Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023 Mar;14(2):139-152.
doi: 10.6004/jadpro.2023.14.2.4. Epub 2023 Mar 1.

Tisotumab Vedotin Safety and Tolerability in Clinical Practice: Managing Adverse Events

Courtney R Arn  1 , Kimberly J Halla  2 , Sally Gill  3
Affiliations
Review

Tisotumab Vedotin Safety and Tolerability in Clinical Practice: Managing Adverse Events

Courtney R Arn et al. J Adv Pract Oncol. 2023 Mar.

Abstract

Tisotumab vedotin-tftv, an antibody-drug conjugate indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, demonstrated clinically meaningful and durable responses with a manageable safety profile in the pivotal phase II innovaTV 204 clinical trial. Based on the proposed mechanism of action of tisotumab vedotin, experience from clinical trials, and the US prescribing information, certain adverse events (AEs) including ocular AEs, peripheral neuropathy, and bleeding have been identified as AEs of interest. This article highlights practical considerations and provides recommendations to support the management of selected AEs associated with tisotumab vedotin. Central to monitoring of patients on tisotumab vedotin is a comprehensive care team comprised of oncologists, advanced practice providers (including nurse practitioners, physician assistants, and pharmacists), and other specialists such as ophthalmologists. As ocular AEs may be less familiar to gynecologic oncology practitioners, adherence to the "Premedication and Required Eye Care" section outlined in the US prescribing information, as well as the incorporation of ophthalmologists into the oncology care team, can help provide timely and appropriate eye care for patients receiving tisotumab vedotin.

PubMed Disclaimer

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Required eye care to mitigate risk of ocular AEs in patients treated with tisotumab vedotin. AE = adverse event. Examples are based on the innovaTV 204 clinical trial. Information from Seagen Inc. & Genmab US Inc. (2022). aOphthalmic exam includes visual acuity and slit-lamp exam by an eye care provider. bPrior to infusion, administer 1 drop of dexamethasone 0.1% per eye and 3 drops of brimonidine tartrate 0.2% per eye. cFor 72 hours after each infusion, 1 drop of dexamethasone 0.1% administered per eye as prescribed.
Figure 2
Figure 2
Anatomy of the eye and grading criteria for ocular AEs. ADL = activities of daily living; AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events. Information from Duncan & Jeng (2015); US Department of Health and Human Services (2017).
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Akpek, E. K., & Smith, R. A. (2013). Overview of age-related ocular conditions. American Journal of Managed Care, 19(5 Suppl), S67–S75. https://www.ajmc.com/view/ace011_13may_agingeye_akpek - PubMed
    1. Alley, S. C., Harris, J. R., Cao, A., Heuvel, E. G.-v. d., Velayudhan, J., Satijn,…Breij, E. C. (2019). Abstract 221: Tisotumab vedotin induces anti-tumor activity through MMAE-mediated, Fc-mediated, and Fab-mediated effector functions in vitro. Cancer Research, 79(13 Supplement), 221–221. 10.1158/1538-7445.AM2019-221 - DOI
    1. Amescua, G., Akpek, E. K., Farid, M., Garcia-Ferrer, F. J., Lin, A., Rhee, M. K.,…American Academy of Ophthalmology Preferred Practice Pattern Cornea and External Disease Panel. (2019). Blepharitis preferred practice pattern®. Ophthalmology, 126(1), P56–P93. 10.1016/j.ophtha.2018.10.019 - DOI - PubMed
    1. Ancuţa, B., Nemes, R., Scurtu, S., Shencker, M., & Iliescu, D. (2012). Quality of life in cervical cancer survivors. Acta Medica Marisiensis, 58(5), 275–277.
    1. Ando, R., Kase, S., Ohashi, T., Dong, Z., Fukuhara, J., Kanda, A.,…Ishida, S. (2011). Tissue factor expression in human pterygium. Molecular Vision, 17, 63–69. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021580/ - PMC - PubMed

LinkOut - more resources