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SaveGeneric Name: DOXOrubicin
FDA Alerts-
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Extravasation
- Severe local tissue necrosis if extravasation occurs. Do not administer IM or sub-Q.
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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.
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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.
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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.
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Myelosuppression
- Severe myelosuppression may occur. (See Hematologic Effects under Cautions.)
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Hepatic Impairment
- Reduce dosage in patients with hepatic impairment. (See Special Populations under Dosage and Administration and also see Hepatic Impairment under Cautions.)
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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.
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Experience of Supervising Clinician
- Administer only under the supervision of qualified clinician experienced in the use of cancer chemotherapeutic agents.
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- Interactions
Do not use doxorubicin without first talking to your doctor if you have had previous treatment with doxorubicin (Adriamycin, Rubex), doxorubicin liposomal (Doxil), daunorubicin (Cerubidine), daunorubicin liposomal (Daunoxome), idarubicin (Idamycin), or mitoxantrone (Novantrone). Because there is a maximum amount of these medications that should be administered to an individual, you may not be able to use doxorubicin.
Before using doxorubicin, tell your doctor if you are taking any of the following medicines.
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paclitaxel (Taxol);
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progesterone (Prometrium);
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verapamil (Calan, Calan SR, Covera-HS, Isoptin, Isoptin SR, Verelan, Verelan PM, others)
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cyclosporine (Gengraf, Neoral, Sandimmune);
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cyclophosphamide (Cytoxan, Cytoxan Lyophilized, Neosar);
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phenobarbital;
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phenytoin (Dilantin); or
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streptozocin (Zanosar).
You may not be able to take doxorubicin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Do not receive "live" vaccines during treatment with doxorubicin. Administration of a live vaccine may be dangerous during treatment with doxorubicin.
Drugs other than those listed here may also interact with doxorubicin. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with doxorubicin.
If you experience any of the following serious side effects from doxorubicin, contact your doctor immediately:
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an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
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decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
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congestive heart failure (difficulty breathing, fluid retention, chest pain);
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irregular heartbeats;
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tissue or vein reactions near the site of administration;
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liver damage (abdominal pain, yellowing of the skin or eyes);
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severe nausea, vomiting, diarrhea, and loss of appetite;
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inflamation and sores inside the mouth, throat, or intestines;
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fever, chills, or other signs of infection;
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numbness, tingling, or difficult movement of a body part;
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seizures; or
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increased levels of uric acid in the body (joint pain and stiffness).
Other, less serious side effects may be more likely to occur. Continue taking doxorubicin and talk to your doctor if you experience:
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facial flushing during administration;
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eye irritation or tearing;
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darkening of the nail beds and skin folds;
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temporary hair loss; or
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red colored urine for 1 or 2 days following a dose.
Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with doxorubicin.
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