Adult Dosing
Acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma
- Monotherapy
- 60-75 mg/m2 IV over 3-5 mins x1 q21 days
- Give lower effective dose in patient with inadequate marrow reserve
- In combination with other chemotherapeutic agents
- 40-60 mg/m2 IV x1 q21-28 days
Early breast cancer involving axillary lymph nodes
- 60 mg/m2 IV 3-5 mins on day 1 of each 21 days treatment cycle x 4 cycles, give in combination with cyclophosphamide 600 mg/m2
Note:
- Administered into the tubing of a freely running intravenous infusion of sodium chloride injection or 5% dextrose injection
Pediatric Dosing
Acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma
- Monotherapy
- 35-75 mg/m2 IV over 3-5 mins x1 q21 days
Note:
- Administered into the tubing of a freely running intravenous infusion of sodium chloride injection or 5% dextrose injection
[Outline]
- Administer doxorubicin only under the supervision of a qualified physician experienced in the use of cytotoxic therapy [US Black Box Warning]
- Cardiotoxicity manifested by early or late events has been reported with anthracycline treatment. The risk of serious cardiac impairment can be decreased through regular monitoring of LVEF during the course of treatment. Discontinue doxorubicin immediately at the first sign of impaired function [US Black Box Warning]
- Secondary AML or MDS has been reported with chemotherapy regimens containing anthracyclines (including doxorubicin) and DNA-damaging antineoplastic agents, in combination with radiotherapy [US Black Box Warning]
- Before starting doxorubicin treatment, patients should recover from acute toxicities of prior cytotoxic treatment such as stomatitis, neutropenia, thrombocytopenia, and generalized infections
- Evaluate carefully baseline blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF), before initiating doxorubicin treatment
- Monitor the patient carefully for possible clinical complications due to myelosuppression and cardiotoxicity. Provide necessary supporitive care for the treatment of severe neutropenia and severe infectious complication
- Myelosuppression has been reported with doxorubicin, Severe myelosuppression results in fever, infections, sepsis/septicemia, septic shock, hemorrhage, tissue hypoxia, or death. Measure total and differential WBC, red blood cell (RBC), and platelet counts before and during each cycle of therpy
- Leukopenia and/or granulocytopenia, the predominant manifestations of doxorubicin hematologic toxicity, are dose dependant and reversible, reaching nadir 10 to 14 days after treatment with recovery usually occurring by the 21st day
- Injection into a small vessel or repeated injections into the same vein, can result in phlebosclerosis. Follow the recommended administration procedures to minimize the risk of phlebitis/thrombophlebitis at the injection site
- Extravasation with or without an accompanying stinging or burning sensation, even if blood returns well on aspiration of the infusion needle, can occur on intravenous administration of doxorubicin. Immediately terminate the injection or infusion and restart in another vein if any sign of extravasation occurs
- As doxorubicin is metabolized and excreted predominantly by the hepatobiliary route, toxicity due to doxorubicin is enhanced by hepatic impairment. Hence evaluate hepatic function using conventional laboratory tests such as SGOT, SGPT, alkaline phosphatase, and bilirubin prior to individual dosing
- Vaccination with a live vaccine should be avoided in patients receiving doxorubicin as administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including doxorubicin, may result in serious or fatal infections
- Doxorubicin can cause fetal harm when administered to a pregnant woman, avoid use in pregnancy. Women of childbearing age should be advised to avoid becoming pregnant and if the patient becomes pregnant during therapy, the patient should be warned of the potential hazard to the fetus
- Doxorubicin is emetigenic, therefore use prophylactic antiemetics before administering doxorubicin particularly when given in conjunction with other emetigenic drugs
- Do not administer doxorubicin in combination with other cardiotoxic agents unless the patient's cardiac function is closely monitored
Cautions: Use cautiously in
- Hepatic impairment
- Cardiovascular diseases
- History of cardiovascular diseases
- Concomitant use of cardiotoxic agent
- Concomitant myelosuppressive agents
- Concomitant radiotherapy
- Myelosuppression
- Pediatric patients
- Elderly patients
Pregnancy Category:D
Breastfeeding: Breastfeeding is contraindicated during maternal antineoplastic drug therapy, however it might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence; however, high levels and persistence of doxorubicinol in milk make defining an appropriate abstinence interval difficult. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 5 March 2011). Doxorubicin and its major metabolite doxorubicinol is excreted in the milk. Because of the potential for serious adverse reactions in nursing infants from doxorubicin, manufacturer advises to discontinue nursing during doxorubicin therapy.
