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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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Uses
Breast Cancer
Conventional doxorubicin: Treatment (in combination with other antineoplastic agents) of breast cancer.
Combination chemotherapy, as adjunct to surgery, increases disease-free (i.e., decreased recurrence) and overall survival in premenopausal and postmenopausal women with node-negative or -positive early (TNM stage I or II) breast cancer.
Adjuvant combination chemotherapy that includes cyclophosphamide, methotrexate, and fluorouracil has been used most extensively and is considered a regimen of choice for early breast cancer, but doxorubicin-containing regimens (e.g., combined cyclophosphamide and doxorubicin with or without fluorouracil; combined cyclophosphamide and doxorubicin with or without tamoxifen) appear to be comparably effective and also are considered regimens of choice; differences in toxicity profiles may influence choice of regimen.
In stage III (locally advanced) breast cancer, commonly employed effective regimens (with or without hormonal therapy) used sequentially after surgery and radiation therapy for operable disease and after biopsy and radiation therapy for inoperable disease include cyclophosphamide, methotrexate, and fluorouracil; cyclophosphamide, doxorubicin, and fluorouracil; and cyclophosphamide, methotrexate, fluorouracil, and prednisone; combined cyclophosphamide and doxorubicin therapy also has been used. These and other regimens have been used in treatment of more advanced (stage IV) and recurrent disease.
AIDS-related Kaposi’s Sarcoma
Conventional doxorubicin: Has been used alone or in combination chemotherapy for the palliative treatment of AIDS-related Kaposi’s sarcoma†.
Liposomal doxorubicin: Palliative treatment of AIDS-related Kaposi’s sarcoma in adults intolerant to combination chemotherapy or whose disease has progressed while receiving such therapy.
Combination chemotherapy that includes conventional doxorubicin (with bleomycin and vincristine) has been a preferred regimen, but many clinicians currently consider a liposomal anthracycline (doxorubicin or daunorubicin) the first-line therapy of choice for advanced AIDS-related Kaposi’s sarcoma.
Ovarian Cancer
Conventional doxorubicin: Has been used in treatment (in combination chemotherapy regimens) of ovarian carcinoma, but other agents currently are preferred.
Liposomal doxorubicin: Palliative treatment of metastatic ovarian carcinoma that is refractory to both paclitaxel- and platinum-based chemotherapy regimens (designated an orphan drug by FDA for this use).
Further study is needed to establish role of liposomal doxorubicin in the treatment of advanced epithelial ovarian cancer.
Bladder Cancer
Conventional doxorubicin: Treatment (in combination regimens with cisplatin, methotrexate, and vinblastine) of invasive and advanced bladder carcinoma.
Has been used intravesically† for treatment of residual tumor and/or as adjuvant therapy for prophylaxis of superficial bladder carcinoma†.
Evidence is limited, but other agents (e.g. mitomycin, epirubicin) appear to be similar in efficacy but less toxic than doxorubicin and generally are preferred for prophylaxis or treatment of superficial bladder cancer.
Small Cell Lung Cancer
Conventional doxorubicin: Treatment (in combination chemotherapy regimens) of extensive-stage small cell lung cancer†.
Other Uses
Conventional doxorubicin hydrochloride: Treatment of solid tumors including thyroid carcinoma, gastric carcinoma, soft-tissue and osteogenic sarcomas, neuroblastoma, and Wilms' tumor; malignant lymphomas of both Hodgkin and non-Hodgkin type; and acute lymphocytic (lymphoblastic) leukemia.
Conventional doxorubicin hydrochloride: Treatment of carcinoid tumors†, hepatoblastoma†, and retinoblastoma†.
Conventional doxorubicin hydrochloride: Treatment of Ewing’s sarcoma†, squamous cell carcinoma of the cervix† and prostate†, and uterine cancer†.
Conventional doxorubicin hydrochloride: Used in combination therapy (with vincristine and high-dose dexamethasone) for refractory multiple myeloma†.
Although conventional doxorubicin is labeled for use in the treatment of AML, other agents are preferred.
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