WELL CHARACTERIZED MANAGEABLE SAFETY PROFILE
Most Commonly Reported Adverse Events (greater than 20%) in APEX with VELCADE® (n=331)
| |
Grade 3
|
Grade 4
|
| Asthenic |
11.8
|
0.3
|
| Diarrhea |
7.3
|
0
|
| Nausea |
2.4
|
0
|
| Constipation |
2.1
|
0
|
| Peripheral neuropathy |
7.3
|
0.6
|
| Vomiting |
3.3
|
0
|
| Pyrexia |
1.8
|
0
|
| Thrombocytopenia |
25.7
|
3.6
|
| Psychiatric disorders |
2.7
|
0.6
|
| Anorexia/ decreased appetite |
2.7
|
0
|
| Paresthesia/dysesthesia |
1.8
|
0
|
| Anemia |
9.4
|
0.6
|
| Headache |
0.9
|
0
|
| Cough |
0.6
|
0
|
In the integrated analysis of multiple myeloma and MCL studies (N=1163),* the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), vomiting (33%), and anemia (29%)
|
|
Twenty percent (20%) of patients experienced at least 1 episode of
≥ grade 4 toxicity, most commonly thrombocytopenia (5%) and
neutropenia (3%)
|
*The integrated safety analysis was conducted to evaluate the overall safety population of patients who received VELCADE dosed at 1.3 mg/m2 at the same schedule in multiple myeloma and mantle cell lymphoma trials.
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