Monograph Details
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Neoplasms
> Cytotoxic antibiotics
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DOXIL |
| Manufacturer |
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Ortho Biotech Products, L.P. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Anthracycline. |
| Generic Name |
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Doxorubicin HCl (liposomal) 2mg/mL; dispersion for IV infusion after dilution; preservative-free. |
| Indications |
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AIDS-related Kaposi's sarcoma refractory to combination chemotherapy. Ovarian cancer refractory to platinum-based chemotherapy. Multiple myeloma, in combination with bortezomib, in patients not previously treated with bortezomib and who have received at least one prior therapy. |
| Children |
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Not recommended. |
| Adults |
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Give by IV infusion at initial rate of 1mg/min; may increase rate to complete infusion over 1 hour if no infusion reactions occur; may premedicate with antiemetics. Kaposi's sarcoma: 20mg/m2 once every 3 weeks. Ovarian cancer: 50mg/m2 once every 4 weeks; continue for at least 4 cycles as tolerated. Multiple myeloma: 30mg/m2 on day 4 of each cycle following bortezomib (see literature 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 literature. |
| Contraindications |
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Pregnancy (Cat.D); nursing mothers: not recommended. |
| Precautions |
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Not substitutable on a mg/mg basis with other doxorubicin products. Have resuscitative/antiallergic equipment and expertise available. Avoid extravasation. Monitor blood (esp. CBC + platelets, hepatic (esp. SGOT/SGPT, alkaline phosphatase), and cardiac function (esp. myocardial biopsy). |
| Interactions |
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Caution with cyclosporine, phenobarbital, phenytoin, streptozocin, digoxin, myelosuppressants, others. Previous mediastinal irradiation, cyclophosphamide, other cardiotoxic drugs: monitor for cardiotoxicity and hepatotoxicity. |
| Adverse Reactions |
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GI upset, fever, alopecia, myelosuppression, stomatitis, infusion reaction (eg, back pain, flushing, dyspnea, hypotension), hand-foot syndrome, cardiovascular events (eg, cardiomyopathy, CHF, acute LV failure), recall of skin reaction from prior radiation therapy, toxoplasmosis, urine discoloration (red/orange), others. |
| How Supplied |
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Single-use vials (10mL, 30mL)—6 |
| Additional Resources |
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• Related Prescribing Note |
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