Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)
Hikma Pharmaceuticals USA Inc.
DEXRAZOXANE HYDROCHLORIDE
DEXRAZOXANE 10 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
DEXRAZOXANE- DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION HIKMA PHARMACEUTICALS USA INC. ---------- 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 Izlasiet visu dokumentu