Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 12 years and above.
Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 12 years and above.
Xofluza should be used in accordance with official recommendations.
A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours of symptom onset.
A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours following close contact with an individual known or suspected to have influenza (see section 5.1).
The recommended oral dose of baloxavir marboxil depending on body weight is shown in Table 1.
Table 1. Baloxavir marboxil dosing by patient weight:
| Patient body weight | Recommended oral dose |
|---|---|
| <80 kg | Single dose of 40 mg taken as 2 × 20 mg tablets |
| ≥80 kg | Single dose of 80 mg taken as 2 × 40 mg tablets |
There are no clinical data on the use of a repeat dose of baloxavir marboxil for the treatment of uncomplicated influenza or for post-exposure prophylaxis in any one influenza season.
No dosage adjustment is required (see section 5.2).
No dose adjustment is required in patients with renal impairment (see section 5.2).
No dose adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh class A or B). The safety and efficacy of baloxavir marboxil has not been established in patients with severe hepatic impairment (Child-Pugh class C).
The safety and efficacy of baloxavir marboxil in children aged <12 years has not been established.
Oral use. The tablets should be taken with water.
Xofluza may be taken with or without food (see section 5.2).
Xofluza should not be taken with products that contain polyvalent cations such as laxatives, antacids or oral supplements containing iron, zinc, selenium, calcium or magnesium (see section 4.5).
Reports of overdoses with baloxavir marboxil have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Data are insufficient to determine what symptoms may be anticipated as a result of an overdose.
No known specific antidote exists for Xofluza. In the event of overdose, standard supportive medical care should be initiated based on the patient’s signs and symptoms.
Baloxavir is unlikely to be significantly removed by dialysis due to high serum protein binding.
3 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original package in order to protect from moisture.
Blister pack (OPA/Aluminum foil/PVC, sealed with aluminium foil).
Pack of 2 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
