LUTATHERA^® Resource HUB for Healthcare Professionals

Indication and clinical use:

LUTATHERA^® (lutetium (¹⁷⁷Lu) oxodotreotide) is indicated for the treatment of unresectable or metastatic, well-differentiated, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adults with progressive disease.

• Dosing instructions include the use of concomitant medications for renal protection and mitigation of nausea and vomiting; provisions for patient monitoring and dose modifications are also provided
• Administer under the supervision of a qualified healthcare professional experienced in the use of therapeutic radiopharmaceuticals
• Not indicated for use in pediatric patients
• Of the 1325 patients treated with LUTATHERA^® in clinical trials, 438 patients (33%) were 65 years and older

Contraindications:

• Severe renal impairment
• Established or suspected pregnancy

Most serious warnings and precautions:

Radiation Contamination: LUTATHERA^® can contribute to a patient’s overall long-term exposure to radiation, which is associated with increased risk of cancer.

Acute and chronic renal toxicity: Can develop gradually during and after treatment. Patients should be advised to urinate frequently during and after administration.

Myelodysplastic syndrome and acute leukemia: Have both been observed after treatment. Patients over 70 years old, those with impaired renal function, pre-existing cytopenias, or prior exposure to chemo or radiation therapy may be at increased risk.

Other relevant warnings and precautions:

• Myelosuppression
• Hepatotoxicity
• Neuroendocrine hormonal crisis
• Embryo-fetal toxicity
• Risk of infertility
• Breastfeeding
• Elderly (≥70 years old), close monitoring is advised
• Patients with hepatic impairment
• Patients with renal impairment
• Hypersensitivity reactions (including severe/life-threatening angioedema events)
• LUTATHERA^® should be administered under the supervision of a health professional who is experienced in the use of radiopharmaceuticals.
• Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.
• The radiopharmaceutical product may be received, used and administered only by authorized persons in designated clinical settings.
• Receipt, storage, use, transfer and disposal are subject to the regulations and/or appropriate licenses of local competent official organizations.
• Care should be taken to minimize radiation exposure to patients consistent with proper patient management
• Amino Acid Solution Related Risks:
  • Hyperkalemia: A transient increase in serum potassium levels may occur in patients receiving arginine and lysine, usually returning to normal levels within 24 hours from the start of the amino acid infusion.
  • Heart Failure: Due to potential for clinical complications related to volume overload, specifically with the amino acid solution, care should be taken with use of arginine and lysine in patients with severe heart failure defined as class III or class IV in the NYHA classification.
  • Metabolic Acidosis: Shifts in acid-base balance alter the balance of extracellular-intracellular potassium and the development of acidosis may be associated with rapid increases in plasma potassium.

For more information:

Consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information relating to adverse reactions, drug interactions, and dosing and administration which has not been discussed in this piece.

The Product Monograph is also available by emailing medinfo.canada@novartis.com or by calling 1-800-363-8883.

References:

1. LUTATHERA^® (lutetium (¹⁷⁷Lu) oxodotreotide) Product Monograph. September 9, 2022.
2. Data on file. Advanced Accelerator Applications. September 29, 2022.