Daunorubicin (daunorubicin HCl)

Dosage of daunorubicin hydrochloride is expressed in terms of daunorubicin. Dosage of daunorubicin must be based on the clinical and hematologic response and tolerance of the patient and whether or not other chemotherapy or radiation therapy has been or is also being used in order to obtain optimum therapeutic results with minimum adverse effects. Clinicians should consult published protocols for the dosage of daunorubicin and other chemotherapeutic agents and the method and sequence of administration.

Doses of conventional or liposomal daunorubicin should be reduced in patients with hepatic or renal impairment. The manufacturers recommend that patients with serum bilirubin concentrations of 1.2-3 mg/dL receive 75% of the usual dose and those with serum bilirubin concentrations exceeding 3 mg/dL receive 50% of the usual dose of daunorubicin. The manufacturers recommend that patients with serum creatinine concentrations exceeding 3 mg/dL receive 50% of the usual dose of daunorubicin.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Liposomal daunorubicin citrate has been studied mainly in patients with Kaposi's sarcoma; such patients usually receive a variety of concomitant drugs (e.g., antiretroviral agents, antiviral agents, anti-infective agents). Although interactions of daunorubicin citrate liposomal injection with other drugs have not been reported, no formal drug interaction studies employing liposomal daunorubicin citrate have been performed to date.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Conventional (nonencapsulated) daunorubicin can cause fetal toxicity when administered to pregnant women, but potential benefits from use of the drug may be acceptable in certain conditions despite possible risks to the fetus. An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was observed in rabbits receiving conventional (nonencapsulated) daunorubicin at doses of 0.05 mg/kg daily (approximately 1/100th of the highest recommended human dose based on body surface area). An increased incidence of esophageal, cardiovascular, and urogenital abnormalities as well as rib fusions were observed in rats receiving conventional (nonencapsulated) daunorubicin at doses of 4 mg/kg daily (approximately one-half the human dose based on body surface area). Decreased fetal birthweight and post-delivery growth rate were observed following administration of the drug to mice.

Encapsulated daunorubicin citrate in liposomes also can cause fetal toxicity when administered to pregnant women. Reproduction studies in rats given liposomal daunorubicin dosages of 2 mg/kg daily (approximately (1/3) of the recommended human dosage on a mg/m2 basis) revealed evidence of severe maternal toxicity and embryolethality, while dosages of 0.3 mg/kg daily (approximately 120th of the recommended human dosage on a mg/m2 basis) were associated with embryotoxicity (e.g., increased embryofetal deaths, reduction in the number of offspring per litter, decreased litter sizes) and fetal malformations (characterized by anophthalmia, microphthalmia, and incomplete ossification).

There are no adequate and well-controlled studies using conventional or liposomal daunorubicin in pregnant women. Conventional or liposomal daunorubicin should be used during pregnancy only in life-threatening situations or severe disease for which safer drugs cannot be used or are ineffective. If the drug is administered during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant while receiving the drug.

It is not known whether daunorubicin is distributed into milk. Because of the potential for serious adverse reactions to daunorubicin in nursing infants, nursing should be discontinued during daunorubicin therapy.

No enhanced messaging available.