Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Celltrion Healthcare Hungary Kft., 1062 Budapest, Váci út 1-3. WestEnd Office Building B torony, Hungary
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Hypersensitivity reactions, including infusion-related and anaphylactic reactions, have been observed during and following administration of regdanvimab (see section 4.8).
Patients should be clinically monitored during administration and be observed for at least 1 hour after infusion is complete.
Signs and symptoms of infusion-related reactions may include fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia, palpitation), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vaso-vagal reactions (e.g., presyncope, syncope), dizziness and diaphoresis.
If an infusion-related reaction occurs, slowing or stopping the infusion should be considered and appropriate medicinal products and/or supportive care should be administered.
The clinical trials with regdanvimab were conducted in subjects who were predominantly infected with the wild-type virus and the Alpha (UK origin/B.1.1.7 lineage) variant. Clinical efficacy data for regdanvimab against some circulating SARS-CoV-2 variants with decreased in vitro susceptibility is currently limited (see section 5.1).
No interaction studies have been performed with regdanvimab.
Regdanvimab is a monoclonal antibody, which is not renally excreted or metabolised by cytochrome P450 enzymes; therefore, interactions with concomitant medicinal products that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are considered unlikely.
No interaction studies have been performed.
Reproductive and developmental studies have not been performed with regdanvimab.
Nonclinical reproductive toxicity studies have not been conducted with regdanvimab (see section 5.3). In tissue cross-reactivity (TCR) studies with regdanvimab using human foetal and neonatal tissues, no binding of clinical concern was detected in the foetal tissues. Human immunoglobulin G1 (IgG1) antibodies are known to cross the placental barrier; therefore, regdanvimab has the potential to be transferred from the mother to the developing foetus. It is unknown whether the potential transfer of regdanvimab provides any treatment benefit or risk to the developing foetus.
Regdanvimab should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
It is not known whether regdanvimab is excreted in human milk or absorbed systemically after ingestion. Administration of regdanvimab while breast-feeding can be considered when clinically indicated.
No fertility studies have been performed.
Regkirona has no or negligible influence on the ability to drive and use machines.
Overall, 906 subjects have been exposed to regdanvimab in clinical trials in both healthy subjects and non-hospitalised patients. The safety of regdanvimab is based on exposure of ambulatory (nonhospitalised) patients with COVID-19.
Adverse reactions reported with regdanvimab based on experience from clinical trials in healthy subjects and mild to moderate COVID-19 patients as well as adverse reactions reported from post-marketing experience are listed in Table 2 by 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). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 2. Tabulated list of adverse reactions:
| System organ class Frequency | Adverse reaction |
|---|---|
| Injury, poisoning and procedural complications | |
| Uncommon | Infusion-related reactions1 |
1 Infusion-related reaction (IRR) includes hypersensitivity and anaphylaxis, and symptoms reported as IRRs are described below in ‘Infusion-related reactions’. Anaphylaxis was identified from postmarketing experience.
Immediate infusion-related reactions were noted for 0.6% of regdanvimab-treated patients and 1.2% of placebo-treated patients. Reported events of fever, pruritus, hypertension and dyspnoea were mild with two cases of fever being moderate and one case of hypertension being severe and palpitation, presyncope and urticaria were moderate in the regdanvimab-treated patients. All patients in the regdanvimab treatment group recovered from the events.
In post-marketing experience, one case of anaphylaxis was reported during infusion of regdanvimab with symptoms of dyspnoea, chest discomfort and cough.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
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