Summary of the safety profile
Overall, 7 116 subjects (4 666 via intravenous administration and 2 450 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 3 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).
Table 3: Tabulated list of adverse reactions identified from clinical trials:
| System organ class | Adverse reaction | Frequency category |
| Intravenous administration | ||
| Immune system disorders | Anaphylaxis | Rare |
| Nervous system disorders | Dizziness* | Uncommon |
| Vascular disorders | Flushing* | Rare |
| Gastrointestinal disorders | Nausea* | Uncommon |
| Skin and subcutaneous tissue disorders | 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 |
1 ISRs include erythema, pruritus, ecchymosis, oedema, pain, tenderness and urticaria
* In some cases, symptoms of IRRs and ISRs have been reported as individual ADRs
M-PL-00002072
References:
- Summary of Product Characteristic https://www.roche.pl/content/dam/rochexx/roche-pl/roche_poland_rwd/pl_PL/documents/SmPC/Ronapreve_1332.pdf
▼The medicinal product is additionally monitored. This will allow you to quickly identify new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
Reports of adverse reactions should be submitted to: Department of Monitoring Undesirable Effects of Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: + 48 22 49 21 301; fax: + 48 22 49 21 309; website: https://smz.ezdrowie.gov.pl or Roche Polska Sp. z o.o., ul. Domaniewska 39 B, 02-672 Warsaw, tel. +48 22 345 18 88, fax +48 22 345 18 74 or using the application form available at www.roche.pl/portal/pl/zglaszanie_dzialan_niepozadanych.