XOFLUZA Film-coated tablet Ref.[49734] Active ingredients: Baloxavir marboxil

Posology

Treatment of influenza

A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours of symptom(s) onset.

Post-exposure prophylaxis of influenza

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).

Adults, adolescents, children and infants (≥3 weeks of age)

The recommended single oral dose of baloxavir marboxil is determined by body weight (see Table 1).

Adults, adolescents and children who are unable to, or experience difficulty swallowing tablets, or those who require enteral administration may instead receive treatment with Xofluza granules for oral suspension. Refer to the Xofluza granules for oral suspension prescribing information.

Table 1. Baloxavir marboxil dosing by patient body weight (≥3 weeks of age):

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.

Special populations

Elderly

No dose adjustment is required (see section 5.2).

Hepatic impairment

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 have not been established in patients with severe hepatic impairment (Child-Pugh class C).

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2).

Paediatric population

The safety and efficacy of baloxavir marboxil in preterm neonates and children aged <3 weeks have not been established. No data are available.

Method of administration

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.

Management

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.

Xofluza 20 mg and 40 mg film-coated tablets: 7 years.

Xofluza 80 mg film-coated tablets: 5 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/aluminium foil/PVC, sealed with aluminium foil).

Pack sizes

Xofluza 20 mg film-coated tablets:

1 blister containing 2 film-coated tablets

Xofluza 40 mg film-coated tablets:

1 blister containing 1 film-coated tablet
1 blister containing 2 film-coated tablets

Xofluza 80 mg film-coated tablets:

1 blister containing 1 film-coated tablet

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.