Dexrazoxane Side Effects

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 Hikma Pharmaceuticals USA Inc.

at 1-877-845-0689, 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.