal drug interaction studies have not been performed with BENLYSTA. In clinical trials, BENLYSTA was administered concomitantly with other drugs, including corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (including azathioprine, cyclophosphamide, methotrexate, and mycophenolate), angiotensin pathway antihypertensives, HMG‑CoA reductase inhibitors (statins), and/or non-steroidal anti-inflammatory drugs (NSAIDs) without evidence of a clinically meaningful effect of these concomitant medications on belimumab pharmacokinetics. The effect of belimumab on the pharmacokinetics of other drugs has not been evaluated [see Clinical Pharmacology ( 12.3 )] .
Every belimumab product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Benlysta.
Belimumab recalls
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
Belimumab and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for belimumab: levels in milk, effects in breastfed infants, and the drugs it would consider insteadPreliminary information and a predictive model indicate that belimumab levels in milk are very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. If belimumab is required by the mother, it is not a reason to discontinue breastfeeding. Some international guidelines consider belimumab to be acceptable during breastfeeding. Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.
National Institute of Child Health and Human Development, record revised September 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about belimumab
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,768 reports naming belimumab, and the FDA flagged 89% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- systemic lupus erythematosus1,199 reports
- fatigue279 reports
- inappropriate schedule of product administration259 reports
- arthralgia243 reports
- lupus nephritis237 reports
- nausea202 reports
- headache200 reports
- malaise197 reports
Read these as a signal, not a rate. A report does not mean belimumab caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
Related calculators
Frequently asked questions
What is belimumab?
Benlysta (Belimumab) is a b lymphocyte stimulator-specific inhibitor used to treat Systemic Lupus Erythematosus.
What kind of drug is belimumab?
The FDA classifies belimumab as a b lymphocyte stimulator-specific inhibitor. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take belimumab with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run belimumab against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does belimumab come in?
Across the brands we track, belimumab is currently marketed as injectable and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic belimumab?
We do not currently list a generic-labelled belimumab product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Has belimumab been recalled?
The FDA's Enforcement database lists 1 recall record whose product description mentions belimumab. The most recent: BENLYSTA (belimumab) for injection (Apr 21, 2025). A recall applies to specific lots, not to the drug as a whole — check the record for the affected lot numbers.
Cite this page
- APA
- pharmaranks. (2026, July 24). Belimumab: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/belimumab
- MLA
- “Belimumab: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/belimumab.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for belimumab on DailyMed (NIH) ↗.