DEXRAZOXANE 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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

DEXRAZOXANE HYDROCHLORIDE

Composition:

DEXRAZOXANE 10 mg in 1 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. Teratogenic Effects. 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)] .  Ani

Product summary:

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.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXRAZOXANE- DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HIKMA PHARMACEUTICALS USA 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 [ROUTE OF ADMINISTRATION] 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 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 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 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
c