Bortezomib Injection
Product Images NDC 70511-161

Product Visual Gallery

This gallery contains 26 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 70511-161). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Maia Pharmaceuticals, 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 (Figure 1)

A Kaplan-Meier survival curve comparing time to progression between two groups: Bortezomib plus Melphalan and Prednisone (Vc-MP) and Melphalan plus Prednisone alone (MP). The y-axis represents the percentage of patients, and the x-axis shows time in months up to 24 months. Vc-MP shows a higher percentage of patients without progression over time compared to MP.*

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Figure 2 (Figure 2)

This is a Kaplan-Meier survival curve graph illustrating overall survival over time in months for patients treated with Bortezomib, Melphalan, and Prednisone (Vc-MP) compared to Melphalan and Prednisone alone (MP). The y-axis shows the percentage of patients surviving, and the x-axis shows time in months. A data table below the graph indicates the number of patients at risk at various time points for both treatment groups, with the Vc-MP group showing a higher survival rate over time.*

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Figure 4 (Figure 4)

A Kaplan-Meier survival curve comparing overall survival of patients treated with Bortezomib versus Dexamethasone in a relapsed multiple myeloma study. The graph shows the proportion of patients on the y-axis over time in days on the x-axis, indicating higher survival with Bortezomib throughout the study period up to 450 days. Patient counts at various time points and a p-value from a log-rank test are also included.*

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Figure 5 (Figure 5)

A Kaplan-Meier survival curve chart comparing progression-free survival between VcR-CAP and R-CHOP treatments in previously untreated Mantle Cell Lymphoma patients. The y-axis represents the percentage of patients, while the x-axis shows time in months. The chart includes a log-rank test p-value less than 0.001, indicating statistical significance, and tables of subjects at risk over time for both groups.*

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Figure 6 (Figure 6)

A survival curve graph comparing overall survival between VcR-CAP and R-CHOP treatment groups in previously untreated Mantle Cell Lymphoma. The y-axis shows the percentage of subjects alive from 0 to 100%, and the x-axis shows months from randomization up to 108 months. The solid line represents VcR-CAP, and the dashed line represents R-CHOP, with subject numbers at risk displayed below the x-axis.*

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Instructions For Use (Instructions Revised)

A text panel showing dosing calculation formulas for Bortezomib Injection at 1 mg/mL and 2.5 mg/mL concentrations. It describes how to calculate the total injection volume to be administered based on the patient's body surface area (BSA) and Bortezomib dose in mg/m².*

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Table 10 (Table 10)

A data table titled 'Most Commonly Reported Adverse Reactions (≥5%) with Grades 3 and ≥4 Intensity in the Previously Untreated Mantle Cell Lymphoma Study' comparing adverse reactions between VcR-CAP (n=240) and R-CHOP (n=242) treatment groups. The table categorizes reactions by body system and details incidence counts and percentages for grade 3 and grade 4 toxicities across multiple adverse events such as neutropenia, anemia, peripheral neuropathy, fatigue, nausea, pneumonia, alopecia, and others.*

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Table 11 (Table 11)

Data table titled 'Most Commonly Reported (≥10% Overall) Adverse Reactions in Integrated Analyses of Relapsed Multiple Myeloma and Relapsed Mantle Cell Lymphoma Studies using the 1.3 mg/m² Dose.' It presents the frequency and severity (≥Grade 3) of adverse reactions for all patients (N=1163) and separately for Multiple Myeloma (N=1008) and Mantle Cell Lymphoma (N=155) groups. Reactions include nausea, diarrhea, fatigue, peripheral neuropathies, thrombocytopenia, and others, with counts and percentages detailed in columns.*

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Table 13 (Table 13)

A data table titled "Summary of Baseline Patient and Disease Characteristics in the Relapsed Multiple Myeloma Study" comparing characteristics between patients treated with Bortezomib (N=333) and Dexamethasone (N=336). It includes demographic data, disease specifics, duration since diagnosis, number of prior treatments, and previous therapy types with corresponding percentages and values for each group.*

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Table 14 (Table 14)

A data table titled 'Summary of Efficacy Analyses in the Relapsed Multiple Myeloma Study' comparing Bortezomib and Dex across various endpoints. It includes columns for all patients, one prior line of therapy, and more than one prior line of therapy, with data on time to progression, overall survival, and response rate, including hazard ratios, median times, events, response percentages, and p-values.*

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Table 15 (Table 15)

A table summarizing efficacy analyses from a clinical study in previously untreated Mantle Cell Lymphoma. It compares outcomes between VcR-CAP (n=243) and R-CHOP (n=244) treatments, reporting progression-free survival, complete response rate, overall response rate, and overall survival with related statistics such as median months, hazard ratios, and confidence intervals.*

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Table 16 (Table 16)

A data table titled 'Response Outcomes in a Phase 2 Relapsed Mantle Cell Lymphoma Study' presenting response analyses of 155 subjects. It includes overall response rates, complete and partial response percentages, and median duration of response with 95% confidence intervals.*

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Table 7 (Table 7)

A data table titled 'Severity of Thrombocytopenia Related to Pretreatment Platelet Count in the Relapsed Multiple Myeloma Study of Bortezomib vs Dexamethasone.' It presents patient counts distributed by pretreatment platelet count ranges, along with the number and percentage of patients with platelet counts below 10,000/μL and between 10,000 to 25,000/μL. The table includes notes on baseline eligibility and missing data.*

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Table 8 (Table 8)

A table presenting the most commonly reported adverse reactions (≥10%) with Grades 3 and ≥4 intensity in a study of previously untreated multiple myeloma patients. It compares the incidence of adverse reactions, grouped by body system, between the Bortezomib, Melphalan and Prednisone arm and the Melphalan and Prednisone arm, reporting total cases and severity grades.*

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Table 9 (Table 9)

A data table titled 'Most Commonly Reported Adverse Reactions (≥10% in Bortezomib arm), with Grades 3 and 4 Intensity in the Relapsed Multiple Myeloma Study of Bortezomib vs Dexamethasone.' The table compares adverse reactions between Bortezomib (N=331) and Dexamethasone (N=332) arms, listing reactions such as nausea, diarrhea, fatigue, peripheral neuropathies, and more, with counts and percentages for all grades and specifically Grades 3 and 4 intensities.*

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Figure 3 (Figure 3)

A line graph titled 'Time to Progression Bortezomib vs Dexamethasone (Relapsed Multiple Myeloma Study)' showing proportion of patients over time in days. Two curves compare bortezomib and dexamethasone, with bortezomib maintaining a higher proportion of patients over time. The x-axis is labeled 'Time (days)' from 0 to 480, and the y-axis 'Proportion of Patients' from 0 to 1. Patient numbers at various timepoints and a p-value from a log-rank test are noted.*

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Label 1 mg (Label Revised 0008 1 mg)

Bortezomib Injection label showing 3.5 mg per 1.4 mL concentration (2.5 mg per mL) in a ready-to-use vial for intravenous use only. The label indicates it is for MAIA Pharmaceuticals, Inc., Princeton, NJ, with caution that the product is a hazardous agent. Includes space for lot and expiry date information.*

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Label 2.5 mg (Label Revised 0008 2 5mg)

Label for Bortezomib Injection, 3.5 mg per 3.5 mL (1 mg per mL) intravenous injection, ready-to-use vial. The single-dose vial contains 3.5 mg bortezomib with inactive ingredients and is labeled for intravenous use only. Manufactured by MAIA Pharmaceuticals, Inc., the label includes storage instructions, lot number, and expiration date fields.*

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Bortezomib-structure (Structure)

Chemical structure of bortezomib, the active ingredient in Bortezomib injection. The diagram shows the molecular arrangement including nitrogen, oxygen, boron atoms, and rings typical of the compound's chemical formula.*

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Table 12 (Table 12)

Data table titled 'Summary of Efficacy Analyses in the Previously Untreated Multiple Myeloma Study' comparing efficacy endpoints between treatment groups: Bortezomib, Melphalan and Prednisone (n=344) versus Melphalan and Prednisone (n=338). It presents statistical data on Time to Progression, Progression-free Survival, Response Rate, and Overall Survival at median follow-up of 36.7 months including events, median months, hazard ratios, confidence intervals, and p-values.*

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Table 1 (Table 1 Revised)

A data table titled 'Dosage Regimen for Patients with Previously Untreated Multiple Myeloma' showing weekly schedules for Bortezomib injection. It details twice weekly injections for cycles 1 to 4 and once weekly injections for cycles 5 to 9 when combined with Melphalan and Prednisone, indicating dose days and rest periods across six weeks.*

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Table 2 (Table 2 Revised)

Table presenting dose modifications or delays during cycles of combination therapy with Bortezomib Injection, Melphalan, and Prednisone. It details toxicity criteria and corresponding dosing adjustments or withholding instructions for hematological toxicity, platelet counts, repeated dose withholding, and Grade 3 or higher nonhematological toxicities.*

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Table 3 (Table 3 Revised)

A table titled "Dosage Regimen for Patients with Previously Untreated Mantle Cell Lymphoma" showing a twice-weekly bortezomib injection schedule over six three-week cycles. It lists administration days for bortezomib injection (1.3 mg/m2), rituximab, cyclophosphamide, doxorubicin, and prednisone across weeks 1 to 3 with specified rest periods and notes on additional cycles if response is seen.*

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Table 4 (Table 4 Revised)

Table presenting dose modification or delay guidelines for Bortezomib Injection during combination therapy with Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. It addresses hematological and nonhematological toxicities, specifying conditions for withholding therapy, dose reductions, and criteria for therapy reinitiation based on toxicity severity and patient blood counts.*

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Table 5 (Table 5 Revised)

Table titled 'Recommended Dose Modification for Bortezomib Injection related Neuropathic Pain and/or Peripheral Sensory or Motor Neuropathy' outlining severity grades of peripheral neuropathy symptoms and corresponding dose modification guidelines for bortezomib injection therapy, including dose reductions, withholding therapy, or discontinuation based on symptom severity.*

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Table 6 (Table 6 Revised)

A table titled "Recommended Starting Dose Modification for Bortezomib Injection in Patients with Hepatic Impairment." It categorizes hepatic impairment into mild, moderate, and severe based on bilirubin and SGOT (AST) levels and provides corresponding dose modification guidance for bortezomib injection. Mild impairment requires no dose change, moderate suggests reducing to 0.7 mg/m² initially, and severe advises similar dose adjustment with considerations for further reductions based on patient tolerance. Abbreviations for SGOT, AST, and ULN are explained below the table.*

* 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.