Special precautions for disposal and other handling: Preparation of solution for infusion: BLENREP is a cytotoxic anticancer medicinal product. Proper handling procedures should be followed. Use aseptic technique for the reconstitution and dilution of the dosing solution.
The recommended dose of BLENREP is 2.5 mg/kg administered as an intravenous infusion once every 3 weeks.
Calculate the dose (mg), total volume (mL) of solution required and the number of vials needed based on the patient's actual body weight (kg).
Reconstitution: 1. Remove the vial(s) of BLENREP from the refrigerator and allow to stand for approximately 10 minutes to reach room temperature.
2. Reconstitute each vial with 2 mL of water for injections to obtain a concentration of 50 mg/mL. Gently swirl the vial to aid dissolution. Do not shake.
3. Visually inspect the reconstituted solution for particulate matter and discoloration. The reconstituted solution should be a clear to opalescent, colourless to yellow to brown liquid. Discard the reconstituted vial if extraneous particulate matter other than translucent to white proteinaceous particles is observed.
Dilution Instructions for Intravenous Use: 1. Withdraw the necessary volume for the calculated dose from each vial.
2. Add the necessary amount of BLENREP to the infusion bag containing 250 mL of sodium chloride 9 mg/mL (0.9%) solution for injection. Mix the diluted solution by gentle inversion. The final concentration of the diluted solution should be between 0.2 mg/mL to 2 mg/mL. DO NOT SHAKE.
3. Discard any unused reconstituted solution of BLENREP left in the vial.
If the diluted solution is not used immediately, it may be stored in a refrigerator (2°C to 8°C) for up to 24 hours prior to administration. If refrigerated, allow the diluted solution to equilibrate to room temperature prior to administration. The diluted solution may be kept at room temperature (20°C to 25°C) for a maximum of 6 hours (including infusion time).
Administration Instructions: 1. Administer the diluted solution by intravenous infusion over a minimum of 30 minutes using an infusion set made of polyvinyl chloride or polyolefin.
2. Filtration of the diluted solution is not required. However, if the diluted solution is filtered, polyethersulfone (PES) based filter is recommended.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.