Lutetium oxodotreotide lu-177

BEXLUTRY is indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors. 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. BEXLUTRY is a radiolabeled somatostatin analog indicated for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors.

Lutetium Lu 177 dotatate binds to somatostatin receptors with highest affinity for subtype 2 somatostatin receptors (SSTR2). Upon binding to somatostatin receptor expressing cells, including malignant somatostatin receptor-positive tumors, the compound is internalized. The beta-minus emission from lutetium-177 induces cellular damage by formation of free radicals in somatostatin receptor-positive cells and in neighboring cells.

Verify pregnancy status of females of reproductive potential prior to initiating BEXLUTRY. Administer GBq (200 mCi) every 8 weeks (± 1 week) for a total of 4 doses. Administer long-acting octreotide 30 mg intramuscularly 4 to 24 hours after each BEXLUTRY dose and short-acting octreotide for symptomatic management. Continue long-acting octreotide 30 mg intramuscularly every 4 weeks after completing BEXLUTRY until disease progression or for 18 months following treatment initiation. Administer antiemetics before recommended amino acid solution. Initiate recommended intravenous amino acid solution 30 minutes before BEXLUTRY infusion, continue during and for at least 3 hours after BEXLUTRY infusion. Do not decrease dose of amino acid solution if BEXLUTRY dose is reduced.

None. None.

Risk From Radiation Exposure: Minimize radiation exposure during and after treatment with BEXLUTRY consistent with institutional good radiation safety practices and patient management procedures. Myelosuppression: Monitor blood cell counts. Withhold dose, reduce dose, or permanently discontinue based on the severity. Secondary Myelodysplastic Syndrome (MDS) and Leukemia: Median time to onset: MDS is 29 months, acute leukemia is 55 months. Renal Toxicity: 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. Hepatotoxicity: Monitor transaminases, bilirubin, serum albumin and INR. Hypersensitivity Reactions: Monitor patients closely for signs and symptoms of hypersensitivity reactions, including anaphylaxis. Permanently discontinue BEXLUTRY based on severity.

The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression Secondary Myelodysplastic Syndrome and Leukemia Renal Toxicity Hepatotoxicity Hypersensitivity Reactions Neuroendocrine Hormonal Crisis Most common Grade 3-4 adverse reactions (≥ 4% with a higher incidence in lutetium Lu 177 dotatate injection arm) are lymphopenia, increased GGT, vomiting, nausea, increased AST, increased ALT, hyperglycemia and hypokalemia.

Somatostatin Analogs: Discontinue long-acting analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each BEXLUTRY dose.

Store upright at controlled room temperature 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original package to protect from ionizing radiation (lead shielding).