Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)
Pharmacia and Upjohn Company LLC
DEXRAZOXANE HYDROCHLORIDE
DEXRAZOXANE 250 mg in 25 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
New Drug Application
ZINECARD- DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION PHARMACIA AND UPJOHN COMPANY LLC ---------- 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 Perskaitykite visą dokumentą