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

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'.

Effects of other medicinal products on baloxavir marboxil or its active metabolite baloxavir

Products that contain polyvalent cations may decrease plasma concentrations of baloxavir. 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.

Immune response to influenza virus

Interaction studies with influenza vaccines and baloxavir marboxil have not been conducted. In studies of naturally acquired influenza, treatment with Xofluza did not impair the humoral antibody response to influenza infection.

Paediatric population

Interaction studies have only been performed in adults.

Pregnancy

There are no or limited data from the use of baloxavir marboxil in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

As a precautionary measure, it is preferable to avoid the use of Xofluza during pregnancy.

Breast-feeding

It is unknown whether baloxavir marboxil or baloxavir are excreted in human milk. Baloxavir marboxil and its metabolites are secreted in the milk of lactating rats.

A risk to the newborns/infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to abstain from Xofluza therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

No effects on male or female fertility were observed in animal studies performed with baloxavir marboxil (see section 5.3).

Xofluza has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Hypersensitivity reactions have been observed in the postmarketing 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 postmarketing 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).

Table 2. Adverse drug reactions from postmarketing experience in adults, adolescents and paediatric patients:

^* The frequency for urticaria is based on clinical trial data from studies in adults and adolescents. The other PTs listed above were not reported in 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. 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 postmarketing in the paediatric population (see Table 2).

Table 3. Adverse drug reactions in children from clinical trial experience:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.