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RLT Institute
A 3-part illustration depicting a radioactivity measurement device and radioactive-labeled package, a patient receiving radioligand therapy, and a male health care professional disposing of waste in a radioactivelabeled waste bin.

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.

Postadministration

Patient considerations

Ensuring the safe discharge of patients after RLT administration is vital for their well-being and safety, as well as the safety of those around them. Proper patient discharge education and instructions are essential for safely managing radioactive material, minimizing radiation exposure to others, and ensuring proper follow-up care after RLT infusion.1-3

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Expert insight

When relaying precautions to the patient and their care team, anticipate their concerns and take measures to comfort and educate them by providing relevant safety principles. Ensure that the patient and their care team fully understand the instructions and why they are important.4

Survey requirements

Conduct a radiation survey using a digital survey meter (not a Geiger counter) at 1 m from the patient and document the reading to confirm levels are within safe limits for discharge (institution-specific guidelines may include specific release criteria for discharge). This process includes taking measurements from multiple body areas (abdomen, head and neck, other critical organs) and recording the highest reading.5

Patient release calculations

Per the NRC, a patient may be released to the public if the total effective dose equivalent to any other individual (including any caregiver or family member) who is exposed to the patient is not likely to exceed 5 mSv (0.5 rem).2,6 State regulators may have additional requirements.

Per the NRC, if the total effective dose equivalent is likely to exceed 1 mSv (0.1 rem) to any individual, instructions (including written instructions) must be provided to the patient on actions to limit radiation exposure to others by utilizing the ALARA (as low as reasonably achievable) principle.2,6

For patients receiving a 200 mCi dosage of PLUVICTO® (lutetium Lu 177 vipivotide tetraxetan) or LUTATHERA® (lutetium Lu 177 dotatate), the total effective dosage is ~2 mSv (see sample calculation below), exceeding the 1 mSv limit for any individual. Therefore, written instructions are required prior to discharge.

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Example precautions and discharge discussion for PLUVICTO and LUTATHERA

When discussing release instructions with patients, detailing discharge precautions and guidelines for safety for themselves and others, topics include1-3,5:

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Hydration

  • The patient should stay hydrated and urinate as frequently as possible to avoid drug accumulation in the bladder5,8,9
  • If urine is spilled or splashed on the toilet seat, wash and rinse the area with disposable towels2
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Hygiene

  • The patient should minimize contamination upon discharge with simple hygiene measures, such as use of private room and a designated bathroom, thorough handwashing after each restroom use, urinating while seated, flushing 2 to 3 times with the toilet lid closed, and cleaning bathroom areas after use2
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Social distancing from others

  • The patient should limit close contact (ie, less than 3 feet) with others in their household and sleep in a separate bedroom for at least 3 days2,8
  • The patient should refrain from sexual activity for 7 days2,8
  • Refer to prescribing information for use of contraception following treatment8.9
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Expert insight

Offer real-life examples and guidance grounded in the ALARA principle to reassure patients and ease feelings of isolation due to necessary social distancing measures. For instance, a quick hug and dining with adult family members who are not pregnant and who maintain a distance greater than 3 feet may be OK, provided interactions are brief.2,4

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Travel

  • Patient use of personal or public transportation in the company of others for more than 1 hour is discouraged for the first 3 days following therapy2
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Laundry

  • The patient should wash laundry separately from others for 1 week and wash laundry twice4
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Biowaste contamination

  • Any items contaminated with urine or blood cannot be disposed of in regular trash for the first 3 days post-treatment2
  • Toilet paper and tissue should be flushed down the toilet2
  • Typically, any other contaminated items for the first 3 days post-treatment that cannot be washed or flushed down the toilet need to be stored (away from high-traffic and sleeping areas in the home, eg, in the basement or a garage) for at least 70 days before being discarded2
  • The radiation safety officer for the facility can advise on institution-specific guidelines2
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Guidance for interaction with pregnant women and children

  • Pregnant women, whether they are members of the patient’s household or not, should be limited to 1 mSv (0.1 rem) of radiation2
  • The patient should limit close contact (ie, less than 3 feet) with children and pregnant women for 7 days2,8
  • The patient should sleep in a bedroom separate from children for 7 days and separate from pregnant women for 15 days2,8
Administration methods
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