This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.
Background and Date of Approval
Enfortumab vedotin-ejfv, marketed as Padcev, is an antibody-drug conjugate (ADC) designed to target Nectin-4, a protein highly expressed in urothelial carcinoma. The U.S. Food and Drug Administration (FDA) granted accelerated approval for this therapy on December 18, 2019, for adult patients with locally advanced or metastatic urothelial cancer who had previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy. This approval was based on clinical trials demonstrating significant efficacy in this patient population. Subsequent studies, including the EV-301 trial, have provided further evidence supporting its clinical benefit.
Mechanism of Action of undefined
This therapy operates by binding to Nectin-4 on cancer cells, delivering monomethyl auristatin E (MMAE), a cytotoxic agent. Once internalised, MMAE disrupts the microtubule network within the cancer cells, leading to cell cycle arrest and apoptosis. This targeted approach allows for the selective destruction of cancer cells while minimising damage to healthy tissues.
Uses of undefined
- Treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1 or PD-L1 inhibitor and platinum-containing chemotherapy.
undefined Drug administaration and Dosage available
The recommended dosage is 1.25 mg/kg (up to a maximum of 125 mg) administered intravenously over 30 minutes on Days 1, 8, and 15 of a 28-day cycle. Treatment continues until disease progression or unacceptable toxicity occurs.
Warnings, Precautions and Side Effects of undefined
Warnings
- Peripheral Neuropathy: Monitor patients for symptoms such as numbness or tingling in the hands and feet.
- Ocular Disorders: Patients may experience dry eyes or blurred vision; regular ophthalmologic evaluations are recommended.
- Hyperglycemia: Monitor blood glucose levels, especially in patients with diabetes or risk factors for hyperglycemia.
- Infusion Site Reactions: Observe for redness, swelling, or discomfort at the infusion site during and after administration.
- Embryo-Fetal Toxicity: Advise pregnant women of the potential risk to the fetus and recommend effective contraception during treatment.
Precautions
Before initiating therapy, assess patients for pre-existing peripheral neuropathy and monitor for new or worsening symptoms during treatment. Patients with a history of hyperglycemia should have their blood glucose levels closely monitored. Advise patients to use artificial tears or other lubricating ophthalmic treatments to alleviate dry eyes. Women of childbearing potential should use effective contraception during treatment and for at least two months after the final dose.
Side Effects
Serious Side Effects:
- Severe Peripheral Neuropathy: May necessitate dose modification or discontinuation.
- Serious Skin Reactions: Including Stevens-Johnson syndrome and toxic epidermal necrolysis; discontinue treatment if these occur.
- Hyperglycemia: Can lead to ketoacidosis or hyperosmolar hyperglycemic state; monitor and manage appropriately.
Common Side Effects:
- Fatigue
- Nausea
- Decreased Appetite
- Diarrhea
- Rash
- Alopecia
- Dysgeusia (altered taste)
- Dry Eyes
Word Of Advice
Patients should promptly report any new or worsening symptoms, particularly those related to nerve function, skin reactions, or blood sugar levels. Maintaining open communication with healthcare providers ensures timely management of side effects. Adherence to scheduled appointments and monitoring protocols is crucial for safe and effective treatment.
Frequently Asked Question
References
- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-enfortumab-vedotin-ejfv-metastatic-urothelial-cancer
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s019lbl.pdf
- https://fda.report/DailyMed/b5631d3e-4604-4363-8f20-11dfc5a4a8ed
- https://www.padcev.com/about-padcev
Disclaimer
This content is intended for informational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.