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Generic Name and Formulations:
Paclitaxel [bound to albumin (human)] 100mg/vial; pwd for IV infusion after reconstitution; solvent-free.
Company:
Celgene Corp
Indications for ABRAXANE:
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).
Adult Dose for ABRAXANE:
Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. 260mg/m2 by IV infusion over 30 minutes every 3 weeks. 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 full labeling. Avoid extravasation.
Children's Dose for ABRAXANE:
Not eva luated.
Pharmacological Class:
Taxane antimicrotubule.
Contraindications:
Baseline neutrophil count <1,500 cells/mm3. Prior severe hypersensitivity reaction (do not rechallenge).
Warnings/Precautions:
Do not substitute for, or with, other paclitaxel products (due to formulation differences). Do frequent complete blood cell counts. Monitor for sensory neuropathy, sepsis, or pneumonitis. Hepatic or renal dysfunction. Contains human albumin; remote risk of viral transmission. Use appropriate contraception (men and women). Pregnancy (Cat.D), nursing mothers: not recommended.
Interactions:
May potentiate or be potentiated by CYP2C8 and/or CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, efavirenz, nevirapine) and/or inhibitors (eg, ketoconazole, other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir).
Adverse Reactions:
Bone marrow suppression (eg, neutropenia, anemia), infections, alopecia, sensory neuropathy (may require dose reduction or interruption), peripheral neuropathy, GI upset, mucositis, fatigue/asthenia, myalgia/arthralgia, abnormal ECG; alkaline phosphatase or AST elevation; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events.
Metabolism:
Hepatic (CYP2C8, 3A4).
Elimination:
Renal, fecal.
Generic Availability:
NO
How Supplied:
Single-use vial—1
Indications for ABRAXANE:
First-line treatment of metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Adult Dose for ABRAXANE:
Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. 125mg/m2 IV over 30–40 minutes on Days 1, 8, and 15 of each 28-day cycle. Dose reductions for hematologic and neurologic adverse reactions, hepatic impairment: see full labeling. Avoid extravasation.
Children's Dose for ABRAXANE:
Not eva luated.
Pharmacological Class:
Taxane antimicrotubule.
Contraindications:
Baseline neutrophil count <1,500 cells/mm3. Prior severe hypersensitivity reaction (do not rechallenge).
Warnings/Precautions:
Do not substitute for, or with, other paclitaxel products (due to formulation differences). Do frequent complete blood cell counts. Monitor for sensory neuropathy, sepsis, or pneumonitis. Hepatic or renal dysfunction. Contains human albumin; remote risk of viral transmission. Use appropriate contraception (men and women). Pregnancy (Cat.D), nursing mothers: not recommended.
Interactions:
May potentiate or be potentiated by CYP2C8 and/or CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, efavirenz, nevirapine) and/or inhibitors (eg, ketoconazole, other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir).
Adverse Reactions:
Bone marrow suppression (eg, neutropenia, anemia), infections, alopecia, sensory neuropathy (may require dose reduction or interruption), peripheral neuropathy, GI upset, mucositis, fatigue/asthenia, myalgia/arthralgia, abnormal ECG; alkaline phosphatase or AST elevation; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events.
Metabolism:
Hepatic (CYP2C8, 3A4).
Elimination:
Renal, fecal.
Generic Availability:
NO
How Supplied:
Single-use vial—1
Indications for ABRAXANE:
First-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
Adult Dose for ABRAXANE:
Do not treat if neutrophil count <1,500 cells/mm3 or platelets <100,000 cells/mm3. In combination with carboplatin: 100mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Dose reductions for hematologic and neurologic adverse reactions, hepatic impairment: see full labeling. Avoid extravasation.
Children's Dose for ABRAXANE:
Not eva luated.
Pharmacological Class:
Taxane antimicrotubule.
Contraindications:
Baseline neutrophil count <1,500 cells/mm3. Prior severe hypersensitivity reaction (do not rechallenge).
Warnings/Precautions:
Do not substitute for, or with, other paclitaxel products (due to formulation differences). Do frequent complete blood cell counts. Monitor for sensory neuropathy, sepsis, or pneumonitis. Hepatic or renal dysfunction. Contains human albumin; remote risk of viral transmission. Use appropriate contraception (men and women). Pregnancy (Cat.D), nursing mothers: not recommended.
Interactions:
May potentiate or be potentiated by CYP2C8 and/or CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, efavirenz, nevirapine) and/or inhibitors (eg, ketoconazole, other imidazole antifungals, erythromycin, fluoxetine, gemfibrozil, cimetidine, ritonavir, saquinavir, indinavir, nelfinavir).
Adverse Reactions:
Bone marrow suppression (eg, neutropenia, anemia), infections, alopecia, sensory neuropathy (may require dose reduction or interruption), peripheral neuropathy, GI upset, mucositis, fatigue/asthenia, myalgia/arthralgia, abnormal ECG; alkaline phosphatase or AST elevation; dyspnea, edema, hypotension, rash (may be serious); rare: thrombotic events.
Metabolism:
Hepatic (CYP2C8, 3A4).
Elimination:
Renal, fecal.
Generic Availability:
NO
How Supplied:
Single-use vial—1
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