Padcev Injection, Powder, Lyophilized, For Solution
Product Images NDC 51144-030

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Padcev (NDC 51144-030). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Seagen Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure 1 (Image 01)

Chemical structure diagram showing components of the drug-linker conjugate of Enfortumab Vedotin, including AGS-22C3, PABC (p-aminobenzyl alcohol carbamate), valine-citrulline dipeptide, and the cytotoxic agent SGD-1010 (MMAE). The image details the molecular arrangement and bond connectivity of these components.*

FDA Label Image

Figure 2 (Image 02)

Packaging label for PADCEV (enfortumab vedotin-ejfvy) injection, powder, lyophilized, for solution, 20 mg/vial. The label specifies it is for intravenous use, single-dose vial, requiring reconstitution and dilution before use. Labeled with warnings for cytotoxic agent use. Manufactured and distributed by Astellas Pharma US, Inc. and Seagen Inc. Includes storage instructions and barcode.*

FDA Label Image

Figure 3 (Image 03)

Packaging label for PADCEV (enfortumab vedotin-ejfv) injection, powder, lyophilized, for solution, 30 mg/vial. The label shows it is for intravenous use, a cytotoxic agent, single-dose vial, and must be reconstituted and diluted before use. Manufactured by Astellas and distributed by Seagen Inc. Storage instructions specify refrigeration at 2°C to 8°C. The label includes barcodes, trademarks, and regulatory information indicating it is a U.S. prescription drug product.*

FDA Label Image

Figure 4 (Image 04)

A Kaplan-Meier survival curve comparing the probability of overall survival over 24 months between Enfortumab Vedotin and Chemotherapy. The graph shows survival probabilities on the y-axis and duration of overall survival in months on the x-axis, including censored data points and number of patients at risk for each treatment group.*

FDA Label Image

Figure 5 (Image 05)

A Kaplan-Meier survival curve graph showing the probability of progression-free survival over time (in months) comparing Enfortumab Vedotin to chemotherapy. The plot includes censored data points and a table below indicating the number of subjects at risk at various time points for both treatment groups.*

FDA Label Image

Figure 6 (Image 06)

A Kaplan-Meier survival curve comparing overall survival (%) over time in months for two treatments: PADCEV with IV pembrolizumab (solid line) versus Cisplatin or Carboplatin plus Gemcitabine (dashed line). The PADCEV group consistently shows higher survival percentages up to 38 months. A table below the graph lists the number of patients at risk over time for each group.*

FDA Label Image

Figure 7 (Image 07)

A Kaplan-Meier curve chart depicting progression-free survival percentage over time in months for two treatment groups: PADCEV with intravenous pembrolizumab and Cisplatin or Carboplatin with Gemcitabine. The chart includes a survival curve for each group with corresponding risk population counts listed below for various time points up to 32 months.*

FDA Label Image

Figure 8 (Image 08)

A Kaplan-Meier survival curve comparing the probability of overall survival over 24 months between PADCEV (enfortumab vedotin) and chemotherapy treatment groups. The graph shows time in months on the horizontal axis and probability of overall survival on the vertical axis, with PADCEV represented by a solid black line and chemotherapy by a dashed gray line. A table below indicates the number of patients at risk at various time points for each treatment group.*

FDA Label Image

Figure 9 (Image 09)

A Kaplan-Meier survival curve chart showing the probability of progression-free survival over time in months. The graph compares PADCEV (solid line) and Chemotherapy (dashed line) with probability values declining from 1.0 to 0.0 along the y-axis over 0 to 21 months on the x-axis. Below the graph, a number-at-risk table lists patient counts at various time points for each treatment group.*

FDA Label Image

Padcev (enfortumab Vedotin-ejfv) For Injection 20 mg/vial Label (Image 10)

Packaging label for PADCEV (enfortumab vedotin-ejfv) injection, powder, lyophilized, for solution, 20 mg per vial. The label shows dosage instructions, cautions about cytotoxicity, single-dose use, storage conditions, and manufacturer information including Astellas Pharma US, Inc. and Seagen Inc. The product is indicated for intravenous infusion and includes barcode and lot/expiration marking areas.*

FDA Label Image

Padcev (enfortumab Vedotin-ejfv) For Injection 30 mg/vial Label (Image 11)

Packaging label for PADCEV 30 mg/vial injection, powder, lyophilized, for solution by Seagen Inc. The label indicates the product contains enfortumab vedotin-ejfv for intravenous use. It includes dosing instructions, storage information, and cautions about the cytotoxic nature of the agent. Also displayed are manufacturer and distributor details, barcode, and necessary regulatory and trademark markings.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.