Dexrazoxane For Injection
Generic Name: dexrazoxane for injection
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 whitish 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 whitish 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/m2 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. ( 2.1 ) • Reduce dose by 50% for patients with creatinine clearance <40 mL/min. ( 2.2 , 8.7 ) 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 for Injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving Dexrazoxane for Injection versus placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almaject, Inc. at 1-866-770-3024 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 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 ) 5.1 Myelosuppression Dexrazoxane for Injection 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 for Injection and chemotherapy only when adequate hematologic parameters are met. 4 CONTRAINDICATIONS Do not use Dexrazoxane for Injection with non-anthracycline chemotherapy regimens. Dexrazoxane for Injection should not be used with non-anthracycline chemotherapy regimens. ( 4 )
Pregnancy
8.1 Pregnancy 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 )].
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Dexrazoxane for injection is available in the following strength as sterile, pyrogen-free lyophilized. NDC 72611-716-72 500 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
Frequently Asked Questions
What is Dexrazoxane For Injection 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/m2 and who will continue to receive doxorubicin therapy to maintain tumor control.
What are the side effects of Dexrazoxane For Injection?▼
6 ADVERSE REACTIONS In clinical studies, Dexrazoxane for Injection was administered to patients also receiving chemotherapeutic agents for cancer. Pain on injection was observed more frequently in patients receiving Dexrazoxane for Injection versus placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Almaject, Inc. at 1-866-770-3024 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 For Injection during pregnancy?▼
8.1 Pregnancy 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 )].
What are the important warnings for Dexrazoxane For Injection?▼
5 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 ) 5.1 Myelosuppression Dexrazoxane for Injection 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 for Injection and chemotherapy only when adequate hematologic parameters are met. 4 CONTRAINDICATIONS Do not use Dexrazoxane for Injection with non-anthracycline chemotherapy regimens. Dexrazoxane for Injection 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.