DEXRAZOXANE- dexrazoxane for injection injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)

Available from:

Alvogen Inc.

INN (International Name):

DEXRAZOXANE HYDROCHLORIDE

Composition:

DEXRAZOXANE 500 mg in 50 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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/m2 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)] . Do not use Dexrazoxane for Injection with non-anthracycline chemotherapy regimens. Pregnancy Category D Risk Summary Dexrazoxane for Injection can cause fetal harm when administered to pregnant women. Dexrazoxane administration resulted in maternal toxicity, embryotoxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Warnings and Precautions (5.5)]. Animal Data Dexrazoxane res

Product summary:

Dexrazoxane for injection is available in the following strength as sterile, pyrogen-free lyophilized. NDC 47781-578-07 500 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.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXRAZOXANE- DEXRAZOXANE FOR INJECTION INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
ALVOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DEXRAZOXANE FOR INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DEXRAZOXANE FOR
INJECTION.
DEXRAZOXANE FOR INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
• Reconstitute vial contents and dilute before use. (2.3)
• Administer Dexrazoxane for Injection by intravenous infusion over
15 minutes.
• DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. (2.1,2.3)
• The recommended dosage ratio of Dexrazoxane for Injection to
doxorubicin is 10:1 (e.g., 500 mg/m Dexrazoxane for
Injection to 50 mg/m doxorubicin). Do not administer doxorubicin
before Dexrazoxane. (2.1)
• Reduce dose by 50% for patients with creatinine clearance <40
mL/min. (2.2, 8.7)
DOSAGE FORMS AND STRENGTHS
500 mg single dose vials as sterile, pyrogen-free lyophilized. (3)
CONTRAINDICATIONS
Dexrazoxane for Injection should not be used with non-anthracycline
chemotherapy regimens. (4)
WARNINGS AND PRECAUTIONS
• Myelosuppression: Dexrazoxane for Injection may increase the
myelosuppresive effects of chemotherapeutic agents.
Perform hematological monitoring. (5.1)
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise female
patients of reproductive potential of the potential hazard to
the fetus. (5.5, 8.1)
ADVERSE REACTIONS
In clinical studies, Dexrazoxane for Injection was administered to
patients also receiving chemotherapeutic agents for
cancer. Pain on inject