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- Drug Reference Sheets (http://dev-voice.ons.org/topic/drug-reference-sheets)
Oncology Drug Reference Sheet: Enfortumab Vedotin-Ejfv
Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-metastatic-urothelial-cancer) in December 2019 for adults with locally advanced or metastatic urothelial cancer who previously received an immune checkpoint inhibitor (PD-1 or PD-L1 inhibitor) and platinum-containing therapy.
Category/Class
Antibody-drug conjugate (ADC). Agents in this class of drugs consist of (https://voice.ons.org/news-and-views/antibody-drug-conjugates-join-the-best-of-two-worlds-into-one-new-treatment) an antibody that is chemically linked to a biologically active drug or cytotoxic compound. The antibody in enfortumab vedotin-ejfv is directed against Nectin-4 expressed on certain cells. The cytotoxic agent is a microtubule toxic agent used in other ADCs. The antibody is tumor-specific (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6359697) and helps deliver the cytotoxic compound directly to the tumor cells (https://doi.org/10.1200/JCO.19.01140).
Indication
Adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy (https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf) in the neoadjuvant or adjuvant, locally advanced, or metastatic setting.
Dosing
Administer 1.25 mg/kg with a maximum dose of 125 mg on days 1, 8, and 15 of a 28-day cycle until patients experience disease progression or unacceptable toxicity. Dose modifications are necessary for adverse reactions (e.g., hyperglycemia, peripheral neuropathy, skin reactions).
Administration
Give via IV infusion over 30 minutes.
Adverse Reactions
More than 20% of patients experience fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea, dry eye, pruritus, or dry skin.
Warnings/Precautions
Possible severe adverse reactions include diabetic ketoacidosis, which can occur in patients without preexisting diabetes mellitus, ocular toxicities; gastrointestinal toxicity; peripheral neuropathy; infusion site extravasation; and embryo-fetal toxicity.
Nursing Considerations
Verify pregnancy status prior to starting treatment. Ensure patients are aware that male fertility may be impaired. Patients with moderate to severe hepatic impairment should avoid use of enfortumab vedotin-ejfv. Dose reductions may be necessary for hyperglycemia, peripheral neuropathy, skin reactions, or other severe toxicities; see package insert. Monitor during infusion for possible extravasation.
Drug-Drug and Drug-Food Interactions
Concurrent use with strong CYP3A4 inhibitors may increase the incidence or severity of toxicities. Concurrent use of strong CYP3A4 inducers may decrease exposure of the cytotoxic agent.
Patient Education
Patients should use effective birth control during treatment and for two months after the last dose (four months for men with female partners of reproductive potential). Women should avoid breastfeeding during treatment and for at least three weeks after the last dose. Educate patients on symptoms of hyperglycemia. Advise them that delayed symptoms of an extravasation are possible.
Gero-Oncology Considerations
No differences in safety or effectiveness between older and younger patients were observed in clinical studies.
Safe Handling
This agent is cytotoxic. Use proper handling precautions and personal protective equipment.
Patient Assistance
Visit astellaspharmasupportsolutions.com/patient/padcev/index.aspx or call 888-402-0627 for more information.