Ixchiq · 4.4 Special warnings and precautions for use · 1

HOS-288597 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Adults ≥ 18 years of age 5 The overall safety of IXCHIQ is based on an analysis of the pooled safety data from three completed phase I and III clinical studies conducted in the US on 3 610 participants ≥18 years old who received one dose of IXCHIQ with a follow-up of 6 months. The most common vaccination site reactions were tenderness (10.8%) and pain (6.1%). The most common systemic adverse reactions were headache (32%), fatigue (29.4%), myalgia (23.7%), arthralgia (16.6%), fever (13.8%) and nausea (11.4%). In the post-marketing setting, serious adverse reactions have been reported, particularly in males aged 65 years and older with underlying chronic medical conditions such as cardiovascular disease, diabetes mellitus or chronic kidney disease, but also in young adults with no relevant comorbidities. These adverse reactions included neurological events such as fatal encephalitis, aseptic meningitis, deterioration of general condition, and exacerbation of chronic medical conditions (see section 4.4). Adolescents 12 to <18 years of age Safety in adolescent participants 12 to <18 years was assessed in 502 participants in Brazil who received one dose of IXCHIQ with a follow-up of 6 months. 18.7% of the participants had pre-existing antibodies against chikungunya virus (94 adolescents). The most common vaccination site reactions in adolescents 12 to <18 years of age were tenderness (19.9%) and pain (19.3%). The most common systemic adverse reactions were headache (51.0%), myalgia (26.9%), fever (24.1%), fatigue (22.3%), nausea (15.9%), and arthralgia (12.9%). Baseline seropositive adolescents The proportion of participants that experienced solicited systemic AEs was higher in baseline seronegative participants vaccinated with IXCHIQ than in baseline seropositive participants vaccinated with IXCHIQ (67.9% and 44.7% respectively). The proportion of participants who experienced solicited local AEs and unsolicited AEs was similar in the IXCHIQ arms of each stratum. Laboratory parameters Adults ≥ 18 years of age The most common abnormal laboratory parameters were neutropenia (41.8%), leukopenia (31.2%), lymphopenia (22.3%), Alanine aminotransferase increased (ALT: 15.5%), and Aspartate aminotransferase increased (AST: 11.7%) (based on an immunogenicity subset of 372 IXCHIQ recipients). Adolescents 12 to <18 years The most common abnormal laboratory parameters were neutr

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HOS-288593 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Immunodeficient or immunosuppressed individuals due to disease or medical therapy (e.g., from malignancies, chemotherapy, immunosuppressive therapy, congenital immunodeficiency, or HIV infection with severe immunosuppression).

HOS-288592 · has-indication-information · PDF-Seite 2

IXCHIQ is indicated for active immunisation for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 12 years and older at high risk of acquiring chikungunya infection. The use of this vaccine should be in accordance with official recommendations.

HOS-288595 · has-interaction-information · PDF-Seite 4

Concomitant administration with other vaccines 4 IXCHIQ is not recommended to be co-administered with other vaccines because there are no data on the safety and immunogenicity following concomitant administration of IXCHIQ with other vaccines. Administration of immune globulins, blood or plasma transfusions 3 months before or up to 1 month after IXCHIQ administration may interfere with the expected immune response.

HOS-288596 · has-pregnancy-information · PDF-Seite 5

Pregnancy Animal studies did not indicate any direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). There is limited amount of data from the use of IXCHIQ in pregnant women. These data are not sufficient to conclude on the absence of potential effects of IXCHIQ on pregnancy, embryo-foetal development, parturition and post-natal development. Vertical transmission of wild-type CHIKV from pregnant individuals with viraemia at delivery is common and can cause potentially fatal CHIKV disease in neonates. Vaccine viraemia occurs in the first week following administration of IXCHIQ, with resolution of viraemia by 14 days after vaccination. It is not known if the vaccine virus can be vertically transmitted and cause foetal or neonatal adverse reactions. Decisions to administer IXCHIQ during pregnancy should take into consideration the individual’s risk of exposure to wild-type CHIKV, gestational age, and risks to the foetus or neonate from vertical transmission of wild-type CHIKV. Breast-feeding It is unknown if IXCHIQ is excreted in human milk. A risk to the breastfed child cannot be excluded. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for IXCHIQ and any potential adverse effects on the breastfed child from IXCHIQ. Animal studies did not indicate any direct or indirect harmful effects with respect to lactation (see section 5.3). Fertility No specific studies have been performed on fertility. Animal studies did not indicate any harmful effects with respect to female fertility (see section 5.3).

HOS-288594 · has-warning-information · PDF-Seite 3

IXCHIQ should only be given when there is a high risk of acquiring chikungunya infection, and after careful consideration of the potential risks and benefits (see Section s 4.1, 4.3 and below). Serious adverse reactions have been reported with the use of IXCHIQ, particularly in individuals aged 65 years and older and in individuals with multiple underlying chronic and/or uncontrolled medical conditions, but also in young adults with no relevant comorbidities (see section 4.8). Severe reactogenicity or chikungunya-like adverse reactions may lead to deterioration of general condition including malaise and decreased appetite, exacerbation of pre-existing diseases, confusional state, aseptic meningitis, encephalopathy, or encephalitis, leading to falls, hospitalisation and death. Vaccinees should be instructed to promptly seek medical attention if they experience, after vaccination, symptoms suggestive of severe reactogenicity or severe chikungunya-like adverse reactions. 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. Close observation for at least 15 minutes is recommended following vaccination. 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 precautions are in place to avoid injury from fainting. Concurrent illness 3 Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders The vaccine should be given with caution to individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular injection in these individuals. Limitations of vaccine effectiveness The ability of IXCHIQ to prevent disease due to chikungunya virus was based on a serological surrogate endpoint (see section 5.1). As

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