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 weighing ≥ 20 kg who are able to swallow tablets may instead receive treatment with Xofluza tablets at a dose of 40 mg or 80 mg depending on the patient’s body weight. Refer to the Xofluza tablet SmPC for dose information.

Table 1. Baloxavir marboxil dosing by patient body weight (≥ 3 weeks of age) Patient body weight (kg) Recommended single dose of oral suspension Volume of oral suspension* < 20 kg 2 mg per kg of body weight 1 mL per kg of body weight ≥ 20 kg to < 80 kg 40 mg 20 mL ≥ 80 kg 80 mg 40 mL** * The volume of the suspension in the bottle after reconstitution is 22 mL.

The exact volume to be administered should be measured using the oral dispenser(s) included in the carton. , 20 mL of suspension provides the recommended single dose of 40 mg. **Dose requires 2 bottles of Xofluza granules for oral suspension.

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 or enteral use. 2). Granules for oral suspension and final oral suspension should not be mixed with food. Any mixing outside the recommendations is the responsibility of the healthcare professional or the user.

It is recommended that Xofluza granules for oral suspension be reconstituted by a healthcare professional prior to dispensing. If the patient or caregiver is reconstituting the oral suspension, they must be advised to read the instructions for use before preparing and administering.

6. The appearance after reconstitution is a greyish white, white to light yellow opaque suspension. The recommended dose can be administered via an enteral feeding tube. The tube should be flushed with water before and after delivering Xofluza.

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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 clinicalstudies. 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.

Table 3 presents adverse drug reactions identified from clinical trial experience. Anaphylactic reaction, anaphylaxis, urticaria and angioedema (face, eyelid and lip swelling) have been reported post-marketing in the paediatric population (see Table 2).

Table 3. Adverse drug reactions in children from clinical trial experience System organ class (SOC) Adverse reaction (preferred term (PT), MedDRA) Frequency Diarrhoea CommonGastrointestinal disorders Vomiting Common Skin and subcutaneous disorders Rash Common Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. Maltitol This medicinal product contains 700 mg of maltitol per 20 mL of oral suspension. Patients with rare hereditary problems of fructose intolerance should not take this medicine.

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