References

1. Acromegaly Guidelines Task Force. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Acromegaly. Endocr Pract. 2011;17 (Suppl 4).
2. Bronstein M, Musolino N, Jallad R, et al. Pharmacokinetic profile of lanreotide Autogel in patients with acromegaly after four deep subcutaneous injections of 60, 90, or 120 mg every 28 days. Clin Endocrinol (Oxf). 2005;63(5):514-519.
3. Cendros JM, Peraire C, Troconiz I, et al. Lanreotide Autogel in acromegaly: a pharmacokinetic and pharmacodynamic analysis. Endocr Abs. 2003;6: 47.
4. Chanson P, Borson-Chazot F, Kuhn JM, et al. Control of IGF-I levels with titrated dosing of lanreotide Autogel over 48 weeks in patients with acromegaly. Clin Endocrinol (Oxf). 2008;69(2):299-305.
5. Christ E, Cummings MH, Westwood NB, et al. The importance of growth hormone in the regulation of erythropoiesis, red cell mass, and plasma volume in adults with growth hormone deficiency. J Clin Endocrinol Metab. 1997;82(9):2985-2990.
6. Colao A, Pivonello R, Galderisi M, et al. Impact of Treating Acromegaly First with Surgery or Somatostatin Analogs on Cardiomyopathy. J Clin Endocrinol Metab. 2008;93(7):2639-2646.
7. Data on file (NDA). Brisbane, CA: Tercica, Inc., 2007.
8. Florini JR, Ewton DZ, Magri KA. Hormones, growth factors, and myogenic differentiation. Annu Rev Physiol. 1991;53:203.
9. Katznelson L. Approach to the Patient with Persistent Acromegaly after Pituitary Surgery. J Clin Endocrinol Metab. 2010;95(9):4114-4123.
10. Lim EM, Pullan P. Biochemical Assessment and Long-Term Monitoring in Patients with Acromegaly: Statement from a Joint Consensus Conference of The Growth Hormone Research Society and The Pituitary Society. J Clin Endocrinol Metab. 2004;89(7):3099-3102.
11. Melmed S. Acromegaly. N Engl J Med. 2006;355(24):2558-2573.
12. Melmed S, Cook D, Schopohl J, et al. Rapid and sustained reduction of serum growth hormone and insulin-like growth factor-1 in patients with acromegaly receiving lanreotide Autogel® therapy: a randomized, placebo-controlled, multicenter study with a 52 week open extension. Pituitary. 2010;13(1):18-28.
13. Rajasoorya C, Holdaway IM, Wrightson P, et al. Determinants of clinical outcome and survival in acromegaly. Clin Endocrinol. 1994;41(1):95-102.
14. Salomon F, Cuneo R, Sönksen PH. Growth hormones and protein metabolism. J Appl Physiol. 1991;36(1):42.
15. Sandostatin® LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation, 2006.
16. Somatuline® Depot (lanreotide) Injection [US prescribing information]. Brisbane, CA: Ipsen Pharma, 2007.
17. Valéry C et al. Biomimetic organization: Octapeptide self-assembly into nanotubes of viral capsid-like dimension. Proc Natl Acad Sci U S A. 2003;100(18):10258-10262.
18. Data on file. Supplemental NDA 22-074. Module 2.5. 30 April 2010. Brisbane, CA: Ipsen Pharma.

Indication and Important Safety Information

  • Somatuline® Depot (lanreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

CONTRAINDICATIONS

  • None.

WARNINGS & PRECAUTIONS

  • Somatuline Depot may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically.
  • Somatuline Depot and other somatostatin analogs can inhibit the secretion of insulin and glucagon. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia.
  • Antidiabetic treatment may need to be adjusted when Somatuline Depot treatment is initiated or when the dose is altered.
  • Slight decreases in thyroid function have been seen during treatment with Somatuline Depot. Thyroid function tests are recommended where clinically indicated.
  • The most common cardiac adverse reactions observed in patients in 3 pooled cardiac studies were sinus bradycardia (5.5%), bradycardia (2.8%), and hypertension (5.6%).
    • In patients without underlying cardiac disease, Somatuline Depot may lead to a decrease in heart rate without necessarily reaching the threshold of bradycardia.
    • In patients suffering from cardiac disorders prior to Somatuline Depot treatment, sinus bradycardia may occur. Care should be taken when initiating Somatuline Depot treatment in patients with bradycardia.
  • The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs.
  • Somatuline Depot may decrease the relative bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.

SPECIAL POPULATIONS

  • Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60 mg. Caution should be exercised when considering these patients for an extended dosing interval of Somatuline Depot 120 mg every 6 or 8 weeks.
  • There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.
  • A decision should be made whether to discontinue nursing or discontinue Somatuline Depot taking into account the importance of the drug to the mother.
  • Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments to those drugs. Somatuline Depot may reduce the intestinal absorption of coadministered drugs. Caution should be used.

ADVERSE EVENTS

  • In pooled studies (N = 416), the most common adverse reactions (incidence > 5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection–site reaction (9%), constipation (8%), flatulence (7%), headaches (7%), arthralgia (7%),vomiting (7%), and loose stools (6%).
  • Gastrointestinal adverse reactions were mild to moderate and typically resolved within 8 to 10 weeks.
    • 1% of patients in the pooled studies with Somatuline Depot discontinued treatment due to gastrointestinal adverse events.
  • Occasional cases of pancreatitis have been reported.
  • Injection-site pain (4.1%) and injection-site mass (1.7%) were the most frequently reported local adverse reactions.
  • Local side effects were more common at the start of treatment and less common as treatment continued.
    • Injection–site reactions were usually mild to moderate but did lead to withdrawal from clinical studies in two patients.
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