Pregnancy Cat

Pregnancy Category D. There are no adequate and well-controlled studies in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions from Epirubicin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Precautions

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours of equilibration at controlled room temperature (15°-25°C). Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures for proper handling and disposal of anticancer drugs should be used when handling and preparing Epirubicin.Epirubicin Injection should be administered only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Before beginning treatment with Epirubicin, patients should be recovered from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment. Also, initial treatment with Epirubicin should be preceded by a careful baseline assessment of blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF). Patients should be monitored carefully during treatment for possible clinical complications due to myelosuppression. Supportive care may be necessary for the treatment of severe neutropenia and severe infectious complications. Monitoring for potential cardiotoxicity is also important, especially with greater cumulative exposure to Epirubicin.

Overdose Effects

If an overdose occurs, supportive treatment should be provided (including antibiotic therapy, blood and platelet transfusions, colony-stimulating factors, and intensive care as needed) until the recovery of toxicities. Delayed CHF has been observed months after anthracycline administration. Patients should be observed carefully over time for signs of CHF and provided with appropriate supportive therapy.

Drug Classes

Cytotoxic Chemotherapy

Storage Conditions

Store in refrigerator or at 2-8°C. Do not freeze. Protect from light and keep out of the reach of children.

Composition

n/a

Mode Of Action

Epirubicin Hydrochloride, an anthracycline with cytotoxic properties. It inhibits DNA and RNA synthesis by steric obstruction after intercalating between DNA base pairs that triggers DNA cleavage by topoisomerase II. It also inhibits DNA helicase and generates cytotoxic free radicals.Distribution: Following IV administration, Epirubicin is rapidly and widely distributed into the tissues. Binding of Epirubicin to plasma proteins, predominantly albumin, is about 77% and is not affected by drug concentration.Metabolism: Epirubicin is extensively and rapidly metabolized by the liver and is also metabolized by other organs and cells, including red blood cells.Excretion: Epirubicin and its major metabolites are eliminated through biliary excretion and, to a lesser extent, by urinary excretion. Terminal elimination half-life is 30-40 hrs.

Reconstitution

n/a