(idarubicin hydrochloride)
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of IDAMYCIN PFS in combination with cytarabine has been evaluated in four controlled clinical studies with 823 patients with AML randomized to receive idarubicin hydrochloride (n=401) or daunorubicin (n=422) [see Clinical Studies (14)].
Southeastern Cancer Study Group (SEG)
Table 3 below lists the adverse reactions that occurred in patients with AML who received idarubicin hydrochloride in the Southeastern Cancer Study Group (SEG) study.
Adverse Reactions | Idarubicin with Cytarabine (N=110) | Daunorubicin with Cytarabine (N=118) |
All Grades % | All Grades % | |
Infection | 95 | 97 |
Nausea/Vomiting | 82 | 80 |
Alopecia | 77 | 72 |
Abdominal Pain/Diarrhea | 73 | 68 |
Hemorrhage | 63 | 65 |
Mucositis | 50 | 55 |
Dermatologic | 46 | 40 |
Mental Status Changes | 41 | 34 |
Pulmonary Disorders | 39 | 39 |
Fever | 26 | 28 |
Headache | 20 | 24 |
Cardiac Disorder | 16 | 24 |
Peripheral Neuropathy | 7 | 9 |
Clinically relevant adverse reactions in <5% of patients who received idarubicin hydrochloride included pulmonary allergy, seizure, and cerebellar adverse reactions.
Other Clinical Trials
The following additional adverse reactions associated with the use of idarubicin hydrochloride were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac
Dermatologic
Gastrointestinal
Hepatic
Renal
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