DEXRAZOXANE HYDROCHLORIDE- dexrazoxane kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Institutional LLC

INN (International Name):

DEXRAZOXANE HYDROCHLORIDE

Composition:

DEXRAZOXANE 250 mg in 25 mL

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. 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)] . Dexrazoxane resulted in maternal toxicity in rats at doses of

Product summary:

Dexrazoxane for Injection is available in the following strengths as sterile, pyrogen-free lyophilizates. NDC 67457-207-25 250 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 67457-208-50 500 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.1

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXRAZOXANE HYDROCHLORIDE- DEXRAZOXANE
MYLAN INSTITUTIONAL 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
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•
•
•
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
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•
ADVERSE REACTIONS
In clinical studies, dexrazoxane for injection was administered to
patients also receiving chemotherapeutic agents for
cancer. Pain on injection was observed more frequently in patients
receiving dexrazoxane for injection versus placebo.
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
2.2 Dose Modifications
2.3 Preparation and Administration
2
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
inject