Doxorubicin Hcl Liposome (doxorubicin HCl pegylated liposomal)

To obtain optimum therapeutic results with minimum adverse effects, dosage of doxorubicin hydrochloride must be based on the clinical, cardiac, hepatic, renal, and hematologic response and tolerance of the patient and on other chemotherapy or irradiation being used. Dosage reduction may be necessary in patients who have received extensive prior radiation therapy or in those whose bone marrow has been infiltrated with malignant cells, since severe myelosuppression is likely to occur. Clinicians should consult published protocols for the dosage of doxorubicin hydrochloride and other chemotherapeutic agents and the method and sequence of administration. Dosage of doxorubicin hydrochloride is based indirectly on body weight; if the patient has abnormal fluid retention, the patient's ideal weight is used to calculate body surface area.

Accidental substitution of liposomal doxorubicin for conventional doxorubicin hydrochloride injection has resulted in severe adverse effects. Liposomal doxorubicin hydrochloride should not be substituted for conventional doxorubicin hydrochloride, and the drugs are not equivalent on a mg per mg basis.

The total cumulative dose of doxorubicin hydrochloride should not exceed 550 mg/m2 because of the risk of potentially irreversible cardiotoxicity, but higher cumulative doses may be tolerated when dexrazoxane (Zinecard(R)) is used concomitantly as a cardioprotectant. (See Cautions: Cardiac Effects.) If previous or concomitant therapy includes the use of other potentially cardiotoxic agents, such as cyclophosphamide, or irradiation of the cardiac region, total doxorubicin hydrochloride dosage should not exceed 400 mg/m2. The total dosage of doxorubicin hydrochloride should include any previous or concomitant therapy with other anthracycline agents or related compounds.

In adults with impairment of hepatic function, conventional or liposomal doxorubicin dosage must be reduced. Patients with serum bilirubin concentrations of 1.2-3 mg/dL should receive 50% of the usual dose of doxorubicin hydrochloride and those with serum bilirubin concentrations exceeding 3 mg/dL should receive 25% of the usual dose.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies employing liposomal doxorubicin have not been performed to date; therefore, pending further accumulation of data, drugs known to interact with conventional (nonencapsulated) doxorubicin should be considered to also interact with the liposomal formulation. In addition, although most patients who have received liposomal doxorubicin to date were receiving antiviral therapy concomitantly, the potential for interactions with these drugs has not been evaluated.

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.

Doxorubicin can cause fetal toxicity when administered to pregnant women, but potential benefits from use of the drug may be acceptable in certain conditions despite the possible risks to the fetus. The drug is embryotoxic and teratogenic in rats and embryotoxic and abortifacient in rabbits, and trace amounts of drug have been found in mouse fetuses and in one aborted human fetus following administration of conventional (nonencapsulated) doxorubicin. Liposomal doxorubicin is embryotoxic at doses of 1 mg/kg daily (about one-eighth the 50 mg/m2 human dose on a mg/m2 basis) in rats and is embryotoxic and abortifacient at doses of 0.5 mg/kg daily (about one-eighth the 50 mg/m2 human dose on a mg/m2 basis) in rabbits. Embryotoxicity consisted of increased embryo-fetal deaths and reduced live litter sizes.

There are no adequate and well-controlled studies to date using conventional or liposomal doxorubicin in pregnant women. Doxorubicin should be used during pregnancy only in life-threatening situations or for disease for which safer drugs cannot be used or are ineffective. When conventional or liposomal doxorubicin is used during pregnancy, or if the patient becomes pregnant while receiving the drug, the patient should be apprised of the potential hazard to the fetus. If a patient becomes pregnant during the first few months following liposomal doxorubicin therapy, the prolonged elimination half-life of the drug must be taken into account. Women of childbearing potential should be advised to avoid becoming pregnant during doxorubicin therapy.

Conventional (nonencapsulated) doxorubicin is distributed into milk. It is not known whether liposomal doxorubicin is distributed into milk. Because of the potential for serious adverse reactions to doxorubicin in nursing infants, nursing should be discontinued during doxorubicin therapy. Liposomal doxorubicin is contraindicated in nursing women.

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