• High Alert: Radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure. Use waterproof gloves and radiation shielding when handling drug. Used by or under control of health care professionals who are licensed and qualified by specific training and experience in safe use and handling and whose experience and training have been approved by appropriate governmental agency. Minimize radiation exposure to patients, medical personnel, and household contacts during and after therapy consistent with institutional radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.
• Discontinue long-acting somatostatin analogs (long-acting octreotide) ≥4 wk before starting therapy. Administer short-acting octreotide as needed; discontinue ≥24 hr before starting therapy.
• Administer long-acting octreotide 30 mg IM 4–24 hr after each dose during therapy. Do not administer long-acting octreotide within 4 wk of each subsequent dose. May give short-acting octreotide to manage symptoms during therapy, but hold for ≥24 hr before each dose.
• Continue long-acting octreotide 30 mg IM every 4 wk after therapy is completed until disease progression or for 18 mo following after starting therapy.
• Administer antiemetics before amino acid solution.

IV Administration:

• Start IV amino acid solution of L-lysine (18–25 g) and L-arginine (18–25 g) in 1–2 L volume 30 min before administering Lutathera. Use a 3-way valve to administer amino acids using same venous access as Lutathera or administer amino acids through separate venous access in patient’s other arm. Continue infusion during and for ≥3 hr after Lutathera infusion. Do not ↓ dose of amino acid solution if dose of Lutathera is ↓ to decrease reabsorption of Lutathera through proximal tubules and ↓ radiation dose to kidneys.
• Use aseptic technique and radiation shielding when administering Lutathera. Use tongs when handling vial to minimize radiation exposure. Do not inject Lutathera directly into any other IV solution. Confirm amount of radioactivity of Lutathera in radiopharmaceutical vial with an appropriate dose calibrator before and after Lutathera administration. Solution is colorless to slightly yellow; do not administer solutions that are cloudy, discolored, or contain particulate matter. Dispose of any unused medicinal product or waste material in accordance with local and federal laws.
• Intermittent Infusion: Gravity Method: Insert a 2.5 cm 20-gauge needle (short needle) into vial and connect via a catheter to 500 mL 0.9% NaCl (to transport Lutathera during infusion). Ensure short needle does not touch solution in vial, and do not connect this short needle directly to patient. Do not allow 0.9% NaCl to flow into vial before infusion, and do not inject Lutathera directly into 0.9% NaCl. Insert a second 9 cm 18-gauge needle (long needle) into vial, ensuring that this long needle touches and is secured to bottom of vial during entire infusion. Connect long needle to patient by an IV catheter that is prefilled with 0.9% NaCl and is used exclusively for Lutathera infusion.
• Rate: Use a clamp or pump to regulate flow of 0.9% NaCl via short needle into vial at a rate of 50–100 mL/hr for 5–10 min, then 200–300 mL/hr for additional 25–30 min (0.9% NaCl entering vial through short needle will carry Lutathera from vial to patient via catheter connected to long needle over a total duration of 30 to 40 min). During infusion, ensure level of solution in vial remains constant. Disconnect vial from long needle line and clamp 0.9% NaCl once level of radioactivity is stable for ≥5 min. Follow infusion with an IV flush of 25 mL 0.9% NaCl.
• Intermittent Infusion: Infusion Pump Method: Use when administering ↓ dose after ↓ dose for an adverse reaction; gravity method may result in delivery of incorrect volume if dose is not adjusted before administration. Insert 2.5 cm 20-gauge needle (short venting needle) into vial. Ensure short needle does not touch solution in vial, and do not connect short needle directly to patient or infusion pump. Insert second 9 cm 18-gauge needle (long needle) into vial, ensuring long needle touches and is secured to bottom of vial during entire infusion. Connect long needle and 0.9% NaCl to 3­way stopcock valve via appropriate tubing. Connect output of 3-way stopcock valve to tubing installed on input side of peristaltic infusion pump according to manufacturer’s instruction. Prime line by opening 3-way stopcock valve and pumping solution through tubing until it reaches exit of valve. Prime IV catheter connected to patient by opening 3-way stopcock valve to 0.9% NaCl and pumping 0.9% NaCl until it exits end of catheter tubing. Connect purged catheter to patient and set 3-way stopcock valve so Lutatherasolution is in line with infusion pump.
• Rate: Infuse appropriate volume over a 30–40 min period. When correct volume has been delivered, stop infusion pump and change position of 3-way stopcock valve so that infusion pump is in line with 0.9% NaCl. Restart infusion pump and infuse an IV flush of 25 mL of 0.9% NaCl through catheter to patient.
• Y-Site Incompatibility: Do not mix with or infuse with other drug or solutions.