FDA approves Belimumab intravenous infusion for children under 5 years of age with systemic lupus
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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systemic lupus erythematosus (SLE), commonly referred to simply as lupus, is a serious chronic disease that causes inflammation and various body damage to tissues and organsRecently, theFDA(http://(http://Administration of Food andMedicines (http:// approved belimumab intravenous infusion (IV) for children under the age of 5 with systemic lupus erythematosus (SLE)A clinicaltrial(http://studied the efficacy of belimumab, which evaluated the efficacy, safety and pharmacodynamics of 93 children aged 5 to 17 with active SLE for 1 yearhad a higher proportion of children receiving belimumab IV plus standard treatment to achieve the Comprehensive Primary Endpoint SLE Response Index (SRI-4) than the placebo plus standard treatment groupChildren receiving belimumab IV plus standard treatment have a lower risk of severe seizures and longer duration spree essuing up to severe seizures (160 days VS 82 days)The drug's safety and pharmacokinetic characteristics in children are consistent with adult SLE patientsAccording to SLE adult clinical studies, belimumab includes a warning of death, severe infection, allergies and depressionThe drug should not be used with live vaccinesManufacturers must provide drug guidelines to inform patients of the risks associated with belimumabThe most common side effects include nausea, diarrhea and feverPatients often experience infusion reactions, so it is recommended that medical personnel treat patients in advance with antihistamines
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