Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**2.2 DOSAGE AND ADMINISTRATION** **General** Xofluza may be taken with or without food (see section 3.2 Pharmacokinetic Properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Treatment of Influenza_ A single dose of Xofluza should be taken within 48 hours of symptom onset. _Prophylaxis of Influenza_ A single dose of Xofluza should be taken within 48 hours following close contact with a symptomatic individual. **Dosage** _Treatment or Post-Exposure Prophylaxis of Adults and Adolescents (≥12 years of age)_ The recommended dose of Xofluza depending on body weight is shown in Table 1.  **Dose Modifications** No dose reductions of Xofluza are recommended. **2.2.1 Special Dosage Instructions** **Pediatric use** The safety and efficacy of Xofluza in patients < 12 years of age has not been established. For patients ≥ 12 years see 2.2 Dosage and Administration. **Geriatric use** No dosage adjustment is recommended (see section 3.2.5 Pharmacokinetics in Special Populations, Geriatric Population – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Renal Impairment** The safety and efficacy of Xofluza has not been studied in patients with renal impairment. A change in dose is not required for patients with renal impairment (see section 3.2.5 Pharmacokinetics in Special Populations, Renal impairment – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Hepatic Impairment** No dose adjustment is required in patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment (see section 3.2.5 Pharmacokinetics in Special Populations, Hepatic impairment – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Xofluza has not been studied in patients with severe hepatic impairment.
ORAL
Medical Information
**2.1 THERAPEUTIC INDICATION(S)** _Treatment of Influenza_ Xofluza is indicated for the treatment of acute uncomplicated influenza in patients aged 12 and above who have been symptomatic for no more than 48 hours and who are: - otherwise healthy, or - at high risk of developing influenza-related complications (see section 3.1.2 Clinical/Efficacy Studies – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Prophylaxis of Influenza_ Xofluza is indicated for the post-exposure prophylaxis of influenza in individuals aged 12 and above. **Limitations of Use** Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use Xofluza (see section 3.1.2 Clinical/Efficacy Studies, Resistance Monitoring during Clinical Development – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**2.3 CONTRAINDICATIONS** Xofluza is contraindicated in patients with a known hypersensitivity to baloxavir marboxil or any of the excipients (see section 2.6.2 Postmarketing Experience – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
J05AX25
baloxavir marboxil
Manufacturer Information
ROCHE SINGAPORE PTE. LTD.
Shionogi Pharma Co. Ltd. (Settsu Plant)
Sharp Packaging Services, LLC (Primary and Secondary Packager)
F. Hoffmann-La Roche Ltd (Primary and Secondary Packager)
Active Ingredients
Documents
Package Inserts
Xofluza PI.pdf
Approved: January 19, 2023