Shingrix · 4.3 Contraindications · 1

HOS-098134 · has-adverse-reaction-information · PDF-Seite 24

Summary of the safety profile In adults aged 50 years and above, the most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose; 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose; 3.0% severe/dose) and headache (26.3% overall/dose; 1.9% severe/dose). Most of these reactions were not long-lasting (median duration of 2 to 3 days). Reactions reported as severe lasted 1 to 2 days. In adults ≥ 18 years of age who are immunodeficient or immunosuppressed due to disease or therapy (referred to as immunocompromised (IC)), the safety profile was consistent with that observed in adults 50 years and above. There are limited data in adults aged 18-49 years at increased risk of HZ who are not IC. Overall, there was a higher incidence of some adverse reactions in younger age groups: - studies in IC adults ≥ 18 years of age (pooled analysis): the incidence of pain at the injection site, fatigue, myalgia, headache, shivering and fever was higher in adults aged 18-49 years compared to those aged 50 years and above. - studies in adults ≥ 50 years of age (pooled analysis): the incidence of myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms was higher in adults aged 50-69 years compared to those aged 70 years and above. Tabulated list of adverse reactions The safety profile presented below is based on a pooled analysis of data generated in placebo- controlled clinical studies on 5 887 adults 50-69 years of age and 8 758 adults ≥ 70 years of age. Of these 14 645 adults, 7 408 were included in a long-term follow-up extension study over a follow-up period of approximately 11 years after vaccination. In clinical studies in IC adults ≥ 18 years of age (1 587 subjects) the safety profile is consistent with the data presented in Table 1 below. Adverse reactions reported during post-marketing surveillance are also tabulated below. Adverse reactions reported are listed according to the following frequency: 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) Within each frequency grouping the adverse reactions are reported in the order of decreasing seriousness. 24 Table 1: Adverse reactions System Organ Class1 Frequency

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098128 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In adults aged 50 years and above, the most frequently reported adverse reactions were pain at the injection site (68.1% overall/dose; 3.8% severe/dose), myalgia (32.9% overall/dose; 2.9% severe/dose), fatigue (32.2% overall/dose; 3.0% severe/dose) and headache (26.3% overall/dose; 1.9% severe/dose). Most of these reactions were not long-lasting (median duration of 2 to 3 days). Reactions reported as severe lasted 1 to 2 days. In adults ≥ 18 years of age who are immunodeficient or immunosuppressed due to disease or therapy (referred to as immunocompromised (IC)), the safety profile was consistent with that observed in adults 50 years and above. There are limited data in adults aged 18-49 years at increased risk of HZ who are not IC. Overall, there was a higher incidence of some adverse reactions in younger age groups: - studies in IC adults ≥ 18 years of age (pooled analysis): the incidence of pain at the injection site, fatigue, myalgia, headache, shivering and fever was higher in adults aged 18-49 years compared to those aged 50 years and above. - studies in adults ≥ 50 years of age (pooled analysis): the incidence of myalgia, fatigue, headache, shivering, fever and gastrointestinal symptoms was higher in adults aged 50-69 years compared to those aged 70 years and above. Tabulated list of adverse reactions The safety profile presented below is based on a pooled analysis of data generated in placebo- controlled clinical studies on 5 887 adults 50-69 years of age and 8 758 adults ≥ 70 years of age. Of these 14 645 adults, 7 408 were included in a long-term follow-up extension study over a follow-up period of approximately 11 years after vaccination. In clinical studies in IC adults ≥ 18 years of age (1 587 subjects) the safety profile is consistent with the data presented in Table 1 below. Adverse reactions reported during post-marketing surveillance are also tabulated below. Adverse reactions reported are listed according to the following frequency: 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) Within each frequency grouping the adverse reactions are reported in the order of decreasing seriousness. 5 Table 1: Adverse reactions System Organ Class1 Frequency

Auszug; vollständigen Abschnitt im Original lesen.

HOS-098124 · has-contraindication-information · PDF-Seite 3

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

HOS-098130 · has-contraindication-information · PDF-Seite 22

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

HOS-098123 · has-indication-information · PDF-Seite 2

Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in: • adults 50 years of age or older; • adults 18 years of age or older at increased risk of HZ. The use of Shingrix should be in accordance with official recommendations.

HOS-098129 · has-indication-information · PDF-Seite 21

Shingrix is indicated for prevention of herpes zoster (HZ) and post-herpetic neuralgia (PHN), in: • adults 50 years of age or older; • adults 18 years of age or older at increased risk of HZ. The use of Shingrix should be in accordance with official recommendations.

HOS-098126 · has-interaction-information · PDF-Seite 4

Shingrix can be given concomitantly with seasonal influenza vaccine (inactivated, unadjuvanted), 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13), reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa), coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine or respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted). The vaccines should be administered at different injection sites. The adverse reactions of fever and shivering were more frequent when PPV23 vaccine was co-administered with Shingrix (16% and 21%, respectively) compared to when Shingrix was given alone (7% for both adverse reactions). In adults aged 50 years and above, systemic adverse reactions that are very commonly reported (see Table 1; such as myalgia 32.9%, fatigue 32.2%, and headache 26.3%), and arthralgia, uncommonly reported, following administration of Shingrix alone were reported with increased frequency when Shingrix was co-administered with a COVID-19 mRNA vaccine (myalgia 64%, fatigue 51.7%, headache 39%, arthralgia 30.3%). Concomitant administration of Shingrix with other vaccines than those listed above has not been studied.

HOS-098132 · has-interaction-information · PDF-Seite 23

Shingrix can be given concomitantly with seasonal influenza vaccine (inactivated, unadjuvanted), 23-valent pneumococcal polysaccharide vaccine (PPV23), 13-valent pneumococcal conjugate vaccine (PCV13), reduced antigen diphtheria-tetanus-acellular pertussis vaccine (dTpa), coronavirus disease 2019 (COVID-19) messenger ribonucleic acid (mRNA) vaccine or respiratory syncytial virus (RSV) vaccine (recombinant, adjuvanted). The vaccines should be administered at different injection sites. The adverse reactions of fever and shivering were more frequent when PPV23 vaccine was co-administered with Shingrix (16% and 21%, respectively) compared to when Shingrix was given alone (7% for both adverse reactions). In adults aged 50 years and above, systemic adverse reactions that are very commonly reported (see Table 1; such as myalgia 32.9%, fatigue 32.2%, and headache 26.3%), and arthralgia, uncommonly reported, following administration of Shingrix alone were reported with increased frequency when Shingrix was co-administered with a COVID-19 mRNA vaccine (myalgia 64%, fatigue 51.7%, headache 39%, arthralgia 30.3%). Concomitant administration of Shingrix with other vaccines than those listed above has not been studied.

HOS-098133 · has-pregnancy-information · PDF-Seite 23

Pregnancy There are no data from the use of Shingrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy. Breast-feeding The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. It is unknown whether Shingrix is excreted in human milk. Fertility 23 Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).

HOS-098127 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no data from the use of Shingrix in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Shingrix during pregnancy. Breast-feeding The effect on breast-fed infants of administration of Shingrix to their mothers has not been studied. It is unknown whether Shingrix is excreted in human milk. 4 Fertility Animal studies do not indicate direct or indirect effects with respect to fertility in males or females (see section 5.3).

HOS-098125 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Prior to immunisation As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As with any vaccine, a protective immune response may not be elicited in all vaccinees. The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease. Shingrix should not be administered intravascularly or intradermally. Subcutaneous administration is not recommended. Maladministration via the subcutaneous route may lead to an increase in transient local reactions. Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. 3 There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine. Excipients with known effect Polysorbate 80 This medicinal product contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. Potassium This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.

HOS-098131 · has-warning-information · PDF-Seite 22

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Prior to immunisation As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. As with other vaccines, vaccination with Shingrix should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. As with any vaccine, a protective immune response may not be elicited in all vaccinees. The vaccine is for prophylactic use only and is not intended for treatment of established clinical disease. Shingrix should not be administered intravascularly or intradermally. Subcutaneous administration is not recommended. Maladministration via the subcutaneous route may lead to an increase in transient local reactions. Shingrix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these subjects. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints. 22 There are no safety, immunogenicity or efficacy data to support replacing a dose of Shingrix with a dose of another HZ vaccine. Excipients with known effect Polysorbate 80 This medicinal product contains 0.08 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. Potassium This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’.