Doxorubicin Hcl Solution

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PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

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

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

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

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

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

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

    Disseminated neoplasias (eg, neuroblastoma).

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

    Disseminated neoplasias (eg, gastric carcinoma).

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

    Disseminated neoplasias (eg, ovarian carcinoma).

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

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

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

    Disseminated neoplasias (eg, thyroid carcinoma).

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

    Doxorubicin Hcl Solution Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Doxorubicin HCl 2mg/mL; soln for IV inj.

    Pharmacological Class

    Anthracycline.

    See Also

    How Supplied

    Contact supplier.

    Manufacturer

    Various generic manufacturers

    Doxorubicin Hcl Solution Indications

    Indications

    Disseminated neoplasias (eg, bronchogenic carcinoma).

    Doxorubicin Hcl Solution Dosage and Administration

    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.

    Doxorubicin Hcl Solution Contraindications

    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.

    Doxorubicin Hcl Solution Boxed Warnings

    Boxed Warning

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

    Doxorubicin Hcl Solution Warnings/Precautions

    Warnings/Precautions

    Risk of cardiomyopathy (including left ventricular failure), arrhythmias. Pre-existing heart disease or risk thereof. Obtain CBCs, bilirubin, SGOT/SGPT, creatinine, LVEF prior to and during therapy. Monitor cardiac function (eg, MUGA, echocardiogram), blood uric acid levels, potassium, calcium, and phosphate after initiation. Secondary malignancies. Tumor lysis syndrome. Radiation sensitization/recall. Avoid extravasation. Hepatic impairment. Children (late cardiovascular dysfunction). Elderly. Embryo-fetal toxicity (avoid during 1st trimester). Advise to use effective contraception during and for 6 months (females) and 3 months (males w. female partners) after the last dose. Males w. pregnant partners should use condoms during for ≥10 days after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 10 days after the last dose).

    Doxorubicin Hcl Solution Pharmacokinetics

    See Literature

    Doxorubicin Hcl Solution Interactions

    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).

    Doxorubicin Hcl Solution Adverse Reactions

    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.

    Doxorubicin Hcl Solution Clinical Trials

    See Literature

    Doxorubicin Hcl Solution Note

    Not Applicable

    Doxorubicin Hcl Solution Patient Counseling

    See Literature

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