ZINECARD- dexrazoxane injection, powder, lyophilized, for solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Pharmacia and Upjohn Company LLC

INN (Tên quốc tế):

DEXRAZOXANE HYDROCHLORIDE

Thành phần:

DEXRAZOXANE 250 mg in 25 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

ZINECARD 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 ZINECARD with non-anthracycline chemotherapy regimens. Risk Summary ZINECARD 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 at doses of ≥2 mg/kg (1/40 the human

Tóm tắt sản phẩm:

ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates. NDC 0013-8717-62 250 mg single dose vial with a red flip-top seal, packaged in single vial packs. NDC 0013-8727-89 500 mg single dose vial with a blue flip-top seal, packaged in single vial packs. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Follow special handling and disposal procedures.1

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

ZINECARD- DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
PHARMACIA AND UPJOHN COMPANY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZINECARD SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZINECARD.
ZINECARD (DEXRAZOXANE) FOR INJECTION
INITIAL U.S. APPROVAL: 1995
INDICATIONS AND USAGE
ZINECARD 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 ZINECARD with
doxorubicin initiation. (1)
DOSAGE AND ADMINISTRATION
Reconstitute vial contents and dilute before use. (2.3)
Administer ZINECARD by intravenous infusion over 15 minutes.
DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH. (2.1, 2.3)
The recommended dosage ratio of ZINECARD to doxorubicin is 10:1 (e.g.,
500 mg/m ZINECARD to 50 mg/m
doxorubicin). Do not administer doxorubicin before ZINECARD. (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
ZINECARD should not be used with non-anthracycline chemotherapy
regimens. (4)
WARNINGS AND PRECAUTIONS
Myelosuppression: ZINECARD 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, ZINECARD was administered to patients also
receiving chemotherapeutic agents for cancer. Pain on
injection was observed more frequently in patients receiving ZINECARD
versus placebo. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER, INC. AT
1-800-438-1985 OR FDA AT 1-800-FDA-
1088 OR WW