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DOXIL
Gynecologic cancers
Kaposi's sarcoma
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

DOXIL Rx

Generic Name and Formulations:
Doxorubicin HCl (liposomal) 2mg/mL; dispersion for IV infusion after dilution; preservative-free.

Company:
Janssen Biotech, Inc.

Therapeutic Use:

Indications for DOXIL:

Ovarian cancer refractory to platinum-based chemotherapy.

Adult:

Give by IV infusion at initial rate of 1mg/min; may increase rate to complete infusion over 1hr if no infusion reactions occur; may premedicate with antiemetics. 50mg/m2 once every 4 weeks; continue for at least 4 cycles as tolerated. Hepatic dysfunction (serum bilirubin ≥1.2mg/dL), hand-foot syndrome, hematologic toxicity (esp. ANC, platelets), or stomatitis: reduce dose. Consider total anthracycline and anthracenedione doses and irradiation when calculating total cumulative dose. See full labeling.

Children:

Not established.

Warnings/Precautions:

Not substitutable on a mg/mg basis with other doxorubicin products. Cardiomyopathy (including left ventricular failure), acute infusion-related reactions, myelosuppression may occur. Have medications to treat infusion-related reactions and resuscitative equipment available. Hepatic impairment. Monitor blood (esp. CBC + platelets), hepatic (esp. SGOT/SGPT, alkaline phosphatase), and cardiac function (eg, MUGA, ECG). Monitor periodically for secondary oral cancers with long-term use. Avoid extravasation. Embryo-fetal toxicity. Use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

Caution with cyclosporine, phenobarbital, phenytoin, streptozocin, digoxin, myelosuppressants, others. Previous mediastinal irradiation, cyclophosphamide, other cardiotoxic drugs: monitor for cardiotoxicity and hepatotoxicity.

Pharmacological Class:

Anthracycline.

Adverse Reactions:

Asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand and foot syndrome, rash, neutropenia, thrombocytopenia, anemia; infusion reactions, cardiovascular events (eg, cardiomyopathy, CHF, acute LV failure), recall of skin reaction from prior radiation therapy, toxoplasmosis, urine discoloration (red/orange).

Elimination:

Hepatic.

Generic Availability:

YES

How Supplied:

Single-use vials (10mL, 25mL)—1

Indications for DOXIL:

AIDS-related Kaposi's sarcoma refractory to combination chemotherapy.

Adult:

Give by IV infusion at initial rate of 1mg/min; may increase rate to complete infusion over 1hr if no infusion reactions occur; may premedicate with antiemetics. 20mg/m2 once every 3 weeks. Hepatic dysfunction (serum bilirubin ≥1.2mg/dL), hand-foot syndrome, hematologic toxicity (esp. ANC, platelets), or stomatitis: reduce dose. Consider total anthracycline and anthracenedione doses and irradiation when calculating total cumulative dose. See full labeling.

Children:

Not established.

Warnings/Precautions:

Not substitutable on a mg/mg basis with other doxorubicin products. Cardiomyopathy (including left ventricular failure), acute infusion-related reactions, myelosuppression may occur. Have medications to treat infusion-related reactions and resuscitative equipment available. Hepatic impairment. Monitor blood (esp. CBC + platelets), hepatic (esp. SGOT/SGPT, alkaline phosphatase), and cardiac function (eg, MUGA, ECG). Monitor periodically for secondary oral cancers with long-term use. Avoid extravasation. Embryo-fetal toxicity. Use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

Caution with cyclosporine, phenobarbital, phenytoin, streptozocin, digoxin, myelosuppressants, others. Previous mediastinal irradiation, cyclophosphamide, other cardiotoxic drugs: monitor for cardiotoxicity and hepatotoxicity.

Pharmacological Class:

Anthracycline.

Adverse Reactions:

Asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand and foot syndrome, rash, neutropenia, thrombocytopenia, anemia; infusion reactions, cardiovascular events (eg, cardiomyopathy, CHF, acute LV failure), recall of skin reaction from prior radiation therapy, toxoplasmosis, urine discoloration (red/orange).

Elimination:

Hepatic.

Generic Availability:

YES

How Supplied:

Single-use vials (10mL, 25mL)—1

Indications for DOXIL:

Multiple myeloma, in combination with bortezomib, in patients not previously treated with bortezomib and who have received at least one prior therapy.

Adult:

Give by IV infusion at initial rate of 1mg/min; may increase rate to complete infusion over 1hr if no infusion reactions occur; may premedicate with antiemetics. 30mg/m2 on day 4 of each cycle following bortezomib (see full labeling for bortezomib dose); may treat for up to 8 cycles. Hepatic dysfunction (serum bilirubin ≥1.2mg/dL), hand-foot syndrome, hematologic toxicity (esp. ANC, platelets), or stomatitis: reduce dose. Consider total anthracycline and anthracenedione doses and irradiation when calculating total cumulative dose. See full labeling.

Children:

Not established.

Warnings/Precautions:

Not substitutable on a mg/mg basis with other doxorubicin products. Cardiomyopathy (including left ventricular failure), acute infusion-related reactions, myelosuppression may occur. Have medications to treat infusion-related reactions and resuscitative equipment available. Hepatic impairment. Monitor blood (esp. CBC + platelets), hepatic (esp. SGOT/SGPT, alkaline phosphatase), and cardiac function (eg, MUGA, ECG). Monitor periodically for secondary oral cancers with long-term use. Avoid extravasation. Embryo-fetal toxicity. Use effective contraception during and for 6 months after last dose. Pregnancy (Cat.D); avoid. Nursing mothers: not recommended.

Interactions:

Caution with cyclosporine, phenobarbital, phenytoin, streptozocin, digoxin, myelosuppressants, others. Previous mediastinal irradiation, cyclophosphamide, other cardiotoxic drugs: monitor for cardiotoxicity and hepatotoxicity.

Pharmacological Class:

Anthracycline.

Adverse Reactions:

Asthenia, fatigue, fever, anorexia, nausea, vomiting, stomatitis, diarrhea, constipation, hand and foot syndrome, rash, neutropenia, thrombocytopenia, anemia; infusion reactions, cardiovascular events (eg, cardiomyopathy, CHF, acute LV failure), recall of skin reaction from prior radiation therapy, toxoplasmosis, urine discoloration (red/orange).

Elimination:

Hepatic.

Generic Availability:

YES

How Supplied:

Single-use vials (10mL, 25mL)—1

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