Pluvicto Caution For Usage

Special precautions for disposal and other handling: General warning: Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licences of the competent official organisation.
Radiopharmaceuticals should be prepared in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate aseptic precautions should be taken.
For instructions on preparation of the medicinal product before administration, see Instructions for preparation of radiopharmaceuticals as follows.
If at any time in the preparation of this medicinal product the integrity of the lead container or the vial is compromised, it should not be used.
Administration procedures should be carried out in a way to minimise risk of contamination of the medicinal product and irradiation of the operators. Adequate shielding is mandatory.
The administration of radiopharmaceuticals creates risks for other persons from external radiation or contamination from spill of urine, vomiting, etc. Radiation protection precautions in accordance with local regulations must therefore be taken.
This preparation is likely to result in a relatively high radiation dose to most patients. The administration of Pluvicto may result in significant environmental hazard. This may be of concern to the immediate family of those individuals undergoing treatment or the general public depending on the level of activity administered. Suitable precautions in accordance with local regulations should be taken concerning the activity eliminated by the patients in order to avoid any contaminations.
Lutetium-177 for Pluvicto may be prepared using two different sources of stable isotopes (either lutetium-176 or ytterbium-176). Lutetium-177 for Pluvicto prepared using the stable isotope lutetium-176 ("carrier added") requires special attention with regard to waste management due to the presence of the long-lived metastable lutetium-177 (^177mLu) impurity with a half-life of 160.4 days. Lutetium-177 for Pluvicto is prepared using ytterbium-176 ("non-carrier added") unless otherwise communicated on the product batch release certificate. The user must consult the product batch release certificate provided before using Pluvicto to ensure appropriate waste management.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned in Instructions for preparation of radiopharmaceuticals as follows and Dosage & Administration.
Instructions for preparation of radiopharmaceuticals: The user must consult the product batch release certificate provided before using Pluvicto to ensure appropriate waste management (see Special precautions for disposal and other handling as previously mentioned).
Withdrawals should be performed under aseptic conditions. The vials must not be opened before disinfecting the stopper, the solution should be withdrawn via the stopper using a single-dose syringe fitted with suitable protective shielding and a disposable sterile needle or using an authorised automated application system.
Preparation instructions: Use aseptic technique and radiation shielding when handling or administering Pluvicto, using tongs as needed to minimise radiation exposure.
Visually inspect the vial under a shielded screen for particulate matter and discolouration prior to administration. Discard the vial if particulates and/or discolouration are present.
Do not inject the Pluvicto solution directly into any other intravenous solution.
Confirm the amount of radioactivity delivered to the patient with an appropriately calibrated dose calibrator prior to and after Pluvicto administration.
Intravenous methods of administration: Instructions for the syringe method (with or without a syringe pump): After disinfecting the vial stopper, withdraw an appropriate volume of Pluvicto solution to deliver the desired radioactivity by using a disposable syringe fitted with a syringe shield and a disposable sterile needle.
Administer Pluvicto to the patient by slow intravenous push within approximately 1 to 10 minutes (either with a syringe pump or manually without a syringe pump) via an intravenous catheter that is pre-filled with sterile sodium chloride 9 mg/mL (0.9%) solution for injection and that is used exclusively for Pluvicto administration to the patient.
Once the desired Pluvicto radioactivity has been administered, perform an intravenous flush of ≥10 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection through the intravenous catheter to the patient.
Instructions for the gravity method (with or without an infusion pump): Insert a 2.5 cm, 20 gauge needle (short needle) into the Pluvicto vial and connect via a catheter to 500 mL sterile sodium chloride 9 mg/mL (0.9%) solution for injection (used to transport the Pluvicto solution during the infusion). Ensure that the short needle does not touch the Pluvicto solution in the vial and do not connect the short needle directly to the patient. Do not allow the sterile sodium chloride 9 mg/mL (0.9%) solution for injection to flow into the Pluvicto vial prior to the initiation of the Pluvicto infusion and do not inject the Pluvicto solution directly into the sterile sodium chloride 9 mg/mL (0.9%) solution for injection.
Insert a second needle that is 9 cm, 18 gauge (long needle) into the Pluvicto vial, ensuring that the long needle touches and is secured to the bottom of the Pluvicto vial during the entire infusion. Connect the long needle to the patient by an intravenous catheter that is pre-filled with sterile sodium chloride 9 mg/mL (0.9%) solution for injection and that is used exclusively for the Pluvicto infusion into the patient.
Use a clamp or an infusion pump to regulate the flow of the sterile sodium chloride 9 mg/mL (0.9%) solution for injection via the short needle into the Pluvicto vial (the sterile sodium chloride 9 mg/mL (0.9%) solution for injection entering the vial through the short needle will carry the Pluvicto solution from the vial to the patient via the intravenous catheter connected to the long needle within approximately 30 minutes).
During the infusion, ensure that the level of solution in the Pluvicto vial remains constant.
Disconnect the vial from the long needle line and clamp the sodium chloride line once the level of radioactivity is stable for at least five minutes.
Follow the infusion with an intravenous flush of ≥10 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection through the intravenous catheter to the patient.
Instructions for the vial method (with a peristaltic infusion pump): Insert a 2.5 cm, 20 gauge needle (short venting needle) into the Pluvicto vial. Ensure that the short needle does not touch the Pluvicto solution in the vial and do not connect the short needle directly to the patient or to the peristaltic infusion pump.
Insert a second needle that is 9 cm, 18 gauge (long needle) into the Pluvicto vial, ensuring that the long needle touches and is secured to the bottom of the Pluvicto vial during the entire infusion. Connect the long needle and a sterile sodium chloride 9 mg/mL (0.9%) solution for injection to a 3-way stopcock valve via appropriate tubing.
Connect the output of the 3-way stopcock valve to tubing installed on the input side of the peristaltic infusion pump following the pump manufacturer's instructions.
Pre-fill the line by opening the 3-way stopcock valve and pumping the Pluvicto solution through the tubing until it reaches the exit of the valve.
Pre-fill the intravenous catheter which will be connected to the patient by opening the 3-way stopcock valve to the sterile sodium chloride 9 mg/mL (0.9%) solution for injection and pumping the sterile sodium chloride 9 mg/mL (0.9%) solution for injection until it exits the end of the catheter tubing.
Connect the pre-filled intravenous catheter to the patient and set the 3-way stopcock valve such that the Pluvicto solution is in line with the peristaltic infusion pump.
Infuse an appropriate volume of Pluvicto solution at approximately 25 mL/h to deliver the desired radioactivity.
When the desired Pluvicto radioactivity has been delivered, stop the peristaltic infusion pump and then change the position of the 3-way stopcock valve so that the peristaltic infusion pump is in line with the sterile sodium chloride 9 mg/mL (0.9%) solution for injection. Restart the peristaltic infusion pump and infuse an intravenous flush of ≥10 mL of sterile sodium chloride 9 mg/mL (0.9%) solution for injection through the intravenous catheter to the patient.
Quality control: The solution should be visually inspected for damage and contamination before use, and only clear solutions free of visible particles should be used. The visual inspection of the solution should be performed under a shielded screen for radioprotection purposes. The vial must not be opened.
If at any time in the preparation of this medicinal product the integrity of the lead container or the vial is compromised, it should not be used.
The amount of radioactivity in the vial must be measured prior to administration using a suitable radioactivity calibration system in order to confirm that the actual amount of radioactivity to be administered is equal to the planned amount at the administration time.