Doxorubicin HEXAL

Doxorubicin HEXAL2 mg/ml

IV Infusion

Doxorubicin Hydrochloride

SANDOZ (A Novartis Division)

Product Code : 5313
MRP 540.27
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Medicine overview

Indications of Doxorubicin HEXAL 2 mg/ml

Doxorubicin is an anthracycline topoisomerase II inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy. AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy. ... Read moreDoxorubicin is an anthracycline topoisomerase II inhibitor indicated for: Ovarian cancer: After failure of platinum-based chemotherapy. AIDS-related Kaposi’s Sarcoma: After failure of prior systemic chemotherapy or intolerance to such therapy. Multiple Myeloma: In combination with bortezomib in patients who have not previously received bortezomib and have received at least one prior therapy.

Theropeutic Class

Cytotoxic Chemotherapy

Pharmacology

Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.

Dosage & Administration of Doxorubicin HEXAL 2 mg/ml

Administer Doxorubicin at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution. Ovarian cancer: 50 mg/m2 IV every 4 weeks AIDS-related Kaposi’s Sarcoma: 20 mg/m2 IV every 3 weeks Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib

Dosage of Doxorubicin HEXAL 2 mg/ml

Administer Doxorubicin at an initial rate of 1 mg/min to minimize the risk of infusion reactions. If no infusion related reactions occur, increase rate of infusion to complete administration over 1 hour. Do not administer as bolus injection or undiluted solution. Ovarian cancer: 50 mg/m2 IV every 4 weeks AIDS-related Kaposi’s Sarcoma: 20 mg/m2 IV every 3 weeks Multiple Myeloma: 30 mg/m2 IV on day 4 following bortezomib

Interaction of Doxorubicin HEXAL 2 mg/ml

Doxorubicin interacts with a number of other drugs e.g. antibiotics (aminoglycosides), steroids, aminophylline and propranolol.

Contraindications

Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy.

Side Effects of Doxorubicin HEXAL 2 mg/ml

Leucopenia, thrombocytopenia, nausea, vomiting, diarrhoea. Rarely facial flushing, rash, alopecia. Blurred vision, headache, seizures, paraesthesia, confusion, malaise, lethargy, skin pigmentation.

Pregnancy & Lactation

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Precautions & Warnings

Elderly, children, hepatic impairment. Monitor blood counts and ECG.

Overdose Effects of Doxorubicin HEXAL 2 mg/ml

Acute overdosage may increase the toxic effects of mucositis, leukopenia and thrombocytopenia. Treatment includes hospitalisation of the severely myelosuppressed patient, antimicrobials, platelet transfusions and symptomatic treatment of mucositis. Use of haemopoietic growth factor (G-CSF, GM-CSF) may be considered. Cumulative dosage increases risk of cardiomyopathy and resultant congestive heart failure which may be managed with digitalis preparations, diuretics, and after load reducers such as ACE inhibitors.

Storage Conditions

Powder for injection: Store at 15-30°C. Solution for injection & liposomal formulations: Refrigerate at 2-8°C. Do not freeze.

Use In Special Populations

Hepatic Impairment- serum-bilirubin: 12-30 mcg/ml: Half the normal dose; serum-bilirubin: >30 mcg/ml: Quarter of the usual dose.

Drug Classes

Cytotoxic Chemotherapy

Mode Of Action

Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.

Pregnancy

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Pediatric Uses

Hepatic Impairment- serum-bilirubin: 12-30 mcg/ml: Half the normal dose; serum-bilirubin: >30 mcg/ml: Quarter of the usual dose.
Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.