Xofluza

Xofluza Special Precautions

baloxavir marboxil

Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Special Precautions
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: Treatment of Acute Uncomplicated Influenza in Pediatric Patients: The safety and effectiveness of XOFLUZA for the treatment of acute uncomplicated influenza subjects 12 years of age and older weighing at least 40 kg is supported by one randomized, double-blind, controlled trial in otherwise healthy subjects (Trial 2) and one trial in subjects at high risk of developing influenza-related complications (Trial 3) [see Pharmacology: Clinical Studies: Treatment of Acute Uncomplicated Influenza - Otherwise Healthy Subjects under Actions]. A total of 117 otherwise healthy adolescents 12-17 years old were randomized and received either XOFLUZA (N=76) or placebo (N=41) in Trial 2; 38 adolescents aged 12 to 17 years at high risk for influenza complications were randomized and received either XOFLUZA (N=21) or placebo (N=17) in Trial 3. The median time to alleviation of symptoms in influenza-infected adolescent subjects aged 12 to 17 in Trial 2 was comparable to that observed adults. In Trial 3, the median time to improvement of symptoms in the limited number of influenza-infected adolescent subjects aged 12 to 17 years was similar in the XOFLUZA and placebo arms [see Pharmacology: Clinical Studies: Treatment of Acute Uncomplicated Influenza - Otherwise Healthy Subjects under Actions]. Adverse events reported in adolescents in both trials were similar to those reported in adults [see Clinical Trials Experience under Adverse Reactions].
The safety and efficacy of XOFLUZA in pediatric subjects less than 12 years of age have not been established for the treatment of acute uncomplicated influenza. For information on baloxavir resistance in subjects less than 12 years of age [see Microbiology under Actions].
Post-Exposure Prophylaxis of Influenza in Pediatric Subjects: The safety and effectiveness of XOFLUZA for post-exposure prophylaxis in adolescents (12 years to < 18 years) is supported by one randomized, double-blind, controlled trial conducted in Japan (Trial 4) [see Pharmacology: Clinical Studies: Post-Exposure Prophylaxis of Influenza under Actions]. Subjects in this trial were randomized in a 1:1 ratio to receive XOFLUZA or placebo. A total of 12 subjects from ≥ 12 to < 18 years of age received XOFLUZA. The incidence of RT-PCR-confirmed symptomatic influenza was similar in the XOFLUZA and placebo arms in the limited number of adolescent subjects aged 12 to 17 years of age [see Pharmacology: Clinical Studies: Post-Exposure Prophylaxis of Influenza under Actions]. Adverse events reported in adolescent subjects were similar to those reported in adults in the same trial [see Clinical Trials Experience under Adverse Reactions].
The safety and efficacy of XOFLUZA for post-exposure prophylaxis of influenza in pediatric subjects less than 12 years of age have not been established.
Use in the Elderly: The safety and effectiveness of XOFLUZA in subjects 65 years of age and older has been established and is supported by one randomized, double-blind, controlled trial [see Pharmacology: Clinical Studies: Treatment of Acute Uncomplicated Influenza - High Risk Subjects under Actions]. In Trial 3, of 730 XOFLUZA-treated subjects at high risk of influenza-related complications, 209 (29%) subjects were 65 years of age and older. The median time to improvement of influenza symptoms in subjects 65 years of age and older was 70 hours in subjects who received XOFLUZA (N=112) and 88 hours in those who received placebo (N=102). The safety profile observed for this population was similar to that reported in the overall trial population except for nausea, which was reported in 6% of elderly subjects compared to 1% of subjects from 18 to 64 years of age.
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