Xofluza Adverse Reactions

Clinical Trials: The overall safety profile of XOFLUZA is based on data from 2109 subjects in 17 clinical trials receiving XOFLUZA. No adverse drug reactions have been identified based on pooled data from 3 placebo-controlled clinical studies (Studies 1518T0821, 1601T0831 and 1602T0832) in adult and adolescent patients, in which a total of 1640 patients have received XOFLUZA. This includes otherwise healthy adults, and adolescents and patients at high risk of developing complications associated with influenza, e.g. elderly patients and patients with chronic cardiac or respiratory disease. 1334 patients (81.3%) were adults ≥18 years to ≤64 years, 209 patients (12.7%) were adults ≥65 years and 97 patients (5.9%) were adolescents (≥12 years to <18 years). Of these, 1440 patients received XOFLUZA at 40 mg and 80 mg doses and 100 patients each received 10 mg or 20 mg doses. The safety profile in patients at high risk was similar to that in otherwise healthy adults and adolescents.
Postmarketing Experience: The following adverse drug reactions have been identified from postmarketing experience with baloxavir marboxil (Table 9) based on spontaneous case reports and cases from non-interventional study programs. Adverse drug reactions are listed according to system organ classes in MedDRA and the corresponding frequency category estimation for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). (See Table 9.)

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Description of selected adverse drug reactions from postmarketing experience: Hypersensitivity reactions have been observed in the postmarketing setting which include reports of anaphylaxis/anaphylactic reactions and less severe forms of hypersensitivity reactions including urticaria and angioedema.