The U.S. Food and Drug Administration has approved a 200-mg subcutaneous route of administration of Benlysta (belimumab) for patients 5 years of age and older with active systemic lupus erythematosus (SLE) who are receiving standard therapy.

The B-lymphocyte stimulator-specific inhibiting monoclonal antibody was previously approved for children aged 5 years and older via intravenous administration by health care professionals. With this approval, a child’s health care provider can determine if at-home administration is appropriate, and if so, the patient’s caregiver can administer the medicine at home via an autoinjector once per week for children who weigh ≥40 kg or once every two weeks for children who weigh 15 kg to <40 kg.

In adult trials, the most common serious adverse reactions were serious infections, some of which were fatal. The most common adverse reactions (≥5 percent) were nausea, diarrhea, pyrexia, nasopharyngitis, bronchitis, insomnia, pain in extremity, depression, migraine, pharyngitis, and injection-site reactions. In clinical trials with SLE pediatric patients (aged 5 years and older) and adult patients with lupus nephritis, reported adverse reactions were consistent with those observed in adult SLE trials.