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

Dexrazoxane for injection (dexrazoxane for injection) is available in 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates.

Do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens.

No drug interactions have been identified

There are no data on overdosage in the cardioprotective trials; the maximum dose administered during the cardioprotective trials was 1000 mg/m

Disposition studies with dexrazoxane for injection have not been conducted in cancer patients undergoing dialysis, but retention of a significant dose fraction (>0.4) of the unchanged drug in the plasma pool, minimal tissue partitioning or binding, and availability of greater than 90% of the systemic drug levels in the unbound form suggest that it could be removed using conventional peritoneal or hemodialysis.

There is no known antidote for dexrazoxane. Instances of suspected overdose should be managed with good supportive care until resolution of myelosuppression and related conditions is complete. Management of overdose should include treatment of infections, fluid regulation, and maintenance of nutritional requirements.

Dexrazoxane for Injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration.

Chemically, dexrazoxane is (+)-(

C

Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a whitish crystalline powder that melts at 191° to 197°C. It is sparingly soluble in water and 0.1 N HCl, slightly soluble in ethanol and methanol, and practically insoluble in nonpolar organic solvents. The pK

Each 250 mg vial contains dexrazoxane hydrochloride equivalent to 250 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 25 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.

Each 500 mg vial contains dexrazoxane hydrochloride equivalent to 500 mg dexrazoxane. Hydrochloric Acid, NF is added for pH adjustment. When reconstituted as directed with 50 mL of Sterile Water for Injection, USP, each mL contains: 10 mg dexrazoxane. The pH of the resultant solution is 1.0 to 3.0.

The reconstituted dexrazoxane for injection solutions prepared from Sterile Water for Injection, USP, are intended for further dilution with Lactated Ringer’s Injection, USP, for rapid intravenous drip infusion. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH

The ability of dexrazoxane for injection to prevent/reduce the incidence and severity of doxorubicin-induced cardiomyopathy was evaluated in three prospectively randomized placebo-controlled studies. In these studies, patients were treated with a doxorubicin-containing regimen and either dexrazoxane for injection or placebo starting with the first course of chemotherapy. There was no restriction on the cumulative dose of doxorubicin. Cardiac function was assessed by measurement of the LVEF, utilizing resting multigated nuclear medicine (MUGA) scans, and by clinical evaluations. Patients receiving dexrazoxane for injection had significantly smaller mean decreases from baseline in LVEF and lower incidences of congestive heart failure than the control group; however, in the largest study, patients with advanced breast cancer receiving FAC with dexrazoxane for injection had a lower response rate (48% vs. 63%) and a shorter time to progression than patients who received FAC versus placebo.

In the clinical trials, patients who were initially randomized to receive placebo were allowed to receive dexrazoxane for injection after a cumulative dose of doxorubicin above 300 mg/m

Table 3: Definition of Cardiac Events:

Figure 1 shows the number of patients still on treatment at increasing cumulative doses.

Figure 1

1. “OSHA Hazardous Drugs.” OSHA

Dexrazoxane for Injection is available in the following strengths as sterile, pyrogen-free lyophilizates.

Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature].

Follow special handling and disposal procedures.

NDC 0143-9247-01 Rx only

Dexrazoxane for Injection

250 mg per vial

For Intravenous use ONLY

STERILE, PYROGEN-FREE,

LYOPHILIZATE

Single Dose Vial

NDC 0143-9247-01 Rx only

Dexrazoxane for Injection

250 mg per vial

For Intravenous use ONLY

STERILE,

PYROGEN-FREE,

LYOPHILIZATE

Single Dose Vial

NDC 0143-9248-01 Rx only 

Dexrazoxane for Injection

500 mg per vial

For Intravenous use ONLY

STERILE, PYROGEN-FREE,

LYOPHILIZATE

Single Dose Vial

NDC 0143-9248-01 Rx only 

Dexrazoxane for Injection

500 mg per vial

For Intravenous use ONLY

STERILE, PYROGEN-FREE,

LYOPHILIZATE

Single Dose Vial