Benlysta, illustration of injection vial form (not a photo of the actual pack)

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Benlysta

Belimumab

Prescription required

$315.00

120mg/5ml · 1 vial

BrandBranded medicine· By GlaxoSmithKline

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120mg/5ml

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About Benlysta

Overview

Benlysta contains belimumab, a monoclonal antibody medicine. It treats active systemic lupus erythematosus (SLE) and active lupus nephritis in adults and children aged 5 years and older who are receiving standard therapy. It works by blocking BLyS, a protein that helps B cells survive, including B cells that react against the body’s own tissues. It is not recommended for severe active lupus affecting the central nervous system because its effectiveness in this situation has not been evaluated.

What it treats

- Active systemic lupus erythematosus (SLE) in patients aged 5 years and older who are receiving standard therapy. - Active lupus nephritis in patients aged 5 years and older who are receiving standard therapy.

Safety information

Side effects

Common side effects include nausea, diarrhea, fever, nose and throat inflammation, bronchitis, difficulty sleeping, pain in the arms or legs, depression, migraine, sore throat, and injection-site reactions with injections under the skin. Serious side effects include infections and severe allergic reactions, including anaphylaxis. These can be fatal. Contact a doctor immediately if you develop a new infection or signs of a severe allergic reaction. New or worsening neurological symptoms need prompt medical assessment for progressive multifocal leukoencephalopathy (PML). Severe skin reactions, including Stevens–Johnson syndrome and toxic epidermal necrolysis, are also serious risks. Stop Benlysta and seek immediate medical attention if signs of these reactions occur. Contact your healthcare provider promptly for new or worsening depression, suicidal thoughts, or other mood changes. Malignancy (cancer) is also listed as a serious concern in the label.

When to call your doctor

• Get immediate medical help for a serious allergic reaction. • Seek immediate medical attention for signs of a severe skin reaction. • Seek urgent medical attention for new or worsening symptoms affecting your brain or nerves. • Contact your healthcare provider promptly if you develop a new infection during treatment. • Contact your healthcare provider immediately for new or worsening depression, suicidal thoughts, or other mood changes.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Do not use Benlysta (belimumab) if you have previously had anaphylaxis (a severe allergic reaction), Stevens–Johnson syndrome or toxic epidermal necrolysis (serious skin reactions) caused by belimumab. Benlysta requires caution in people with severe or chronic infections. Serious and sometimes fatal infections have occurred during treatment. If a new infection develops, your healthcare provider may need to interrupt treatment. New or worsening neurological symptoms require assessment for progressive multifocal leukoencephalopathy (PML). If PML is suspected, immunosuppressive treatment, including Benlysta, must be suspended until PML is ruled out. If confirmed, it must be discontinued. Serious and fatal allergic reactions have been reported. Benlysta must be stopped immediately if signs or symptoms of Stevens–Johnson syndrome or toxic epidermal necrolysis occur. Depression and suicide risk should be assessed before treatment and monitored during treatment. Contact your healthcare provider if you develop new or worsening depression, suicidal thoughts or other mood changes. Live vaccines should not be given during Benlysta treatment.

Interactions

Formal drug interaction studies have not been performed with Benlysta (belimumab). In clinical trials, corticosteroids, antimalarials, immunomodulatory and immunosuppressive medicines (including azathioprine, cyclophosphamide, methotrexate and mycophenolate), blood pressure medicines acting on the angiotensin pathway, statins and NSAIDs did not meaningfully affect how the body processes belimumab. Whether belimumab affects how the body processes other medicines has not been evaluated. Discuss any medicines in these groups with your doctor.

Using Benlysta

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC] (DailyMed, retrieved 19 September 2026).

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