Kyprolis Injection, Powder, Lyophilized, For Solution
Product Images NDC 76075-102

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Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Kyprolis (NDC 76075-102). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Onyx Pharmaceuticals, 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

3. Use A 21 Gauge Or Larger Gauge Needle (0.8 Mm Or Smaller External Diameter Needle) To Aseptically Reconstitute Each Vial By Slowly Injecting 29 mL (for 60 mg Vial) Or 15 mL (for 30 mg Vial) Sterile Water For Injection, Usp, Through The Stopper And Directing The Solution Onto The Inside Wall Of The Vial To Minimize Foaming. (Kyprolis 01)

3. Use A 21 Gauge Or Larger Gauge Needle (0.8 Mm Or Smaller External Diameter Needle) To Aseptically Reconstitute Each Vial By Slowly Injecting 29 mL (for 60 mg Vial) Or 15 mL (for 30 mg Vial) Sterile Water For Injection, Usp, Through The Stopper And Directing The Solution Onto The Inside Wall Of The Vial To Minimize Foaming. (Kyprolis 01)
An instructional illustration depicting a syringe needle inserted into the rubber stopper of a vial containing liquid medication, demonstrating the process of drawing medication from the vial.*
FDA Label Image

The Following Structural Formula For Carfilzomib Is A Modified Tetrapeptidyl Epoxide, Isolated As The Crystalline Free Base. The Chemical Name For Carfilzomib Is (2s)-n-((s)-1-((s)-4-methyl-1-((r)-2-methyloxiran-2 Yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((s)-2-(2-morpholinoacetamido)-4 Phenylbutanamido)-4-methylpentanamide. (Kyprolis 02)

The Following Structural Formula For Carfilzomib Is A Modified Tetrapeptidyl Epoxide, Isolated As The Crystalline Free Base.  The Chemical Name For Carfilzomib Is (2s)-n-((s)-1-((s)-4-methyl-1-((r)-2-methyloxiran-2 Yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2-((s)-2-(2-morpholinoacetamido)-4 Phenylbutanamido)-4-methylpentanamide. (Kyprolis 02)
Chemical structure of carfilzomib, the active ingredient in KYPROLIS injection, powder, lyophilized, for solution, used for intravenous administration.*
FDA Label Image

Figure 1: Kaplan-meier Curve Of Progression-free Survival In Study 1 (Kyprolis 03)

Figure 1:  Kaplan-meier Curve Of Progression-free Survival In Study 1 (Kyprolis 03)
A Kaplan-Meier survival curve graph displaying the proportion of subjects surviving without disease progression over 48 months from randomization. Two treatment groups are compared: KRd with a solid line and Rd with a dashed line, each with 396 subjects initially. A table shows progression/death rates, median progression-free survival (PFS) in months, hazard ratio (HR), confidence interval (CI), and p-value comparing KRd and Rd groups.*
FDA Label Image

Figure 2: Kaplan-meier Curve Of Interim Overall Survival In Study 1 (Kyprolis 04)

Figure 2:  Kaplan-meier Curve Of Interim Overall Survival In Study 1 (Kyprolis 04)
A survival curve chart showing the proportion of subjects surviving over months from randomization for two groups labeled KRd and Rd. The chart includes a table with data on death percentages, median overall survival (OS) in months, hazard ratio (HR) with 95% confidence interval, and p-value comparing KRd to Rd. Numbers of subjects at risk are shown for each time point up to 78 months.*
FDA Label Image

Figure 3: Kaplan-meier Plot Of Progression-free Survival In Study 2 (Kyprolis 05)

Figure 3:  Kaplan-meier Plot Of Progression-free Survival In Study 2 (Kyprolis 05)
A Kaplan-Meier survival curve comparing the proportion surviving without progression over 30 months from randomization for two treatments, Kd and Vd. The solid line represents Kd and the dashed line represents Vd. The graph includes a risk table showing the number of subjects at risk at various time points and a statistical summary with progression/death counts, median progression-free survival (PFS) in months, hazard ratio (HR) with confidence interval, and p-value for significance.*
FDA Label Image

Figure 4: Kaplan-meier Plot Of Overall Survival In Study 2 (Kyprolis 06)

Figure 4:  Kaplan-meier Plot Of Overall Survival In Study 2 (Kyprolis 06)
A survival curve graph comparing the proportion of patients surviving over 48 months from randomization between two treatment groups labeled Kd and Vd. The chart includes a risk table indicating the number of subjects at risk at various time points and an inset showing death percentages, median overall survival months, hazard ratio, and p-value for the two groups.*
FDA Label Image

Kyprolis 07

Kyprolis 07
A Kaplan-Meier survival curve graph showing the proportion of subjects surviving without progression over months from randomization comparing twice-weekly Kd 20/27 mg/m2 and once-weekly Kd 20/70 mg/m2 dosing regimens. The x-axis represents months from randomization (0 to 21), and the y-axis shows the proportion surviving without progression (0 to 1.0). The inset table provides summary statistics including progression/death percentages, median progression-free survival (PFS) in months, hazard ratio, confidence interval, and p-value for both dosing groups.*
FDA Label Image

Principal Display Panel1 Single-dose Vialndc 76075-102-01amgen®kyprolis®(carfilzomib) For Injection30 mg/vial30 mg/vialsingle-dose Vial.discard Unused Portion.for Intravenous Administration Onlyrx Only (Kyprolis 08)

Principal Display Panel1 Single-dose Vialndc 76075-102-01amgen®kyprolis®(carfilzomib) For Injection30 mg/vial30 mg/vialsingle-dose Vial.discard Unused Portion.for Intravenous Administration Onlyrx Only (Kyprolis 08)
Kaplan-Meier survival curve depicting the proportion of subjects surviving without disease progression over months from randomization in patients treated with KYPROLIS (carfilzomib) regimens labeled as Kd and DKd. The graph compares survival without progression between the two groups with corresponding numbers at risk over time and includes a statistical summary of progression/death rates, median progression-free survival, hazard ratio, and p-value.*
FDA Label Image

Principal Display Panel1 Single-use Vialndc 76075-101-01amgen®kyprolis®(carfilzomib) For Injection60 mg/vial60 mg/vialsingle-use Vial.discard Unused Portion.for Intravenous Administration Onlyrx Only (Kyprolis 09)

Principal Display Panel1 Single-use Vialndc 76075-101-01amgen®kyprolis®(carfilzomib) For Injection60 mg/vial60 mg/vialsingle-use Vial.discard Unused Portion.for Intravenous Administration Onlyrx Only (Kyprolis 09)
A Kaplan-Meier survival curve chart depicting progression-free survival (PFS) probability over time in months for two treatment groups: Isa-Kd and Kd. The chart includes patient numbers at risk for each group over time and shows statistical data including median PFS, hazard ratio with 95% confidence interval, and p-value comparing the two groups.*
FDA Label Image

Kyprolis 10

Kyprolis 10
Label for KYPROLIS (carfilzomib) injection, showing 10 mg per vial strength. It is a single-dose vial intended for intravenous administration. The label instructs reconstitution with 5 mL Sterile Water for Injection and optionally dilution with 5% Dextrose Injection. The labeler is Amgen.*
FDA Label Image

Kyprolis 11

Kyprolis 11
Label for Kyprolis (carfilzomib) injection, 30 mg per vial. The label indicates a single-dose vial with instructions for reconstitution using sterile water and dilution with 5% dextrose injection. It is for intravenous administration only. The label features the Amgen logo and is marked Rx only.*
FDA Label Image

Kyprolis 12

Kyprolis 12
Kyprolis 60 mg/vial injection powder, lyophilized for solution, manufactured by Amgen. This single-dose vial requires reconstitution with 29 mL Sterile Water for Injection and may be further diluted with 5% Dextrose Injection. It is for intravenous administration only.*

* 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.