XOFLUZA

Posology Treatment of influenza A single dose of baloxavir marboxil should be taken as soon as possible within 48 hours of symptom(s) onset. 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) Patient body weight Recommended oral dose < 20 kg Refer to the Xofluza granules for oral suspension prescribing information. ≥ 20 kg to < 80 kg Single dose of 40 mg taken as 1 x 40 mg tablet ≥ 80 kg Single dose of 80 mg taken as 1 x 80 mg tablet OR 2 x 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.

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).

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.

2). 5).

Summary of the safety profile Hypersensitivity reactions have been observed in the post-marketing, setting which include reports of anaphylaxis/anaphylactic reactions and less severe forms of hypersensitivity reactions, including urticaria and angioedema.

Of these adverse reactions only urticaria has been observed in clinical studies with an estimated frequency category of “uncommon”. Tabulated list of adverse reactions The following adverse drug reactions have been identified from post-marketing experience with baloxavir marboxil (Table 2) based on spontaneous case reports and cases from non-interventional study programmes.

Adverse drug reactions are listed according to system organ classes in MedDRA and the corresponding frequency category estimation for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from the available data).

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Table 2. Adverse drug reactions from post-marketing experience in adults, adolescents and paediatric patients System organ class (SOC) Adverse reaction (preferred term (PT), MedDRA) Frequency Anaphylaxisa Not known Anaphylactic reactionsa Not known Immune system disorders Hypersensitivitya Not known Diarrhoeab CommonGastrointestinal disorders Vomitingb Common Urticariab UncommonSkin and subcutaneous disorders Angioedemaa Not known aNot reported in clinical studies.

bThe frequency calculation is based on completed clinical studies. Paediatric population The safety profile of baloxavir marboxil in paediatric patients (3 weeks to < 12 years) was determined from data collected from treatment and post-exposure prophylaxis studies.

Lactose intolerance Xofluza contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free’.

1.