- Approval Id
- f63155c0570d25ea
- Drug Name
- XOFLUZA FILM COATED TABLETS 40MG
- Product Name
- XOFLUZA FILM COATED TABLETS 40MG
- Approval Number
- SIN15680P
- Approval Date
- 2019-05-03
- Registrant
- ROCHE SINGAPORE PTE. LTD.
- Licence Holder
- ROCHE SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2.2 DOSAGE AND ADMINISTRATION</strong><br>
<strong>General</strong><br>
Xofluza may be taken with or without food (see section 3.2 Pharmacokinetic Properties – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Treatment of Influenza</em><br>
A single dose of Xofluza should be taken within 48 hours of symptom onset.</p>
<p><em>Prophylaxis of Influenza</em><br>
A single dose of Xofluza should be taken within 48 hours following close contact with a symptomatic individual.</p>
<p><strong>Dosage</strong></p>
<p><em>Treatment or Post-Exposure Prophylaxis of Adults and Adolescents (≥12 years of age)</em><br>
The recommended dose of Xofluza depending on body weight is shown in Table 1.</p>
<img src="/TGIF/Xofluza-Table1.png" alt="Xofluza Dosage Table 1" /><br><br>
<p><strong>Dose Modifications</strong><br>
No dose reductions of Xofluza are recommended.</p>
<p><strong>2.2.1 Special Dosage Instructions</strong><br>
<strong>Pediatric use</strong><br>
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.</p>
<p><strong>Geriatric use</strong><br>
No dosage adjustment is recommended (see section 3.2.5 Pharmacokinetics in Special Populations, Geriatric Population – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Renal Impairment</strong><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Hepatic Impairment</strong><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Xofluza has not been studied in patients with severe hepatic impairment.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>2.1 THERAPEUTIC INDICATION(S)</strong><br>
<em>Treatment of Influenza</em><br>
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:</p>
<ul>
<li>otherwise healthy, or</li>
<li>at high risk of developing influenza-related complications</li>
</ul>
<p>(see section 3.1.2 Clinical/Efficacy Studies – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Prophylaxis of Influenza</em><br>
Xofluza is indicated for the post-exposure prophylaxis of influenza in individuals aged 12 and above.</p>
<p><strong>Limitations of Use</strong><br>
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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Contraindications
- <p><strong>2.3 CONTRAINDICATIONS</strong><br>
Xofluza is contraindicated in patients with a known hypersensitivity to baloxavir marboxil or any of the excipients (see section 2.6.2 Postmarketing Experience – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- J05AX25
- Atc Item Name
- baloxavir marboxil
- Pharma Manufacturer Name
- ROCHE SINGAPORE PTE. LTD.
