Product Images Bortezomib

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Product Label Images

The following 28 images provide visual information about the product associated with Bortezomib NDC 72266-244 by Fosun Pharma Usa Inc, such as packaging, labeling, and the appearance of the drug itself. This resource could be helpful for medical professionals, pharmacists, and patients seeking to verify medication information and ensure they have the correct product.

Figure 1 - Figure 1

Figure 1 - Figure 1

The text appears to be a figure caption representing a comparison of the time to progression between two treatments. The first treatment consisted of bortezomib, melphalan, and prednisone while the second treatment only consisted of melphalan and prednisone. The figure shows the number of patients remaining safe at different time points measured in months. The text also mentions a log-rank test.*

Figure 2 - Figure 2

Figure 2 - Figure 2

Figure 4 - Figure 4

Figure 4 - Figure 4

The text is a figure showing the comparison between Bortezomib and Dexamethasone in terms of Overall Survival for Relapsed Multiple Myeloma Study. It includes the number of patients remaining after a certain time point and a p-value obtained through a log-rank test.*

Figure 5 - Figure 5

Figure 5 - Figure 5

The text describes a figure (Figure 5) that compares the Progression Free Survival between two treatments, VeR-CAP and R-CHOP, for previously untreated Mantle Cell Lymphoma. The graph presents the number of subjects at risk for each treatment group over time. No further information is available.*

Figure 6 - Figure 6

Figure 6 - Figure 6

This text includes a figure showing Overall Survival of VeR-CAP versus R-CHOP for previously Untreated Mantle Cell Lymphoma Study. The figure includes a graph with lines indicating the survival rate over time for each treatment. The X-axis shows the Months from randomization and the Y-axis shows % of subjects alive. The figure also includes data points representing the % of subjects alive for each treatment at different time points.*

Instructions for Use - Instructions revised

Instructions for Use - Instructions revised

This appears to be a set of dosage instructions and concentration information for Bortezomib Injection, a medication used to treat certain types of cancer. It includes recommendations for dosages based on patient body surface area (BSA) and the concentration of the medication in either a 1 mg/mL or 2.5 mg/mL vial. The instructions provide guidance for determining the total volume of Bortezomib Injection to administer.*

Table 10 - Table 10

Table 10 - Table 10

The table lists the most common adverse reactions (25%) with grades 3 and 4 intensity for previously untreated Mantle Cell Lymphoma patients who received VeR-CAP (n=240) compared to R-CHOP (n=242). Adverse reactions are categorized according to body system and grade. The results show the number of patients experiencing toxicity for each adverse reaction. The table also includes a key for the drug abbreviations used.*

Table 11 - Table 11

Table 11 - Table 11

This text presents a table showing the most commonly reported adverse reactions in studies of relapsed multiple myeloma and mantle cell lymphoma treatments using a specific dosage. The table lists adverse reactions, the number of patients experiencing them, and their severity grading. The table includes adverse reactions such as nausea, diarrhea, fatigue, peripheral neuropathies, thrombocytopenia, vomiting, constipation, paresthesia, dizziness, and weakness, among others.*

Table 13 - Table 13

Table 13 - Table 13

Table 14 - Table 14

Table 14 - Table 14

The text appears to be a summary of efficacy analyses in a study of patients with relapsed multiple myeloma. The data in Table 14 show the number of patients and efficacy measures for different treatments. Efficacy measures include hazard ratios, median survival time, and response rates based on different criteria. The information is presented in a table with columns for prior line of therapy, treatment types, efficacy endpoints, number of patients, and outcomes. The study uses Cox proportional-hazard model when computing for hazard ratio. The results show that bortezomib offers an advantage for some of the efficacy measures.*

Table 15 - Table 15

Table 15 - Table 15

This text provides a summary of efficacy analyses in a study for previously untreated mantle cell lymphoma. The table includes data on different efficacy endpoints for two treatment groups and the number of patients analyzed for each. The data includes information on progression-free survival, complete response rate, overall response rate, and overall survival. The analysis was performed at a median follow-up duration of 40 months, except for overall survival, which was analyzed at a median follow-up of 78.5 months. The table also includes information on confidence interval, hazard ratio, and the method used for the analysis.*

Table 16 - Table 16

Table 16 - Table 16

Table 16 shows response outcomes in a phase 2 study for Mantle Cell Lymphoma where 155 participants were analyzed. The Overall Response Rate was 86%, while the Complete Response was 8%, and Complete Response unconfirmed was also 8%. On the other hand, a Partial Response of 23% was obtained. The median Duration of Response for CR+ CRu~ PR was 9.3 months. Participants who achieved CRu had a duration of response of 20 months while participants with PR had a duration of response of 6.1 months.*

Table 7 - Table 7

Table 7 - Table 7

Table 7 shows the severity of thrombocytopenia in patients with relapsed multiple myeloma who received either Bortezomib or Dexamethasone, based on their pretreatment platelet count. The table provides the number and percentage of patients with platelet counts less than 10,000/uL, between 10,000/uL and 50,000/uL, and between 50,000/uL and 75,000/uL. However, data is missing for one patient. A baseline platelet count of 30,000/uL was required for study eligibility.*

Table 8 - Table 8

Table 8 - Table 8

This text shows a table with the most commonly reported adverse reactions in a previously untreated multiple myeloma study consisting of Bortezomib, Melphalan, and Prednisone. The table shows the total number of adverse reactions and their intensities with Grades 3 and >4 in percentage. The text also indicates the affected body systems and toxicities caused by the three drugs, including gastrointestinal disorders, blood, and lymphatic system disorders, nervous system disorders, infections and infestations.*

Table 9 - Table 9

Table 9 - Table 9

This is a table titled "Most Commonly Reported Adverse Reactions" from a study comparing Bortezomib versus Dexamethasone for treating Relapsed Multiple Myeloma on 663 subjects. The table shows the adverse reactions with more than 10% incidence in the Bortezomib arm, indicating the total number of patients involved, and the intensity grading of reported adverse reactions graded as 3 or 4. Adverse reactions with their incidence percentage described in the table are Nausea, Diarrhea NOS, Fatigue, Peripheral neuropathies, Thrombocytopenia, Constipation, Vomiting NOS, Anorexia, Pyrexia, Paresthesia, Anemia NOS, Headache NOS, Neutropenia, Rash NOS, Appetite decreased NOS, Dyspnea NOS, Abdominal pain NOS, and Weakness.*

Carton Label 1 mg - carton label 1 mg

Carton Label 1 mg - carton label 1 mg

This is a description of Bortezomib Injection, which is a medication for intravenous use only. It comes in a ready-to-use vial with 3.5 mg of Bortezomib per 3.5 mL and is meant to be used as a single dose. The medication contains 1 mg of bortezomib, 10 mg of mannitol, 0.82 mg of sodium acetate, 20 mg of dimethyl sulfoxide, and Water for Injection. It is recommended to see the prescribing information for the recommended dosage. Bortezomib Injection should be stored at 2-8°C, but can be stored at room temperature (20-25°C) for up to 7 days. It is distributed by Fosun Pharma USA Inc.*

Carton Label 2.5 mg - carton label 2 5 mg

Carton Label 2.5 mg - carton label 2 5 mg

This is a description of Bortezomib, an injectable medication used for intravenous use only. It is a single-dose vial with a recommended dosage found in the prescribing information. The storage and handling of the medication is specified, with information on the retention of its original package to protect it from light. The text also indicates the hazardous nature of the medication and its manufacturer and distributor.*

Figure 3 - figure 3

Figure 3 - figure 3

The description is: "Figure 3 shows a comparison between Bortezomib and Dexamethasone in terms of Time to Progression in Relapsed Multiple Myeloma study. The graph displays the time in days on the X-axis and the number of patients on the Y-axis. There is a legend that states that the blue line corresponds to Bortezomib, while the purple line corresponds to Dexamethasone. The label "p" indicates the p-value obtained from the log-rank test. No further information is available as the text includes some errors and is incomplete."*

Bortezomib Injection 3.5 mg per 3.5 mL - label revised 0008 1 mg

Bortezomib Injection 3.5 mg per 3.5 mL - label revised 0008 1 mg

Bortezomib Injection 3.5 mg per 1.4 mL - label revised 0008 2 5mg

Bortezomib Injection 3.5 mg per 1.4 mL - label revised 0008 2 5mg

This is a description of a medicine named Bortezomib, which is distributed by Fosun Pharma USA Inc. The medicine was made in India, and the code number is AP/DRUGS/03/2011. The medicine is available in ready-to-use vials and should be used for intravenous purposes only. The medicine is available in the strength of 3.5mg per 1.4mL, which is 2.5mg per mL. The lot number is not available in the text. It is a hazardous agent and should be handled with caution. The size of the vial is 16 X 9 mm. The NDC number for this medicine is 72266-244-01, and the barcode number is 00372266244017.*

bortezomib-structure - structure

bortezomib-structure - structure

Table 12 - table 12

Table 12 - table 12

This is a table showing the summary of efficacy analyses in a study done on previously untreated Multiple Myeloma. The study compared bortezomib, melphalan, and prednisone to melphalan and prednisone only. The results show time to progression, progression-free survival, response rate, and overall survival. The analysis was performed at a median follow-up of 16.3 months, except for the overall survival analysis. The hazard ratio estimate is based on a Cox proportional-hazard model, and a hazard ratio less than one indicates an advantage for bortezomib, melphalan, and prednisone. The p-value is based on the stratified log-rank test, adjusted for stratification factors.*

Table 1 - table 1 revised

Table 1 - table 1 revised

This is a table containing the dosage regimen for patients with previously untreated multiple myeloma. It outlines two treatment options - the twice-weekly bortezomib injection for cycles 1 to 4 and the once-weekly bortezomib injection for cycles 5 to 9. For each cycle, the table provides the specific dosage amounts for bortezomib, melphalan, and prednisone and the corresponding days they should be administered.*

Table 2 - table 2 revised

Table 2 - table 2 revised

This text provides guidance for modifying or withholding doses of different drugs during cycles of combination Bortezomib Injection, Melphalan, and Prednisone therapy in case of observed toxicities or symptoms. The modifications are mostly related to hematological toxicity, platelet count, and ANC, and include reducing or withholding the Bortezomib Injection dose until toxicity symptoms have resolved. Additionally, it outlines how to modify Bortezomib Injection in case of neuropathic pain and/or peripheral neuropathy. Overall, this text is intended to help clinicians make appropriate dose adjustments to optimize patient safety and treatment efficacy during cancer therapy.*

Table 3 - table 3 revised

Table 3 - table 3 revised

This is a dosage regimen for patients with previously untreated Mantle Cell Lymphoma. It consists of twice-weekly Bortezomib Injection during three-week cycles. The injection is administered on Day 1, 4, 8, and 11, followed by a rest period. The patients also receive Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone at specific dosages and frequencies. The treatment can continue for eight cycles if a response is observed at Cycle 6.*

Table 4 - table 4 revised

Table 4 - table 4 revised

This text describes dose modifications and delays for a combination therapy involving Bortezomib Injection, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone. The modifications are based on the presence of hematological and non-hematological toxicities, with recommended reductions in Bortezomib Injection dosage levels for hematological toxicities that resolve. Modifications to Bortezomib Injection therapy are also suggested for related neuropathic pain and/or peripheral neuropathy.*

Table 5 - table 5 revised

Table 5 - table 5 revised

This is a table outlining recommended dose modifications for Bortezomib Injection for those experiencing peripheral neuropathy signs and symptoms. The severity of the symptoms are graded from 1-4 and each grade has a corresponding recommended action, ranging from no action to discontinuing the injection. The grading is based on the NCI Common Terminology Criteria CTCAE v4.0 and includes notes on which Activities of Daily Living (ADL) are limited at each grade level.*

Table 6 - table 6 revised

Table 6 - table 6 revised

This is a table that provides recommended starting dose modification for Bortezomib Injection in patients with varying degrees of hepatic impairment, based on the levels of SGOT (AST) in their system. The abbreviation "SGOT" stands for serum glutamic oxaloacetic transaminase, while "AST" refers to aspartate aminotransferase, and "ULN" to upper limit of the normal range. The table highlights that patients with mild impairment and those with SGOT levels less than or equal to 1x ULN may not require any dose modification, while those with moderate impairment (SGOT levels between 1.5% to 3x ULN) may require a reduced starting dose. The dose can then be adjusted further based on the patient's response to treatment.*

* The product label images have been analyzed using a combination of traditional computing and machine learning techniques. It should be noted that the descriptions provided may not be entirely accurate as they are experimental in nature. Use the information in this page at your own discretion and risk.