Editor’s note: This article was updated to include recent news from the Food and Drug Administration regarding tixagevimab-cilgavimab (Evusheld).

The combination of tixagevimab with cilgavimab as an aid in the prevention of COVID-19 is available for certain groups of patients. Julie C. Martin, DNP, AOCN®, NP, director of cancer research at Prisma Health in Greenville, South Carolina, provided an explanation on the use of tixagevimab with cilgavimab as COVID-19 pre-exposure prophylaxis in a recent issue of the Clinical Journal of Oncology Nursing.1

“As of September 2022, tixagevimab-cilgavimab is the only drug authorized in the United States to prevent COVID-19 infection before exposure to the virus,” Dr Martin wrote in her report.


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The tixagevimab-cilgavimab combination received emergency use authorization from the US Food and Drug Administration (FDA) in December 2021 as pre-exposure prophylaxis of COVID-19. This authorization occurred following completion of the PROVENT and STORM CHASER phase 3 pivotal trials (ClinicalTrials.gov Identifiers: NCT04625725, NCT04625972, respectively) that evaluated the safety and efficacy of the combination.

Tixagevimab and cilgavimab are both recombinant human immunoglobulin G monoclonal antibodies, administered as 2 3-mL intramuscular injections. The mechanism of action of this combination involves each agent binding to different areas of the receptor-binding domain of the spike protein of the SARS-CoV-2 virus. There are specific recommendations regarding the administration of tixagevimab-cilgavimab and the timing of administration after a patient has had COVID-19 vaccination or has experienced COVID-19.

Persons eligible to receive tixagevimab-cilgavimab cannot have a current infection with or recent exposure to SARS-CoV-2, must be at least 12 years old, and weigh at least 40 kg. Other eligibility criteria relate to having moderate or severe immunocompromised status or a recommendation to not receive COVID-19 vaccination. Multiple forms of cancer treatment have been associated with having an immunocompromised state.

Although tixagevimab–cilgavimab is considered generally well tolerated, adverse events may occur. The most common adverse events include headache, fatigue, and cough. Reported adverse events have mostly been graded as mild (73%) or moderate (24%), but some serious adverse events have been reported.

In her report, Dr Martin recommended that patients and caregivers be given information about the treatment combination, including a fact sheet on tixagevimab-cilgavimab provided by the FDA. Patients also should be informed of the importance of reporting allergies and any other relevant clinical factors.

Additionally, the FDA recently expressed concerns regarding whether tixagevimab-cilgavimab will neutralize the subvariant XBB.1.5, a SARS-CoV-2 Omicron variant currently estimated to account for 28% of circulating variants in the US. The subvariant is similar to variants that are not neutralized by tixagevimab-cilgavimab. Nurses are advised to inform their patients that tixagevimab-cilgavimab may not protect against developing COVID-19 if exposed to the XBB.1.5 subvariant.2 

Redosing with tixagevimab–cilgavimab may be necessary, explained Dr Martin. “Nurses can inform patients that they may need to receive additional doses of tixagevimab-cilgavimab, but the timing of redosing is currently under investigation.”

References

  1. Martin JC. Tixagevimab-cilgavimab: COVID-19 pre-exposure prophylaxis. Clin J Oncol Nurs. 2022;26(5):479-482. doi:10.1188/22.CJON.479-482
  2. US Food and Drug Administration. FDA releases important information about risk of COVID-19 due to certain variants not neutralized by Evusheld [news release]. US Food & Drug Administration. Published January 6, 2023. Accessed January 9, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-releases-important-information-about-risk-covid-19-due-certain-variants-not-neutralized-evusheld