Providing and administering RLT
This section of the Novartis RLT Institute is designed to help health care professionals (HCPs) understand radiation safety procedures for providing and administering radioligand therapies (RLTs) manufactured by Novartis. It is based on guidelines from regulatory agencies, including the Nuclear Regulatory Commission (NRC), the Department of Transportation (DOT), and the United States Pharmacopeia (USP). Topics include safe transport, administration, and postadministration protocols to prepare the patient and room for subsequent use.
Receiving, handling, and storage
Storage
Once received, proper storage of RLTs is critical to ensure safety, compliance with regulations, and the integrity of the materials until their use.1
NRC requirements
RLTs must be safely stored in compliance with NRC guidelines for secure storage of RAMs, ensuring restricted access and minimizing the risk of exposure and tampering.1-3
Storage requirements for RLTs
Shelf life: The shelf life for PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) is 120 hours (5 days) from the date and time of calibration and the shelf life for LUTATHERA® (lutetium Lu 177 dotatate) is 72 hours from the date and time of calibration4,5
Temperature: PLUVICTO® is stored below 30°C (86°F) and LUTATHERA® is stored below 25°C (77°F); neither should be frozen during storage4,5
Packaging: RLTs must remain in the original lead-shielded package to protect against ionizing radiation4,5
Expiration: RLTs must not be used beyond their expiration date and time, which are indicated on the label4
Disposal: Medicinal products or waste material must be disposed of following established waste management protocols in compliance with local and federal regulations4,5
Signage: Storage areas must be clearly marked with appropriate radiation signage to ensure visibility and safety awareness2,3
By adhering to these storage practices, facilities can maintain compliance and enable the safe handling of RLTs.