SIGNIFOR LAR (pasireotide) for injectable suspension Signifor

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Prevalence and Impact ACROMEGALY IS A RARE DISEASE

Often referred to as somatotroph adenoma or growth hormone excess, acromegaly is a chronic metabolic disorder caused by the presence of too much growth hormone.4

About 25,000 Patients in the U.S.

About 25,000 patients in the U.S.5

3,000 New Cases Per Year

3,000 new cases per year5

Affects Men and Women Equally

Affects men and women equally6

Becomes More Common with Age

Becomes more common with increasing age6

Causes and risk factors

Acromegaly is caused by abnormal production of growth hormone after normal growth of the skeleton and other organs is complete. In children, too much growth hormone causes a condition called gigantism rather than acromegaly.4

The cause of the increased hormone secretion is usually a benign tumor of the pituitary gland. The pituitary gland, which is located just below the brain, controls the production and release of several different hormones including growth hormone.4

There are no known risk factors for acromegaly other than a prior history of a pituitary tumor.4

Symptoms of acromegaly

The most common symptom of acromegaly is abnormal growth of the hands and feet.7

With swelling of the hands and feet being an early symptom of the condition, people with acromegaly might notice that their rings or shoes have become too tight. Over time, as the bones continue to grow, facial features begin to change, with the brow and lower jaw becoming more prominent, the bone of the nose becoming larger, and the teeth developing spaces between them. Acromegaly can also lead to arthritis, carpal tunnel syndrome, and enlargement of the internal organs, including the heart.7

Additional symptoms may include7:

  • Joint aches
  • Headaches
  • Impaired vision
  • Fatigue
  • Weakness
  • Thickening of the skin
  • Oily skin
  • Skin tags
  • Enlargement of the lips, nose, and tongue
  • Deepening of the voice
  • Sleep apnea
  • Excessive sweating
  • Skin odor
  • Abnormal menstrual cycles
  • Breast discharge in women
  • Erectile dysfunction in men
  • Decreased libido
DID YOU KNOW?

The word acromegaly comes from the Greek words “acro,” meaning extremities, and “megaly,” meaning enlargement.

Individualizing Treatment for the Patient with Acromegaly

Presented by Michael H. Shanik, MD, FACP, FACE

WATCH THE ON DEMAND VIDEO

Diagnosing and treating acromegaly

It varies by person and level of severity.

In addition to a full physical exam and a consult around symptoms, a medical evaluation may include the following steps to better diagnosis acromegaly:

  • An IGF-1 measurement
  • Growth hormone suppression test
  • Imaging

Regarding treatment, the goal is to restore the pituitary gland to normal function, producing normal levels of growth hormone. Surgery to remove the pituitary tumor is the treatment recommended for most patients with acromegaly; but while surgery is successful in many patients, some will see their levels of GH and IGF-1 remain too high even after surgery.

Non-surgical treatments may include radiation therapy, and injection of growth hormone blocking medications. But left untreated, acromegaly can lead to worsening diabetes mellitus and hypertension, among other risks.

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


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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. https://www.niddk.nih.gov/health-information/endocrine-diseases/acromegaly. 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: MDText.com, 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.