Dexrazoxane
Generic Name: dexrazoxane
Brand Names:
Dexrazoxane
11 DESCRIPTION Dexrazoxane for injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (S)-4,4'-(1-methyl-1,2-ethanediyl)bis-2,6-piperazinedione. The structural formula is as follows: C 11 H 16 N 4 O 4 M.W. 268.28 Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a white to off-white crystalline powder that melts at 191° to 197°C.
Overview
11 DESCRIPTION Dexrazoxane for injection, a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration. Chemically, dexrazoxane is (S)-4,4'-(1-methyl-1,2-ethanediyl)bis-2,6-piperazinedione. The structural formula is as follows: C 11 H 16 N 4 O 4 M.W. 268.28 Dexrazoxane, an intracellular chelating agent, is a derivative of EDTA. Dexrazoxane is a white to off-white crystalline powder that melts at 191° to 197°C.
Uses
1 INDICATIONS AND USAGE 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/m 2 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) ]. 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 2 and who will continue to receive doxorubicin therapy to maintain tumor control.
Dosage
2 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 2 dexrazoxane for injection to 50 mg/m 2 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 , 8.6 ) 2.1 Recommended Dose Administer dexrazoxane for injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.
Side Effects
6 ADVERSE REACTIONS In clinical studies, dexrazoxane was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving dexrazoxane versus placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
Interactions
7 DRUG INTERACTIONS No drug interactions have been identified [see Clinical Pharmacology (12.3) ].
Warnings
5 WARNINGS AND PRECAUTIONS Myelosuppression: Dexrazoxane may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. ( 5.1 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Myelosuppression Dexrazoxane may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane and chemotherapy only when adequate hematologic parameters are met. 5.2 Concomitant Chemotherapy Only use dexrazoxane in those patients who have received a cumulative doxorubicin dose of 300 mg/m 2 and are continuing with doxorubicin therapy. 4 CONTRAINDICATIONS Do not use dexrazoxane with non-anthracycline chemotherapy regimens. Dexrazoxane should not be used with non-anthracycline chemotherapy regimens. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, dexrazoxane can cause fetal harm when administered to pregnant women [see Clinical Pharmacology (12.1) ] . Available human data with dexrazoxane use in pregnant women is not sufficient to inform the drug-associated risk. In animal reproduction studies, dexrazoxane administration resulted in maternal toxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose (see Data).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Dexrazoxane for injection is available in the following strengths as a sterile, off white to pale yellow pyrogen-free lyophilized powder in a single-dose vials for reconstitution.
Frequently Asked Questions
What is Dexrazoxane used for?▼
1 INDICATIONS AND USAGE 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/m 2 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) ]. 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 2 and who will continue to receive doxorubicin therapy to maintain tumor control.
What are the side effects of Dexrazoxane?▼
6 ADVERSE REACTIONS In clinical studies, dexrazoxane was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving dexrazoxane versus placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novadoz Pharmaceuticals LLC at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
Can I take Dexrazoxane during pregnancy?▼
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action, dexrazoxane can cause fetal harm when administered to pregnant women [see Clinical Pharmacology (12.1) ] . Available human data with dexrazoxane use in pregnant women is not sufficient to inform the drug-associated risk. In animal reproduction studies, dexrazoxane administration resulted in maternal toxicity and teratogenicity in rats and rabbits at doses significantly lower than the clinically recommended dose (see Data).
What are the important warnings for Dexrazoxane?▼
5 WARNINGS AND PRECAUTIONS Myelosuppression: Dexrazoxane may increase the myelosuppresive effects of chemotherapeutic agents. Perform hematological monitoring. ( 5.1 ) Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception. ( 5.5 , 8.1 , 8.3 ) 5.1 Myelosuppression Dexrazoxane may add to the myelosuppression caused by chemotherapeutic agents. Obtain a complete blood count prior to and during each course of therapy, and administer dexrazoxane and chemotherapy only when adequate hematologic parameters are met. 5.2 Concomitant Chemotherapy Only use dexrazoxane in those patients who have received a cumulative doxorubicin dose of 300 mg/m 2 and are continuing with doxorubicin therapy. 4 CONTRAINDICATIONS Do not use dexrazoxane with non-anthracycline chemotherapy regimens. Dexrazoxane should not be used with non-anthracycline chemotherapy regimens. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.