: Lutetium (177Lu) oksodotreotid 370 MBq på datoen og tidspunktet for kalibrering. Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; January 2018. http://www.adacap.com/wp-content/uploads/2018/01/Lutathera_lutetium_Lu_-177_dotatate_PI_2018_01.pdf, LUTATHERA® (lutetium Lu 177 dotatate) Important Safety Information3. Because NETs are poorly diagnosed, often by the time of diagnosis, the tumor has spread to other parts of the body (metastasis)2. Advanced Accelerator Applications. Do not decrease the dose of the amino acid solution if the dose of LUTATHERA is reduced [see Warnings and Precautions (5.4)] . Thrombocytopenia [see Warnings and Precautions (5.2)]. Resume LUTATHERA at 3.7 GBq (100 mCi) in patients with complete or partial resolution. Administer premedications and concomitant medications as recommended [see Dosage and Administration (2.3) ]. Amino Acid SolutionInitiate an intravenous amino acid solution containing L-lysine and L-arginine (Table 1) 30 minutes before administering LUTATHERA. Neuroendocrine tumors (NETs) are rare tumors originating in neuroendocrine cells (cross functional cells that receive signals from the nervous system triggering release of hormones) of numerous organs. The approval of every new therapy offers hope to these patients and their families.”, The NETTER-1 study met its primary endpoint, showing a 79% reduction in risk of disease progression or death in the LUTATHERA® arm compared to the 60 mg octreotide LAR arm (hazard ratio 0.21, 95% CI: 0.13-0.32; p<0.0001).3 Median PFS was not reached in the LUTATHERA® arm compared to 8.5 months for the 60 mg octreotide LAR arm.3 A pre-planned interim overall survival analysis determined that LUTATHERA® treatment lead to a 48% reduction in the estimated risk of death (hazard ratio 0.52, 95% CI: 0.32-0.84) compared to treatment with 60 mg octreotide LAR.3 The objective response rate, composed of complete and partial responses, was 13% for the LUTATHERA® arm compared to 4% in the Octreotide LAR 60mg arm (p<0.0148).3, The most common Grade 3-4 adverse reactions occurring with a greater frequency among patients in the NETTER-1 study receiving LUTATHERA® with octreotide compared to patients receiving high-dose octreotide include: lymphopenia (44%), increased gamma-glutamyl transferase (20%), vomiting (7%), nausea and elevated aspartate aminotransferase (5% each), and increased alanine aminotransferase, hyperglycemia and hypokalemia (4% each).3, About LUTATHERA® (lutetium Lu 177 dotatate) and How it Works. If reduced dose does not result in Grade 3 or 4 anemia or neutropenia, administer LUTATHERA at 7.4 GBq (200 mCi) for next dose. Lutathera (lutetium Lu 177 dotatate) mechanism of action picture, http://www.adacap.com/wp-content/uploads/2018/01/Lutathera_lutetium_Lu_-177_dotatate_PI_2018_01.pdf. Please see full Prescribing Information at:   http://www.adacap.com/wp-content/uploads/2018/01/Lutathera_lutetium_Lu_-177_dotatate_PI_2018_01.pdf. Within the ‘Prescription Medications’ section: Use Trial Bulletin to search for clinical trials involving this product: All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent. Administer short-acting octreotide as needed; discontinue at least 24 hours prior to initiating LUTATHERA. AntiemeticAdminister antiemetics before the recommended amino acid solution. LUTATHERA® has received orphan drug designation from the FDA and the European Medicines Agency (EMA). Hypoalbuminemia less than 30 g/L with a decreased prothrombin ratio less than 70%. LUTATHERA® has been administered to more than 2,000 patients on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in 10 European countries and in the US under an Expanded Access Program (EAP). GEP-NETs are subdivided into two categories: tumors of the gastrointestinal (GI) tract and pancreatic NETs. Discontinue long-acting somatostatin analogs at least 4 weeks and short-acting octreotide at least 24 hours prior to each LUTATHERA® dose. This first-in-class drug belongs to a class of treatments called Peptide Receptor Radionuclide Therapy (PRRT). Verify pregnancy status of females of reproductive potential prior to initiating LUTATHERA [see Use in Specific Populations (8.1, 8.3)]. Advanced Accelerator Applications, LUTATHERA™ Product Monograph, January 9, 2019. N Engl J Med 2017; 376:125-35. Lutathera is comprised of a targeting molecule which carries a radioactive component. JAMA Oncol. There can be no guarantee that the products described in this press release will be commercially successful in the future. Your healthcare provider may fill out a LUTATHERA treatment card and give it to you after treatment. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; general economic and industry conditions, including the effects of the persistently weak economic and financial environment in many countries; safety, quality or manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. Withhold dose until complete or partial resolution (Grade 0 to 2). Trends in the incidence, prevalence, and survival outcomes in patients with neuroendocrine tumors in the United States.

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