Avsola Injection, Powder, Lyophilized, For Solution
Product Images NDC 55513-670

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Avsola (NDC 55513-670). 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.

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Figure 1: Kaplan Meier Estimate Of The Proportion Of Patients Who Had Not Lost Response Through Week 54 (Avsola 01)

A line graph depicting the percentage of patients who had not lost response over study weeks up to week 54, comparing placebo maintenance, 5 mg/kg infliximab maintenance, and 10 mg/kg infliximab maintenance. The graph shows higher maintenance of response in both infliximab groups compared to placebo, with statistical significance noted (p < 0.001 for 10 mg/kg and p = 0.004 for 5 mg/kg doses).*

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Figure 2: Life Table Estimates Of The Proportion Of Patients Who Had Not Lost Fistula Response Through Week 54 (Avsola 02)

A line graph comparing the percentage of patients who had not lost response over 54 weeks between placebo maintenance and 5 mg/kg infliximab maintenance groups. The y-axis represents the percentage of patients, and the x-axis represents study weeks. The infliximab group shows a higher retention of response compared to placebo.*

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Figure 3: Proportion Of Patients Achieving Asas 20 Response (Avsola 03)

A line graph showing the proportion of patients (%) over weeks (0 to 24) comparing placebo and infliximab 5 mg/kg. The graph includes two lines: placebo represented by open circles and infliximab by filled squares. Infliximab shows a higher proportion of patients at all time points with significant differences (P < 0.001) indicated by asterisks.*

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Figure 4: Proportion Of Patients Achieving ≥75% Improvement In Pasi From Baseline Through Week 50; Patients Randomized At Week 14 (Avsola 04)

A line graph showing the percent of patients over weeks in four treatment groups: 3 mg/kg infliximab administered every 8 weeks, 3 mg/kg infliximab as needed (PRN), 5 mg/kg infliximab every 8 weeks, and 5 mg/kg infliximab as needed (PRN). The x-axis represents weeks from 0 to 50, and the y-axis shows percent of patients from 0 to 100.*

FDA Label Image

Principal Display Panelndc 55513-670-01avsola™(infliximab-axxq)for Injection 100 mg/vialamgen®100 mg/vialfor Intravenous Infusion Onlysingle-dose Vial. Discard Unused Portion.contents: Each Carton Contains One 100 mg Avsola Single-dose Vial.attention: Dispense The Enclosed Medication Guide To Each Patientreconstitute And Dilute Before Intravenous Infusion. Infuse Over At Least 2 Hours With An In-line Filter.protect From Light.dosage: See Prescribing Information.rx Only (Avsola 05)

The label for AVSOLA infliximab-axxq injection shows a lyophilized powder for intravenous use, with a strength of 100 mg per vial. The label indicates it is a single-dose vial, packaged by Amgen, Inc. The label includes usage instructions such as reconstitution and infusion over at least 2 hours using an in-line filter, along with a note to dispense a medication guide. The NDC number 55513-670-01 is visible.*

* 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.