DOSAGE AND ADMINISTRATION
After failure of combination chemotherapy for metastatic breast cancer or relapse within 6 months of adjuvant chemotherapy, the recommended regimen for ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.

Hepatic Impairment
No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate and severe hepatic impairment treated with ABRAXANE may be at increased risk of toxicities known to paclitaxel. Patients should not receive ABRAXANE if AST > 10 × ULN or bilirubin > 5.0 × ULN. Recommendations for dosage adjustment for the first course of therapy are shown in Table 4. The dose of ABRAXANE can be increased up to 200 mg/m2 in patients with severe hepatic impairment in subsequent cycles based on individual tolerance. Patients should be monitored closely. (see CLINICAL PHARMACOLOGY : Hepatic Impairment and PRECAUTIONS: Hepatic Impairment)

Table 4: Recommendations for Starting Dose in Patients with Hepatic Impairment  SGOT (AST) Levels  Bilirubin Levels ABRAXANE*
*
Dosage recommendations are for the first course of therapy. The need for further dose adjustments in subsequent courses should be based on individual tolerance.
†
A dose increase to 200 mg/m2 in subsequent courses should be considered based on individual tolerance. 
Mild <10 × ULN AND >ULN to ≤ 1.25 × ULN 260 mg/m2
Moderate <10 × ULN 1.26 to 2.0 × ULN 200 mg/m2
Severe <10 × ULN 2.01 to 5.0 × ULN 130 mg/m2†
 > 10 × ULN OR > 5.0 × ULN not eligible

Dose Reduction
Patients who experience severe neutropenia (neutrophil <500 cells/mm3 for a week or longer) or severe sensory neuropathy during ABRAXANE therapy should have dosage reduced to 220 mg/m2 for subsequent courses of ABRAXANE. For recurrence of severe neutropenia or severe sensory neuropathy, additional dose reduction should be made to 180 mg/m2. For grade 3 sensory neuropathy hold treatment until resolution to grade 1 or 2, followed by a dose reduction for all subsequent courses of ABRAXANE.

Preparation and Administration Precautions
ABRAXANE is a cytotoxic anticancer drug and, as with other potentially toxic paclitaxel compounds, caution should be exercised in handling ABRAXANE. The use of gloves is recommended. If ABRAXANE (lyophilized cake or reconstituted suspension) contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure to paclitaxel, events may include tingling, burning and redness. If ABRAXANE® contacts mucous membranes, the membranes should be flushed thoroughly with water.

Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration. Limiting the infusion of ABRAXANE to 30 minutes, as directed, reduces the likelihood of infusion-related reactions (see PRECAUTIONS: Injection Site Reaction).

No premedication to prevent hypersensitivity reactions is required prior to administration of ABRAXANE.

Preparation for Intravenous Admi