Kavigale · 4.8 Undesirable effects · 1

HOS-100764 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In patients receiving sipavibart by intramuscular injection, the most common adverse reactions are injection site reactions (5.6%) and hypersensitivity (1.9%). In patients receiving sipavibart by intravenous infusion, the most common adverse reactions are infusion site reactions (1.9%) and infusion-related reactions (1.9%). Tabulated list of adverse reactions Table 1 presents the adverse reactions identified from the clinical studies. 5 The adverse reactions in Table 1 are listed by MedDRA system organ class (SOC). Within each SOC, preferred terms are arranged by decreasing frequency, and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: 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). Table 1 Tabulated list of adverse reactions MedDRA SOC MedDRA Preferred Term Frequency Intramuscular administration Immune system disorders Hypersensitivitya Common General disorders and Injection site reactionb Common administration site conditions Intravenous administration General disorders and Infusion site reactionc Common administration site conditions Injury, poisoning and procedural Infusion related reactiond Common complications a Including the following preferred terms: pruritus, erythema, hypersensitivity, urticaria, dermatitis allergic, drug eruption, rash, and hypotension. b Including the following preferred terms: injection site pain, injection site bruising, injection site erythema, injection site haemorrhage, injection site swelling, injection site haematoma, injection site pruritus, injection site paraesthesia, injection site reaction, injection site rash, injection site discolouration, injection site warmth, injection site discomfort, and injection site inflammation. c Including the followin

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HOS-100760 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 3

HOS-100759 · has-indication-information · PDF-Seite 2

KAVIGALE is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents 12 years of age and older weighing at least 40 kg and who are immunocompromised due to a medical condition or receipt of immunosuppressive treatments. KAVIGALE should be used in accordance with official recommendations where available and based on information on the activity of sipavibart against presently circulating viral variants (see sections 4.4 and 5.1).

HOS-100762 · has-interaction-information · PDF-Seite 5

No interaction studies have been performed. Sipavibart is not expected to be renally excreted or metabolised by cytochrome P450 enzymes (see section 5.2). Therefore, interactions with concomitant medicinal products that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

HOS-100763 · has-pregnancy-information · PDF-Seite 5

Pregnancy There are no data on the use of sipavibart in pregnant women. Non-clinical reproductive toxicity studies have not been performed with sipavibart. In a tissue cross reactivity study with sipavibart, no binding was detected to human foetal tissue or reproductive tissues. Human IgG1 antibodies are known to cross the placenta barrier; therefore, sipavibart has the potential to be transferred from the mother to the developing foetus. It is unknown whether the potential placental transfer of sipavibart provides any treatment benefit or risk to the developing foetus. Sipavibart should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the foetus. Breast-feeding It is unknown whether sipavibart is excreted in human milk. In humans, excretion of IgG antibodies in milk occurs during the first few days after birth, decreasing to low concentrations soon afterwards. Consequently, a risk to the breast-fed infant cannot be excluded during this short period. Afterwards, sipavibart could be used during breast-feeding if clinically needed. Fertility There are no data on the effects of sipavibart on human fertility.

HOS-100761 · has-warning-information · PDF-Seite 4

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. Antiviral resistance Sipavibart was designed to be effective against early omicron strains, with pseudovirus neutralisation IC50 values ranging from 3.6 ng/ml (XBB.1 variant) to 25.0 ng/ml (BA.2.75 variant). The extent and duration of protective efficacy against viruses with moderately increased IC50 (e.g. JN.1, IC50 83.1 ng/ml) is reduced and the clinical relevance of any prophylactic effect unclear. Due to the absence of in vitro neutralising activity, sipavibart is not anticipated to provide any protection against symptomatic COVID-19 due to viral variants containing F456L mutations in the spike protein (see section 5.1). Decisions regarding the use of sipavibart for the prevention of COVID-19 should take into consideration what is known about the characteristics of the circulating SARS-CoV-2 viral variants, including geographical prevalence. The in vitro neutralisation activity of sipavibart against SARS-CoV-2 viral variants is shown in Table 2 (see section 5.1). Patients who receive sipavibart should be informed of the potential for breakthrough infections to occur. If signs or symptoms of COVID-19 occur (the most common symptoms include fever, chills, sore throat, cough, tiredness, and new loss of taste or smell; the most serious symptoms include difficulty breathing or shortness of breath, loss of speech or mobility, or confusion and chest pain), advise individuals to promptly seek medical attention. Hypersensitivity including anaphylaxis Serious hypersensitivity reactions, including anaphylaxis, have been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medicinal products and/or supportive therapy. Infusion-related reactions IRRs were observed in clinical trials with intravenous administration of sipavibart and were mild in severity (see section 4.8). If signs and symptoms of an IRR occur, the infusion should be interrupted, slowed, or stopped and appropriate medicinal products and/or supportive therapy should be administered. Clinically significant bleeding disorders As with any other intramuscular injections, sipavibart should be given with caution to patients with thrombocytopenia or any c

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