Hypersensitivity: Cases of anaphylaxis, urticaria, angioedema, and erythema multiforme have been reported in post-marketing experience with XOFLUZA. Appropriate treatment should be instituted if an allergic-like reaction occurs or is suspected. The use of XOFLUZA is contraindicated in patients with known hypersensitivity to XOFLUZA [see Contraindications and Postmarketing Experience under Adverse Reactions].
Risk of Bacterial Infections: There is no evidence of efficacy of XOFLUZA in any illness caused by pathogens other than influenza viruses. Serious bacterial infections may begin with influenza-like symptoms, may coexist with, or occur as a complication of influenza. XOFLUZA has not been shown to prevent such complications. Prescribers should be alert to potential secondary bacterial infections and treat them as appropriate.
Use in Children: The safety and effectiveness of XOFLUZA for the treatment of influenza have been established in pediatric patients 12 years of age and older weighing at least 40 kg [see Clinical Trials Experience under Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. The safety and effectiveness of XOFLUZA have not been established in pediatric patients less than 12 years of age.
The use of XOFLUZA in pediatric patients 12 years of age and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions]. In this phase 3 trial, 118 adolescents were randomized to receive either XOFLUZA (N=80) or placebo (N=38). The median time to alleviation of symptoms in adolescent subjects was 54 hours compared to 93 hours for subjects who received placebo. Adverse reactions reported in adolescents were similar to those reported in adults [see Clinical Trials Experience under Adverse Reactions].
Use in Elderly: Clinical trials of XOFLUZA did not include subjects 65 years of age and older to determine whether they respond differently from younger subjects.