ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)(六)
el; discontinue treatment if toxicity persists
Gastrointestinal Toxicity:
Grade 3 mucositis or diarrhea Withhold until improves to ≤ Grade 1;
resume at next lower dose level
2.6 Preparation and Administration Precautions
ABRAXANE is a cytotoxic 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 Adverse Reactions (6.4)].
Premedication to prevent hypersensitivity reactions is generally not needed prior to the administration of ABRAXANE. Premedication may be needed in patients who have had prior hypersensitivity reactions to ABRAXANE. Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be re-challenged with this drug [see Warnings and Precautions (5.5)].
2.7 Preparation for Intravenous Administration
ABRAXANE is supplied as a sterile lyophilized powder for reconstitution before use. AVOID ERRORS, READ ENTIRE PREPARATION INSTRUCTIONS PRIOR TO RECONSTITUTION.
Aseptically, reconstitute each vial by injecting 20 mL of 0.9% Sodium Chloride Injection, USP.
Slowly inject the 20 mL of 0.9% Sodium Chloride Injection, USP, over a minimum of 1 minute, using the
sterile syringe to direct the solution flow onto the INSIDE WALL OF THE VIAL.
DO NOT INJECT the 0.9% Sodium Chloride Injection, USP, directly onto the lyophilized cake as this
will result in foaming.
Once the injection is complete, allow the vial to sit for a minimum of 5 minutes to ensure proper wetting of
the lyophilized cake/powder.
Gently swirl and/or invert the vial slowly for at least 2 minutes until complete dissolution of any cake/powder
occurs. Avoid generation of foam.
If foaming or clumping occurs, stand solution for at least 15 minutes until foam subsides.
Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.
Calculate the exact total dosing volume of 5 mg/mL suspension required for the patient: Dosing volume (mL) = Total dose (mg)/5 (mg/mL).
The reconstituted suspension should be milky and homogenous without visible particulates. If particulates or settling are visible, the vial should be gently inverted again to ensure complete resuspension prior to use. Discard the reconstituted suspension if precipitates are observed. Discard any unused portion.
Inject the appropriate amount of reconstituted ABRAXANE into an empty, sterile intravenous bag [plasticized polyvinyl chloride (PVC) containers, PVC or non-PVC type intravenous bag]. The use of specialized DEHP-free solution containers or administration sets is not necessary to prepare or administer ABRAXANE infusions. The use of an in-line filter is not recommended.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container perm |
