DEXRAZOXANE kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eugia US LLC

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. Risk Summary Dexrazoxane 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 resulted in maternal toxicity in rats

Product summary:

Dexrazoxane for injection is available in the following strengths as sterile, pyrogen-free lyophilizates. NDC 55150-434-01 250 mg single-dose vial with a green flip-top seal, packaged in single vial packs. (This package also contains a 25 mL vial of 0.167 Molar (M/6) sodium lactate injection, USP.) NDC 55150-437-01 500 mg single-dose vial with a blue flip-top seal, packaged in single vial packs. (This package also contains a 50 mL vial of 0.167 Molar (M/6) sodium lactate injection, USP.) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Reconstituted solutions of dexrazoxane for injection are stable for 6 hours at controlled room temperature or under refrigeration, 2° to 8°C (36° to 46°F). Discard unused solutions. Follow special handling and disposal procedures. The vial stopper is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXRAZOXANE- DEXRAZOXANE
EUGIA US LLC
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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/m 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 slow I.V. push or rapid drip
intravenous infusion from a bag.
(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
for injection. (2.1)
Reduce dose by 50% for patients with creatinine clearance < 40 mL/min.
(2.2, 8.7)
DOSAGE FORMS AND STRENGTHS
250 mg or 500 mg single-dose vials as sterile, pyrogen-free
lyophilizates. (3)
CONTRAINDICATIONS
Dexrazoxane for injection should not be used with non-anthracycline
chemotherapy regimens. (4)
WARNINGS AND PRECAUTIONS
Myelosuppression: Dexrazoxane 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 was administered to patients also
receiving chemotherapeutic agents for
cancer. Pain on injection was observed more frequently in patients
receiving dexrazoxane versus placebo.
(6.1)
TO REPORT SUSPECT