SIGNIFOR LAR (pasireotide) for injectable suspension Signifor

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Hyperglycemia can occur in patients treated with SIGNIFOR LAR24,*

  • Hyperglycemia is reversible upon SIGNIFOR LAR discontinuation25
  • Metformin alone or in combination with other anti-diabetic medication may help control elevations in glucose levels that may occur with SIGNIFOR-LAR treatment25,†
  • Most patients who had hyperglycemia were able to achieve the American Diabetes Association Goal of 7% with medical management25
  • Key elements in addressing hyperglycemia include close monitoring, patient education, and prompt action25
  • There have been postmarketing cases of ketoacidosis with SIGNIFOR LAR in patients with history of diabetes and in patients without history of diabetes. Assess patients who present with signs and symptoms consistent with ketoacidosis during SIGNIFOR LAR treatment3

Importantly, in patients with poorly controlled diabetes mellitus, optimize anti-diabetic treatment before starting SIGNIFOR LAR3

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*Up to a third of patients experienced hyperglycemia with SIGNIFOR LAR:
— 29% of medically naive patients treated with SIGNIFOR LAR experienced hyperglycemia1
— 33% and 30% of previously inadequately controlled patients experienced hyperglycemia when switched to 40 and 60 mg SIGNIFOR LAR, respectively1
Glucose control generally defined as HbA1c <7% by the ADA guidelines.26

Current antidiabetic treatment therapies may help you manage hyperglycemia in patients treated with SIGNIFOR LAR.

The first prospective, multicenter, randomized, open-label phase 4 study to investigate the management of pasireotide-associated hyperglycemia27

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The objective of this study was to assess the efficacy of incretin-based or insulin therapy in patients with pasireotide-associated hyperglycemia who were eligible for randomization

  • Patients eligible for randomization had an average fasting blood sugar of ≥126 mg/dL on three consecutive days during pre-randomization period, despite optimized treatment with metformin/other permitted OADs
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Some patients receiving pasireotide did not develop treatment-associated hyperglycemia requiring antidiabetic medication

  • Of 249 patients enrolled in the study (190 with acromegaly and 59 with Cushing’s disease), 103 (41%) did not require antidiabetic medication
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For some patients who developed hyperglycemia with pasireotide, antidiabetic treatment options such as metformin, incretin-based therapy, and/or insulin, were shown to be effective

  • 46 (18%) patients were managed with metformin or other oral antidiabetic drugs
  • Among patients requiring additional therapy (N=81/249), incretin-based therapy was more effective than insulin in lowering HbA1c

In this study, hyperglycemia observed during pasireotide treatment was manageable in most patients without the need for treatment discontinuation.27

Indications and Usage

SIGNIFOR LAR (pasireotide) is a somatostatin analog indicated for the treatment of:

Important Safety Information

Warnings and Precautions

Indications and Usage

SIGNIFOR LAR (pasireotide) is a somatostatin analog indicated for the treatment of:

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Females and Males of Reproductive Potential

References: 1. Gatto F, Barbieri F, Arvigo M, et al. Biological and biochemical basis of the differential efficacy of first and second generation somatostatin receptor ligands in neuroendocrine neoplasms. Int J Mol Sci. 2019;20(16):3940. 2. Poullot A-G, Chevalier N. New options in the treatment of Cushing’s disease: a focus on pasireotide. Res Rep Endocr Disord. 2013;3:31-38. 3. SIGNIFOR LAR (pasireotide) for injectable suspension, for intramuscular use [prescribing information]. Lebanon, NJ: Recordati Rare Diseases Inc.; 2020. 4. Acromegaly. UCLA Health System. Accessed August 23, 2022. 5. Broder MS, Chang E, Cherepanov D, Neary MP, Ludlam WH. Incidence and Prevalence of Acromegaly in the United States: A Claims-Based Analysis. AACE Endocrine Practice. Published November 1, 2016. Accessed August 23, 2022. 6. Christofides EA. Clinical importance of achieving biochemical control with medical therapy in adult patients with acromegaly. Patient Prefer Adherence. 2016;10:1217-1225. 7. Acromegaly. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed August 23, 2022. 8. Carmichael JD, Bonert VS, Nu.o M, Ly D, Melmed S. Acromegaly clinical trial methodology impact on reported biochemical efficacy rates of somatostatin receptor ligand treatments: a meta-analysis. J Clin Endocrinol Metab. 2014;99(5):1825-1833. 9. Carroll PV, Jenkins PJ. Acromegaly. In: Feingold KR, Anawalt B, Boyce A, et al, eds. Endotext [Internet]. South Dartmouth, MA:, Inc.; 2016 10. Giustina A, Barkhoudarian G, Beckers A, et al. Multidisciplinary management of acromegaly: A consensus. Rev Endocr Metab Disord. 2020;21(4):667-678. 11. Katznelson L, Laws ER Jr, Melmed S, et al. Endocrine Society Acromegaly: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2014;99(11):3933-3951. 12. Lavrentaki A, Paluzzi A, Wass JA, Karavitaki N. Epidemiology of acromegaly: review of population studies. Pituitary. 2017;20(1):4-9. 13. SOMATULINE® DEPOT (lanreotide) injection, for subcutaneous use [prescribing information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; 2019 14. SANDOSTATIN LAR DEPOT (octreotide acetate) for injectable suspension, for gluteal intramuscular use [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2021. 15. Coopmans EC, Muhammad A, van der Lely AD, et al. How to position pasireotide LAR treatment in acromegaly. J Clin Endocrinol Metab. 2019;104(6):1978-1988. 16. Shanik MH, Cao PD, Ludlam WH. Historical response rates of somatostatin analogues in the treatment of acromegaly: a systematic review. Endocr Pract. 2016;22(3):350-356. 17. Casar-Borota O, Heck A, Schulz S, et al. Expression of SSTR2a, but not of SSTRs 1, 3, or 5 in somatotroph adenomas assessed by monoclonal antibodies was reduced by octreotide and correlated with the acute and long-term effects of octreotide. J Clin Endocrinol Metab. 2013;98(11):E1730-E1739. 18. Silverstein JM. Hyperglycemia induced by pasireotide in patients with Cushing’s disease or acromegaly. Pituitary. 2016;19:536-543. 19. Zambre Y, Ling Z, Chen MC, et al. Inhibition of human pancreatic islet insulin release by receptor-selective somatostatin analogs directed to somatostatin receptor subtype 5. Biochem Pharmacol. 1999;57(10):1159-1164. 20. Singh V, Brendel MD, Zacharias S, et al. Characterization of somatostatin receptor subtype-specific regulation of insulin and glucagon secretion: an in vitro study on isolated human pancreatic islets. J Clin Endocrinol Metab. 2007;92(2):673-680. 21. Breitschaft A, Hu K, Hermosillo Res.ndiz K, Darstein C, Golor G. Management of hyperglycemia associated with pasireotide (SOM230): healthy volunteer study. Diabetes Res Clin Pract. 2014;103(3):458-465. 22. Henry RR, Ciaraldi TP, Armstrong D, Burke P, Ligueros-Saylan M, Mudaliar S. Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. J Clin Endocrinol Metab. 2013;98(8):3446-3453. 23. Gadelha MR, Bronstein MD, Brue T, et al. Pasireotide versus continued treatment with octreotide or lanreotide in patients with inadequately controlled acromegaly (PAOLA): a randomised, phase 3 trial. Lancet Diabetes Endocrinol. 2014;2(11):875-884. 24. Colao A, Bronstein MD, Freda P, et al. Pasireotide versus octreotide in acromegaly: a head-to-head superiority study. J Clin Endocrinol Metab. 2014;99(3):791-799. 25. Gadelha MR, Gu F, Bronstein MD, et al. Risk factors and management of pasireotide-associated hyperglycemia in acromegaly. Endocr Connect. 2020;9(12):1178-1190. 26. American Diabetes Association. Standards of Medical Care in Diabetes-2020 Abridged for Primary Care Providers. Clin Diabetes. 2020;38(1):10-38. doi:10.2337/cd20-as01. 27. Samson SL, Gu F, Feldt-Rasmussen U, Zhang S, Yu Y, et al. Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study. Pituitary. 2021;24(6):887-903.