FREQUENTLY ASKED QUESTIONS
ANSWERS TO COMMON QUESTIONS ABOUT BEXLUTRY, SUPPORT SERVICES, AND MORE
Explore frequently asked questions designed to help support integration of BEXLUTRY into clinical practice. Use the categories below to quickly find the information you need.
Patient selection
Which patients are appropriate for treatment with BEXLUTRY?
BEXLUTRY is indicated for the treatment of adults with SSTR+ GEP-NETs, including foregut, midgut, and hindgut neuroendocrine tumors.1
Is prior SSA therapy required?
Prior SSA therapy is not a prerequisite. BEXLUTRY is appropriate for patients who are newly diagnosed and for those who have progressed on SSA therapy.1,2
Radioligand equivalent and FDA approval pathways
What is a radioligand equivalent?
A radioligand equivalent is a drug that the FDA has determined to have comparable physicochemical properties and binding affinity to a reference RLT, with efficacy and safety supported by clinical trials of the reference therapy.3,4
Is a radioligand equivalent approved the same way as a generic?
No. They are approved differently. BEXLUTRY is a radioligand equivalent approved through the 505(b)(2) pathway.1,3,5,6 Generic radioligand therapies are approved through the 505(j) Abbreviated New Drug Application, and share the same label and reimbursement code as the reference therapy.3
Can a radioligand equivalent differ from the reference RLT?
Yes. While a radioligand equivalent like BEXLUTRY is designed to have comparable chemical, biological, and targeting characteristics, it may differ in aspects such as manufacturing process, formulation (inactive ingredients), or reimbursement or regulatory pathways.3,4
Mechanism of action
What is the mechanism of action of BEXLUTRY?
BEXLUTRY is a radioligand therapy composed of a somatostatin analog (dotatate) that binds to SSTR2 and a beta-minus–emitting radionuclide (lutetium-177). After binding to SSTR-expressing tumor cells, the compound is internalized, delivering targeted beta-minus radiation that causes DNA damage and tumor cell death.1,7
Dosing and administration
What is the recommended dosing regimen of BEXLUTRY?
The recommended dose is 7.4 GBq (200 mCi) every 8 weeks (±1 week), for a total of 4 doses. Treatment is administered in combination with long-acting octreotide (30 mg IM).1
What is the physical half-life of lutetium-177?
The physical half-life of lutetium-177 is approximately 6.7 days.1
Why are amino acids administered? And when?
An amino acid solution (containing lysine and arginine) is co-administered to reduce renal tubular reabsorption and decrease radiation exposure to the kidneys. The amino acid solution should be administered 30 minutes before the BEXLUTRY infusion, during, and for at least 3 hours after completion of the infusion.1
When should octreotide be administered or discontinued in relation to BEXLUTRY therapy?
Listed below are the appropriate time frames for administration and discontinuation.
When to discontinue1
- Long-acting octreotide: Withhold for at least 4 weeks prior to initiating BEXLUTRY therapy
- Short-acting octreotide: Discontinue at least 24 hours before each BEXLUTRY infusion
When to administer1
- Long-acting octreotide (30 mg IM): Administer 4 to 24 hours after each BEXLUTRY dose
- After completion of BEXLUTRY treatment, long-acting octreotide may be resumed as clinically indicated
What if a patient becomes nauseated?
Administer antiemetics as directed to relieve nausea and prevent vomiting.1,8 If additional management is needed, follow institutional guidelines or prescribing physician’s direction.
What should I do if a radiation spill occurs?
If a radiation spill occurs, you should always follow the guidance of your institution's radiation safety department. Refer to the Nuclear Regulatory Commission for additional considerations at www.nrc.gov.9
Efficacy and safety
What clinical studies support BEXLUTRY?
NETTER-1, a phase 3, randomized, open-label, multicenter study, evaluated lutetium Lu 177 dotatate + octreotide 30 mg vs high-dose octreotide (60 mg) in 229 patients with well-differentiated, grade 1 and 2 advanced GEP-NETs after SSA progression.1,14
NETTER-2, a phase 3, randomized, open-label, multicenter study, evaluated lutetium Lu 177 dotatate + octreotide 30 mg vs high-dose octreotide (60 mg) in 226 newly diagnosed patients with metastatic or locally advanced grade 2 or 3 inoperable SSTR+ GEP-NETs.2
ERASMUS was an international, single-institution, open-label, expanded-access study that assessed objective response rate using prospectively defined RECIST criteria in adults with foregut, midgut, or hindgut GEP-NETs. Patients received lutetium Lu 177 dotatate (7.4 GBq [200 mCi] per cycle) every 6 to 13 weeks for up to 4 cycles, with long-term follow-up.1
How is BEXLUTRY clinically equivalent to the reference therapy?
BEXLUTRY was approved through the FDA's 505(b)(2) pathway, allowing it to leverage the established efficacy and safety demonstrated in the NETTER-1 and NETTER-2 trials, as well as the safety profile from the ERASMUS trial.1,2,5,6 See clinical data.
What are the most common adverse reactions?
In NETTER-1, the most common grade 3 and 4 adverse reactions occurring with a greater frequency among patients receiving lutetium Lu 177 dotatate injection with octreotide compared with patients receiving high-dose octreotide include: lymphopenia (44%); increased GGT (20%); vomiting (7%); nausea and increased AST (5% each); and increased ALT, hyperglycemia, and hypokalemia (4% each).1
In NETTER-2, the most common grade 3 and 4 adverse events (≥3% in either arm) were lymphocyte count decreased (5% vs 0%), GGT increased (5% vs 3%), small intestinal obstruction (3% vs 0%), and abdominal pain (3% vs 4%) for the lutetium Lu 177 dotatate + 30 mg octreotide LAR arm vs the 60 mg octreotide LAR arm, respectively.2 See ERASMUS Study for additional safety information.
Are dose modifications described in the Prescribing Information?
Yes. Dose delays, reductions, or discontinuation may be required based on hematologic, renal, hepatic, hypersensitivity, and other adverse reactions.1 View full Prescribing Information.
What radiation precautions should my patients be made aware of?
Patients should receive counseling on temporary distancing from others (especially children and pregnant individuals), bathroom hygiene, sleeping arrangements, and other precautions.10-13 Specific duration depends on institutional radiation safety guidance.
Is BEXLUTRY safe to administer during pregnancy?
Based on mechanism of action, BEXLUTRY can cause fetal harm when administered to a pregnant woman. There is a potential risk of temporary or permanent infertility. Verify pregnancy status of females of reproductive potential prior to initiating BEXLUTRY.1
Support services
What is Curium Connects™?
Curium Connects is a support services program that offers financial, educational, and logistical support for both healthcare professionals and patients. Learn about how Curium Connects can help facilitate ordering and shipping needs or provide resources to support for you and your staff.
How can I order BEXLUTRY?
Curium Connects will help coordinate scheduling, shipping, and tracking for on-time delivery of BEXLUTRY through our online portal.
What services are available to support my patients?
Curium Connects offers educational, logistical, and financial support, including a co-pay savings program. Our patient hotline connects your patients to a fully dedicated team member who can answer any questions that they have at any point in their treatment journey. Learn more about support services available to your patients.
How is BEXLUTRY reimbursed?
Claims may initially use a miscellaneous code to help ensure proper billing and accurate reimbursement until a unique HCPCS code is assigned. For questions about coding and billing during this time, call our reimbursement team at 1-844-287-2628.
What should I do about delayed or unused doses?
If your patient cancels but the dose has already shipped, Curium’s partnerships with nuclear pharmacies ensure the safe return and disposal of unused doses. Contact Curium Connects™ at 1-844-287-2628 about unused doses, delayed doses, or patient cancellations.
Abbreviations
ALT, alanine aminotransferase; AST, aspartate aminotransferase; DNA, deoxyribonucleic acid; FDA, US Food and Drug Administration; GEP-NET, gastroenteropancreatic neuroendocrine tumor; GGT, gamma-glutamyltransferase; RLT, radioligand therapy; SSA, somatostatin analog; SSTR, somatostatin receptor; SSTR+, SSTR-positive; SSTR2, somatostatin receptor 2.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
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Risk From Radiation Exposure: Bexlutry contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. These risks of radiation associated with the use of Bexlutry are greater in pediatric patients than in adults.
Radiation can be detected in the urine for up to 30 days following Bexlutry administration. Minimize radiation exposure to patients, medical personnel, and household contacts during and after treatment with Bexlutry consistent with institutional good radiation safety practices, patient management procedures, Nuclear Regulatory Commission patient-release guidance, and instructions to the patient for follow-up radiation protection at home.
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Myelosuppression: In NETTER-1, myelosuppression occurred more frequently in patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to patients receiving high-dose long-acting octreotide (all Grades/Grade 3 or 4): anemia (81%/0) versus (54%/1%); thrombocytopenia (53%/1%) versus (17%/0); and neutropenia (26%/3%) versus (11%/0). In NETTER-1, platelet nadir occurred at a median of 5.1 months following the first dose. Of the 59 patients who developed thrombocytopenia, 68% had platelet recovery to baseline or normal levels. The median time to platelet recovery was 2 months. Fifteen of the nineteen patients in whom platelet recovery was not documented had post-nadir platelet counts. Among these 15 patients, 5 improved to Grade 1, 9 to Grade 2, and 1 to Grade 3. Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of myelosuppression.
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Secondary Myelodysplastic Syndrome (MDS) and Leukemia: In NETTER-1, with a median follow-up time of 76 months in the main study, myelodysplastic syndrome (MDS) was reported in 2.3% of patients receiving lutetium Lu 177 dotatate injection with long-acting octreotide compared to no patients receiving high-dose long-acting octreotide.
In ERASMUS, 16 patients (2.0%) developed MDS and 4 (0.5%) developed acute leukemia. The median time to onset was 29 months (9 to 45 months) for MDS and 55 months (32 to 125 months) for acute leukemia.
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Renal Toxicity: In ERASMUS, 8 patients (< 1%) developed renal failure 3 to 36 months following lutetium Lu 177 dotatate injection. Two of these patients had underlying renal impairment or risk factors for renal failure (e.g., diabetes or hypertension) and required dialysis.
Administer the recommended amino acid solution before, during and after Bexlutry to decrease the reabsorption of lutetium Lu 177 dotatate through the proximal tubules and decrease the radiation dose to the kidneys. Advise patients to hydrate and to urinate frequently before, on the day of, and the day after administration of Bexlutry.
Monitor serum creatinine and calculated creatinine clearance. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of renal toxicity.
Patients with baseline renal impairment may be at increased risk of toxicity due to increased radiation exposure.
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Hepatotoxicity: In ERASMUS, 2 patients (< 1%) were reported to have hepatic tumor hemorrhage, edema, or necrosis, with one patient experiencing intrahepatic congestion and cholestasis. Patients with hepatic metastasis may be at increased risk of hepatotoxicity due to radiation exposure.
Monitor transaminases, bilirubin, serum albumin, and international normalized ratio (INR) during treatment. Withhold dose, reduce dose, or permanently discontinue Bexlutry based on the severity of hepatotoxicity.
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Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, occurred in patients treated with lutetium Lu 177 dotatate injection. Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis, during and following Bexlutry administration for a minimum of 2 hours in a setting where cardiopulmonary resuscitation medication and equipment are available. Discontinue the infusion upon the first observation of any signs or symptoms consistent with a severe hypersensitivity reaction and initiate appropriate therapy.
Premedicate patients with a history of Grade 1 or 2 hypersensitivity reactions to Bexlutry before subsequent doses. Permanently discontinue Bexlutry in patients who experience Grade 3 or 4 hypersensitivity reactions.
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Neuroendocrine Hormonal Crisis: Neuroendocrine hormonal crises, manifesting with flushing, diarrhea, bronchospasm and hypotension, occurred in < 1% of patients in ERASMUS and typically occurred during or within 24 hours following the initial lutetium Lu 177 dotatate injection dose. Two (< 1%) patients were reported to have hypercalcemia. Monitor patients for flushing, diarrhea, hypotension, bronchoconstriction or other signs and symptoms of tumor-related hormonal release. Administer intravenous somatostatin analogs, fluids, corticosteroids, and electrolytes as indicated.
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Embryo-Fetal Toxicity: Based on its mechanism of action, Bexlutry can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating Bexlutry. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Bexlutry and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Bexlutry and for 4 months after the last dose.
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Risk of Infertility: Bexlutry may cause infertility in males and females. The recommended cumulative dose of 29.6 GBq of Bexlutry results in a radiation absorbed dose to the testes and ovaries within the range where temporary or permanent infertility can be expected following external beam radiotherapy.
ADVERSE REACTIONS
The most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in lutetium Lu 177 dotatate injection arm) reported in NETTER-1 were lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.
With a median follow-up time of more than 4 years, the following rates of serious adverse reactions were reported in ERASMUS: myelodysplastic syndrome (2%), acute leukemia (1%), renal failure (2%), hypotension (1%), cardiac failure (2%), myocardial infarction (1%), and neuroendocrine hormonal crisis (1%).
DRUG INTERACTIONS
Somatostatin Analogs: Somatostatin and its analogs competitively bind to somatostatin receptors and may interfere with the efficacy of Bexlutry. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each Bexlutry dose. Administer short- and long-acting octreotide during Bexlutry treatment as recommended.
Glucocorticoids: Glucocorticoids can induce down-regulation of subtype 2 somatostatin receptors (SSTR2). Avoid repeated administration of high doses of glucocorticoids during treatment with Bexlutry.
USE IN SPECIFIC POPULATIONS
Lactation
Advise women not to breastfeed during treatment with Bexlutry and for 2.5 months after the last dose.
Pediatric Use
Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors: The risks of radiation exposure associated with Bexlutry are greater in pediatric patients than in adult patients due to longer life expectancy. The safety and effectiveness of Bexlutry have not been established in pediatric patients younger than 12 years old with somatostatin receptor-positive GEP-NETs.
Pediatric use information is approved for Advanced Accelerator Applications USA INC’s LUTATHERA (lutetium Lu 177 dotatate) injection for intravenous use. However, due to Advanced Accelerator Applications USA Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
LUTATHERA® is a registered trademark of Advanced Accelerator Applications International SA.
INDICATIONS AND USAGE
Bexlutry™ (lutetium Lu 177 dotatate injection) is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.
References
- BEXLUTRY. Prescribing information. Curium US LLC; 2026.
- Singh S, Halperin D, Myrehaug S, et al; NETTER-2 trial investigators. [177Lu]Lu-DOTA-TATE plus long-acting octreotide versus high‑dose long-acting octreotide for the treatment of newly diagnosed, advanced grade 2-3, well-differentiated, gastroenteropancreatic neuroendocrine tumours (NETTER-2): an open-label, randomised, phase 3 study. Lancet. 2024;403(10446):2807-2817. doi:10.1016/S0140-6736(24)00701-3
- US Food and Drug Administration. Approved Drug Products With Therapeutic Equivalence Evaluations. 44th ed. 2024. Accessed April 13, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
- US Food and Drug Administration. Determining Whether to Submit an ANDA or a 505(b)(2) Application: Guidance for Industry. Published May 2019. Accessed May 22, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/determining-whether-submit-anda-or-505b2-application
- Lutathera. Prescribing information. Advanced Accelerator Applications USA Inc; 2024.
- Curium submits New Drug Application for Lutetium Lu 177 Dotatate Injection. News release. Curium. July 9, 2024. Accessed June 18, 2026. https://www.curiumpharma.com/2024/07/09/lutetium-lu-177-dotatate-injection/
- Ferro-Flores G, Azorín-Vega E, Ocampo-García B, Luna-Gutiérrez M, Cruz-Nova P, Meléndez-Alafort L. Effects of targeted radionuclide therapy on cancer cells beyond the ablative radiation dose. Int J Mol Sci. 2025;26(14):6968. doi:10.3390/ijms26146968
- Becx MN, Minczeles NS, Brabander T, de Herder WW, Nonnekens J, Hofland J. A clinical guide to peptide receptor radionuclide therapy with 177Lu-DOTATATE in neuroendocrine tumor patients. Cancers (Basel). 2022;14(23):5792. doi:10.3390/cancers14235792
- Attachment 1, Item 19, Emergency Procedures. Nuclear Radiation Commission. Accessed March 27, 2026. https://www.nrc.gov/docs/ML0827/ML082750235.pdf
- Ladrière T, Faudemer J, Levigoureux E, Peyronnet D, Desmonts C, Vigne J. Safety and therapeutic optimization of Lutetium-177 based radiopharmaceuticals. Pharmaceutics. 2023;15(4):1240. doi:10.3390/pharmaceutics15041240
- Levart D, Kalogianni E, Corcoran B, Mulholland N, Vivian G. Radiation precautions for inpatient and outpatient 177Lu-DOTATATE peptide receptor radionuclide therapy of neuroendocrine tumours. EJNMMI Phys. 2019;6(1):7. doi:10.1186/s40658-019-0243-1
- Radiation safety patient instructions: LUTATHERA (Lu-177 dotatate). Dartmouth Health. Accessed April 8, 2026. https://geiselmed.dartmouth.edu/radiology/wp-content/uploads/sites/47/2024/09/LUTATHERA-radiation-safety.pdf
- Hosono M, Ikebuchi H, Nakamura Y, et al. Manual on the proper use of lutetium-177-labeled somatostatin analogue (Lu-177-DOTA-TATE) injectable in radionuclide therapy (2nd ed.). Ann Nucl Med. 2018;32(3):217-235. doi:10.1007/s12149-018-1230-7
- Strosberg J, El-Haddad G, Wolin E, et al; NETTER-1 trial investigators. Phase 3 trial of 177Lu-dotatate for midgut neuroendocrine tumors. N Engl J Med. 2017;376(2):125-135. doi:10.1056/NEJMoa1607427