Xofluza

Xofluza Adverse Reactions

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Manufacturer:

Roche

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The overall safety profile of XOFLUZA is based on data from 1,943 subjects 12 years of age and older in 4 controlled clinical trials who received XOFLUZA [see Pharmacology: Clinical Studies under Actions].
Treatment of Acute Uncomplicated Influenza: The safety of XOFLUZA in adult and adolescent subjects is based on data from 3 placebo-controlled trials in which a total of 1,640 subjects received XOFLUZA: 1,334 subjects (81%) were 18 to 64 years of age, 209 subjects (13%) were adults 65 years of age or older and 97 subjects (6%) were adolescents 12 to 17 years of age. These trials included otherwise healthy adults and adolescents (N=910) and subjects at high risk of developing complications associated with influenza (N=730). Of these, 1,440 subjects received XOFLUZA at the recommended dose [see Pharmacology: Clinical Studies under Actions]. Trial 1 was a phase 2 dose-finding placebo-controlled trial where otherwise healthy adult subjects 20 to 64 years of age received single oral dose of XOFLUZA or placebo. Trial 2 was a placebo- and active-controlled trial in otherwise healthy adults and adolescents 12 to 64 years of age; subjects received weight-based XOFLUZA or placebo as a single oral dose on Day 1 or oseltamivir twice a day for 5 days. Trial 3 was a randomized, double-blind, placebo- and active-controlled trial where adults and adolescents at high risk of influenza complications 12 years of age and older received either XOFLUZA, placebo or oseltamivir.
Table 9 displays the most common adverse events (regardless of causality assessment) reported in at least 1% of adult and adolescent subjects who received XOFLUZA at the recommended dose in Trials 1, 2 and 3. (See Table 9.)

Click on icon to see table/diagram/image

Post-Exposure Prophylaxis of Influenza: The safety of XOFLUZA in adult and adolescent subjects is based on data from one placebo-controlled clinical trial in which 374 subjects, of which 303 were adult and adolescent subjects ≥ 12 years, received XOFLUZA: eight (3%) subjects were adults 65 years of age or older, and 12 (4%) subjects were adolescents 12 to 17 years of age. The most frequently reported AE in the total study population was nasopharyngitis which occurred in 6% of subjects who received XOFLUZA and 7% on placebo [see Pharmacology: Clinical Studies: Post-Exposure Prophylaxis of Influenza under Actions].
Postmarketing Experience: The following adverse reactions have been identified during post-marketing use of XOFLUZA. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to XOFLUZA exposure.
Immune System Disorders: Anaphylactic reactions, anaphylactic shock, anaphylactoid reactions, hypersensitivity reactions, angioedema (swelling of face, eyelids, tongue and lips).
Skin and Subcutaneous Tissue Disorders: Rash, urticaria, erythema multiforme.
Gastrointestinal Disorders: Vomiting, hematochezia, melena, colitis.
Psychiatric Disorders: Delirium, abnormal behavior, hallucinations.
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