<p><strong>Traceability</strong>: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.<br />
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<strong>Subcutaneous administration for treatment of COVID-19</strong>: 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.<br />
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<strong>Hypersensitivity reactions including anaphylaxis</strong>: 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.<br />
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<strong>Infusion-related reactions</strong>: 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.</p>