Indication:
Cardiomyopathy associated with doxorubicin use ( except Totect )
Adverse Reaction:
Adverse reactions-
Cardiovascular - cardiac disorders 4% vascular disorders 12%
CNS - depression 7% dizziness 10% fatigue 11% headache 5%
insomnia 4% nervous system disorders 22%
psychiatric disorders 12%
Dematological- alopecia 12% skin and subcutaneous disorders 16%
GI - abdominal pain 5% anorexia 4% constipation 5%
diarrhea 10% GI disorders 52% nausea 40%
vomiting 18%
Hematologic - anemia 5% blood and lymphatic system disorders 12%
Local - general disorders -site conditions 55% injection site pain 14%
injection site phlebitis 5%
Respiratory - cough 4% dyspnea 7% pneumonia 5%
respiratory throacic and mediastinal disorders 15%
Miscellaneous - edema peripheral 8% infections and infestations 28%
metabolism and nutritional disorders 8%
musculo-skeletal and connective tissue disorders 12%
post operative infection 14% pyrexia 20%
Contra-Indications:
Chemotherapy regimens that do not contain anthracycline
Special Precautions/ Warnings-
Myelosuppression - Dexrazoxane is a cytotoxic drug. Dexrazoxane may add to myelosuppression caused by chemotherapeutic agents . Frequent complete blood counts are recommended..
Anti-tumor interference - use of dexrazoxane concurently with initiation of fluorrouracil , doxorubicin, and cylclophosphamide therapy inteferes with the anti-tumor efficacy of the regimem. This use is not recommended
Hepatic effects - reversible elevations of liver enzymes may occur with dexrazoxane
Dimethylsulfoxide - do not use dimethylsulfoxide in patients who are receiving dexrazoxane to treat anthracycline induced extravasation
Pregnancy - if the drug is used during pregnancy while taking this drug appraise the patient
of the potential hazard to the fetus.
Lactation- Decide whether to discontinue breast beeding or the drug depending upon the
importance of the drug to the mother.
Children - safety and efficacy for use in children have not been established
Elderly - caution elderly patients of the greater frequency of decreased hepatic, renal or
cardiac functions.
Monitoring- frequent blood counts are recommended and carefully monitor cardiac and
liver enzymes
Dosages/ Overdosage Etc:
Indication-
Cardiomyopathy associated with doxorubicin use ( except Totect )
Dosage -
Recommended dose ratio of dexrazoxane : doxorubicin is 10: 1
eg dexrazoxane 500mg/m2 : doxorubicin 50mg/m2
Renal function impairment - in patient with moderate to severe renal function impairment
( creatinine clearance CrCl values less than 40ml/min , the recommended dose ratio is
dexrazoxane : doxtorubicin is 5: 1 eg dexrazoxane 250mg/m2 : doxorubicin 50mg/m2
Hepatic function impairment - dexrazoxane dose should be proportionately reduced
maintaining the 10: 1 ratio in patients with hepatic function impairment
Patient Information:
1. Doxazoxane is always used together with doxorubicin . Advice patients to tell, their doctor,
if any of the following occur.- Appetite loss, chills, diarrhea, difficulty in swallowing, fever,
general body discomfort , hair loss, hives, nausea, numbness or tingling , pain at injection
site , sore throat, stomach pain, streaking or redness of the skin, tiredness, unusual bleeding or vomiting.
2, Advice women who have the potential to become pregnant that dexrazoxane might
cause fetal harm.
Pregnancy and lactation:
Pregnancy -
If the drug is used during pregnancy while taking this drug appraise the patient
of the potential hazard to the fetus.
Lactation-
Decide whether to discontinue breast beeding or the drug depending upon the
importance of the drug to the mother.
Children -
Safety and efficacy for use in children have not been established
Elderly -
Caution elderly patients of the greater frequency of decreased hepatic, renal or
cardiac functions
Manufacturer Details