Evusheld

EVUSHELD must be administered by a healthcare professional. Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be observed after administration according to local medical practice.

Medicinal product no longer authorised 3 Posology Pre-exposure prophylaxis The recommended dose in adults and adolescents aged 12 years and older weighing at least 40 kg is 150 mg of tixagevimab and 150 mg of cilgavimab (Table 1), administered as two separate sequential intramuscular injections.

There are no safety and efficacy data available on repeat dosing. 1). Treatment The recommended dose in adults and adolescents aged 12 years and older weighing at least 40 kg is 300 mg of tixagevimab and 300 mg of cilgavimab (Table 1), administered as two separate sequential intramuscular injections.

1). 5 mL). 2). 2). 2). 2). The safety and efficacy of EVUSHELD in children under 12 years of age have not yet been established. No data are available. Method of administration For intramuscular injection. Tixagevimab and cilgavimab must be given as two separate sequential intramuscular injections at different injection sites in two different muscles, preferably in the gluteal muscles.

0 mL Medicinal product no longer authorised 4 Each carton contains two vials: • tixagevimab solution for injection (dark grey cap); • cilgavimab solution for injection (white cap). 6.

Summary of the safety profile A total of 4 210 adult participants have received 150 mg tixagevimab and 150 mg cilgavimab, via intramuscular injection, in the Phase III prophylaxis development program (including PROVENT). 0%). A total of 452 non-hospitalised adult patients with mild to moderate COVID-19 have received 300 mg tixagevimab and 300 mg cilgavimab, via intramuscular injection, in TACKLE.

The overall safety profile was similar to that reported in participants who received 150 mg tixagevimab and 150 mg cilgavimab in the prophylaxis studies. 4%). Tabulated list of adverse reactions The adverse reactions in Table 2 are listed by MedDRA system organ class and frequency.

Frequencies are defined as follows: 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 available data). Medicinal product no longer authorised 7 Table 2 Tabulated list of adverse reactions MedDRA system organ class Adverse reaction Frequencya Immune system disorders Hypersensitivityb Common Anaphylaxisc Rare General disorders and administration site conditions Injection related reactiond Uncommon Injury, poisoning and procedural complications Injection site reactione Common a Frequencies are based on exposure to 150 mg tixagevimab and 150 mg cilgavimab in the pooled data from the prophylaxis studies.

b Including the preferred terms Rash and Urticaria. 4). d Description of events reported under the preferred term Injection related reaction include headache, chills and redness, discomfort or soreness near where the injection was given.

e Including the preferred terms Injection site pain, Injection site erythema, Injection site pruritus, Injection site reaction and Injection site induration. 2). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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. 8). 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.

9%). The majority of participants had cardiovascular risk factors and/or history of cardiovascular disease that could explain the occurrence of such events. A causal relationship between EVUSHELD and these events has not been established.

The risks and benefits should be considered prior to initiating EVUSHELD in individuals at high risk for cardiovascular or thrombo-embolic events. Patients should be advised of signs or symptoms suggestive of cardiovascular event (notably chest pain, dyspnoea, malaise, feeling lightheaded or faint) and to seek immediate medical attention if such symptoms occur.

Clinically significant bleeding disorders As with any other intramuscular injections, EVUSHELD should be given with caution to patients with thrombocytopenia or any coagulation disorder. Antiviral resistance The clinical trials with EVUSHELD were conducted when Alpha, Beta, Gamma and Delta variants were predominant.

Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies such as tixagevimab and cilgavimab. 1). Patients who received EVUSHELD prophylactically should be informed of the potential for breakthrough infections to occur.

The duration of protection for variants with an observed decrease in in-vitro neutralisation activity is uncertain. Medicinal product no longer authorised 5 Patients should be instructed to promptly seek medical advice if signs or symptoms of COVID-19 occur (the most common symptoms include fever, cough, tiredness and 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).

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