Kesimpta Injection, Solution
Product Images NDC 0078-1007

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Kesimpta (NDC 0078-1007). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

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

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Figure 1: Time To First 3-month Confirmed Disability Progression By Treatment Full Analysis Set (Omb157g 01)

A Kaplan-Meier curve comparing the cumulative event rate percentages over time (up to 33 months) between two patient groups treated with KESIMPTA (N=944) and Teriflunomide (N=932). The graph shows a lower cumulative event rate for KESIMPTA, with a risk reduction of 34.4% and a statistically significant p-value of 0.002. The x-axis is labeled Study Month, and the y-axis is the cumulative event rate percentage. Patient numbers at risk decrease over time and are noted below the x-axis.*

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Principal Display Panel Ndc 0078-1007-68 Rx Only Kesimpta® (ofatumumab) Injection 20 mg/0.4 mL Single-dose Prefilled Sensoready® Pen For Subcutaneous Use Only Sterile Solution (Contains No Preservatives Carton contains: 1 Single-dose Prefilled Sensoready ® Pen, Prescribing Information, Instructions for Use, and Medication Guide Attention: Dispense with enclosed Medication Guide. REFRIGERATE NOVARTIS)

Packaging label for Kesimpta (ofatumumab) injection, 20 mg/0.4 mL, a single-dose prefilled Sensoready Pen for subcutaneous use. The label indicates the sterile solution contains no preservatives and includes prescribing information and a medication guide. The labeler is Novartis Pharmaceuticals Corporation.*

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Figure J (Omb157g 03)

An instructional illustration showing a hand holding a filled syringe above a sharps disposal container labeled "SHARPS." The image demonstrates proper disposal of used needles or syringes, relevant for subcutaneous injection administration like Kesimpta (ofatumumab) injection.*

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Figure A (Omb157g 04)

An instructional diagram of a Kesimpta injection pen showing labeled parts including the needle, needle guard, cap, internal needle cover, and viewing window.*

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Figure B (Omb157g 05)

An illustration of a subcutaneous injection pen for KESIMPTA (ofatumumab) 20 mg/0.4 mL. The pen features a capped needle end with directional arrows indicating parts of the device, designed for delivering the injectable solution.*

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Figure C (Omb157g 06)

An instructional illustration showing three items in sequence: a wipe packet labeled 'WIPE,' a round cotton pad or similar material, and a container labeled 'SHARPS,' suggesting a stepwise process for cleaning, applying, and disposing of injection materials.*

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Figure D (Omb157g 07)

An instructional diagram showing a single-dose pen device for KESIMPTA (ofatumumab) injection, solution, subcutaneous. The diagram highlights the viewing window and the location of the expiration date on the pen.*

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Figure E (Omb157g 08)

Illustration showing recommended subcutaneous injection sites for Kesimpta (ofatumumab) on a human male figure with shaded areas on the lower abdomen and anterior thighs as suitable injection locations.*

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Figure F (Omb157g 09)

An anatomical illustration showing the back view of a human figure highlighting the outer upper arms. The shaded areas indicate the subcutaneous injection sites suitable for administration.*

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Figure G (Omb157g 10)

An instructional illustration showing a hand performing a circular motion on the thigh area, typically used to demonstrate proper technique for subcutaneous injection site preparation or massage after injection.*

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Figure H (Omb157g 11)

An instructional illustration showing hands removing the cap from a Kesimpta (ofatumumab) autoinjector pen prior to subcutaneous injection. The image depicts the proper way to prepare the injection device by separating the cap from the pen body.*

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Figure I (Omb157g 12)

An instructional illustration showing a hand holding a KESIMPTA (ofatumumab) injection pen in preparation for subcutaneous administration. The pen is grasped firmly with the thumb on top, indicating proper technique for injection.*

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Correct/incorrect Image (Omb157g 13)

An instructional illustration showing the correct and incorrect ways to hold an injection pen. The correct method is shown with the pen held vertically downwards, accompanied by a green check mark and 'Correct' label. The incorrect method shows the pen tilted, marked with a black X and 'Incorrect' label.*

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Figure I (Omb157g 14)

An instructional diagram showing the use of a prefilled subcutaneous injection device. The image depicts a hand pressing the injection device against the skin with an arrow indicating the direction to push for activation or injection.*

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Figure J (Omb157g 15)

An instructional illustration showing a hand firmly holding a Kesimpta subcutaneous injection pen vertically above the skin surface, with a downward arrow indicating the direction to press the pen for injection.*

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Figure K (Omb157g 16)

An instructional illustration showing a hand holding a prefilled syringe poised for subcutaneous injection. The syringe tip is circled with a green dashed line, indicating the injection site on the skin. This image relates to KESIMPTA injection, solution by Novartis Pharmaceuticals.*

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Figure L (Omb157g 17)

An instructional illustration showing a hand gripping and preparing to use an injection pen device, likely demonstrating the proper technique for holding or administering a subcutaneous injection.*

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Figure M (Omb157g 18)

An instructional illustration showing a used injection device being disposed of into a labeled sharps container. The injection device corresponds to subcutaneous injection usage, consistent with products like Kesimpta (ofatumumab) injection solution.*

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Figure A (Omb157g 19)

Illustration of a subcutaneous injection device for KESIMPTA (ofatumumab) 20 mg/.4 mL solution. The diagram labels key parts including the needle cap, syringe guard body, viewing window with label and expiration date, finger grips, syringe guard wings, plunger, and plunger head.*

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Figure B (Omb157g 20)

An instructional illustration showing three items in sequence: a wipe, a pad or cotton ball, and a sharps disposal container labeled "SHARPS." The image appears to guide proper disposal or use of these items, likely related to injection procedures.*

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Figure C (Omb157g 21)

An instructional diagram showing a cross-sectional view of a prefilled syringe for KESIMPTA (ofatumumab) injection, solution 20 mg/.4 mL. The image highlights the location of the expiration date label on the syringe barrel, indicating where the user can find this information before administration.*

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Figure D (Omb157g 22)

An anatomical illustration showing common subcutaneous injection sites for KESIMPTA (ofatumumab) injection. The diagram highlights the abdomen around the navel and the front upper thigh areas as preferred locations for subcutaneous administration.*

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Figure E (Omb157g 23)

Illustration showing a rear view of a human body with shaded areas on the outer upper arms indicating possible injection sites for subcutaneous administration.*

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Figure F (Omb157g 24)

An instructional black-and-white illustration showing one hand holding a syringe at the needle end and the other hand removing a protective cap from the needle. The image depicts the step of preparing an injection by removing the needle cover prior to use.*

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Figure G (Omb157g 25)

An instructional illustration showing the proper technique for subcutaneous injection of KESIMPTA (ofatumumab) 20 mg/0.4 mL. It depicts a hand holding an autoinjector angled at approximately 45 degrees to the skin on the forearm, demonstrating how to position the device for injection.*

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Figure H (Omb157g 26)

An instructional diagram showing a hand preparing to administer a subcutaneous injection with the device held in the other hand. Two close-up insets emphasize pressing a specific part of the injection device with a thumb, highlighting the mechanism and correct finger placement for injection.*

* 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.