Monograph Details
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Neoplasms
> Antimicrotubule agents
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ABRAXANE |
| Manufacturer |
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Abraxis Oncology |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Taxane antimicrotubule. |
| Generic Name |
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Paclitaxel [bound to albumin (human)] 100mg/vial; for IV infusion; inj susp after reconstitution; preservative- and solvent-free. |
| Indications |
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Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy (prior therapy should have included an anthracycline unless clinically contraindicated). |
| Children |
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Not recommended. |
| Adults |
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260mg/m2 by IV infusion over 30–45 minutes every 3 weeks. Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. If severe neutropenia (neutrophil <500 cells/mm3 for ≥1week) or severe sensory neuropathy occurs: reduce subsequent doses to 220mg/m2; reduce to 180mg/m2 if severe neutropenia or sensory neuropathy recurs. If grade 3 sensory neuropathy occurs, suspend use until resolution to grade 1 or 2; reduce subsequent doses. Hepatic impairment: see literature. Avoid extravasation. |
| Contraindications |
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Baseline neutrophil count <1,500 cells/mm3. |
| Precautions |
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Do not substitute for, or with, other paclitaxel products (due to formulation differences). Do frequent peripheral blood cell counts. Hepatic or renal dysfunction. Use appropriate contraception (men and women). Pregnancy (Cat.D), nursing mothers: not recommended. |
| Interactions |
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May potentiate or be potentiated by CYP2C8 and CYP3A4 substrates and/or inhibitors. |
| Adverse Reactions |
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Bone marrow suppression (eg, neutropenia, anemia), infections, alopecia, sensory neuropathy, GI upset, mucositis, asthenia, myalgia/arthralgia, abnormal ECG; elevated alkaline phosphatase, ALT; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events. |
| How Supplied |
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Single-use vial—1 |
| Additional Resources |
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• Related Prescribing Note |
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