Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, bladder carcinoma, Wilms' tumor).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Bone and connective tissue cancer:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, soft tissue and bone sarcomas).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Breast cancer:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, breast carcinoma). Adjunct in breast cancer after resection.

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

CNS cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, neuroblastoma).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Colorectal and other GI cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, gastric carcinoma).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Gynecologic cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, ovarian carcinoma).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Leukemias, lymphomas, and other hematologic cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, acute lymphoblastic leukemia, acute myeloblastic leukemia, Hodgkin's disease, malignant lymphoma).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Pancreatic, thyroid, and other endocrine cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, thyroid carcinoma).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.

Respiratory and thoracic cancers:

Indications for Doxorubicin HCl:

Disseminated neoplasias (eg, bronchogenic carcinoma).

Adults and Children:

Monotherapy: usually 60–75mg/m2 IV every 21 days. Combination therapy: usually 40–60mg/m2 IV every 21 to 28 days. Hyperbilirubinemia, inadequate bone marrow reserves: reduce dose.

Contraindications:

Severe myelosuppression (baseline neutrophils <1500cells/mm3) or severe hepatic impairment. Cardiac disease (eg, severe myocardial insufficiency, arrhythmias). Recent MI. Previous treatment with max cumulative doses of anthracyclines, anthracenediones.

Boxed Warning:

Cardiomyopathy. Secondary malignancies. Extravasation and tissue necrosis. Severe myelosuppression.

Warnings/Precautions:

Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain baseline CBC, bilirubin, SGOT/SGPT, creatinine, LVEF. Monitor cardiac function (eg, MUGA, echocardiogram), hepatic function, CBC, uric acid levels. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity. Advise females and males of reproductive potential to use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D): avoid during 1st trimester. Nursing mothers: not recommended.

Pharmacologic Class:

Anthracycline.

Interactions:

See Contraindications. Avoid concomitant inhibitors or inducers of CYP3A4, CYP2D6, or P-gp. Mediastinal irradiation, cyclophosphamide, other anthracyclines increase risk of cardiac toxicity. May increase toxicity of cyclophosphamide, mercaptopurine. Avoid dexrazoxane (during initiation), trastuzumab (for up to 7 months). Doxorubicin toxicity increased if given after paclitaxel infusion (give doxorubicin dose first).

Adverse Reactions:

Local necrosis if extravasation occurs, myocardial toxicity (immediate or delayed), arrhythmias, leukemia, myelosuppression, hyperuricemia, urine discoloration, alopecia, hyperpigmentation, severe GI upset/ulceration, phlebosclerosis, facial flushing, fever, urticaria, peripheral neuropathy, anaphylaxis.

How Supplied:

Contact supplier.