Daunoblastina Dosage/Direction for Use

The single dose can vary from 0.5 to 3 mg/kg. The doses of 0.5-1 mg/kg can be repeated at intervals of 1 or more days; the doses of 2 mg/kg should be given at intervals of 4 or more days; the doses of 2.5-3 mg/kg, although rarely used, should be given only at intervals of 7-14 days. The number of injections required varies widely from patient to patient and should be prescribed for each individual case, depending on individual response and tolerability, taking into account blood chemistry and bone marrow conditions and any association with other antiblastic agents. In both adults and children it is recommended not to exceed the total dose of 20 mg/kg (see Precautions).
Hepatic impairment: The dosage of Daunorubicin should be reduced in patients who present impairment of liver function so as to avoid an increase in global toxicity.
It is recommended a dosage reduction in patients with the following chemical parameters in the blood: Daunorubicin should not be administered to patients with severe hepatic impairment (Child-Pugh Grade C [total score 10-15] - see Contraindications).
For patients with mild and moderate hepatic impairment (Child-Pugh Grade A [total score 5-6] and B [total score 7-9]), dose reductions are recommended based on the following serum bilirubin values: Bilirubin 1.2 to 3 mg/dL: one-half of recommended starting dose.
Bilirubin >3 mg/dL: one-fourth of recommended starting dose.
Renal impairment: For patients with moderate renal impairment, glomerular filtration rate (GFR) between 10-20 mL/min or serum creatinine approximately between 3.4-7.9 mg/dL, the daunorubicin dose should be reduced by one-half (see Contraindications).
Method of Administration: Daunorubicin is not active if taken orally and should not be administered by intramuscular or intrathecal route. Administration is to be effected only by intravenous injection; it is advisable to effect the injection into the tubing of an intravenous infusion of normal saline solution already in situ, after ascertaining that the needle is perfectly in the vein. This technique reduces the danger of the drug leaking out and ensures that the vein is well washed through after administration of the drug.
Daunorubicin must not be mixed with heparin since these drugs show chemical incompatibility and, in certain proportions, form a precipitate.
Paediatric population: Daunorubicin dosage for children (over 2 years of age) is usually calculated based on the body surface area and adjusted to meet individual requirements of each patient, on the basis of clinical response and the patient's haematological status. Courses may be repeated after 3 to 6 weeks.
Current specialized protocols and guidelines should be consulted for appropriate treatment regimen.
For children over 2 years of age the maximum cumulative dose is 300 mg/m².
For children under 2 years of age (or with body surface area below 0.5 m²), the maximum cumulative dose is 10 mg/kg.