Enfortumab Vedotin-ejfv

Class: Antineoplastic Agents
Chemical Name: Complex with N-[[[4-[[N-[6-(3-mercapto-2,5-dioxo-1-pyrrolidinyl)-1- oxohexyl]-l-valyl-N5-(aminocarbonyl)-l-ornithyl]amino]phenyl]methoxy]carbonyl]-N-methyl-l-valyl-N- [(1S,2R)-4-[(2S)-2-[(1R,2R)-3-[[(1R,2S)-2-hydroxy-1-methyl-2-phenylethyl]amino]-1-methoxy-2- methyl-3-oxopropyl]-1-pyrrolidinyl]-2-methoxy-1-[(1S)-1-methylpropyl]-4-oxobutyl]-N-methyl-l-valinamide, dimer, disulfide with human monoclonal AGS- 22M6 k-chain, anti-(human PVRL4 (poliovirus receptor-related 4, nectin 4) (human monoclonal AGS-22M6 γ1-chain), immunoglobulin G1
Molecular Formula: C₆₆₄₂H₁₀₂₈₄N₁₇₄₂O₂₀₆₃S₄₆
CAS Number: 1346452-25-2
Brands: Padcev

Medically reviewed by Drugs.com on Oct 19, 2020. Written by ASHP.

Introduction

Antineoplastic agent; an anti-nectin-4 antibody conjugated with a microtubule inhibitor (monomethyl auristatin E [MMAE]).

Uses for Enfortumab Vedotin-ejfv

Urothelial Carcinoma

Treatment of locally advanced or metastatic urothelial carcinoma in patients who have previously received platinum-containing therapy in the neoadjuvant, adjuvant, or locally advanced or metastatic setting and either an anti-programmed-death receptor-1 (anti-PD-1) or anti-programmed-death ligand-1 (anti-PD-L1) antibody.

Accelerated approval based on objective response rate. Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.

Enfortumab Vedotin-ejfv Dosage and Administration

General

• Consult specialized references for procedures for proper handling and disposal of antineoplastics. Contact manufacturer for additional information.

Restricted Distribution

• Obtain through designated specialty distributors.

Administration

IV Administration

Administer by IV infusion. Do not administer by rapid IV injection (e.g., IV push or bolus).

Enfortumab vedotin-ejfv powder for injection must be reconstituted and diluted prior to administration.

Do not mix with or administer through the same IV line with other drugs.

Reconstitution

Reconstitute vial containing 20 or 30 mg of enfortumab vedotin with 2.3 or 3.3 mL, respectively, of sterile water for injection to provide a solution containing 10 mg/mL; direct diluent toward the wall of the vial. Gently swirl vial and allow solution to stand for at least 1 minute to allow bubbles to dissipate. Do not shake reconstituted solution.

Reconstituted solution should be clear to slightly opalescent, colorless to light yellow, and free of visible particulates. Do not use if discoloration or particulate matter is present.

Dilution

Dilute dose in appropriate volume of 0.9% sodium chloride injection, 5% dextrose injection, or lactated Ringer's injection to yield a final concentration of 0.3–4 mg/mL. Mix diluted solution by gentle inversion.

Do not use if discoloration or particulate matter is present.

Discard any partially used vial or infusion bag.

Rate of Administration

Administer by IV infusion over 30 minu...