Applies to cilgavimab / tixagevimab: parenteral injection for im use.
Warning
Special Alerts:
As of January 26, 2023, the FDA is no longer recommending use of tixagevimab and cilgavimab in any region in the US due to the increasing circulation of COVID-19 variants that tixagevimab and cilgavimab are not effective against.8
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are cautioned that a combined regimen of Tixagevimab and Cilgavimab is not an approved treatment for coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, but rather, is being investigated for and is currently available under an FDA emergency use authorization (EUA) for the preexposure prophylaxis of COVID-19 in adults and pediatric individuals. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information contained in the accompanying monograph, and specifically disclaims all such warranties. Readers of this information are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information contained in the monograph in any and all practice settings. Readers are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Side effects include:
Most common treatment-emergent adverse events occurring in ≥3% of individuals receiving tixagevimab 150 mg and cilgavimab 150 mg (median duration of follow-up of 83 days): Headache (6%), fatigue (4%), and cough (3%).
Overall safety profile of tixagevimab and cilgavimab at a median duration of follow-up of 6.5 months was similar.
Insomnia and dizziness reported in 1% of individuals receiving tixagevimab 300 mg and cilgavimab 300 mg; no other adverse effects reported at higher incidence rates than placebo.
For Healthcare Professionals
Applies to cilgavimab / tixagevimab: intramuscular solution.
Cardiovascular
All patients who experienced cardiac serious adverse events had cardiac risk factors and/or history of cardiovascular disease at baseline.[Ref]
Uncommon (0.1% to 1%): Serious cardiovascular events (including myocardial infarction, cardiac failure), serious thromboembolic events
Frequency not reported: Cardiac serious adverse events, acute myocardial infarction, cardiac failure leading to death, sudden cardiac death[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Hypersensitivity (included rash, urticaria)[Ref]
Local
Common (1% to 10%): Injection site reaction (included injection site pain, injection site erythema, injection site pruritus, injection site reaction, injection site induration)
Frequency not reported: Injection-related reaction[Ref]
