Belimumab Injection
Belimumab Injection (Benlysta) is a lupus medicine given by IV infusion or subcutaneous injection for active systemic lupus erythematosus (SLE) and active lupus nephritis (lupus-related kidney disease) in people 5 years and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Belimumab (Benlysta) is a lupus biologic, on the U.S. market since about 2011, added to standard therapy for active SLE and lupus nephritis (lupus affecting the kidneys) in people 5 and older; it blocks BLyS, a protein B cells (immune cells) need to survive, so fewer survive or mature into antibody-making plasma cells. Most people tolerate it well, noticing mainly nausea, diarrhea, or cold-like nose and throat symptoms. It dampens part of the immune system, so the main thing to watch for is infection; report fever or any new infection. Also report low mood or allergic and skin reactions, which can surface up to a week after a dose.
Clinical pearls
- Live vaccines are off limits during treatment and for 30 days before it starts, so plan any needed ones well ahead.
- Make sure every prescriber knows you take Benlysta, since adding rituximab raised the risk of serious infections and injection reactions.
- Self-injections go in the abdomen or thigh, while IV doses are given by a healthcare provider over about an hour.
- If pregnancy is possible, use effective contraception during treatment and for at least 4 months after the last dose.
Patient information guide A plain-language walkthrough of Belimumab Injection, written from its FDA label.
What Belimumab Injection is used for
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Benlysta (belimumab) is used with standard therapy for these conditions in people 5 years and older:
- Active systemic lupus erythematosus (SLE)
- Active lupus nephritis
It is not recommended for severe active central nervous system lupus, which has not been studied.
How Belimumab Injection works
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Benlysta blocks BLyS, a protein that helps B cells survive. It does not attach to B cells directly. By blocking BLyS, it reduces survival of B cells, including those that attack the body's own tissues, and reduces their turning into antibody-producing plasma cells.
Belimumab Injection dosage
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Benlysta is given either as an IV infusion or as a subcutaneous injection, depending on the product used.
- IV: given by a healthcare provider over about 1 hour, every 2 weeks for the first 3 doses, then every 4 weeks. Premedication may be considered to help prevent infusion or allergic reactions.
- Subcutaneous: adults use an autoinjector or prefilled syringe, usually weekly. Children's schedules depend on weight, and only the autoinjector is used in children. Lupus nephritis starts with a loading phase.
- Children under 10 must have injections given by a healthcare professional or trained caregiver.
- If you miss a dose, give it as soon as you remember, then go back to your usual day or start a new schedule from that day.
Food is not mentioned. Follow your prescriber and the label.
Dosing details from the FDA-approved label
From the Belimumab Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Intravenous dosage for active SLE or lupus nephritis (patients 5 years of age and older)
- 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter
- Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour
- Consider premedication for prophylaxis against infusion reactions and hypersensitivity reactions
- Subcutaneous: Active SLE, adults (autoinjector or prefilled syringe)
- 200 mg once weekly
- Subcutaneous: Active SLE, pediatric patients 5 years of age and older, 40 kg or more (autoinjector only)
- 200 mg once weekly
- Weight-based dosing; prefilled syringe not studied in patients less than 18 years of age
- Subcutaneous: Active SLE, pediatric patients 5 years of age and older, 15 kg to less than 40 kg (autoinjector only)
- 200 mg once every 2 weeks
- Weight-based dosing; prefilled syringe not studied in patients less than 18 years of age
- Subcutaneous: Active lupus nephritis, adults (autoinjector or prefilled syringe)
- 400 mg once weekly for 4 doses, followed by 200 mg once weekly
- The 400-mg dose requires two 200-mg injections
- Subcutaneous: Active lupus nephritis, pediatric patients 5 years of age and older, 40 kg or more (autoinjector only)
- 400 mg once weekly for 4 doses, followed by 200 mg once weekly
- The 400-mg dose requires two 200-mg injections
- Subcutaneous: Active lupus nephritis, pediatric patients 5 years of age and older, 15 kg to less than 40 kg (autoinjector only)
- 200 mg once weekly for 4 doses, followed by 200 mg once every 2 weeks
- Weight-based dosing
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION • 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). Precautions Prior to Intravenous Use BENLYSTA should be administered by healthcare providers prepared to manage anaphylaxis [see Warnings and Precautions ( 5.2 )]. Prior to intravenous dosing with BENLYSTA, consider administering premedication for prophylaxis against infusion reactions and hypersensitivity reactions [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 )] . 2.2 Recommended Intravenous Dosage, and Preparation and Administration Instructions BENLYSTA for intravenous use must be reconstituted and diluted prior to administration. Do not administer as an intravenous push or bolus.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Belimumab Injection side effects
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Common side effects include:
Common side effects
- Nausea
- Diarrhea
- Fever
- Stuffy or runny nose and sore throat (nasopharyngitis, pharyngitis)
- Bronchitis
- Trouble sleeping (insomnia)
- Pain in arms or legs
- Depression, migraine, and injection site reactions (with under-the-skin use)
When to get medical help
- Get emergency help for signs of a severe allergic reaction, such as trouble breathing, swelling of the face, hives, itching, or low blood pressure.
- Call your doctor if you develop a new infection, fever, or signs of infection.
- Call your doctor right away for new or worsening neurological symptoms, which could signal a rare brain infection called PML.
- Stop and get medical help for a severe skin reaction (Stevens-Johnson syndrome or toxic epidermal necrolysis).
- Contact your doctor if you have new or worsening depression, suicidal thoughts, or mood changes.
- Reactions can happen hours later or up to a week after a dose, with rash, nausea, tiredness, muscle pain, headache, or facial swelling.
Belimumab Injection warnings and precautions
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- Serious infections: some have been fatal. Use caution with severe or chronic infections, and your doctor may pause treatment for a new infection.
- PML: a rare brain infection. New or worsening neurological symptoms need prompt evaluation.
- Allergic reactions: including anaphylaxis, which can happen even if earlier doses were tolerated, and may occur hours to a week later.
- Severe skin reactions: SJS/TEN. Stop immediately if suspected.
- Depression and suicidality: your doctor should assess and monitor mood.
- Cancer: immune-suppressing medicines raise cancer risk; Benlysta's effect is unknown.
- Vaccines: may blunt vaccine response; avoid live vaccines.
Belimumab Injection interactions
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No formal interaction studies were done, but a few points matter:
- Live vaccines: avoid for 30 days before and during treatment because safety is not established.
- Rituximab: more serious infections and injection reactions occurred when used together.
- Other biologic therapies: safety and effectiveness together are not established, so use caution.
- Steroids, antimalarials, azathioprine, cyclophosphamide, methotrexate, mycophenolate, statins, blood pressure medicines of the angiotensin type, and NSAIDs were used in trials without a meaningful effect on belimumab levels.
Interactions listed in the FDA-approved label
From the Belimumab Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Corticosteroids, antimalarials, immunomodulatory and immunosuppressive agents (azathioprine, cyclophosphamide, methotrexate, mycophenolate), angiotensin pathway antihypertensives, HMG-CoA reductase inhibitors (statins), NSAIDs: Given concomitantly in clinical trials without evidence of a clinically meaningful effect of these medications on belimumab pharmacokinetics.
- Other drugs (effect of belimumab on their pharmacokinetics): The effect of belimumab on the pharmacokinetics of other drugs has not been evaluated; formal drug interaction studies have not been performed.
Read the label’s full interactions text
7 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 )] .
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Belimumab Injection
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- Do not use if you previously had anaphylaxis, SJS, or TEN with belimumab.
- Tell your doctor about severe or chronic infections.
- Share any history of depression or suicidal thoughts.
- Mention multiple drug allergies or serious allergic reactions.
- Mention any cancer history or risk factors.
- Pregnancy: data are insufficient to determine risk; belimumab crosses the placenta late in pregnancy and may affect the baby's immune system. Infants may need monitoring and careful vaccine decisions. Use effective contraception during treatment and for at least 4 months after if pregnancy prevention is needed.
- Breastfeeding: effects are unknown, so weigh benefits and risks with your doctor.
- Children: studied in ages 5 and up; not established under 5.
- Older adults: use with caution due to limited data.
Belimumab Injection overdose
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Experience with overdose is limited. Two IV doses of up to 20 mg/kg were given to people without an increase in the frequency or severity of side effects. Contact your healthcare provider or poison control if you think too much was used.
What Belimumab Injection does in the body
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In adults, Benlysta lowered several types of B cells, including those linked to lupus, along with IgG and anti-double-stranded DNA antibodies. In people with low complement levels at baseline, complement C3 and C4 rose. In lupus nephritis, changes in these markers were consistent with SLE studies and IgG changes were associated with less protein in the urine. The clinical meaning of these markers has not been established.
How your body processes Belimumab Injection
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With IV dosing, the terminal half-life is about 19 days in adults with SLE. With weekly subcutaneous dosing, the body absorbs about 74% of the dose, reaching peak levels in roughly 2.6 days, and the half-life is about 18 days. In lupus nephritis, protein loss in urine can lower drug levels early on, but levels become similar to SLE as protein drops. Age did not significantly affect levels, and children's levels were similar to adults'.
How to store Belimumab Injection
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Refrigerate vials at 36°F to 46°F (2°C to 8°C). Store vials in the original carton until use to protect from light. Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Belimumab Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Belimumab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Benlysta for?
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How will I get my doses?
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What if I miss a dose?
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What side effects should I expect, and which are urgent?
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Can I get vaccines while on it?
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Is it safe in pregnancy?
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Is Belimumab Injection available over the counter?
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When was Belimumab Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Belimumab Injection on HelloPharmacist
Belimumab Injection forms and strengths (how it comes)
Belimumab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Belimumab Injection inactive ingredients by manufacturer.
Injection
How this form is used
- Benlysta is used with standard therapy for active SLE in patients 5 years and older.
- Benlysta is used with standard therapy for active lupus nephritis in patients 5 years and older.
- Benlysta vials are for IV use only; the autoinjector and prefilled syringe are for subcutaneous use only.
- Benlysta IV is mixed and given by a healthcare professional as an infusion over about 1 hour.
- Benlysta subcutaneous doses go in the abdomen or thigh; the first injection is given under healthcare provider supervision.
- Benlysta autoinjector or prefilled syringe should sit at room temperature for 30 minutes before injecting; do not use it if it was dropped.
Belimumab Injection on the U.S. market: products, makers and brands
How Belimumab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Belimumab Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2011. Brand names on the directory include Benlysta; the rest are generics.
How widely Belimumab Injection is used (Medicaid data)
A general measure of how commonly Belimumab Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Belimumab Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Belimumab Injection prescribed? Of the 1,601 medications we measure, Belimumab Injection ranks #587 by Medicaid prescriptions — more than 63% of them.
Utilization by Belimumab Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1 ML belimumab 200 MG/ML Auto-Injector Most dispensed
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1939296
belimumab 120 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1656395
belimumab 400 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1656400
1 ML belimumab 200 MG/ML Prefilled Syringe
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1939346
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Belimumab Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 9 listed Belimumab Injection NDCs with Medicaid activity.
Compare Belimumab Injection products
A representative set of FDA-listed product records for Belimumab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 120 mg/1.5 mL | Intravenous | GlaxoSmithKline LLC | BLA | View NDC → |
| 200 mg/mL | Subcutaneous | GlaxoSmithKline LLC | BLA | View NDC → |
| 400 mg/5 mL | Intravenous | GlaxoSmithKline LLC | BLA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Belimumab Injection NDCs →
Belimumab Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Belimumab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Belimumab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Belimumab Injection FDA approval history
How Belimumab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Belimumab Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Belimumab recall since July 2021. It is still ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. Lots: Lot: YK4W, Expiration date: 4/30/2029 FDA record D-0540-2025 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1092437 3 dose forms · 4 strengths
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Dose form (SCDF) Auto-Injector RxCUI 1939295In current FDA listingsClinical drug / strength (SCD) 1 ML belimumab 200 MG/MLRxCUI 1939296 -
Dose form (SCDF) Injection RxCUI 1656394In current FDA listings -
Dose form (SCDF) Prefilled Syringe RxCUI 1939345No current FDA listingClinical drug / strength (SCD) 1 ML belimumab 200 MG/MLRxCUI 1939346
Look up RxCUI 1092437 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Belimumab Injection supply and shortage status
Whether Belimumab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Belimumab Injection brand names
Belimumab Injection is sold under one brand name in the FDA directory — Benlysta. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Belimumab Injection: manufacturers and labelers
One company lists Belimumab Injection products with the FDA. By number of product records, the largest are GlaxoSmithKline LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Belimumab Injection drug class (RxNorm)
Belimumab Injection belongs to the B Lymphocyte Stimulator-specific Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Belimumab Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. GlaxoSmithKline LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →