YERVOY

Preparation should be performed by trained personnel in accordance with good practices rules, especially with respect to asepsis. Calculating the dose: Ipilimumab monotherapy or ipilimumab in combination with nivolumab: The prescribed dose for the patient is given in mg/kg.‍​‍‍‍​‍‍‍‍‍‍‍‍​‍ Based on this prescribed dose, calculate the total dose to be given. More than one vial of YERVOY concentrate may be needed to give the total dose for the patient. ▪ Each 10 ml vial of YERVOY concentrate provides 50 mg of ipilimumab; each 40 ml vial provides 200 mg of ipilimumab. ▪ The total ipilimumab dose in mg = the patient's weight in kg × the prescribed dose in mg/kg. ▪ The volume of YERVOY concentrate to prepare the dose (ml) = the total dose in mg, divided by 5 (the YERVOY concentrate strength is 5 mg/ml). Preparing the infusion: Take care to ensure aseptic handling when you prepare the infusion. YERVOY can be used for intravenous administration either: ▪ without dilution, after transfer to an infusion container using an appropriate sterile syringe; or ▪ after diluting to up to 5 times the original volume of concentrate (up to 4 parts of diluent to 1 part of concentrate). The final concentration should range from 1 to 4 mg/ml. To dilute the YERVOY concentrate, you can use either: ▪ sodium chloride 9 mg/ml (0.9%) solution for injection; or ▪ 50 mg/ml (5%) glucose solution for injection STEP 1 ▪ Allow the appropriate number of vials of YERVOY to stand at room temperature for approximately 5 minutes. ▪ Inspect the YERVOY concentrate for particulate matter or discoloration. YERVOY concentrate is a clear to slightly opalescent, colourless to pale yellow liquid that may contain light (few) particulates. Do not use if unusual amount of particles and signs of discoloration are present. ▪ Withdraw the required volume of YERVOY concentrate using an appropriate sterile syringe. STEP 2 ▪ Transfer the concentrate into a sterile, evacuated glass bottle or intravenous bag (PVC or non‑PVC). ▪ If applicable, dilute with the required volume of sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection. For ease of preparation, the concentrate can also be transferred directly into a pre-filled bag containing the appropriate volume of sodium chloride 9 mg/mL (0.9%) solution for injection or 50 mg/mL (5%) glucose solution for injection. Gently mix the infusion by manual rotation. Administration: The YERVOY infusion must not be administered as an intravenous push or bolus injection. Administer the YERVOY infusion intravenously over a period of 30 minutes. The YERVOY infusion should not be infused at the same time in the same intravenous line with other agents. Use a separate infusion line for the infusion. Use an infusion set and an in‑line, sterile, non‑pyrogenic, low protein binding filter (pore size of 0.2 μm to 1.2 μm). The YERVOY infusion is compatible with: ▪ PVC infusion sets ▪ Polyethersulfone (0.2 μm to 1.2 μm) and nylon (0.2 μm) in‑line filters Flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection or 50 mg/ml (5%) glucose solution for injection at the end of the infusion. Any unused medicinal product or waste material should be discarded in accordance with local requirements.