LUTATHERA® (lutetium Lu 177 dotatate) Regimen and Administration Procedures
Important safety instructions1
LUTATHERA is a radiopharmaceutical; handle with appropriate safety measures to minimize radiation exposure. Use waterproof gloves and effective radiation shielding when handling LUTATHERA. Radiopharmaceuticals, including LUTATHERA, should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radiopharmaceuticals, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radiopharmaceuticals. Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA.
“ALARA” principle: keeping radiation exposure “as low as reasonably achievable”2
ALARA is the guiding principle of radiation safety. It means that even a small radiation dose should be avoided if there is no benefit to receiving it. It includes 3 basic protective measures:
TIME: minimize time near a radiation source. Spend only the time needed to complete your job near the radiation source, and then leave the area.
DISTANCE: maximize distance from a radiation source. Stay as far away as you can from the radiation source.
SHIELDING: use appropriate shielding between yourself and a radiation source. Put appropriate materials between you and the radiation source. The appropriate materials will depend on what type of radiation the source emits.
You should follow these procedures, in addition to your institution’s radiation safety guidelines, whenever handling or administering LUTATHERA:
- Use disposable plastic, latex, or rubber gloves
- Wear a lab coat, which must be monitored before leaving the laboratory
- Wear safety glasses
- Minimize handling time
- Use tongs to handle unshielded sources and potentially contaminated vessels
- Use disposable absorbent liners on trays
- Ensure that waste and medical consumables exposed to radioactivity are disposed of in compliance with your institution’s radiation safety policies
Radiation associated with LUTATHERA
The 177Lu isotope in LUTATHERA decays with a half-life of 6.647 days1 and emits 2 types of radiation4:
- A low-to-medium-energy β particle, which is predominantly absorbed within the body of the patient
- γ radiation at a low quantity and low-to-medium energy
These characteristics help keep radiation exposure to bystanders, such as medical personnel and caregivers, within the established regulatory guidance.5
Preparing for LUTATHERA administration
Absorbent drapes should be used to cover vulnerable areas in the patient room and bathroom. This might include certain areas of the floor and toilet.3
Patients may arrive in street clothes but may change into hospital gowns before the LUTATHERA infusion, so that their gowns may be quarantined in the event of a radiation spill.
The patient should be provided with access to an isolated bathroom unavailable to the general public as 177Lu is excreted in the urine, which will therefore contain radioactive material. The patient should be encouraged to urinate as frequently as possible to help eliminate radioactive material concentrated in the urine. Patients should be instructed regarding procedures to avoid contamination of the bathroom. Men should sit on the toilet to urinate. Patients should double-flush the toilet after use.
In case of a radiation spill
If a radiation spill occurs, you should always follow the guidance of your institution’s radiation safety department.
Nausea and vomiting are often seen during the infusion procedure.1 Vomit from a patient who has received LUTATHERA should be considered radioactive and cleaned up following the procedures for a radiation spill. Patients should be administered an antiemetic as described in premedication and concomitant medications.
Urine and feces from a patient who has received LUTATHERA is radioactive and should be cleaned up following the procedures for a radiation spill.
The LUTATHERA regimen1
The recommended treatment regimen consists of 7.4 GBq (200 mCi) IV every 8 weeks, for a total of 4 doses. Following each dose, the patient should receive long-acting octreotide 30 mg IM between 4 and 24 hours after each LUTATHERA dose. Long-acting octreotide 30 mg IM should be continued every 4 weeks after completing LUTATHERA until disease progression or for up to 18 months following LUTATHERA treatment initiation.
Administer premedication and concomitant medications..
In case of toxicity: Interval between doses can be extended up to 16 weeks as needed. Information is provided in the LUTATHERA full prescribing information as to when treatment with LUTATHERA should be suspended, the dose adjusted, or treatment permanently discontinued due to adverse reactions, including thrombocytopenia, anemia and neutropenia, renal toxicity, hepatotoxicity, and other non-hematologic toxicity.1
Premedication and concomitant medications
Antiemetics and amino acids1
An antiemetic should be administered 30 minutes before the start of the amino acid solution infusion to avoid treatment-related nausea and vomiting.
An IV infusion of an amino acid solution is started 30 minutes before LUTATHERA administration and continued during and for at least 3 hours after. Always administer the full amino acid solution treatment, even if administering a reduced dose of LUTATHERA.
Infusion schedule and procedures
The following is a brief overview of the administration procedure. For the full procedure, please see LUTATHERA full prescribing information.
In the LUTATHERA infusion method, a saline solution carries the LUTATHERA dose into the IV infusion catheter. A clamp or pump is used to regulate the saline flow, and thus the rate of LUTATHERA infusion. The amino acid solution is delivered using the same venous access or separately into the patient’s other arm through a venous access.1
The LUTATHERA infusion is usually not administered by the nurse. The radiopharmaceutical infusion will usually be administered by a nuclear medicine technologist or nuclear medicine physician, depending upon the institution. These individuals are sometimes called the “authorized user.”
The LUTATHERA infusion should be conducted over the course of 30 to 40 minutes. LUTATHERA must not be administered as an intravenous bolus. Use a clamp or pump to regulate the flow of the sodium chloride solution via the short needle into the LUTATHERA vial at a rate of 50 mL/hour to 100 mL/hour for 5 to 10 minutes and then 200 mL/hour to 300 mL/hour for an additional 25 to 30 minutes.1
The LUTATHERA infusion can be disconnected once the level of radioactivity is stable for at least 5 minutes (this is the only parameter to determine the procedure’s end).1
Use radiation shielding and tongs whenever handling the LUTATHERA vial to minimize exposure.1
Downloadable resources for nursing care and about the administration of LUTATHERA are available here.
IM, intramuscular; IV, intravenous.
References: 1. LUTATHERA®[prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; July 2018. 2. Centers for Disease Control and Prevention. https://www.cdc.gov/nceh/radiation/alara.html. Accessed October 3, 2017. 3. Data on file. Advanced Accelerator Applications USA, Inc. 4. Olmstead C, Cruz K, Stodilka R, Zabel P, Wolfson R. Quantifying public radiation exposure related to lutetium-177 octreotate therapy for the development of a safe outpatient treatment protocol. Nucl Med Commun. 2015;36(2):129-134. 5. Calais PJ, Turner JH. Radiation safety of outpatient 177Lu-octreotate radiopeptide therapy of neuroendocrine tumors. Ann Nucl Med. 2014;28(6):531-539.
IMPORTANT SAFETY INFORMATION1
WARNINGS AND PRECAUTIONS
The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in LUTATHERA arm) observed in NETTER-1 were lymphopenia (44%), increased GGT (20%), vomiting (7%), nausea (5%), elevated AST (5%), increased ALT (4%), hyperglycemia (4%), and hypokalemia (4%).
In ERASMUS, the following serious adverse reactions have been observed with a median follow-up time of more than 4 years after treatment with LUTATHERA: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%). Patients should be counseled and monitored in accordance with the LUTATHERA Prescribing Information.
Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of LUTATHERA. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA dose. Administer short- and long-acting octreotide during LUTATHERA treatment as recommended.
To report SUSPECTED ADVERSE REACTIONS, contact Advanced Accelerator Applications USA, Inc. at 1-844-863-19301-844-863-1930, or email@example.com, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.
Distributed by: Advanced Accelerator Applications USA, Inc., NJ 07041
References: 1. LUTATHERA® [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; July 2018.