Zinecard (Dexrazoxane) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

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Zinecard

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SIDE EFFECTS

ZINECARD (dexrazoxane) at a dose of 500 mg/m² has been administered in combination with FAC in randomized, placebo-controlled, double-blind studies to patients with metastatic breast cancer. The dose of doxorubicin was 50 mg/m² in each of the trials. Courses were repeated every three weeks, provided recovery from toxicity had occurred. Table 2 below lists the incidence of adverse experiences for patients receiving FAC with either ZINECARD (dexrazoxane) or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving ZINECARD (dexrazoxane) or placebo with FAC beginning with their first course of therapy (column 1 & 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 (dexrazoxane) or placebo with FAC are also displayed (column 2 & 4, respectively).

TABLE 2

ADVERSE EXPERIENCE	PERCENTAGE (%) OF BREAST CANCER PATIENTS WITH ADVERSE EXPERIENCE
	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/Malasie	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

The adverse experiences listed above are likely attributable to the FAC regimen with the exception of pain on injection that was observed mainly on the ZINECARD (dexrazoxane) arm.

Myelosuppression

Patients receiving FAC with ZINECARD (dexrazoxane) experienced more severe leucopenia, granulocytopenia and thrombocytopenia at nadir than patients receiving FAC without ZINECARD (dexrazoxane) , but recovery counts were similar for the two groups of patients.

Hepatic and Renal

Some patients receiving FAC + ZINECARD (dexrazoxane) or FAC + placebo experienced marked abnormalities in hepatic or renal function tests, but the frequency and severity of abnormalities in bilirubin, alkaline phosphatase, BUN, and creatinine were similar for patients receiving FAC with or without ZINECARD (dexrazoxane) .