DEXRAZOXANE- dexrazoxane for injection injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Gland Pharma Limited

INN (International Name):

DEXRAZOXANE HYDROCHLORIDE

Composition:

DEXRAZOXANE 500 mg in 50 mL

Administration route:

INTRAVENOUS

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. 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)].

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DEXRAZOXANE - DEXRAZOXANE FOR INJECTION INJECTION, POWDER,
LYOPHILIZED, FOR
SOLUTION
GLAND PHARMA LIMITED
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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/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