Arexvy · 4.6 Fertility, pregnancy and lactation · 1

HOS-100464 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In a phase 3 placebo-controlled study (RSV OA=ADJ-006), participants 60 years of age and older received either one dose of Arexvy (N = 12 469) or placebo (N = 12 503), with a follow-up period of approximately 12 months. The most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). In a phase 3 placebo-controlled study (RSV OA=ADJ-018) that included participants 50 through 59 years of age (N = 769), the most commonly reported adverse reactions were injection site pain (76%), fatigue (40%), myalgia (36%), headache (32%), and arthralgia (23%). In a phase 3 open-label study (RSV OA=ADJ-025) that included participants 18 through 49 years of age (N = 1 029), the most commonly reported adverse reactions were injection site pain (76%), fatigue (60%), myalgia (60%), headache (44%), and arthralgia (28%). Across the three studies, these adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Tabulated list of adverse reactions The safety profile presented in Table 1 is based on data from phase 3 clinical studies (RSV OA=ADJ-006, -018 and -025) conducted in Europe, North America, Asia and Southern hemisphere in adults ≥18 years of age, and on post-marketing experience. Adverse reactions are listed below by MedDRA system organ class and 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) Not known (Cannot be estimated from the available data) 5 Table 1. Adverse reactions System Organ Class Frequency Adverse reactions Blood and lymphatic system Uncommon lymphadenopathy disorders hypersensitivity reactions (such Immune system disorders Uncommon as rash) Very common headache Nervous system disorders Very rare Guillain-Barré syndr

Auszug; vollständigen Abschnitt im Original lesen.

HOS-100460 · has-contraindication-information · PDF-Seite 3

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

HOS-100459 · has-indication-information · PDF-Seite 2

Arexvy is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 18 years of age and older. The use of this vaccine should be in accordance with official recommendations. 2

HOS-100462 · has-interaction-information · PDF-Seite 4

Use with other vaccines Arexvy may be administered concomitantly with a COVID-19 mRNA vaccine, pneumococcal conjugate vaccine, herpes zoster vaccine (recombinant, adjuvanted), or inactivated seasonal influenza vaccine (standard dose unadjuvanted, high dose unadjuvanted, or standard dose adjuvanted). If Arexvy is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites. Concomitant administration of Arexvy with other vaccines than those listed above has not been studied.

HOS-100463 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are no data from the clinical trials on the use of Arexvy in pregnant women. After administration of an investigational unadjuvanted RSVPreF3 vaccine to 3 557 pregnant women in a single clinical study, an increase in preterm births was observed compared to placebo. Currently no conclusion on a causal relationship between administration of unadjuvanted RSVPreF3 and preterm birth can be drawn. Results from animal studies with Arexvy or with an investigational unadjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to developmental and reproductive toxicity (see section 5.3). Arexvy is not recommended during pregnancy. Breast-feeding There are no data on the excretion of Arexvy in human or animal milk. Arexvy is not recommended in breast-feeding/lactating women. Fertility There are no data on the effects of Arexvy on human fertility. Animal studies with Arexvy or with an investigational unadjuvanted RSVPreF3 vaccine do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-100461 · 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 Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. Vaccination should be postponed in individuals suffering from an acute severe febrile illness. 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. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with the vaccination process itself. It is important that precautions are in place to avoid injury from fainting. Precautions for use Do not administer the vaccine intravascularly or intradermally. No data are available on subcutaneous administration of Arexvy. As with other intramuscular injections, Arexvy should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following intramuscular administration to these individuals. Systemic immunosuppressive medicinal products and immunodeficiency Patients receiving immunosuppressive treatment or patients with immunodeficiency may have a reduced immune response to Arexvy (see section 5.1). 3 Excipients with known effect Each dose of Arexvy powder and suspension for suspension for injection contains 0.18 milligrams of polysorbate 80. Each dose of Arexvy powder and suspension for suspension for injection in pre-filled syringe contains 0.20 milligrams of polysorbate 80. Polysorbates may cause allergic reactions. This medicinal product contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially ‘potassium-free’. This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.