1 INDICATIONS AND USAGE Dexrazoxane for Injection is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m 2 and who will continue to receive doxorubicin therapy to maintain tumor control.

Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions ( 5.2 )] .

Dexrazoxane for Injection is a cytoprotective agent indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control.

Do not use Dexrazoxane for Injection with doxorubicin initiation.

( 1 )

6 ADVERSE REACTIONS In clinical studies, Dexrazoxane for Injection was administered to patients also receiving chemotherapeutic agents for cancer.

Pain on injection was observed more frequently in patients receiving Dexrazoxane for Injection versus placebo.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almaject, Inc.

at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 Dexrazoxane for Injection.

The dose of doxorubicin was 50 mg/m 2 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 Dexrazoxane for Injection experienced more severe leukopenia, granulocytopenia, and thrombocytopenia than patients receiving FAC without Dexrazoxane for Injection [see Warnings and Precautions ( 5.1 )].

Table 1 below lists the incidence of adverse reactions for patients receiving FAC with either Dexrazoxane for Injection or placebo in the breast cancer studies.

Adverse experiences occurring during courses 1 through 6 are displayed for patients receiving Dexrazoxane for Injection 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 Dexrazoxane for Injection 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 Dexrazoxane for Injection arm, as compared to placebo.

Table 1 Adverse Reaction Percentage (%) of Breast Cancer Patients With Adverse Reaction FAC + Dexrazoxane for Injection 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