• Use waterproof gloves, tongs, and effective radiation shielding when handling.
  • Use safe handling procedures and minimize exposure to patients, medical personnel, and household contacts during and after treatment.
  • Confirm radioactivity in vial with dose calibrator prior to and after administration of lutetium lu-177 vipivotide tetraxetan.
  • The recommended dosage may be administered as an IV injection using a disposable syringe fitted with a syringe shield (with or without a syringe pump), as an IV infusion using the gravity method (with or without an infusion pump), or as an IV infusion using the vial (with a peristaltic infusion pump). Use the syringe or vial method when administering a ↓ dose, as the gravity method may result in delivery of the incorrect volume if the dose is not adjusted prior to administration.

IV Administration:

• Prior to administration, flush the IV catheter used exclusively for lutetium lu-177 vipivotide tetraxetan administration with ≥10 mL of 0.9% NaCl to ensure patency and to minimize the risk of extravasation.

  Syringe Method: After disinfecting the vial stopper, withdraw the appropriate volume of lutetium lu-177 vipivotide tetraxetan solution by using a disposable syringe fitted with a syringe shield and a disposable sterile needle. Administer by slow IV push within approximately 1–10 min (either with a syringe pump or manually without a syringe pump) via an IV catheter prefilled with 0.9% NaCl that is used exclusively for administration. Flush with ≥10 mL 0.9% NaCl through the IV catheter following administration. Gravity Method: Insert short needle (2.5 cm, 20 gauge) into lutetium lu-177 vipivotide tetraxetan vial and connect via a catheter to 500 mL 0.9% NaCl; do not touch the short needle to the solution in the vial; do not connect short needle directly to the patient. Do not allow 0.9% NaCl solution to flow into the vial prior to initiation of the infusion; do not inject lutetium lu-177 vipivotide tetraxetan directly into the 0.9% NaCl solution. Insert a long needle (9 cm, 18 gauge) into the vial; ensure the long needle touches the bottom of the vial and is secured during the entire infusion. Connect the long needle to the patient by a prefilled sterile 0.9% NaCl IV catheter that is used exclusively for infusion. Use a pump or clamp to adjust the flow of the 0.9% NaCl solution via the short needle into vial; this will allow the 0.9% NaCl solution entering the vial through the short needle to carry the lutetium lu-177 vipivotide tetraxetan from the vial to the patient within 30 min. During the infusion, ensure that the level of solution in the lutetium lu-177 vipivotide tetraxetan vial remains constant. When the level of radioactivity is stable for ≥5 min, disconnect the vial from the long needle line and clamp the 0.9% NaCl line. After the infusion, flush IV line with ≥10 mL of 0.9% NaCl. Vial Method: Insert a short venting needle (2.5 cm, 20 gauge) into the lutetium lu-177 vipivotide tetraxetan vial. Do not touch the short needle to the solution in the vial and do not connect short needle directly to the patient or the peristaltic infusion pump. Insert a long needle (9 cm, 18 gauge) into the vial, ensuring that the long needle touches and is secured to the bottom of the vial during the entire infusion. Connect the long needle and a 0.9% NaCl solution 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 per manufacturer's instruction. Prefill the line by opening the 3-way stopcock valve and pumping the solution through the tubing until it reaches the exit of the valve. Prefill the IV catheter that will be connected to the patient by opening the 3-way stopcock valve to the 0.9% NaCl solution and pumping the solution until it exits the end of the catheter tubing. Connect the prefilled IV catheter to the patient and set the 3-way stopcock valve such that the lutetium lu-177 vipivotide tetraxetan solution is in line with the peristaltic infusion pump. Infuse an appropriate volume at approximately 25 mL/hr to deliver the desired radioactivity. When the correct volume of lutetium lu-177 vipivotide tetraxetan has been delivered, stop the peristaltic infusion pump and change the position of the 3-way stopcock valve so that the infusion pump is in line with the 0.9% NaCl solution. Restart the infusion pump and infuse an IV flush of ≥10 mL 0.9% NaCl through the IV catheter to the patient.