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DOXORUBICIN

Package(a):
VIAL: 10 mg/5 ml.
Dosage(a):
I.V. (bolus) injection over 2-5 minutes or as continuous infusion into a running infusion of sodium chloride 0.9% w/v I.V. injection, dextrose I.V. injection 5% w/v or sodium chloride and dextrose I.V. injection. 
Adults: Depends on tumor type, cardiac or hepatic function and concurrent chemotherapy. 
The recommended dose as single agent: 60-75 mg/m² by I.V. injection, once every three weeks. Alternative dose schedule: 20 mg/m² I.V., for three consecutive days, once every three weeks. Maximum cumulative dose: 550 mg/m². 
Combination therapy: Dosage should be decreased when combination with other cytostatic drugs with any similar toxicity is used. If a patient received mediastinal irradiation, has concomitant heart disease, or is also treated with other cardiotoxic, non-anthracycline oncolytics, recommended maximum cumulative dose is 450 mg/m². 
Hepatic dysfunction: Dosage should be reduced. If bilirubin is elevated, dosage should be reduced as follows: Serum bilirubin 12-30 mg: ½ of normal dose; bilirubin >30mg: ¼ of normal dose. 
Patients with cardiac risk: Should be considered for treatment with a 24-hours continuous infusion, rather than bolus injection. See prescribing information for full details.
Prescribing Restrictions:  

Package(b):
VIAL: 50 mg/25 ml.
Dosage(b):
I.V. (bolus) injection over 2-5 minutes or as continuous infusion into a running infusion of sodium chloride 0.9% w/v I.V. injection, dextrose I.V. injection 5% w/v or sodium chloride and dextrose I.V. injection. 
Adults: Depends on tumor type, cardiac or hepatic function and concurrent chemotherapy. 
The recommended dose as single agent: 60-75 mg/m² by I.V. injection, once every three weeks. Alternative dose schedule: 20 mg/m² I.V., for three consecutive days, once every three weeks. Maximum cumulative dose: 550 mg/m². 
Combination therapy: Dosage should be decreased when combination with other cytostatic drugs with any similar toxicity is used. If a patient received mediastinal irradiation, has concomitant heart disease, or is also treated with other cardiotoxic, non-anthracycline oncolytics, recommended maximum cumulative dose is 450 mg/m². 
Hepatic dysfunction: Dosage should be reduced. If bilirubin is elevated, dosage should be reduced as follows: Serum bilirubin 12-30 mg: ½ of normal dose; bilirubin >30mg: ¼ of normal dose. 
Patients with cardiac risk: Should be considered for treatment with a 24-hours continuous infusion, rather than bolus injection. See prescribing information for full details.
Prescribing Restrictions:  


Package(c):
ONCOSAFE VIAL: 1 x 200 mg/100 ml.
Dosage(c):
I.V. (bolus) injection over 2-5 minutes or as continuous infusion into a running infusion of sodium chloride 0.9% w/v I.V. injection, dextrose I.V. injection 5% w/v or sodium chloride and dextrose I.V. injection. 
Adults: Depends on tumor type, cardiac or hepatic function and concurrent chemotherapy. 
The recommended dose as single agent: 60-75 mg/m² by I.V. injection, once every three weeks. Alternative dose schedule: 20 mg/m² I.V., for three consecutive days, once every three weeks. Maximum cumulative dose: 550 mg/m². 
Combination therapy: Dosage should be decreased when combination with other cytostatic drugs with any similar toxicity is used. If a patient received mediastinal irradiation, has concomitant heart disease, or is also treated with other cardiotoxic, non-anthracycline oncolytics, recommended maximum cumulative dose is 450 mg/m². 
Hepatic dysfunction: Dosage should be reduced. If bilirubin is elevated, dosage should be reduced as follows: Serum bilirubin 12-30 mg: ½ of normal dose; bilirubin >30mg: ¼ of normal dose. 
Patients with cardiac risk: Should be considered for treatment with a 24-hours continuous infusion, rather than bolus injection. See prescribing information for full details.
Prescribing Restrictions:  None


Indications:
Soft tissue and bone sarcomas, Hodgkin's and non Hodgkin's lymphoma, acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms' tumor, carcinomas of the thyroid, breast, ovary, bladder, small cell bronchogenic carcinoma and neuroblastoma.
Contra-Indications:
Patients who have a marked myelosuppression, pre-existing or acute cardiac insufficiency or patients who have previously received the maximum cumulative dose of doxorubicin or daunorubicin. Presence of buccal ulceration. Pregnancy and lactation. Hypersensitivity to doxorubicin, chemically related products or any other excipient. Should not be used intravesically for the treatment of bladder carcinoma in patients with urethral stenosis who can not be catheterized. The intravesical route of administration should not be attempted in patients with invasive tumors that have penetrated the bladder wall, urinary tract infections or inflammatory conditions of the bladder.
Special Precautions:
Should only be administered under the supervision of a physician experienced in the use of chemotherapy. It is recommended that the patient be hospitalized during at least the first phase of treatment since close observation and laboratory monitoring is necessary. Prior to treatment, cardiac and hepatic function and hematology baseline tests should be carried out. If extravasation occurs, the injection should be terminated immediately and restarted in another vein. Cumulative dose of 450-550 mg/m² should not be exceeded because of increased risk of cardiac failure. Cardiac function should be addressed prior to treatment, carefully monitored throughout, and assessed after therapy. The high incidence of bone marrow depression requires careful hematological monitoring. Therapy should not be started or continued when polynuclear granulocyte counts are below 2,000/mm³. Secondary infection should be prevented. Risk of hyperuricemia resulting in acute gout or urate nephropathy. Hepatic function tests should be carried out prior to and during the treatment. Men as well as women should take effective contraceptive measures during and for at least three months after doxorubicin therapy. Patients should be warned that doxorubicin may impart a red color to the urine. See prescribing information for full details.
Side Effects:
Very common (>10%). Dose limiting toxicities of therapy are myelosuppression and cardiotoxicity. May potentiate the toxicity of radiotherapy and other anticarcinogenic therapies (streptozocin, methotrexate, cyclophosphamide). Neoplasms benign and malignant (rare >0.01->01.1%). Blood and the lymphatic system disorders (very common: >10%). Cardiac disorders (common-very common >1% - 10%): May occur as arrhythmia directly following drug administration; ECG changes, including T-wave flattening and S-T depression, may last up to two weeks after administration. Age over 70 or below 15 should be regarded as high risk factor. Also, concomitant or previous treatment with mitomycin C, cyclophosphamide or dacarbazine has been reported to potentiate doxorubicin cardiomyopathy. Cardiotoxicity may be delayed several weeks, months or even years after discontinuation of doxorubicin therapy. Gastrointestinal disorders (very common: >10%): Nausea, vomiting, mucositis and diarrhea may occur 5-10 days after administration. Damage of the GI tract can lead to ulceration, hemorrhage and perforation. Hepato-biliary disorders: Slight transient increases of liver enzymes have been reported. Skin and S.C. tissue disorders (very common: >10%): Reversible alopecia, hyperpigmentation of nailbeds, dermal creases, onycholysis.
Drug Interactions:
Other cardiotoxic or anticancer (especially myelotoxic) agents. Verapamil. Known hepatotoxic chemotherapeutic agents (e.g. methotrexate). Cyclosporin, inhibitors of cytochrome P-450 (e.g. cimetidine and ranitidine, inducers of enzyme cytochrome P-450 (e.g. rifampicin and barbiturates). See prescribing information for full details.