XOFLUZA FILM COATED TABLETS 40MG [SIN15680P]

Product Info

XOFLUZA FILM COATED TABLETS 40MG

[SIN15680P]

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).

2.2 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.

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).