Indications & Uses
Daunobin is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Check all parenteral products visually for particulate matter before giving them. Representative dose schedules and combination for the approved indication of remission induction in adult acute nonlymphocytic leukemia, in combination: for patients under 60 years of age, Daunorubicin 45 mg/m2/day IV on days 1, 2 and 3 of the first course and on days 1 and 2 of later courses, together with cytosine arabinoside 100 mg/m2/day by IV infusion daily for 7 days in the first course and for 5 days in later courses. For patients aged 60 years and above, Daunorubicin 30 mg/m2/day IV on days 1, 2 and 3 of the first course and on days 1 and 2 of later courses, together with cytosine arabinoside 100 mg/m2/day by IV infusion daily for 7 days in the first course and for 5 days in later courses. This reduction in the Daunorubicin dose is based on a single study and may not be appropriate where optimal supportive care is available. Representative dose schedule and combination for the approved indication of remission induction in pediatric acute lymphocytic leukemia, in combination: Daunorubicin 25 mg/m2 IV on day 1 every week, Vincristine 1.5 mg/m2 IV on day 1 every week, and prednisone 40 mg/m2 by mouth daily. A complete remission is generally achieved within four such courses of therapy. If the patient is only in partial remission after four courses, one further course, or two if necessary, may be given in an effort to achieve complete remission. In children under 2 years of age or with a body surface area below 0.5 m2, it is recommended that the Daunorubicin dose be calculated by weight (1 mg/kg) rather than by body surface area. Representative dose schedules and combination for the approved indication of remission induction in adult acute lymphocytic leukemia, in combination: Daunorubicin 45 mg/m2/day IV on days 1, 2 and 3, and Vincristine 2 mg IV on days 1, 8 and 15; prednisone 40 mg/m2/day by mouth on days 1 through 22, then tapered between days 22 and 29; L-asparaginase 500 IU/kg/day IV for 10 days on days 22 through 32. Or, as directed by the registered physician.
Side Effects
Dose-limiting toxicity includes myelosuppression and cardiotoxicity. Other reactions include the following. Skin: Reversible hair loss occurs in most patients. Rash, contact dermatitis and hives have occurred rarely. Digestive system: Acute nausea and vomiting occur but are usually mild, and anti-sickness treatment may help to some extent. Mouth and gut lining inflammation may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported. At the injection site: If the drug leaks into surrounding tissue during administration, severe local tissue damage, severe cellulitis, vein inflammation or painful hardening of the skin can result. Acute reactions: Rarely, an allergic-type reaction, fever and chills can occur. Raised uric acid levels may occur, especially in patients with leukemia, so blood uric acid should be monitored.
Cautions & Contraindications
Warnings & Precautions
Daunobin therapy requires close patient observation and frequent complete blood-count testing. Cardiac, kidney, and liver function should be checked before each course of treatment. Any systemic infection must be brought under control before starting Daunobin therapy. The medicine may cause a temporary red coloration of the urine after it is given, and patients should be told to expect this. Daunobin 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 damage will occur if the drug leaks outside the vein during administration. Myocardial toxicity, which in its most severe form appears as potentially fatal congestive heart failure, may occur either during therapy or months to years after it ends. The risk of this myocardial toxicity rises once the total cumulative dose passes 400 to 550 mg/m2 in adults, 300 mg/m2 in children older than 2 years, or 10 mg/kg in children younger than 2 years. Severe suppression of bone marrow function occurs at therapeutic doses and may lead to infection or bleeding. Daunobin Hydrochloride should be given only by physicians experienced in leukemia chemotherapy, in facilities with the laboratory and supportive resources needed to monitor how well a patient tolerates the drug and to protect and support a patient affected by its toxicity. The physician and institution must be able to respond quickly and fully to severe bleeding and to overwhelming infection. Dosage should be lowered in patients with impaired liver or kidney function.
Contraindications
This medicine should not be used by anyone who is known to be hypersensitive to Daunorubicin or to any of the other ingredients in this product.