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Generic Name: DOXOrubicin

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An antibiotic/antineoplastic - treats Hodgkin's Disease, Lymphoma, Acute Myeloblastic Leukemia, Bron... more

FDA Alerts

Extravasation

Severe local tissue necrosis if extravasation occurs. Do not administer IM or sub-Q.

Myocardial Toxicity

Possible cardiotoxicity and potentially fatal CHF during or months to years after therapy; risk of developing CHF increases rapidly with increasing total cumulative dosages >450 mg/m². Toxicity may occur at lower cumulative dosages whether or not risk factors are present. (See Cardiotoxicity under Cautions.)
Probability of developing impaired myocardial function based on combined index of signs, symptoms, and decline in LVEF is estimated to be 1–2, 3–5, 5–8, or 6–20% at total cumulative dosage of 300, 400, 450, or 500 mg/m², respectively.
Risk factors (active or dormant cardiovascular disease, doxorubicin exposure at an early or advanced age, prior or concomitant mediastinal/pericardial irradiation, previous therapy with other anthracyclines or anthracenediones, concomitant use of other cardiotoxic agents) may increase risk of cardiotoxicity.
Pediatric patients are at increased risk for developing delayed cardiotoxicity.
Experience with liposomal doxorubicin at high cumulative dosages is too limited to have established effects on the myocardium; assume myocardial toxicity is similar to that of conventional doxorubicin formulations. Administer to patients with history of cardiovascular disease only when benefits outweigh risk.

Secondary Acute Myelogenous Leukemia (AML)

Possible secondary AML in patients treated with anthracyclines, including doxorubicin; occurrence of refractory secondary leukemia is more common when such drugs are given in combination with other DNA-damaging antineoplastics, after extensive exposure to cytotoxic agents, or when anthracyline dosages have been escalated. (See Mutagenicity and Carcinogenicity under Cautions.)
Pediatric patients are at risk of developing secondary AML.

Infusion-related Effects

Infusion-related reactions (e.g., flushing, shortness of breath, facial swelling, headache, chills, back pain, tightness of chest or throat, hypotension) reported in patients receiving liposomal doxorubicin. Reactions generally resolve within several hours to a day once infusion terminated; may resolve in some patients with slowing of infusion rate.
Serious and sometimes life-threatening or fatal allergic/anaphylactoid-like infusion reactions reported; appropriate therapy and emergency equipment should be available for immediate use.
Administer liposomal doxorubicin at initial rate of 1 mg/minute to minimize risk of infusion reactions.

Myelosuppression

Severe myelosuppression may occur. (See Hematologic Effects under Cautions.)

Hepatic Impairment

Reduce dosage in patients with hepatic impairment. (See Special Populations under Dosage and Administration and also see Hepatic Impairment under Cautions.)

Accidental Substitution

Accidental substitution of liposomal doxorubicin for conventional doxorubicin has resulted in severe adverse effects; do not substitute for conventional doxorubicin on a mg-per-mg basis.

Experience of Supervising Clinician

Administer only under the supervision of qualified clinician experienced in the use of cancer chemotherapeutic agents.

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What is the most important information I should know about doxorubicin?

Doxorubicin should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of doxorubicin including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); severe heart damage with prolonged use; decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection); severe nausea, vomiting, diarrhea, and loss of appetite; and others. Talk to your doctor about the possible side effects from treatment with doxorubicin.

What is doxorubicin?

Doxorubicin is a cancer (antineoplastic) medication. Doxorubicin interferes with the growth of cancer cells and slows their growth and spread in the body.

Doxorubicin is used to treat many types of cancer.

Doxorubicin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using doxorubicin?

Do not use doxorubicin without first talking to your doctor if you have

kidney disease;
liver disease;
heart disease;
poor bone marrow function;
received radiation therapy that encompassed the heart; or
previously received treatment with doxorubicin (Adriamycin, Rubex), doxorubicin liposomal (Doxil), daunorubicin (Cerubidine), daunorubicin liposomal (Daunoxome), idarubicin (Idamycin), or mitoxantrone (Novantrone).

The use of doxorubicin may be dangerous if you have any of the conditions listed above.

Doxorubicin is in the FDA pregnancy category D. This means that doxorubicin is known to be harmful to an unborn baby. Do not use doxorubicin without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment with doxorubicin if necessary. Because of the potential for serious side effects in a nursing infant, breast-feeding should be avoided during treatment with doxorubicin. Children have an increased risk of heart problems due to treatment with doxorubicin. Growth and gonadal development may also be affected.

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