Doxutec Injection

Doxorubicin Injection is an anthracycline topoisomerase inhibitor indicated: - as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer - for the treatment of:,,, Non-,,,,, metastatic bone sarcomas,,,,, Adjuvant Breast Cancer Doxorubicin Injection is indicated. Other Cancers Doxorubicin Injection is indicated for the treatment of - acute lymphoblastic leukemia - acute myeloblastic leukemia - Hodgkin lymphoma - non- (NHL) - metastatic breast cancer - metastatic Wilms' tumor - metastatic neuroblastoma - metastatic soft tissue sarcoma - metastatic bone sarcoma - metastatic ovarian carcinoma - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION - Cardiomyopathy: Myocardial damage, including acute left ventricular failure, can occur with Doxorubicin. The risk of cardiomyopathy is proportional to the cumulative exposure with incidence rates from 1%–20% for cumulative doses ranging from 300 mg/m 2 to 500 mg/m 2 when Doxorubicin is administered every 3 weeks. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with Doxorubicin. - Secondary Malignancies: Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including Doxorubicin. - Extravasation and Tissue Necrosis: Extravasation of Doxorubicin can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting. Immediately terminate the drug and apply ice to the affected area. - Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION See full prescribing information for complete boxed warning. - Cardiomyopathy: Myocardial damage can occur with Doxorubicin with incidences from 1%–20% for cumulative doses from 300 mg/m 2 to 500 mg/m 2 when Doxorubicin is administered every 3 weeks. - Extravasation and Tissue Necrosis: Extravasation of Doxorubicin can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. - Radiation-Induced Toxicity: Can be increased by the administration of Doxorubicin Injection. Radiation recall can occur in patients who receive Doxorubicin Injection after prior radiation therapy. - Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms. Cardiomyopathy and Arrhythmias Cardiomyopathy Doxorubicin can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to the cumulative exposure. Include prior doses of other anthracyclines or anthracenediones in calculations of total cumulative dosage for Doxorubicin. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are described elsewhere in the labeling. - Cardiomyopathy and Arrhythmias - Secondary Malignancies - Extravasation and Tissue Necrosis - Severe Myelosuppression - Tumor Lysis Syndrome - Radiation Sensitization and Radiation Recall The most common (>10%) adverse reactions are alopecia, nausea and vomiting. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Breast Cancer The safety data below were collected from 1492 women who received Doxorubicin at a dose of 60 mg/m 2 and cyclophosphamide at a dose of 600 mg/m 2 (AC) every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer. The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in Table 2. No treatment-related deaths were reported in patients on either arm of the study. Table 2. Selected Adverse Reactions in Patients with Early Breast Cancer Involving Axillary Lymph Nodes Adverse Reactions AC Includes pooled data from patients who received either AC for 4 cycles or AC for 4 cycles followed by CMF for 3 cycles N = 1492 Conventional CMF N = 739 % % AC = Doxorubicin, cyclophosphamide; CMF = cyclophosphamide, methotrexate, fluorouracil Alopecia 92 71 Vomiting Vomiting ≤12 hours 34 25 Vomiting >12 hours 37 12 Intractable 5 2 Leukopenia Grade 3 (1,000–1,999 /mm 3 ) Grade 4 (<1000 /mm 3 ) Shock, sepsis 2 1 Systemic infection 2 1 Cardiac dysfunction Asymptomatic Transient 0.1 0 Symptomatic 0.1 0 Thrombocytopenia Grade 3 (25,000–49,999 /mm 3 ) 0 Grade 4 (<25,000 /mm 3 ) 0.1 0 Postmarketing Experience The following adverse reactions have been identified during postapproval use of Doxorubicin Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.