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HSA Approval

XOFLUZA FILM COATED TABLETS 20MG

SIN15679P

XOFLUZA FILM COATED TABLETS 20MG

XOFLUZA FILM COATED TABLETS 20MG

May 3, 2019

ROCHE SINGAPORE PTE. LTD.

ROCHE SINGAPORE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantROCHE SINGAPORE PTE. LTD.
Licence HolderROCHE SINGAPORE PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore 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. ![Xofluza Dosage Table 1](https://cdn.medpath.com/drug/dosage/20240520/07dc42891674b5facdc311896d46428b.png) **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)

Active Ingredients

Baloxavir Marboxil

20mg

Baloxavir marboxil

Documents

Package Inserts

Xofluza PI.pdf

Approved: October 19, 2021

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XOFLUZA FILM COATED TABLETS 20MG - HSA Approval | MedPath