Spevigo Injection
Product Images NDC 50222-360

Product Visual Gallery

This gallery contains 53 technical images submitted to the FDA as part of the official labeling for Spevigo (NDC 50222-360). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Leo Pharma 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 (Spevigo 01)

A Kaplan-Meier curve showing the estimated probability of first GPP flare up to week 48 for SPEVIGO (spesolimab) 600 mg loading dose followed by 300 mg every 4 weeks versus placebo. The y-axis represents flare-up probability while the x-axis shows time in weeks from the first dose, with accompanying numbers of subjects at risk for each group over time.*

FDA Label Image

Image (Spevigo 02)

An instructional illustration depicting two views of a SPEVIGO (spesolimab) prefilled injection syringe. The syringe is shown with a blue plunger and transparent barrel. Step 1 and Step 2 are indicated with numbered circles, showing different stages of the syringe prior to use. The image focuses on the syringe design for subcutaneous injection.*

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Image (Spevigo 03)

An instructional diagram of a SPEVIGO subcutaneous injection syringe, labeled with parts before and after use. It identifies the thumb pad, plunger rod, finger grip, syringe body, medicine, safety shield, cap, covered needle, and activated safety cover, demonstrating proper needle safety post-injection.*

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Image (Spevigo 04)

An instructional diagram showing a refrigerator with a right-pointing arrow, indicating storage directions for the product SPEVIGO (spesolimab) injection.*

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Image (Spevigo 05)

An instructional illustration showing components related to SPEVIGO prefilled syringes for subcutaneous injection. It depicts one syringe and lists additional items including 2 cotton balls or gauze, 2 alcohol wipes, and 1 sharps container, noting that these items are not included.*

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Image (Spevigo 06)

An instructional illustration showing two steps: first, bringing the medicine to room temperature for 15 to 30 minutes; second, washing hands with soap and water before administration. The image aims to guide proper preparation for injection use.*

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Image (Spevigo 07)

An instructional diagram showing a prefilled syringe labeled with the medicine area and an expiration date placeholder marked as EXP YYYY-MM. It highlights the importance of checking both prefilled syringes before use.*

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Image (Spevigo 08)

Illustration showing two views of a prefilled syringe for SPEVIGO (spesolimab), a subcutaneous injection. The image highlights the syringe with a needle cover attached and then the syringe with the needle cover removed, demonstrating preparation steps for injection.*

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Image (Spevigo 09)

An illustration showing recommended injection areas for SPEVIGO (spesolimab) subcutaneous injection. Injection sites include the abdomen and upper thighs, with blue circles highlighting the specific areas on a human figure's front torso and upper legs.*

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Image (Spevigo 10)

An instructional illustration showing a hand using a pad or wipe to clean a skin area in preparation for a subcutaneous injection. The skin area is marked with colorful circular patterns, likely indicating the injection site or cleaning focus.*

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Image (Spevigo 11)

An instructional illustration showing two safety icons: a hand touching a cracked surface inside a red circle with a slash indicating 'do not touch,' and a face exhaling vapors inside a similar red circle with a slash indicating 'do not inhale.' These warnings advise against hand contact with broken materials and inhalation of vapors.*

FDA Label Image

Image (Spevigo 12)

An instructional illustration showing hands preparing a subcutaneous injection with a syringe, specifically removing the cap from the syringe needle, indicated by an arrow and the label 'Cap.' The image depicts steps relevant to administering SPEVIGO (spesolimab) injection.*

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Image (Spevigo 13)

An instructional illustration showing a hand pressing down on a circular patch or injection site on the skin with two green arrows indicating the direction of pressure. The image likely demonstrates a step related to subcutaneous injection technique or site care.*

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Image (Spevigo 14)

An instructional illustration showing a hand inserting a needle at a 45-degree angle into the skin, demonstrating the proper technique for subcutaneous injection.*

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Image (Spevigo 15)

An instructional illustration showing the subcutaneous injection of SPEVIGO (spesolimab). It depicts a hand holding a syringe at a 45-degree angle while injecting medication into another person's forearm. The image includes directional arrows and the text 'Push firmly' to guide proper injection technique.*

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Image (Spevigo 16)

An instructional illustration showing how to remove the thumb to activate the safety cover on a prefilled injection device held at a 45-degree angle, labeled as step 'C' with the caption 'Checking injection is complete.'*

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Image (Spevigo 17)

An instructional illustration showing two steps of a SPEVIGO injection device preparation or use. Step 1 shows a syringe with a plunger partially depressed, and step 2, highlighted with a red box, shows the syringe with the plunger fully depressed or extended downward. The device has blue and gray components typical of an injection device for subcutaneous delivery.*

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Image (Spevigo 18)

An instructional illustration showing the correct disposal of used syringes by placing them into a sharps container. The image includes arrows indicating the syringe moving toward the container opening, demonstrating safe disposal of injection equipment.*

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Image (Spevigo 19)

An illustration of a subcutaneous injection device, likely a pre-filled syringe with a blue thumb rest and plunger, corresponding to the dosage forms available for SPEVIGO (spesolimab). No text or other labels are visible in the image.*

FDA Label Image

Image (Spevigo 20)

An instructional diagram showing a subcutaneous injection device for SPEVIGO (spesolimab). It depicts the syringe before use, labeling parts like thumb pad, plunger rod, finger grip, medicine area, safety cover, and cap. The 'After Use' side shows the syringe body with the needle covered by an activated safety cover, emphasizing the needle should be inside the safety cover after use.*

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Image (Spevigo 21)

An instructional diagram showing a rectangular object, likely a device or container, with a black arrow pointing to the left side, indicating a step or direction related to the object. No text is visible.*

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Image (Spevigo 22)

Illustration showing components associated with SPEVIGO prefilled syringe injection, including the prefilled syringe, a cotton ball or gauze (not included), an alcohol wipe (not included), and a sharps container (not included). The image visually represents items recommended for use during administration but not supplied with the product.*

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Image (Spevigo 23)

An instructional diagram illustrating two hygiene steps: bringing medicine to room temperature for 15 to 30 minutes, and washing hands thoroughly with running water and soap prior to medication handling or administration.*

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Image (Spevigo 24)

Instructional illustration showing a prefilled syringe labeled with 'Medicine' and an expiration date placeholder 'EXP YYYY-MM', advising to check both prefilled syringes before use.*

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Image (Spevigo 25)

An instructional diagram showing recommended injection areas for SPEVIGO (spesolimab) subcutaneous injection. The highlighted injection sites are the abdomen and upper thighs, visually indicated with blue circles on a human torso and upper leg illustration.*

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Image (Spevigo 26)

An instructional illustration showing a hand pressing a swab or pad onto skin, likely demonstrating pre-injection site preparation by cleaning the area before administering an injection.*

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Image (Spevigo 27)

Two instructional icons related to drug administration safety. The first icon, inside a red circle with a diagonal line (prohibition), shows a hand touching a cube or block. The second icon, also inside a similar prohibition circle, depicts a person exhaling or blowing air. These emphasize actions not to perform when using the product.*

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Image (Spevigo 28)

An instructional illustration showing a hand removing the cap from a prefilled syringe, held in the other hand, indicating preparation for injection with a subcutaneous injection syringe.*

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Image (Spevigo 29)

An illustration showing a hand pinching the skin at an injection site, with arrows indicating the pinching motion. This diagram is used as an instructional image related to the subcutaneous injection method for the drug Spevigo (spesolimab).*

FDA Label Image

Image (Spevigo 30)

An instructional illustration showing the subcutaneous injection technique for SPEVIGO (spesolimab). It depicts a hand holding a syringe at a 45-degree angle, inserting the needle into the skin of another hand. The image is labeled with the step title 'Inserting the needle.'*

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Image (Spevigo 31)

An instructional illustration demonstrating how to inject SPEVIGO (spesolimab) subcutaneously. It shows a hand holding the syringe at a 45-degree angle to the skin while pushing firmly to administer the injection. The diagram emphasizes the proper injection angle and force for correct subcutaneous delivery.*

FDA Label Image

Image (Spevigo 32)

An instructional illustration showing the proper technique for completing a subcutaneous injection with an angle of 45 degrees. It depicts removing the thumb to activate a safety cover on the injection device. The step is labeled as 'Checking injection is complete.'*

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Image (Spevigo 33)

An instructional illustration showing a syringe and its cap being disposed into a red sharps container. The syringe is labeled, and arrows point from the syringe and cap to the container's opening, indicating proper disposal of injection materials.*

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Image (Spevigo 34)

An illustration showing two steps involving a medical syringe designed for injection. The syringe features a blue plunger handle and a translucent barrel. Step 1 depicts the syringe with the plunger fully extended, and step 2 shows the plunger partially pressed down, indicating use or preparation for subcutaneous injection.*

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Image (Spevigo 35)

An instructional diagram showing a prefilled syringe before and after use. The labeled parts include thumb pad, plunger rod, finger grip, syringe body containing medicine, safety cover, and cap. After use, the covered needle is shown inside the activated safety cover.*

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Image (Spevigo 36)

Illustration showing a refrigerator door with an arrow pointing to the middle shelf, indicating proper storage placement.*

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Image (Spevigo 37)

An instructional illustration showing components for SPEVIGO subcutaneous injection. It includes 2 prefilled syringes of SPEVIGO, depictions of 2 cotton balls or gauze pieces, 2 alcohol wipes, and a sharps container, with notes that cotton balls, alcohol wipes, and sharps container are not included.*

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Image (Spevigo 38)

An instructional illustration showing two steps: first, to bring the medicine to room temperature for 15-30 minutes as indicated by a clock graphic, and second, to wash hands with soap and water prior to administration.*

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Image (Spevigo 39)

Illustration showing a prefilled syringe labeled for subcutaneous injection. The image highlights the location of the medicine inside the syringe and directs to check the expiration date printed on the barrel, formatted as EXP YYYY-MM.*

FDA Label Image

Image (Spevigo 40)

Illustration showing two views of a subcutaneous injection device for SPEVIGO (spesolimab) injection. The device depicted includes a plunger, barrel, and needle cover, with the first image highlighted by a red border. The illustration likely demonstrates preparation or administration steps of the injection device.*

FDA Label Image

Image (Spevigo 41)

An instructional diagram showing recommended injection areas for subcutaneous administration. The highlighted areas include the abdomen and upper thighs on the front view of a human figure.*

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Image (Spevigo 42)

An instructional illustration showing a hand placing an alcohol prep pad onto a skin area, indicating preparation for a subcutaneous injection site, relevant to SPEVIGO (spesolimab) injection.*

FDA Label Image

Image (Spevigo 43)

Two warning illustrations related to medication administration precautions. The left shows a hand touching a pillow with a red prohibition circle and slash, indicating not to touch or contaminate. The right shows a person exhaling or talking with a red prohibition circle and slash, indicating not to breathe, blow, or speak near the medication.*

FDA Label Image

Image (Spevigo 44)

Illustration showing how to remove the cap from a prefilled syringe of SPEVIGO (spesolimab) injection. The image depicts a hand holding the syringe while the other hand pulls the cap off, indicated by a green arrow pointing away from the syringe tip.*

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Image (Spevigo 45)

An illustration showing hands performing a subcutaneous injection into the skin. The diagram highlights the injection site on the skin with arrows indicating the direction of the injection, consistent with administration instructions for SPEVIGO (spesolimab) injection.*

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Image (Spevigo 46)

An instructional illustration showing a hand injecting SPEVIGO (spesolimab) subcutaneously. The needle is inserted at a 45-degree angle into the skin on the forearm. A green arrow indicates the direction of needle insertion.*

FDA Label Image

Image (Spevigo 47)

An instructional illustration showing a hand holding a SPEVIGO (spesolimab) injection device at a 45-degree angle while administering a subcutaneous injection into the skin. The image includes the text 'Push Firmly' and demonstrates proper injection technique for the SPEVIGO injection.*

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Image (Spevigo 48)

Illustration showing the step to check completion of a SPEVIGO subcutaneous injection. It depicts a hand removing the thumb to activate the safety cover on the syringe held at a 45-degree angle above the injection site on the forearm.*

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Image (Spevigo 49)

Illustration showing two views of a subcutaneous injection device for SPEVIGO (spesolimab). The first image depicts the device without the needle exposed, while the second image highlights the device with the needle extended, indicating preparation for injection.*

FDA Label Image

Image (Spevigo 50)

An instructional illustration showing the disposal process for SPEVIGO injection syringes and their caps into a red sharps container. The image highlights removing caps and placing the syringes into the container opening for safe disposal.*

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Principal Display Panel (300 mg/2 mL Syringe Carton)

Carton packaging label for Spevigo (spesolimab-sbzo) Injection, 300 mg/2 mL (150 mg/mL) strength, a subcutaneous injection supplied in a single-dose prefilled syringe. The label shows the product name, strength, dosage form, route of administration, and states it is for prescription use only. Manufactured by LEO Pharma Inc.*

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Principal Display Panel (150 mg/mL Syringe Carton)

Packaging label for Spevigo (spesolimab-sbzo) injection, strength 150 mg/mL per syringe, for subcutaneous use only. The carton contains two 150 mg single-dose prefilled syringes. The labeler is LEO Pharma Inc. The label includes dosing instructions stating that two 150 mg syringes are required for a complete 300 mg dose and features a graphic of two prefilled syringes.*

FDA Label Image

Principal Display Panel (450 mg/7.5 mL Vial Carton)

Packaging label for Spevigo (spesolimab-sbzo) injection, 450 mg/7.5 mL (60 mg/mL) per vial. The label indicates this product is for intravenous infusion after dilution and includes instructions to discard any unused portion. The carton contains two single-dose vials, manufactured by LEO Pharma A/S and distributed by LEO Pharma Inc. Additional information includes the NDC 50222-360-72 and a medication guide reference.*

* 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.