Xofluza · 4.6 Fertility, pregnancy and lactation · 3

HOS-098977 · has-adverse-reaction-information · PDF-Seite 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 5 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 Frequency (preferred term (PT), MedDRA) Immune system disorders Anaphylaxisa Not known Anaphylactic reactionsa Not known Hypersensitivitya Not known Gastrointestinal disorders Diarrhoeab Common Vomitingb Common Ischaemic colitisa Not known Skin and subcutaneous Urticariab Uncommon disorders Angioedemaa Not known a Not reported in clinical studies. b The 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 and for patients 5 years and

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098989 · has-adverse-reaction-information · PDF-Seite 37

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 37 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 Frequency (preferred term (PT), MedDRA) Immune system disorders Anaphylaxisa Not known Anaphylactic reactionsa Not known Hypersensitivitya Not known Gastrointestinal disorders Diarrhoeab Common Vomitingb Common Ischaemic colitisa Not known Skin and subcutaneous disorders Urticariab Uncommon Angioedemaa Not known a Not reported in clinical studies. b The 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 and for patients 5

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098983 · has-adverse-reaction-information · PDF-Seite 21

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 Frequency (preferred term (PT), MedDRA) Immune system disorders Anaphylaxisa Not known Anaphylactic reactionsa Not known Hypersensitivitya Not known Gastrointestinal disorders Diarrhoeab Common Vomitingb Common Ischaemic colitisa Not known Skin and subcutaneous Urticariab Uncommon disorders Angioedemaa Not known a Not reported in clinical studies. b The 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 and for patients 5 years and above from the household influenza transmission

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HOS-098985 · has-contraindication-information · PDF-Seite 36

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098979 · has-contraindication-information · PDF-Seite 20

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098973 · has-contraindication-information · PDF-Seite 4

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-098984 · has-indication-information · PDF-Seite 34

Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 3 weeks and above. Post-exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 3 weeks and above. Xofluza should be used in accordance with official recommendations. 34

HOS-098978 · has-indication-information · PDF-Seite 18

Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 3 weeks and above. Post-exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 3 weeks and above. Xofluza should be used in accordance with official recommendations.

HOS-098972 · has-indication-information · PDF-Seite 3

Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 3 weeks and above. Post-exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 3 weeks and above. Xofluza should be used in accordance with official recommendations.

HOS-098981 · has-interaction-information · PDF-Seite 20

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.

HOS-098975 · has-interaction-information · PDF-Seite 4

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. 4 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.

HOS-098987 · has-interaction-information · PDF-Seite 36

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. 36 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.

HOS-098976 · has-pregnancy-information · PDF-Seite 5

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).

HOS-098988 · has-pregnancy-information · PDF-Seite 37

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).

HOS-098982 · has-pregnancy-information · PDF-Seite 20

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. 20 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).

HOS-098974 · has-warning-information · PDF-Seite 4

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’.

HOS-098980 · has-warning-information · PDF-Seite 20

Sodium This medicinal product contains 23.6 mg of sodium per 20 mL of oral suspension, equivalent to 1.2 % 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.

HOS-098986 · has-warning-information · PDF-Seite 36

Sodium The 10 mg and 30 mg granules in sachet contain less than 23 mg of sodium per sachet, that is to say essentially ´sodium-free´. The 40 mg granules in sachet contains 23.6 mg of sodium. per sachet. This is equivalent to 1.2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. Maltitol This medicinal product contains 175 mg, 525 mg and 700 mg of maltitol per 10 mg, 30 mg and 40 mg granules in sachet, respectively. Patients with rare hereditary problems of fructose intolerance should not take this medicine.