Nanoxel Caution For Usage

Instructions for Reconstitution: The components of Nanoxel should be reconstituted at the bedside prior to the IV infusion. Depending on the required dosage (calculated as per body surface area) the required volume of Nanoxel should be calculated. Based upon the calculated dose the required number of vials should be taken out of the refigerator and brought to room temperature prior to reconstitution. Nanoxel should be reconstituted only in 10% w/v dextrose injection in glass bottle (do not use dextrose injection available in plastic containers) and not in other solutions like sodium chloride injection or dextrose and sodium chloride injection. Nanoxel is reconstituted in following 3 steps:
Step 1: "Concentrate of excipients for Nanoxel" in volume equal to the calculated volume of Nanoxel should be drawn in a suitable sterile disposable syringe and added to the 10% w/v dextrose injection bottle. The bottle should then be shaken gently to mix the contents. Vigorous shaking should be avoided to prevent foaming of the solution.
Step 2: The bottle should then be placed in an inverted position on the IV stand and another fresh sterile disposable suitable size syringe should be used to draw the required amount of Nanoxel using a 22G 1-inch needle. Precautions should be taken to avoid air bubbles in the solution if any. The drug solution should then be rapidly injected in the 10% w/v dextrose injection bottle containing the concentrate of excipients (in the inverted position only) such that the contents of the syringe flow out in a continuous stream without any interruption. Precautions should be taken that the contents are injected rapidly in 1 go. Both hands, if required, may be used to push the piston/plunger.
Step 3: Nanoxel solution is now ready to be infused in the patient.
Reconstituted solutions will be slightly opalescent, which is attributed to the formation of nanoparticles. Nanoxel should be administered through an IV set with an in-line filter with a microporous membrane of 0.2 microns. No significant losses in potency have been noted following simulated delivery of the solution through IV tubing containing an in-line (0.2 microns) filter. No drug or any other substance should be added to the Nanoxel infusion as addition may affect the stability of nanoparticles.
Note: Ten percent dextrose injection should only be used for flushing of the IV set. Other liquids like saline etc, should not be used.
Handling and Disposal: Paclitaxel is a cytotoxic agent and as with other cytotoxic drugs caution should be exercised in handling Nanoxel. The use of gloves and safety goggles is recommended. If Nanoxel or the reconstituted solution comes in contact with the skin it should be washed thoroughly with soap and water. If Nanoxel comes in contact with the mucous membranes, it should be flushed thoroughly with water.
Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.