Single agent: 60 to 75 mg/m2 given intravenously every 21 days.

In combination therapy: 40 to 75 mg/m2 given intravenously every 21 to 28 days. Doxorubicin HCl should be discontinued in patients who develop signs or symptoms of cardiomyopathy, and dose should be reduced in patients with hepatic impairment. As an intravenous injection, Doxorubicin HCl is administered through a central intravenous line or a secure and free-flowing peripheral venous line containing 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP over 3 to 10 minutes. The rate of Doxorubicin HCl administration should be decreased if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. As intravenous Infusion, Doxorubicin HCl is administered only through a central catheter.

Doxorubicin HCl is contraindicated in patients with:

• Severe myocardial insufficiency
• Recent (occurring within the past 4-6 weeks) myocardial infarction
• Severe persistent drug-induced myelosuppression
• Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dl)
• Severe hypersensitivity reaction to Doxorubicin HCl including anaphylaxis

The most common (>10%) adverse drug reactions are alopecia, nausea and vomiting. Other adverse reactions include- cardiomyopathy and arrhythmias, secondary malignancies, extravasation and tissue necrosis, severe myelosuppression, tumor lysis syndrome, radiation sensitization and radiation recall.

Pregnancy Category D. Doxorubicin HCl can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. Female patients of reproductive potential should be advised to use highly effective contraception during treatment with Doxorubicin HCl and for 6 months after treatment. There is evidence of Doxorubicinbe excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Doxorubicin HCl, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Caution should be exercised in handling Adribin HCl solution. Procedures for proper handling and disposal of anticancer drugs should be utilized. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and IV sets containing Adribin HCl. If Adribin HCl contacts the skin or mucosa, immediately and thoroughly wash the skin with soap and water or sodium bicarbonate solution and flush the mucosa with water.

The symptoms of overdose are likely to be an extension of Adribin's pharmacological action. Single doses of 250 mg and 500 mg of Adribin have proven to be fatal. Such doses may cause acute myocardial degeneration within 24 hours and severe myelosuppression, the greatest effects of which are seen between 10 and 15 days after administration. Delayed cardiac failure may occur up to six months after the overdose. Patients should be observed carefully and treatment should aim to support the patient during this period.

Store in a dry place at 2°-8° C temperature. Protect from light and do not freeze. Keep out of the reach of children.