Side Effects > Dexrazoxane

Dexrazoxane Side Effects

Brand Names: Totect, Zinecard

Please note - some side effects for Dexrazoxane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dexrazoxane - for the Consumer

Dexrazoxane

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dexrazoxane:

Diarrhea; difficulty swallowing; fever; general body discomfort; hair loss; infection (chills; sore throat); loss of appetite; nausea; pain or swelling at the injection site; streaking or flushing of the skin; swelling of the throat or tongue; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Dexrazoxane:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

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Dexrazoxane Side Effects - for the Professional

Dexrazoxane

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 Dexrazoxane or placebo in the breast cancer studies. Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving 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 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 + Dexrazoxane		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

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 Dexrazoxane arm.

Myelosuppression

Patients receiving FAC with Dexrazoxane experienced more severe leukopenia, granulocytopenia and thrombocytopenia at nadir than patients receiving FAC without Dexrazoxane, but recovery counts were similar for the two groups of patients.

Hepatic and Renal

Some patients receiving FAC + 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 Dexrazoxane.

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Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including nausea (43%), vomiting (19%), diarrhea (11%), abdominal pain (6%), and constipation (6%) have been reported.

General

General side effects including pyrexia (21%), postoperative infection (16%), fatigue (13%), peripheral edema (10%), chest pain, chest discomfort, decreased drug effect, hyperpyrexia, and decreased therapeutic response have been reported.

Local

Local side effects including injection site pain (16%) and injection site phlebitis (6%) have been reported.

Cardiovascular

Cardiovascular side effects including vascular disorders (15%) and cardiac disorders (5%) have been reported.

Dermatologic

Dermatologic side effects including alopecia (14%) have been reported.

Musculoskeletal

Musculoskeletal side effects including "musculoskeletal and connective tissue disorders" (13%) have been reported.

Nervous system

Nervous system side effects including dizziness (11%) and headache (6%) have been reported.

Respiratory

Respiratory side effects including dyspnea (8%), pneumonia (6%), and cough (5%) have been reported.

Psychiatric

Psychiatric side effects including depression (8%), anorexia (5%), and insomnia (5%) have been reported.

Hematologic

Hematologic side effects including anemia (6%), decreased WBC, decreased neutrophils, and decreased platelets have been reported.

Hepatic

Hepatic side effects including increased bilirubin, increased AST, increased ALT, increased alkaline phosphatase, and increased LDH have been reported

Metabolic

Metabolic side effects including increased creatinine, decreased sodium, and increased total calcium have been reported.

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