Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
DEXRAZOXANE HYDROCHLORIDE (UNII: 5346058Q7S) (DEXRAZOXANE - UNII:048L81261F)
Gland Pharma Limited
DEXRAZOXANE HYDROCHLORIDE
DEXRAZOXANE 500 mg in 50 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. 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)]. Animal Data Dexrazoxane resulted in maternal toxicity in rats at doses of ≥2 mg/kg (1/40 the human dose on a mg/m2 basis) and embryotoxicity and teratogenicity at 8 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) when given daily to pregnant rats during the period of organogenesis. Teratogenic effects in the rat included imperforate anus, microphthalmia, and anophthalmia. In offspring allowed to develop to maturity, fertility was impaired in the male and female rats treated in utero during organogenesis at 8 mg/kg. In rabbits, doses of ≥5 mg/kg (approximately 1/10 the human dose on a mg/m2 basis) daily during the period of organogenesis caused maternal toxicity and doses of 20 mg/kg (1/2 the human dose on a mg/m2 basis) were embryotoxic and teratogenic. Teratogenic effects in the rabbit included several skeletal malformations such as short tail, rib and thoracic malformations, and soft tissue variations including subcutaneous, eye and cardiac hemorrhagic areas, as well as agenesis of the gallbladder and of the intermediate lobe of the lung. It is not known whether dexrazoxane or its metabolites are excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from dexrazoxane, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. The safety and effectiveness of dexrazoxane in pediatric patients have not been established [see Warnings and Precautions (5.4)]. Clinical studies of Dexrazoxane for Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Contraception Dexrazoxane for Injection can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment [see Use in Specific Populations (8.1)]. Greater exposure to dexrazoxane may occur in patients with compromised renal function. Reduce the Dexrazoxane for Injection dose by 50% in patients with creatinine clearance values <40 mL/min [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].
Dexrazoxane for injection is available in the following strengths as sterile, pyrogen-free lyophilized. NDC 68083-195-01 500 mg single dose vial with a blue flip-top seal, packaged in single vial packs. NDC 68083-388-01 250 mg single dose vial with a green 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 FOR INJECTION INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GLAND PHARMA LIMITED ---------- 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/m2 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. (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 lyophilized.(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 can Soma hati kamili