Description

It is contraindicated in patients with known hypersensitivity to Daunorubicin or any other components of this product.

Dose-limiting toxicity includes myelosuppression and cardiotoxicity. Other reactions include: Cutaneous: Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely. Gastrointestinal: Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported. Local: If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis or painful induration can result. Acute Reactions: Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.

Pregnancy Category D. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Daunorubicin, mothers should be advised to discontinue nursing during Daunorubicin therapy.

Therapy with Daunorubicin requires close patient observation and frequent complete blood-count determinations. Cardiac, renal, and hepatic function should be evaluated prior to each course of treatment. Appropriate measures must be taken to control any systemic infection before beginning therapy with Daunorubicin. It may transiently impart a red coloration to the urine after administration, and patients should be advised to expect this. Daunorubicin Hydrochloride Injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration. Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m2 in adults, 300 mg/m2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. It is recommended that Daunorubicin Hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection. Dosage should be reduced in patients with impaired hepatic or renal function.

Cytotoxic Chemotherapy

The sterile vial contents provide 20 mg of Daunorubicin, with 5 mg of Daunorubicin per ml. The desired dose is withdrawn into a syringe containing 10 ml to 15 ml of 0.9% sodium chloride injection, USP and then injected into the tubing or sidearm in a rapidly flowing IV infusion of 5% Dextrose injection, USP or 0.9% Sodium Chloride Injection, USP. Daunorubicin Hydrochloride should not be administered mixed with other drugs or heparin.