Brand Name
Dexrazoxane
View Brand InformationFDA approval date: March 31, 2005
Classification: Cytoprotective Agent
Form: Injection, Kit
What is Dexrazoxane?
Dexrazoxane for Injection is indicated for reducing the incid ence and severity of cardiomyopathy associated with doxorubicin ad m inistration in wo men with metastatic breast cancer who have received a cu mulative doxorubicin dose of 300 mg / m 2 and who will c ontinue to receive doxor ubicin therapy to maintain tu mor control. Do not use with the initiat ion of doxorubicin therapy [see Warnings and Precautions.
Approved To Treat
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Brand Information
Dexrazoxane (Dexrazoxane)
1INDICATIONS 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
2DOSAGE FORMS AND STRENGTHS
Dexrazoxane for injection (dexrazoxane for injection) is available in 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates.
3CONTRAINDICATIONS
Do not use dexrazoxane for injection with non-anthracycline chemotherapy regimens.
4DRUG INTERACTIONS
No drug interactions have been identified
5OVERDOSAGE
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.
6DESCRIPTION
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
7CLINICAL STUDIES
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:
- Development of congestive heart failure, defined as having two or more of the following:
- Decline from baseline in LVEF by ≥10% and to below the lower limit of normal for the institution.
- Decline in LVEF by ≥20% from baseline value.
- Decline in LVEF to ≥5% below lower limit of normal for the institution.
Figure 1 shows the number of patients still on treatment at increasing cumulative doses.
Figure 1
Cumulative Number of Patients On Treatment FAC vs. FAC/Dexrazoxane for Injection Patients
Patients Receiving at Least Seven Courses of Treatment
8REFERENCES
1. “OSHA Hazardous Drugs.” OSHA
9HOW SUPPLIED
Dexrazoxane for Injection is available in the following strengths as sterile, pyrogen-free lyophilizates.
NDC 0143-9247-01 250 mg single dose vial with a gray flip-top seal, packaged in single vial packs.
NDC 0143-9248-01 500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.
Store at 20° to 25°C (68° to 77° F) [See USP Controlled Room Temperature].
Follow special handling and disposal procedures.
10Vial Label 250 mg
NDC 0143-9247-01 Rx only
Dexrazoxane for Injection
250 mg per vial
For Intravenous use ONLY
STERILE, PYROGEN-FREE,
LYOPHILIZATE
Single Dose Vial
11Carton 250 mg
NDC 0143-9247-01 Rx only
Dexrazoxane for Injection
250 mg per vial
For Intravenous use ONLY
STERILE,
PYROGEN-FREE,
LYOPHILIZATE
Single Dose Vial
12Vial Label 500 mg
NDC 0143-9248-01 Rx only
Dexrazoxane for Injection
500 mg per vial
For Intravenous use ONLY
STERILE, PYROGEN-FREE,
LYOPHILIZATE
Single Dose Vial
13Carton 500 mg
NDC 0143-9248-01 Rx only
Dexrazoxane for Injection
500 mg per vial
For Intravenous use ONLY
STERILE, PYROGEN-FREE,
LYOPHILIZATE
Single Dose Vial
