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  2.1 Recommended Dose

  Adjuvant Breast Cancer

  The recommended dose of doxorubicin HCl is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles [see Clinical Studies (14)].

  Metastatic Disease, Leukemia, or Lymphoma

  The recommended dose of doxorubicin HCl when used as a single agent is 60 to 75 mg/m2 intravenously every 21 days. The recommended dose of doxorubicin HCl, when administered in combination with other chemotherapy drugs, is 40 to 75 mg/m2 intravenously every 21 to 28 days. Consider use of the lower doxorubicin dose in the recommended dose range or longer intervals between cycles for heavily pretreated patients, elderly patients, or obese patients. Cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy [see Warnings and Precautions (5.1)]. 2.2 Dose Modifications

  Cardiac Impairment

  Discontinue doxorubicin in patients who develop signs or symptoms of cardiomyopathy.

  Hepatic Impairment

  Doxorubicin HCl is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C or serum bilirubin >5.0 mg/dL) [see Contraindications (4)].

  Decrease the dose of doxorubicin HCl in patients with elevated serum total bilirubin concentrations as follows:

  Serum bilirubin concentration Doxorubicin HCl Dose reduction 1.2 – 3.0 mg/dL 50 % 3.1 – 5.0 mg/dL 75 % greater than 5.0 mg/dL Do not initiate doxorubicin HCl
  Discontinue doxorubicin HCl

  [see Warnings and Precautions (5.5) and Use in Specific Population (8.7)]

  2.3 Preparation and Administration

  Preparation for Continuous Intravenous Infusion

  Dilute doxorubicin HCl solution in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Protect from light following preparation until completion of infusion.

  Administration

  Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if the solution is discolored, cloudy, or contains particulate matter.

  Storage of vials of Doxorubicin HCl Injection under refrigerated conditions can result in the formation of a gelled product. Place gelled product at room temperature [15º to 30ºC (59º to 86ºF)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

  Administration by Intravenous Injection:

  Administer doxorubicin HCl as an intravenous injection 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. Administer doxorubicin HCl intravenously over 3 to 10 minutes. Decrease the rate of doxorubicin HCl administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur.

  Administration by Continuous Intravenous Infusion:

  Infuse only through a central catheter. Decrease the rate of doxorubicin HCl administration if erythematous streaking along the vein proximal to the site of infusion or facial flushing occur. Protect from light from preparation for infusion until completion of infusion.

  Management of Suspected Extravasation

  Discontinue doxorubicin HCl for burning or stinging sensation or other evidence indicating peri-venous infiltration or extravasation. Manage confirmed or suspected extravasation as follows:

  Do not remove the needle until attempts are made to aspirate extravasated fluid. Do not flush the line. Avoid applying pressure to the site. Apply ice to the site intermittently for 15 min 4 times a day for 3 days. If the extravasation is in an extremity, elevate the extremity. In adults, consider administration of dexrazoxane [see Warnings and Precautions (5.3)].

  Incompatibility with Other Drugs

  Do not admix doxorubicin HCl with other drugs. If doxorubicin HCl is mixed with heparin or fluorouracil a precipitate may form. Avoid contact with alkaline solutions which can lead to hydrolysis of doxorubicin HCl.

  2.4 Procedures for Proper Handling and Disposal

  Handle and dispose of doxorubicin HCl consistent with recommendations for the handling and disposal of hazardous drugs.1

  Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. Do not abrade the skin by using a scrub brush. Seek medical attention.

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