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DEXRAZOXANE FOR is a brand name for Dexrazoxane, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: DEXRAZOXANE FOR INJECTION is indicated for: • Reducing (preventing) the incidence and severity of cardiotoxicity associated with doxorubicin administration for the treatment of metastatic breast cancer in patients who have already experienced a partial response or at least maintained stable disease. DEXRAZOXANE FOR…
Verbatim from this product's HC label. Tap a section to expand.
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DEXRAZOXANE FOR INJECTION Page 5 of 25 • Hepatic insufficiency:
Dexrazoxane for Injection has not been studied in patients with hepatic impairment (see 7 WARNINGS AND PRECAUTION, Hepatic/Biliary/Pancreatic and Monitoring and Laboratory Tests). • DEXRAZOXANE FOR INJECTION should not be administered in a dose that exceeds 500 mg/m2.
1 Dosing Considerations DEXRAZOXANE FOR INJECTION should be reconstituted with Sterile Water for Injection, USP to a concentration of 10 mg/mL. 3 Reconstitution. g. 500 mg/m2 DEXRAZOXANE FOR INJECTION : 50 mg/m2 doxorubicin) (see 7 WARNINGS AND PRECAUTIONS).
Hepatic insufficiency:
Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, the DEXRAZOXANE FOR INJECTION dosage should be proportionately reduced in patients with hepatic impairment to maintain the 10:1 ratio of DEXRAZOXANE FOR INJECTION: doxorubicin.
g. 250 mg/m2 DEXRAZOXANE FOR INJECTION: 50 mg/m2 doxorubicin). 3 Reconstitution Parenteral Products: Recommended Diluent for Reconstitution: The reconstitution diluent Sterile Water for Injection, USP, has been studied for compatibility and stability with dexrazoxane.
DEXRAZOXANE FOR INJECTION should only be reconstituted with Water for Injection, USP. No other diluent should be used to reconstitute DEXRAZOXANE FOR INJECTION. The reconstituted DEXRAZOXANE FOR INJECTION solution is intended for further dilution for rapid intravenous drip infusion.
DO NOT ADMINISTER VIA INTRAVENOUS PUSH. Reconstitute each vial with Sterile Water for Injection, USP, according to Table 1. The reconstituted DEXRAZOXANE FOR INJECTION prepared from Sterile Water for Injection, USP, is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2 to 8°C.
0. DISCARD UNUSED DEXRAZOXANE FOR INJECTION Page 6 of 25 SOLUTIONS, (see 11 STORAGE, STABILITY AND DISPOSAL). 0 mg/mL in intravenous infusion bags for rapid intravenous drip infusion. 5. The resultant solution is stable for one hour at room temperature or if storage is necessary up to 4 hours when stored under refrigeration, 2 to 8°C.
). Patients should be monitored for cardiac function before and periodically during therapy to assess left ventricular ejection fraction (LVEF) (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular). It is recommended that routine liver function tests be performed before each administration of dexrazoxane in patients with known liver function disorders (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic and 4 DOSAGE AND ADMINISTRATION).
Since renal dysfunction may decrease the rate of elimination of dexrazoxane, patients with initial impaired renal function should be monitored for signs of haematological toxicity (See 7 WARNINGS DEXRAZOXANE FOR INJECTION Page 9 of 25 AND PRECAUTIONS, Renal and 4 DOSAGE AND ADMINISTRATION).
Renal Patients with moderate or severe renal insufficiency:
Greater exposure to dexrazoxane may occur in patients with compromised renal function. The DEXRAZOXANE FOR INJECTION dose should be reduced by 50% in patients with creatinine clearance values <40 mL/min (see 4 DOSAGE AND ADMINISTRATION).
Reproductive Health:
Female and Male Potential There is no conclusive information about dexrazoxane adversely affecting human fertility. Sensitivity/Resistance Anaphylactic reaction including angioedema, skin reactions, bronchospasm, respiratory distress, hypotension and loss of consciousness have been observed in patients treated with dexrazoxane and anthracyclines.
1 Pregnant Women 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 16 NON-CLINICAL TOXICOLOGY). DEXRAZOXANE FOR INJECTION should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
). 3 Pediatrics). 4 Geriatrics). 2 CONTRAINDICATIONS • DEXRAZOXANE FOR INJECTION should not be used as a chemotherapeutic agent. • DEXRAZOXANE FOR INJECTION is contraindicated in patients who have known hypersensitivity to dexrazoxane or any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STENGTHS, COMPOSISITON AND PACKAGING. • Do not use DEXRAZOXANE FOR INJECTION with non-anthracycline chemotherapy regimens. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions DEXRAZOXANE FOR INJECTION is a potent drug and should be used only by physicians experienced with cancer chemotherapy drugs.
• Myelosuppression: DEXRAZOXANE FOR INJECTION may increase the myelosuppressive effects of chemotherapeutic agents (see 7 WARNINGS AND PRECAUTIONS, Hematologic, Immune, and Monitoring and Laboratory Tests). • Embryo-Fetal Toxicity: DEXRAZOXANE FOR INJECTION can cause fetal harm.
1 Pregnant Women). • Renal insufficiency: Dosage adjustment is recommended in patients with renal impairment (see 7 WARNINGS AND PRECAUTIONS, Renal and 4 DOSAGE AND ADMINISTRATION).
DEXRAZOXANE FOR INJECTION Page 5 of 25 • Hepatic insufficiency:
Dexrazoxane for Injection has not been studied in patients with hepatic impairment (see 7 WARNINGS AND PRECAUTION, Hepatic/Biliary/Pancreatic and Monitoring and Laboratory Tests). • DEXRAZOXANE FOR INJECTION should not be administered in a dose that exceeds 500 mg/m2.
1 Dosing Considerations DEXRAZOXANE FOR INJECTION should be reconstituted with Sterile Water for Injection, USP to a concentration of 10 mg/mL. 3 Reconstitution. g. 500 mg/m2 DEXRAZOXANE FOR INJECTION : 50 mg/m2 doxorubicin) (see 7 WARNINGS AND PRECAUTIONS).
Hepatic insufficiency:
Since a doxorubicin dose reduction is recommended in the presence of hyperbilirubinemia, the DEXRAZOXANE FOR INJECTION dosage should be proportionately reduced in patients with hepatic impairment to maintain the 10:1 ratio of DEXRAZOXANE FOR INJECTION: doxorubicin.
• DEXRAZOXANE FOR INJECTION should not be used as a chemotherapeutic agent. • DEXRAZOXANE FOR INJECTION is contraindicated in patients who have known hypersensitivity to dexrazoxane or any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STENGTHS, COMPOSISITON AND PACKAGING. • Do not use DEXRAZOXANE FOR INJECTION with non-anthracycline chemotherapy regimens.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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DISCARD UNUSED SOLUTIONS (see 11 STORAGE, STABILITY AND DISPOSAL).
Incompatibility:
Unless specific compatibility data are available, Dexrazoxane for Injection should not be mixed with other drugs. 4 Administration The reconstituted solution when further diluted with Lactated Ringer’s Injection MUST be given by rapid drip intravenous infusion.
DO NOT ADMINISTER VIA INTRAVENOUS PUSH. Administer the final diluted solution of DEXRAZOXANE FOR INJECTION over 15 minutes before the administration of doxorubicin. Administer doxorubicin within 30 minutes after the completion of DEXRAZOXANE FOR INJECTION infusion.
DEXRAZOXANE FOR INJECTION should be administered only after the tolerance of the patient to the full dose of doxorubicin- containing chemotherapeutic regimen has been determined. DEXRAZOXANE FOR INJECTION should be given only when there is no need for dose reduction or dose delay, of the chemotherapeutic regimen due to myelosuppression or other toxicities, in two consecutive courses.
DEXRAZOXANE FOR INJECTION should be given only to patients who have already experienced partial response or at least maintained stable disease.
Women of child-bearing potential should be advised to practice effective contraception. 2 Breast-feeding Mothers should be advised not to breastfeed while undergoing therapy with DEXRAZOXANE FOR INJECTION. It is not known whether this drug is 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, it is recommended that nursing be discontinued during treatment. 3 Pediatrics Pediatrics (< 18 years of age): DEXRAZOXANE FOR INJECTION is not indicated for use in patients below the age of 18 years.
Since dexrazoxane is a cytotoxic agent, with topoisomerase II inhibition activity, combination of dexrazoxane with chemotherapy may lead to an increased risk of second primary malignancy. g. etoposide, doxorubicin, cyclophosphamide).
4 Geriatrics Geriatrics (≥ 65 years of age): Clinical studies of dexrazoxane did not include sufficient numbers of subjects 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
In general, elderly patients should be treated with caution due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy. 1 Adverse Reaction Overview Not available. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Dexrazoxane for Injection at a dose of 500 mg/m2 has been administered in combination with fluorouracil, doxorubicin, and cyclophosphamide (FAC) or cyclophosphamide, doxorubicin and vincristine (CAV) in randomized placebo controlled double-blind studies to patients with either metastatic breast cancer (FAC) or extensive disease small cell lung cancer (CAV).
The dose of doxorubicin was 50 mg/m2 in each of the trials. Courses were repeated every three weeks provided recovery from toxicity had occurred. Table 3 lists the incidence of clinical adverse experiences for patients receiving either dexrazoxane or placebo in the breast cancer studies.
Table 3. – PERCENTAGE OF BREAST CANCER PATIENTS WITH ADVERSE EXPERIENCE ADVERSE EXPERIENCE FAC + Dexrazoxane N = 244 (%) FAC + PLACEBO N = 280 (%) Alopecia 94 96 Nausea 82 89 Vomiting 63 77 Fatigue/Malaise 62 64 Anorexia 50 52 Stomatitis 36 45 Fever 35 33 Infection and/or Sepsis 31 28 Diarrhea 22 24 Neurotoxicity 16 13 DEXRAZOXANE FOR INJECTION Page 11 of 25 ADVERSE EXPERIENCE FAC + Dexrazoxane N = 244 (%) FAC + PLACEBO N = 280 (%) Pain on Injection 11 4 Streaking/Erythema 7 5 Dysphagia 6 10 Phlebitis 5 5 Urticaria 4 2 Esophagitis 5 9 Hemorrhage 2 2 Extravasation 2 1 Recall Skin Reaction 1 2 CHF 1 5 The only adverse experience that was observed in 5% more patients on FAC + dexrazoxane than on FAC + placebo was pain on injection.
However, the early drop-out rate for patients receiving dexrazoxane was higher than for patients receiving placebo.
Myelosuppression:
Eighty-eight percent (88%) of breast cancer patients receiving FAC + 500 mg/m2 dexrazoxane and 85% of patients receiving FAC + placebo experienced Grade 3 or 4 granulocytopenia. Ten percent (10%) of patients receiving FAC + […]
g. 250 mg/m2 DEXRAZOXANE FOR INJECTION: 50 mg/m2 doxorubicin). 3 Reconstitution Parenteral Products: Recommended Diluent for Reconstitution: The reconstitution diluent Sterile Water for Injection, USP, has been studied for compatibility and stability with dexrazoxane.
DEXRAZOXANE FOR INJECTION should only be reconstituted with Water for Injection, USP. No other diluent should be used to reconstitute DEXRAZOXANE FOR INJECTION. The reconstituted DEXRAZOXANE FOR INJECTION solution is intended for further dilution for rapid intravenous drip infusion.
DO NOT ADMINISTER VIA INTRAVENOUS PUSH. Reconstitute each vial with Sterile Water for Injection, USP, according to Table 1. The reconstituted DEXRAZOXANE FOR INJECTION prepared from Sterile Water for Injection, USP, is stable for 30 minutes at room temperature or if storage is necessary, up to 3 hours from the time of reconstitution when stored under refrigeration, 2 to 8°C.
0. DISCARD UNUSED DEXRAZOXANE FOR INJECTION Page 6 of 25 SOLUTIONS, (see 11 STORAGE, STABILITY AND DISPOSAL). 0 mg/mL in intravenous infusion bags for rapid intravenous drip infusion. 5. The resultant solution is stable for one hour at room temperature or if storage is necessary up to 4 hours when stored under refrigeration, 2 to 8°C.
DISCARD UNUSED SOLUTIONS (see 11 STORAGE, STABILITY AND DISPOSAL).
Incompatibility:
Unless specific compatibility data are available, Dexrazoxane for Injection should not be mixed with other drugs. 4 Administration The reconstituted solution when further diluted with Lactated Ringer’s Injection MUST be given by rapid drip intravenous infusion.
DO NOT ADMINISTER VIA INTRAVENOUS PUSH. Administer the final diluted solution of DEXRAZOXANE FOR INJECTION over 15 minutes before the administration of doxorubicin. Administer doxorubicin within 30 minutes after the completion of DEXRAZOXANE FOR INJECTION infusion.
DEXRAZOXANE FOR INJECTION should be administered only after the tolerance of the patient to the full dose of […]