Rolvedon Injection, Solution
Product Images NDC 82497-132

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Rolvedon (NDC 82497-132). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Assertio Specialty Pharmaceuticals, Llc, 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

Duration Of Severe Neutropenia (dsn) Graphs (Image 01)

Two bar charts showing duration (days) of severe neutropenia in Cycle 1 from two studies. Study 1 (n=406) compares Rolvedon and Pegfilgrastim across durations of no severe neutropenia (No SN), 1 day, 2 days, 3 days, and 4 or more days. Study 2 (n=237) shows a similar comparison across durations of No SN, 1 day, 2 days, 3 days, and 4 or more days. Percentages of patients are represented on the y-axis for both studies.*

FDA Label Image

Rolvedon Prefilled Syringe (Image 05)

An instructional illustration depicting a syringe-like autoinjector device, showing detailed internal components including the plunger, barrel, and needle cover. The image likely represents the delivery mechanism for the Rolvedon injection solution, 13.2 mg/0.6 mL, for subcutaneous administration.*

FDA Label Image

Figure A (Image 06)

An instructional diagram showing the parts and proper handling of a prefilled syringe before and after use. Key components are labeled, including needle cap, needle, needle guard (unactivated and activated), finger grip, viewing window, plunger rod, plunger head, and needle guard clips. The illustration emphasizes that the needle is covered by the needle cap before use and shows the needle guard in activated position after use.*

FDA Label Image

Figure B (Image 07)

An instructional illustration showing a hand placing a rectangular item inside a refrigerator, indicating storage instructions for the product Rolvedon (eflapegrastim-xnst) injection solution.*

FDA Label Image

Figure C (Image 08)

An instructional diagram showing a medication carton with the expiration date location highlighted, indicating where to find the expiration date (EXP) on the packaging. An eye icon points to the expiration date area, emphasizing the importance of visually checking this information before use.*

FDA Label Image

Figure H (Image 09)

An anatomical illustration showing recommended subcutaneous injection sites for Rolvedon injection. The labeled shaded areas include outer upper arm, abdomen, upper outer thigh, and upper outer buttock on a front and back view of a human figure.*

FDA Label Image

Figure J (Image 10)

An instructional illustration showing hands preparing a syringe for injection by removing a small black cap or cover from the syringe needle prior to use. The image depicts the action of pulling the cap away from the needle with an arrow indicating the direction of removal.*

FDA Label Image

Figure K (Image 11)

Illustration showing the proper angle for subcutaneous injection using a syringe and needle. The image depicts a hand holding the syringe at an angle between 45 and 90 degrees to the skin surface on another hand, demonstrating the injection technique.*

FDA Label Image

Figure L (Image 12)

An instructional illustration showing a hand holding a syringe for subcutaneous injection. The syringe is partially inserted into skin, with an arrow pointing to the thumb pushing down the plunger to administer the injection.*

FDA Label Image

Figure M (Image 13)

An instructional illustration showing a hand holding a prefilled injection syringe with a click mechanism, positioned above skin, depicting the subcutaneous injection process with an audible 'click'.*

FDA Label Image

Figure N (Image 14)

An instructional illustration showing a hand holding a prefilled syringe at an angle above the skin, with an arrow indicating upward movement, likely demonstrating the action of removing the syringe cap or initiating the injection process.*

FDA Label Image

Figure O (Image 15)

An instructional illustration showing a hand disposing of a used prefilled syringe into a red sharps container labeled "SHARPS CONTAINER." The syringe has the needle cap removed, indicated by an arrow pointing to the needle cap.*

FDA Label Image

Figure D (Image 16)

An illustrated stopwatch showing the instruction to 'Wait 30 minutes.' The indicator highlights a 30-minute interval on the timer dial, emphasizing the wait duration.*

FDA Label Image

Figure E (Image 17)

An instructional illustration showing four medical supplies: a cotton ball, two alcohol wipes, a packet of gauze, and a sharps disposal container. Each item is labeled to identify its use, commonly related to injection or wound care procedures.*

FDA Label Image

Figure F (Image 18)

An instructional illustration showing a hand gripping a syringe at the marked area labeled 'Grip here.' The syringe is being removed or inserted into a molded plastic tray or packaging, indicated by directional arrows guiding the motion.*

FDA Label Image

Figure G (Image 19)

Illustration showing a hand holding a prefilled syringe for injection, with labeled details including a viewing window and the location of the expiration date on the label. The syringe is intended for subcutaneous use.*

FDA Label Image

Figure I (Image 20)

An illustration showing a hand holding a small pad or wipe and applying it to a person's skin surface. The image appears instructional, likely demonstrating preparation of an injection site or cleaning the skin prior to subcutaneous injection.*

FDA Label Image

Blister Tray Label (Rolvedon Blister Tray Label)

Label for Rolvedon (eflapegrastim-xnst) injection 13.2 mg/0.6 mL in a single-dose pre-filled syringe. The label indicates the sterile, preservative-free solution for subcutaneous injection. It includes storage instructions and manufacturer details for Assertio Specialty Pharmaceuticals, LLC in Lake Forest, IL, USA.*

FDA Label Image

Carton Labeling (Rolvedon Carton Label)

Rolvedon 13.2 mg/0.6 mL injection carton label for eflapegrastim-xnst subcutaneous injection. The sterile solution is preservative-free and supplied as a single-dose pre-filled syringe. Labeler is Assertio Specialty Pharmaceuticals, LLC. Includes storage instructions and NDC 82497-132-01.*

FDA Label Image

Syringe Label (Rolvedon Syringe Label)

Rolvedon (eflapegrastim-xnst) injection label shows 13.2 mg/0.6 mL strength. The label indicates it is manufactured by Assertio Specialty Pharmaceuticals, LLC. The label includes a barcode and part of the NDC code 82497-132.*

* 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.