Should a Lu-177 spill occur, the priorities are to protect the patient, control the extent of contamination using absorbent paper towels, and to clean up the contaminated areas. 8 The authorized user contacts nuclear medicine, radiation safety, and diagnostic medical physics personnel. Pre- and Posttreatment Support
What type of radiation does lutetium 177 emit?
Lu-177 emits β-rays that have a short range in soft tissue (average 0.23 mm, max. 1.7 mm) and γ-rays. The radionuclide is produced by the Lu-176(n,γ)Lu-177 reaction. Lu is a rare earth element with the atomic number 71 [12].
How is lutetium administered?
The recommended dose of lutetium Lu 177 dotatate is 7.4 GBq (200 mCi) as an intravenous infusion over 30 minutes every 8 weeks for a total of 4 doses. Full prescribing information is available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208700s000lbl.pdf.
Is Lutathera a radiation?
Lutathera is a radioactive targeted therapy. It has 2 main parts: a radioactive part and a tumor-targeted part. The tumor-targeted part helps the medication fight just the tumor cells, not your normal cells. This helps keep the medication from damaging healthy parts of your body.
What type of radiation is Lutathera?
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.
Is lutetium-177 approved?
The FDA has granted approval to Lu 177 vipivotide tetraxetan (Pluvicto; formerly 177Lu-PSMA-617), for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post-taxane-based chemotherapy setting, according to a press release issued by ...
How is lutetium-177 given?
The treatment works by binding a radioactive atom to a drug molecule. It's then injected into the bloodstream where the drug can attach directly to the cancer cells. The drug can identify these cells by detecting the presence of a molecule called prostate-specific membrane antigen (PSMA).
What are the side effects of Lutathera treatment?
The most common and most serious side effects of LUTATHERA include: vomiting, nausea, decreased blood cell counts, increased liver enzymes, decreased blood potassium levels, and increased blood glucose. Talk to your doctor if you experience any of these side effects.
What is the cost of Lutathera?
Advanced Accelerator said Lutathera's list price is about $47,500 per dose, with the usual treatment period including four doses.
Can Lutathera shrink tumors?
Lutathera treatment helps make the tumors grow more slowly, shrink, or stop them from growing altogether, and can also help manage the symptoms caused by the tumors.
Is Lutathera FDA approved?
The FDA approved LUTATHERA based primarily on evidence from one clinical trial, NETTER-1 (NCT01578239) of 229 patients with somatostatin-receptor positive midgut GEP-NETs.
Is Lutathera effective?
In the trial, published in the New England Journal of Medicine, the study demonstrated that the patients treated with Lutathera showed 79 percent reduction in risk of disease progression or death compared to those treated with octreotide LAR.
When was Lutathera FDA approved?
In January 2018, Novartis AG received FDA approval for Lutathera, radiolabeled somatostatin analog for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), which is expected to augment the global neuroendocrine tumors treatment market.
What is this drug used for?
It is used to treat a certain type of cancer called neuroendocrine tumor from the gastrointestinal tract or the pancreas (GEP-NETs).
What do I need to tell my doctor BEFORE I take this drug?
If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
What are some things I need to know or do while I take this drug?
Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
How is this drug best taken?
Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
General drug facts
If your symptoms or health problems do not get better or if they become worse, call your doctor.
What is Lu 177 dotatate?
Lutetium Lu 177 dotatate, a peptide receptor radionuclide therapy (PRRT), is a tumor-targeted treatment that uses radiation to induce tumor cell death in neuroendocrine tumors (NETs) via a β particle-emitting radionuclide linked to a somatostatin peptide analog.
Why do we need a travel card for PRRT?
To help avoid travel delays, patients should be counseled about the possibility of radiation detection when traveling during and after each cycle of PRRT. It's recommended that clinical care teams give patients a travel card to help avoid delays. The travel card should contain: The patient's personal identification.
What is lutetium 177 used for?
Lutetium-177 (DOTATATE) (¹⁷⁷Lu; T1/2 6.7 days), a labelled β⁻ and Auger-electron emitter, is widely used in treatment of neuroendocrine tumours. During performance of the procedure, staff and other patients can potentially receive significant doses in interception of the gamma emissions [113 keV (6.4%) and 208 keV (11%)] that are associated with the particle decays. While radiation protection and safety assessment are required in seeking to ensure practices comply with international guidelines, only limited published studies are available. The objectives of present study are to evaluate patient and occupational exposures, measuring ambient doses and estimating the radiation risk. The results, obtained from studies carried out in Riyadh over an 11 month period, at King Faisal Specialist Hospital and Research Center, concerned a total of 33 ¹⁷⁷Lu therapy patients. Patient exposures were estimated using a calibrated Victoreen 451P survey meter (Fluke Biomedical), for separations of 30 cm, 100 cm and 300 cm, also behind a bed shield that was used during hospitalization of the therapy patients. Occupational and ambient doses were also measured through use of calibrated thermoluminescent dosimeters and an automatic TLD reader (Harshaw 6600). The mean and range of administered activity (in MBq)) was 7115.2 ± 917.2 (4329–7955). The ambient dose at corridors outside of therapy isolation rooms was 1.2 mSv over the 11 month period, that at the nursing station was below the limit of detection and annual occupational doses were below the annual dose limit of 20 mSv. Special concern needs to be paid to comforters (carers) and family members during the early stage of radioisotope administration.
What is PSMA RLT?
PSMA-direct ed radioligand therapy (PSMA-RLT) with Lutetium-177 (¹⁷⁷Lu-PSMA) is currently undergoing clinical validation. Retrospective observational data have documented favourable safety and striking clinical responses. Recent results from a prospective clinical trial (phase II) have been published confirming high response rates, low toxicity and reduction of pain in metastatic castration-resistant prostate cancer (mCRPC) patients who had progressed after conventional treatments. Such patients typically survive for periods less than 1.5 years. This has led some facilities to adopt compassionate or unproven use of this therapy, even in the absence of validation within a randomised-controlled trial. As a result, a consistent body of evidence exists to support efficacy and safety data of this treatment. The purpose of this guideline is to assist nuclear medicine specialists to deliver PSMA-RLT as an “unproven intervention in clinical practice”, in accordance with the best currently available knowledge.
What is the prostate specific membrane antigen?
Prostate-specific membrane antigen (PSMA) is expressed in most prostate cancers and PSMA-directed radioligand therapy (RLT) with Lutetium-177 (Lu-177) PSMA is promising systemic modality, which involves the delivery of targeted radiation therapy in the form of β-particles to sites of tumour tissue. Although, Lu-177 PSMA RLT has been recently introduced for castration-resistant metastatic prostate cancer (CRMPC), has continuously increasing interest and use in many centers. Therapy is well tolerated with relatively few side effects and has a positive effect on overall survival and quality of life. The purpose of this guideline is to assist nuclear medicine specialists in evaluating and managing patients with RCMPC for whom RLT using Lu-177 PSMA as an “unproven intervention in clinical practice”, in accordance with the best currently available knowledge.
Is 177Lu-PSMA safe?
177Lu-PSMA therapy efficacy was assessed by using prospective trials, meta-analyses and major retrospective trials. Predictors of efficacy were also mentioned. Although there are some different approaches regarding the use of 177Lu-PSMA therapy in different countries, this type of therapy is generally safe, with a low toxicity profile. From the oncological point of view, a PSA (prostate specific antigen) decline of ≥50% was seen in 10.6–69% of patients with mCRPC; whereas progression-free survival (PFS) was reported to be 3–13.7 months in different studies. Consequently, 177Lu-PSMA therapy is a promising treatment in patients with mCRPC, with good clinical efficacy, even in heavily pretreated patients with multiple lines of systemic therapy. Currently, there are ongoing clinical trials in the United States, including a phase III multicenter FDA registration trial.
How to minimize time near a maximize distance from use appropriate shielding between radiation source?
minimize time near a maximize distance from use appropriate shielding between radiation source a radiation source yourself and a radiation source Spend only the time needed Stay as far away as you can Put appropriate materials to complete your job near from the radiation source between you and the radiation the radiation source, and then source. The appropriate materials leave the area will depend on what type of radiation the source emits
What is the Alara principle?
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.8 It includes 3 basic protective measures8:
Is lutethera a radioactive drug?
LUTATHERA is a radiopharmaceutical and should be handled with appropriate safety measures to minimize radiation exposure. 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.1