Usual Adult Dose for Breast Cancer

260 mg/m2 IV over 30 minutes every 3 weeks

Use: For metastatic 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

Usual Adult Dose for Non-Small Cell Lung Cancer

100 mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 21-day cycle; administer carboplatin on Day 1 of each 21-day cycle immediately after paclitaxel protein-bound

Use: For locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy

Usual Adult Dose for Pancreatic Cancer

125 mg/m2 IV over 30 to 40 minutes on Days 1, 8, and 15 of each 28-day cycle; administer gemcitabine immediately after paclitaxel protein-bound on Days 1, 8 and 15 of each 28-day cycle

Use: For metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine

Renal Dose Adjustments

• Mild to moderate renal impairment (CrCl greater than or equal to 30 mL/min to less than 90 mL/min): No adjustment recommended
• Severe renal impairment (CrCl 15 to less than 30 mL/min) and end stage renal disease (ESRD) (CrCl less than 15 mL/min): Data not available

Liver Dose Adjustments

• Mild hepatic impairment (total bilirubin greater than 1 x ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN): No adjustment recommended, regardless of indication
• Moderate to severe hepatic impairment in patients with metastatic adenocarcinoma of the pancreas: Not recommended
• Patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN: Not recommended regardless of indication

• Mild impairment (AST less than 10 x ULN and bilirubin greater than 1 to less than or equal to 1.5 x ULN): No adjustment necessary
• Moderate impairment (AST less than 10 x ULN and bilirubin greater than 1 to less than or equal to 3 x ULN): Reduce dose to 200 mg/m2; may increase up to 260 mg/m2 if the reduced dose is tolerated for 2 cycles
• Severe impairment: AST greater than 10 x ULN and bilirubin greater than 3 to less than or equal to 5 x ULN: Reduce dose to 200 mg/m2; may increase up to 260 mg/m2 if the reduced dose is tolerated for 2 cycles
• Severe impairment: AST less than 10 x ULN and bilirubin greater than 5 x ULN: Use is not recommended

• Mild impairment (AST less than 10 x ULN and bilirubin greater than 1 to less than or equal to 1.5 x ULN): No adjustment necessary
• Moderate impairment (AST less than 10 x ULN and bilirubin greater than 1 to less than or equal to 3 x ULN): Reduce dose to 80 mg/m2; may increase up to 100 mg/m2 if the reduced dose is tolerated for 2 cycles
• Severe impairment: AST greater than 10 x ULN and bilirubin greater than 3 to less than or equal to 5 x ULN: Reduce dose to 80 mg/m2; may increase up to 100 mg/m2 if the reduced dose is tolerated for 2 cycles
• Severe impairment: AST less than 10 x ULN and bilirubin greater than 5 x ULN: Use is not recommended

• Mild impairment (AST less than 10 x ULN and bilirubin greater than 1 to less than or equal to 1.5 x ULN): No adjustment necessary
• Moderate impairment (AST less than 10 x ULN and bilirubin greater than 1 to less than or equal to 3 x ULN): Use is not recommended
• Severe impairment: AST greater than 10 x ULN and bilirubin greater than 3 to less than or equal to 5 x ULN: Use is not recommended
• Severe impairment: AST less than 10 x ULN and bilirubin greater than 5 x ULN: Use is not recommended

Dose Adjustments

• Mild hepatic impairment (total bilirubin greater than 1 x ULN and less than or equal to 1.5 x ULN and aspartate aminotransferase [AST] less than or equal to 10 x ULN): No adjustment necessary, regardless of indication
• Moderate to severe hepatic impairment in patients with metastatic adenocarcinoma of the pancreas: Use is not recommended
• Patients with total bilirubin greater than 5 x ULN or AST greater than 10 x ULN: Use is not recommended regardless of indication

• Moderate to Severe impairment (AST less than 10 x ULN and bilirubin greater than 1.5 to less than or equal to 5 x ULN): Reduce dose to 200 mg/m2; may increase up to 260 mg/m2 if the reduced dose is tolerated for 2 cycles

• Moderate to Severe impairment (AST less than 10 x ULN and bilirubin greater than 1.5 to less than or equal to 5 x ULN): Reduce dose to 80 mg/m2; may increase up to 100 mg/m2 if the reduced dose is tolerated for 2 cycles

Precautions

US BOXED WARNINGS:

• NEUTROPENIA: Do not administer this drug to patients who have baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients.
• Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. Do not substitute for or with other paclitaxel formulations.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should only be administered under the supervision of a qualified oncologist in facilities specialized in the administration of cytotoxic agents.
• This drug should not be substituted for or with other paclitaxel formulations.
• For IV administration only

• Store in original container to protect from light.
• Consult the manufacturer product information.

• Consult the manufacturer product information.