Enfortumab vedotin-ejfv (Padcev™) was granted accelerated approval 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.
Antibody-drug conjugate (ADC). Agents in this class of drugs consist of 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 and helps deliver the cytotoxic compound directly to the tumor cells.
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 in the neoadjuvant or adjuvant, locally advanced, or metastatic setting.
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).
Give via IV infusion over 30 minutes.
More than 20% of patients experience fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, dysgeusia, diarrhea, dry eye, pruritus, or dry skin.
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.
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.
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.
No differences in safety or effectiveness between older and younger patients were observed in clinical studies.
This agent is cytotoxic. Use proper handling precautions and personal protective equipment.
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