Ronapreve

Administration should be under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Individuals should be monitored after administration according to local medical practice. , treatment or prevention of COVID-19).

Treatment of COVID-19 in adults, adolescents and children aged 2 years and older weighing at least 10 kg who do not require supplemental oxygen Dosing recommendations are shown in Table 1. For these patients, treatment with casirivimab and imdevimab should be initiated within 7 days of the onset of symptoms of COVID-19.

6) Total volume per single dose Length of intravenous infusion 10 kg to less than 20 kg 155 mg of casirivimab 155 mg of imdevimab. 6 ml 2 hours 20 kg to less than 40 kg 270 mg of casirivimab 270 mg of imdevimab. 6 ml 2 hours At least 40 kg 600 mg of casirivimab 600 mg of imdevimab.

6 In children from 2 years to 11 years of age and in all patients weighing less than 40 kg, casirivimab and imdevimab are administered together as a single intravenous infusion only via pump or gravity (see Table 1). In adults and adolescents 12 years of age and older and weighing at least 40 kg, casirivimab and imdevimab are administered as a single intravenous infusion or by subcutaneous injection (see Tables 1 and 4).

See sections

Summary of the safety profile Overall, 8 796 subjects (6 373 via intravenous administration and 2 423 via subcutaneous administration) have been treated with casirivimab and imdevimab in clinical trials. The most frequently reported adverse drug reactions are hypersensitivity reactions, which include infusion related reactions (IRRs) and injection site reactions (ISRs).

Tabulated summary of adverse reactions The adverse reactions in Table 5 are listed below by system organ class and frequency. Frequencies 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).

Medicinal product no longer authorised 9 Table 5:

Tabulated list of adverse reactions identified from clinical trials and post-marketing: System organ class Adverse reaction Frequency category Intravenous administration Immune system disorders Anaphylaxis Rare Hypersensitivity Rare Nervous system disorders Dizziness* Convulsive syncope Uncommon Unknown Vascular disorders Flushing* Uncommon Respiratory, thoracic and mediastinal disorders Tachypnoea* Uncommon Gastrointestinal disorders Nausea* Uncommon Skin and subcutaneous tissue disorders Pruritus* Uncommon Rash* Uncommon Urticaria* Rare General disorders and administration site conditions Chills* Uncommon Injury, poisoning and procedural complications Infusion related reactions Uncommon Subcutaneous administration Blood and lymphatic system disorders Lymphadenopathy Uncommon Nervous system disorders Dizziness Uncommon Skin and subcutaneous tissue disorders Pruritus1* Rare General disorders and administration site conditions Injection site reactions1 Common 1ISRs include erythema, pruritus, ecchymosis, oedema, pain, tenderness, urticaria, and convulsive syncope * In some cases, symptoms of IRRs and ISRs have been reported as individual ADRs Paediatric population Intravenous administration In study COV-2067, 98 adolescents ≥ 12 and < 18 years old and 102 children ≥ 2 and < 12 years old received treatment with casirivimab and imdevimab.

4. Medicinal product no longer authorised 4 Treatment of COVID-19 in adult and adolescent patients weighing at least 40 kg who require supplemental oxygen Dosing recommendation is 4 000 mg of casirivimab and 4 000 mg of imdevimab administered as a single intravenous infusion (see Table 2 of Ronapreve Summary of Product Characteristics (SmPC)).

9%) sodium chloride or 50 mg/mL (5%) dextrose from the infusion bag prior to adding casirivimab and imdevimab Prevention of COVID-19 in adult and adolescent patients 12 years of age and older weighing at least 40 kg. Post-exposure prophylaxis Dosing recommendation is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection (see Tables 3 and 4).

Casirivimab with imdevimab should be given as soon as possible after contact with a case of COVID-19. Pre-exposure prophylaxis The initial dose is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection (see Tables 3 and 4).

Subsequent doses of 300 mg of casirivimab and 300 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection may be given every 4 weeks until prophylaxis is no longer required. There are no data on repeat dosing beyond 24 weeks (6 doses).

6) Missed dose In case of repeated dosing for pre-exposure prophylaxis, if a dose of Ronapreve is missed it should be administered as soon as possible. Thereafter, the schedule of administration should be adjusted to maintain the appropriate interval between doses.

2). 2). 2). Paediatric population The safety and efficacy of casirivimab and imdevimab has not been established among the following groups as no data are available: ● children <2 years of age and weighing <10 kg, who do not require supplemental oxygen for the treatment of COVID-19 ● children <12 years of age and weighing <40 kg, who receive supplemental oxygen for the treatment of COVID-19 ● children <12 years of age and weighing <40 kg for the prevention of COVID-19 Method of administration Ronapreve is for intravenous or subcutaneous use only.

1.