Abrysvo · 4.8 Undesirable effects · 1

HOS-100417 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The most frequently reported adverse reactions were fatigue (33%), vaccination site pain (27%), headache (24%), myalgia (21%) and arthralgia (10%). The majority of reactions were mild to moderate in severity and resolved within 1-3 days of onset. Tabulated list of adverse reactions The safety of administering a single dose of Abrysvo to pregnant individuals at 24-36 weeks of gestation and individuals 18 years of age and older was evaluated in clinical trials and postmarketing experience. The safety profile is based on a pooled analysis of data from clinical trials (n=24 339, including solicited local and systemic events from 9 367 participants). In the clinical trials, there were 3 813 pregnant individuals ≤49 years of age and 20 526 individuals 18 years of age and older. Adverse reactions are listed according to the following frequency categories: 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); Not known (cannot be estimated from the available data). Adverse reactions reported are listed per system organ class. 5 Table 1 Adverse reactions following administration of Abrysvo System organ class Adverse drug reactions Blood and lymphatic system disorders Lymphadenopathy Rare Immune system disorders Hypersensitivity reactions (includes rash, Rare urticaria) Anaphylaxis Very rare Nervous system disorders Headache Very common Guillain-Barré syndrome Very rare Musculoskeletal and connective tissue disorders Myalgia Very common Arthralgia Very common General disorders and administration site conditions Fatigue Very common Vaccination site pain Very common Vaccination site redness Common Vaccination site swelling Common Pyrexia Uncommon Vaccination site pruritus Rare Vaccination site bruising Rare Vaccination site hae

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100413 · has-contraindication-information · PDF-Seite 3

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

HOS-100412 · has-indication-information · PDF-Seite 2

Abrysvo is indicated for: • Active immunisation of pregnant individuals to protect infants from birth through 6 months of age against lower respiratory tract disease caused by respiratory syncytial virus (RSV). See sections 4.2 and 5.1. • Active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by RSV. The use of this vaccine should be in accordance with official recommendations. 2

HOS-100415 · has-interaction-information · PDF-Seite 4

Abrysvo can be administered concomitantly with: • seasonal influenza vaccines, either standard dose adjuvanted or high dose unadjuvanted • COVID-19 mRNA vaccines, with or without high dose unadjuvanted influenza vaccine administered concomitantly. A minimum interval of two weeks is recommended between administration of Abrysvo and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when Abrysvo was co-administered with Tdap in healthy non-pregnant women. Immune responses to RSV A, RSV B, diphtheria and tetanus on co-administration were non-inferior to those after separate administration. However, the immune responses to the pertussis components were lower on co-administration compared to separate administration and did not meet the criteria for non- inferiority. The clinical relevance of this finding is unknown.

HOS-100416 · has-pregnancy-information · PDF-Seite 4

Pregnancy Data on pregnant women (more than 4 000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity. Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%). 4 No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (38%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (207 (6%) and 172 (5%), respectively), low birth weight (186 (5%) and 158 (4%), respectively) and congenital anomalies (205 (6%) and 245 (7%), respectively). Breast-feeding It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers. Fertility No human data on the effect of Abrysvo on fertility are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

HOS-100414 · 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. Hypersensitivity and anaphylaxis Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. 3 Thrombocytopenia and coagulation disorders Abrysvo should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals. Immunocompromised individuals Safety and immunogenicity have been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy (see sections 4.8 and 5.1). The efficacy of Abrysvo may be lower in immunosuppressed individuals. Individuals less than 24 weeks of gestation Abrysvo has not been studied in pregnant individuals less than 24 weeks of gestation. Since protection of the infant against RSV depends on transfer of maternal antibodies across the placenta, Abrysvo should be administered between weeks 24 and 36 of gestation (see sections 4.2 and 5.1). Limitations of vaccine effectiveness As with any vaccine, a protective immune response may not be elicited after vaccination. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’. This medicinal product contains polysorbate 80. Polysorbates may cause allergic reactions.