United States: The US Food and Drug Administration (FDA) has also authorized subcutaneous auto injection of Benlysta (belimumab) in patients of age greater than 5 years with active lupus nephritis on receiving standard therapy.
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Benlysta (200 mg/mL) is a biologic that is specific to the inhibiting monoclonal antibodies targeting the B-lymphocyte stimulating B-cell that is singularly endorsed as biologic in systemic lupus erythematosus and lupus nephritis.
Patients with severe active central nervous system lupus are not recommended to use it.
The most prevalent major adverse reactions, which were observed with Benlysta included serious infections, and some infections were fatal.
UPDATE: The @FDA has approved a Benlysta autoinjector for children ages five years and older experiencing active #lupus nephritis. This is the first at-home treatment for children with LN. Read the announcement: https://t.co/jGANp1U6ks
— Lupus Foundation of America (@LupusOrg) June 25, 2025
The general negative outcomes (5 percent and above) included nausea, diarrhea, fever, nasal passage and throat inflammation, bronchitis, sleep disturbances, pain in the extremities, depression, migraine, and reaction at the site of injection.
According to Louise Vetter, who is the president and CEO of the Lupus Foundation of America, “In children, lupus tends to be more aggressive and severe than it is in adults. The symptoms can be more intense, and the disease can have long-term effects on a child’s growth and quality of life,” US News reported.
“Having the Benlysta autoinjector provides a much-needed option that can help reduce the burden of frequent clinic visits for treatment and add greater flexibility for children and their families when considering the continuity of care and routines of daily life,” as per Vetter.