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Safety

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Radiation Exposure: Treatment with LUTATHERA contributes to a patient’s overall long-term cumulative radiation exposure and is associated with an increased risk for cancer...

Indication

LUTATHERA® (lutetium Lu 177 dotatate) is indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut...

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References: 1. Lutathera. Prescribing information. Novartis Pharmaceuticals Corp. 2. Strosberg J, El-Haddad G, Wolin E, et al; for the NETTER-1 trial investigators. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-135. 3. Strosberg JR, Caplin ME, Kunz PL, et al; NETTER-1 investigators. 177Lu-dotatate plus long-acting octreotide versus high-dose long-acting octreotide in patients with midgut neuroendocrine tumours (NETTER-1): final overall survival and long-term safety results from an open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2021;22(12):1752-1763. 4. Centers for Disease Control and Prevention. ALARA - as low as reasonably achievable. Accessed August 4, 2021. https://www.cdc.gov/nceh/radiation/alara.html 5. Hope TA, Abbott A, Colucci K, et al. NANETS/SNMMI procedure standard for somatostatin receptor–based peptide receptor radionuclide therapy with 177Lu-DOTATATE. J Nucl Med. 2019;60(7):937-943. 6. Calais PJ, Turner JH. Radiation safety of outpatient 177Lu-octreotate radiopeptide therapy of neuroendocrine tumors. Ann Nucl Med. 2014;28(6):531-539. 7. Friedberg W, Copeland K, Duke FE, O’Brien K III, Darden EB Jr. Radiation exposure during air travel: guidance provided by the Federal Aviation Administration for air carrier crews. Health Phys. 2000;79(5):591-595. 8. National Radiation Commission. Attachment 1, item 19, emergency procedure. Accessed February 24, 2022. https://www.nrc.gov/docs/ML0827/ML082750235.pdf