Tezspire Injection, Solution
Product Images NDC 55513-123

Product Visual Gallery

This gallery contains 33 technical images submitted to the FDA as part of the official labeling for Tezspire (NDC 55513-123). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amgen 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 (Figure1 Needle)

An instructional diagram of a prefilled syringe illustrating the components before and after use. Labeled parts include needle guard activation clips, plunger head, plunger, finger flange, viewing window, syringe body, label with expiration date, needle, needle cover, and needle guard.*

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Number_3_picture (Number3picture)

An instructional illustration showing a hand removing the cap from a syringe. The image features the syringe held by one hand and the cap being pulled off with the other, indicated by an arrow pointing away from the syringe tip.*

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Number4picture (Number4picture)

An instructional illustration showing a hand holding a syringe with a needle inserted into the fingertip of the other hand, demonstrating a fingerstick blood collection technique. The syringe is depicted with a visible plunger and needle cap, and the finger has a small drop of blood emerging from the puncture site.*

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Number5picture (Number5picture)

An instructional illustration showing a hand holding a pen-like injector device administering a subcutaneous injection into the forearm of the other hand. The image emphasizes the proper injection technique by depicting the needle insertion angle and hand positioning for the TEZSPIRE 210 mg/1.9 mL injectable product by Amgen Inc.*

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Number6picture (Number6picture)

An instructional illustration showing a hand holding a TEZSPIRE 210 mg/1.9 mL prefilled syringe. The image demonstrates the removal of a needle cap by pulling it straight upwards, indicated by an arrow above the cap.*

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Figure_2_pre-filled_pen_components (Figure 2 Pre Filled Pen Components)

Instructional diagram showing a prefilled injection pen for TEZSPIRE 210 mg/1.9mL. The left side labeled 'Before use' displays parts including the label with expiration date, viewing window showing liquid medicine, and cap. The right side labeled 'After use' shows the pen with orange plunger visible through the viewing window and orange needle guard in place.*

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Figure_2-image-2 (Figure2 Image2)

An instructional diagram showing hands preparing an autoinjector device, likely for TEZSPIRE 210 mg/1.9 mL. The illustration shows one hand removing the cap from the device and the other hand holding the injector, with an arrow indicating the cap removal direction.*

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Figure2_image-4 (Figure2 Image4)

An instructional illustration showing a hand holding an injection device at a 90-degree angle above the skin on a forearm, demonstrating the proper technique for subcutaneous injection.*

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Figure_2_image_5 (Figure 2 Image 5)

An instructional illustration showing a hand holding an injection device or pen, positioned over the skin of another person's forearm, demonstrating the technique of administering an injection by pressing the device down onto the skin.*

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Figure_2_image_6 (Figure 2 Image 6)

An instructional illustration showing a hand holding and preparing a TEZSPIRE 210 mg/1.9 mL injection pen. The diagram indicates that the pen should be held upright with the hand positioned around it and the injection site on the opposite arm. A 15-second countdown is shown, suggesting the duration for which the pen should remain in place during injection.*

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Figure_2_image_7 (Figure 2 Image 7)

An instructional illustration showing the use of an injection pen for TEZSPIRE 210 mg/1.9 mL. The image depicts a hand holding the injection pen positioned above a forearm, with an arrow indicating the direction to lift the pen after injection.*

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Figure_2 (Image 01)

A forest plot chart showing rate ratios with 95% confidence intervals comparing TEZSPIRE and placebo across different baseline eosinophil counts and FeNO levels. The chart includes subgroup data with numerical estimates, graphically representing TEZSPIRE's effectiveness relative to placebo, favoring TEZSPIRE in all subgroups and overall.*

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Figure_3 (Image 02)

A Kaplan-Meier curve showing probability of first asthma exacerbation over time (weeks) for TEZSPIRE 210 mg/1.9 mL treatment group compared to placebo. The graph includes patient numbers at risk over time, illustrating event probability differences between TEZSPIRE and placebo.*

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Figure_4 (Image 03)

A line graph comparing pre-bronchodilator FEV1 change from baseline over 52 weeks between TEZSPIRE and placebo. The x-axis shows time in weeks, and the y-axis shows change in FEV1. TEZSPIRE consistently shows greater improvement with error bars, compared to placebo, which shows smaller changes with error bars. Subject numbers at each time point are listed below the x-axis.*

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Figure_6 (Figure 6)

A line graph comparing LS Mean Change (95% CI) over time (weeks) for TEZSPIRE 210 mg/1.9mL and placebo groups. TEZSPIRE is represented by a solid line with square markers showing a downward trend from week 0 to 52. Placebo is shown as a dashed line with triangle markers, remaining relatively stable over the same period.*

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Figure_7 (Figure 7)

A line graph depicting LS Mean Change (with 95% Confidence Interval) over 52 weeks comparing treatment groups TEZSPIRE and Placebo. The x-axis represents time in weeks, and the y-axis shows the LS Mean Change values. TEZSPIRE data points are marked with solid squares and a solid line, while Placebo data points are marked with open triangles and a dashed line.*

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Figure_8 (Figure 8)

A line graph comparing the probability of an event over 52 weeks between TEZSPIRE and placebo treatments. The x-axis represents time in weeks, and the y-axis shows the probability of the event. Two lines are present: one for TEZSPIRE marked with squares, showing a low and steady probability, and one for placebo marked with triangles, showing a rising probability over time. A table below the graph indicates the number of subjects at risk per group over the weeks.*

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Tezspire-prefille-pen (Tezspire Prefille Pen)

An instructional diagram showing two states of a prefilled syringe for TEZSPIRE 210 mg/1.9 mL by Amgen Inc. The 'Before use' syringe includes a label with expiration date, a viewing window displaying liquid medicine, and a cap. The 'After use' syringe shows an orange plunger and an orange needle guard in place.*

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Step_1 (Step 1)

An illustration showing components included with the TEZSPIRE pre-filled pen 210 mg/1.9 mL by Amgen Inc. The items depicted are a pre-filled pen, alcohol wipe, cotton ball or gauze, bandage, and sharps disposal container, representing materials for proper injection preparation and disposal.*

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Step_2 (Step 2 Ok)

A simplified illustration of a stopwatch displaying "60 min" in the center, indicating a time duration of 60 minutes.*

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Step_3 (Step 3)

An instructional illustration showing a hand holding a TEZSPIRE (210 mg/1.9 mL) injection pen, highlighting the location of the expiration date on the pen.*

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Step_4_injection_site (Step 4 Injection Site)

Illustration showing recommended injection sites for TEZSPIRE 210 mg/1.9 mL. Areas marked with a pattern indicate injection by caregiver only on the upper arms. Solid black areas indicate sites suitable for self-injection or injection by a caregiver, including the abdomen and the front thighs.*

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Step_5 (Step 5)

Illustration showing two steps of hand hygiene: the left image depicts hands being washed with water and soap, and the right image shows drying hands with a paper towel. No product packaging or text visible related to TEZSPIRE.*

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Step_6 (Step 6)

An instructional illustration showing hands removing the cap from a TEZSPIRE (210 mg/1.9 mL) injection pen. An arrow indicates the direction to pull the cap off the pen before use.*

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Step_7 (Step 7)

An instructional illustration showing a hand holding a TEZSPIRE 210 mg/1.9 mL injection device vertically at a 90-degree angle above the skin on an arm, demonstrating the proper angle for injection.*

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Step_7-b-c-d (Step 7 B C D)

Instructional illustrations for using the TEZSPIRE pre-filled injection pen. The images show pressing the pen down until the orange needle guard disappears, holding firmly for about 15 seconds to complete the injection, then lifting the pen straight up. Text explains timing, audible clicks, and needle guard movement during injection steps.*

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Step_8_with _text (Step 8 With Text)

Illustration showing the appearance of the TEZSPIRE 210 mg/1.9 mL prefilled syringe before and after injection. The image highlights the syringe with a visible solution before injection and an orange plunger position after injection, indicating full dose delivery.*

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Step_8 (Step 8)

An illustration showing a hand holding a TEZSPIRE autoinjector pen, used for subcutaneous injection of the medication. The device is white with an orange window indicator and an orange cap on one end, indicating the injection status.*

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Step_9 (Step 9)

Illustration showing a hand pinching and pulling apart a cotton ball or pad, likely demonstrating a step in preparation or cleaning for an injection or medical procedure.*

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Step_10 (Step 10)

An instructional illustration showing a hand holding a syringe with a cap removed, positioned above a red sharps disposal container. The image demonstrates the proper disposal of the syringe, likely related to TEZSPIRE 210 mg/1.9 mL injection by Amgen Inc.*

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Vial_label_single-dose (Vial Label Single Dose)

TEZSPIRE (tezepelumab-ekko) Injection 210 mg/1.91 mL (110 mg/mL) single-dose vial label. The product is for subcutaneous injection only and is Rx only. The label includes the NDC number 55513-100-01 and the manufacturers Amgen Inc and AstraZeneca. Storage instructions indicate refrigeration at 2-8°C.*

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Carton-apfs-sales (Carton Subcutaneous Injection Ndc 55513 112 01)

TEZSPIRE (tezepelumab-ekko) Injection 210 mg/1.9 mL pre-filled syringe label for subcutaneous injection only. The label includes storage instructions to refrigerate at 36°F to 46°F and warns against shaking, freezing, or heat exposure. Manufactured by AstraZeneca AB, Sweden, and marketed by Amgen Inc. and AstraZeneca AB. The package features the product name, dosage strength, a syringe illustration, and company logos.*

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Carton_201mg_1.91ml_single-dose_pre-filled_pen (Carton Label Single Dose Pre Filled Pen)

TEZSPIRE (tezepelumab-ekko) injection 210 mg per 1.91 mL (110 mg/mL) for subcutaneous injection. The label shows a single-dose pre-filled pen with storage instructions to refrigerate at 36°F to 46°F (2°C to 8°C) and avoid shaking, freezing, or heat. The product is labeled for Rx only and manufactured by Amgen Inc in collaboration with AstraZeneca.*

* 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.