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TAXOL
Breast cancer
Gynecologic cancers
Kaposi's sarcoma
Respiratory and thoracic cancers
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Drug Name:

TAXOL Rx

Generic Name and Formulations:
Paclitaxel 6mg/mL; soln for IV infusion after dilution; contains Cremophor EL (polyoxyethylated castor oil), dehydrated alcohol.

Company:
Bristol-Myers Squibb

Therapeutic Use:

Indications for TAXOL:

Adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy. Breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy.

Adult:

See literature. Premedicate with corticosteroids, diphenhydramine, H2 antagonists. Breast cancer (node-positive): 175mg/m2 IV over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. Breast cancer (after failure of initial chemotherapy for metastatic disease or relapse): 175mg/m2 IV over 3 hours every 3 weeks. Hepatic impairment or neutropenia: see literature for dose modifications. Do not treat if neutrophil count <1,500cells/mm3 or platelets <100,000cells/mm3.

Children:

Not recommended.

Contraindications:

Baseline neutrophil count <1,500cells/mm3.

Warnings/Precautions:

Do frequent peripheral blood cell counts. Hepatic dysfunction. Conduction abnormalities: monitor cardiac function. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

Interactions:

May potentiate or be potentiated by CYP2C8 or CYP3A4 substrates, inducers and/or inhibitors. Potentiated by cisplatin. May potentiate doxorubicin.

Pharmacological Class:

Antimicrotubule agent.

Adverse Reactions:

Bone marrow suppression (eg, neutropenia, leukopenia, thrombocytopenia, anemia), inj site reactions, infections, hypotension, bradycardia, hypersensitivity reactions (if severe, do not rechallenge), peripheral neuropathy, myalgia, arthralgia, GI upset, mucositis, alopecia, abnormal ECG, elevated liver enzymes.

How Supplied:

Multidose vial (5mL, 16.7mL, 50mL)—1

Indications for TAXOL:

First-line therapy (in combination with cisplatin) and subsequent therapy for advanced carcinoma of the ovary.

Adult:

See literature. Premedicate with corticosteroids, diphenhydramine, H2 antagonists. Previously untreated ovarian cancer: 175mg/m2 IV over 3 hours + cisplatin every 3 weeks; or 135mg/m2 IV over 24 hours + cisplatin every 3 weeks. Previously treated ovarian cancer: 135mg/m2 or 175mg/m2 IV over 3 hours every 3 weeks. Hepatic impairment or neutropenia: see literature for dose modifications. Do not treat if neutrophil count <1,500cells/mm3 or platelets <100,000cells/mm3.

Children:

Not recommended.

Contraindications:

Baseline neutrophil count <1,500cells/mm3.

Warnings/Precautions:

Do frequent peripheral blood cell counts. Hepatic dysfunction. Conduction abnormalities: monitor cardiac function. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

Interactions:

May potentiate or be potentiated by CYP2C8 or CYP3A4 substrates, inducers and/or inhibitors. Potentiated by cisplatin. May potentiate doxorubicin.

Pharmacological Class:

Antimicrotubule agent.

Adverse Reactions:

Bone marrow suppression (eg, neutropenia, leukopenia, thrombocytopenia, anemia), inj site reactions, infections, hypotension, bradycardia, hypersensitivity reactions (if severe, do not rechallenge), peripheral neuropathy, myalgia, arthralgia, GI upset, mucositis, alopecia, abnormal ECG, elevated liver enzymes.

How Supplied:

Multidose vial (5mL, 16.7mL, 50mL)—1

Indications for TAXOL:

Second-line treatment of AIDS-related Kaposi's sarcoma.

Adult:

See literature. Premedicate with corticosteroids, diphenhydramine, H2 antagonists. 135mg/m2 IV over 3 hours every 3 weeks; or 100mg/m2 IV over 3 hours every 2 weeks. Hepatic impairment or neutropenia: see literature for dose modifications. Do not treat if neutrophil count <1,000cells/mm3 or platelets <100,000cells/mm3.

Children:

Not recommended.

Contraindications:

Baseline neutrophil count <1,000cells/mm3.

Warnings/Precautions:

Do frequent peripheral blood cell counts. Hepatic dysfunction. Conduction abnormalities: monitor cardiac function. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

Interactions:

May potentiate or be potentiated by CYP2C8 or CYP3A4 substrates, inducers and/or inhibitors. Potentiated by cisplatin. May potentiate doxorubicin.

Pharmacological Class:

Antimicrotubule agent.

Adverse Reactions:

Bone marrow suppression (eg, neutropenia, leukopenia, thrombocytopenia, anemia), inj site reactions, infections, hypotension, bradycardia, hypersensitivity reactions (if severe, do not rechallenge), peripheral neuropathy, myalgia, arthralgia, GI upset, mucositis, alopecia, abnormal ECG, elevated liver enzymes.

How Supplied:

Multidose vial (5mL, 16.7mL, 50mL)—1

Indications for TAXOL:

First-line treatment of non-small cell lung cancer in combination with cisplatin in patients who are not candidates for potentially curative surgery and/or radiation therapy.

Adult:

See literature. Premedicate with corticosteroids, diphenhydramine, H2 antagonists. 135mg/m2 IV over 24 hours + cisplatin every 3 weeks. Hepatic impairment or neutropenia: see literature for dose modifications. Do not treat if neutrophil count <1,500cells/mm3 or platelets <100,000cells/mm3.

Children:

Not recommended.

Contraindications:

Baseline neutrophil count <1,500cells/mm3.

Warnings/Precautions:

Do frequent peripheral blood cell counts. Hepatic dysfunction. Conduction abnormalities: monitor cardiac function. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended.

Interactions:

May potentiate or be potentiated by CYP2C8 or CYP3A4 substrates, inducers and/or inhibitors. Potentiated by cisplatin. May potentiate doxorubicin.

Pharmacological Class:

Antimicrotubule agent.

Adverse Reactions:

Bone marrow suppression (eg, neutropenia, leukopenia, thrombocytopenia, anemia), inj site reactions, infections, hypotension, bradycardia, hypersensitivity reactions (if severe, do not rechallenge), peripheral neuropathy, myalgia, arthralgia, GI upset, mucositis, alopecia, abnormal ECG, elevated liver enzymes.

How Supplied:

Multidose vial (5mL, 16.7mL, 50mL)—1

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