Onivyde Caution For Usage

Incompatibilities: ONIVYDE pegylated liposomal must not be mixed with other medicinal products except those mentioned in Special precautions for disposal and other handling as follows.
Special precautions for disposal and other handling: ONIVYDE pegylated liposomal is a cytotoxic medicinal product, and caution should be exercised in handling it. The use of gloves, goggles and protective clothing when handling or administering ONIVYDE pegylated liposomal is recommended. If the dispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water. If the dispersion contacts mucous membranes, they should be flushed thoroughly with water. Pregnant staff should not handle ONIVYDE pegylated liposomal considering the cytotoxic nature of the medicinal product.
Preparation of the dispersion and administration: ONIVYDE pegylated liposomal is supplied as a sterile liposomal dispersion at a concentration of 4.3 mg/ml and must be diluted prior to administration using a needle not larger than 21 gauge. Dilute with 5% glucose solution for injection or sodium chloride 9 mg/ml (0.9%) solution for injection to prepare a dispersion of the appropriate dose of ONIVYDE pegylated liposomal diluted to a final volume of 500 ml. Mix the diluted dispersion by gentle inversion. The diluted dispersion is clear to slightly white to slightly opalescent and free from visible particles.
ONIVYDE pegylated liposomal should be administered before LV followed by 5-FU. ONIVYDE pegylated liposomal must not be administered as a bolus injection or an undiluted dispersion.
Aseptic techniques must be followed during the preparation of the infusion. ONIVYDE pegylated liposomal is for single use only.
Care should be taken to avoid extravasation, and the infusion site should be monitored for signs of inflammation. Should extravasation occur, flushing the site with sodium chloride 9 mg/ml (0.9%) solution for injection and/or sterile water and applications of ice are recommended.
For storage conditions after dilution of the medicinal product, see Shelf life under Storage.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.