Ronapreve

The dosage in adult patients and in adolescent patients 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection. Post-exposure prophylaxis : The dosage in adult patients and in adolescent patients 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection. Casirivimab with imdevimab should be given as soon as possible after contact with a case of COVID-19. Pre-exposure prophylaxis : The initial dose in adult patients and in adolescent patients 12 years of age and older weighing at least 40 kg is 600 mg of casirivimab and 600 mg of imdevimab administered as a single intravenous infusion or by subcutaneous injection. 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).

Casirivimab (IgG1κ) and imdevimab (IgG1λ) are two recombinant human monoclonal antibodies which are unmodified in the Fc regions. Casirivimab and imdevimab bind to non-overlapping epitopes of the spike protein receptor-binding domain (RBD) of SARS-CoV-2. This prevents RBD binding to the human ACE2 receptor, so preventing virus entry into cells.

Hypersensitivity to the active substances or to any of the excipients.

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. Subcutaneous administration for treatment of COVID-19 : The clinical efficacy of this drug when administered by the subcutaneous route for treatment of COVID-19 has not been evaluated in clinical trials. The pharmacokinetics of casirivimab and imdevimab in the first 48 hours after subcutaneous administration of 600 mg of each monoclonal antibody indicate lower serum exposures compared to intravenous administration of the same dose. It is unknown whether differences in initial systemic exposure result in differences in clinical efficacy. It is recommended that the subcutaneous route of administration is used only if intravenous administration is not feasible and would lead to a delay in treatment. Hypersensitivity reactions including anaphylaxis : Hypersensitivity reactions, including anaphylaxis, have been reported with administration of casirivimab and imdevimab. If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care. Infusion-related reactions : Infusion-related reactions (IRRs) have been observed with intravenous administration of casirivimab and imdevimab. IRRs observed in clinical studies were mostly moderate in severity and were typically observed during or within 24 hours of infusion. The frequently reported signs and symptoms for these reactions included nausea, chills, dizziness (or syncope), rash, urticaria and flushing. However, infusion-related reactions may present as severe or life threatening events and may include other signs and symptoms. If an IRR occurs, the infusion may be interrupted, slowed or stopped.