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ZINECARD® (dexrazoxane) Adverse Reactions

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

The adverse reaction profile described in this section was identified from randomized, placebo-controlled, double-blind studies in patients with metastatic breast cancer who received the combination of the FAC chemotherapy regimen with or without ZINECARD. The dose of doxorubicin was 50 mg/m2 in each of these trials. Treatment was administered every three weeks until disease progression or cardiac toxicity.

Patients in clinical trials who received FAC with ZINECARD experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without ZINECARD [see Warnings and Precautions (5.1)].

Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either ZINECARD or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving ZINECARD or placebo with FAC beginning with their first course of therapy (columns 1 and 3, respectively). Adverse experiences occurring at course 7 and beyond for patients who received placebo with FAC during the first six courses and who then received either ZINECARD or placebo with FAC are also displayed (columns 2 and 4, respectively).

The adverse reactions listed below in Table 1 demonstrate that the frequency of adverse reaction "Pain on Injection" has been greater for ZINECARD arm, as compared to placebo.

Table 1
Adverse Reaction Percentage (%) of Breast Cancer Patients With Adverse Reaction
FAC + ZINECARD FAC + Placebo
Courses 1–6
N = 413
Courses ≥ 7
N = 102
Courses 1–6
N = 458
Courses ≥ 7
N = 99
Alopecia 94 100 97 98
Nausea 77 51 84 60
Vomiting 59 42 72 49
Fatigue/Malaise 61 48 58 55
Anorexia 42 27 47 38
Stomatitis 34 26 41 28
Fever 34 22 29 18
Infection 23 19 18 21
Diarrhea 21 14 24 7
Pain on Injection 12 13 3 0
Sepsis 17 12 14 9
Neurotoxicity 17 10 13 5
Streaking/Erythema 5 4 4 2
Phlebitis 6 3 3 5
Esophagitis 6 3 7 4
Dysphagia 8 0 10 5
Hemorrhage 2 3 2 1
Extravasation 1 3 1 2
Urticaria 2 2 2 0
Recall Skin Reaction 1 1 2 0

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