Most common adverse events occurring at an incidence >5% and at a higher rate than placebo in pivotal trial 11*
A patient is counted only once for each body symptom and preferred term.
- Adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were considered related to study drug in 7% (24/332) of patients1
- In the pooled clinical studies (N=416), the majority of gastrointestinal reactions were mild to moderate in severity1
- 1% of acromegalic patients treated with Somatuline® Depot (lanreotide) Injection in the pooled clinical studies discontinued treatment because of gastrointestinal reactions1
*Data are from pivotal trial 1. Somatuline Depot was administered at 4-week intervals at doses of 60, 90, or 120 mg.
IMPORTANT SAFETY INFORMATION & INDICATION
- SOMATULINE DEPOT is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.
Warnings and Precautions
- Cholelithiasis and Gallbladder Sludge
- SOMATULINE DEPOT may reduce gallbladder motility and lead to gallstone formation.
- Periodic monitoring may be needed.
- If complications of cholelithiasis are suspected, discontinue SOMATULINE DEPOT and treat appropriately.
- Hypoglycemia or Hyperglycemia
- Patients treated with SOMATULINE DEPOT may experience hypoglycemia or hyperglycemia.
- Blood glucose levels should be monitored when SOMATULINE DEPOT treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly.
- Cardiovascular Abnormalities
- SOMATULINE DEPOT may decrease heart rate.
- In cardiac studies with acromegalic patients, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension.
- 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 treatment, sinus bradycardia may occur. Care should be taken when initiating treatment in patients with bradycardia.
- Thyroid Function Abnormalities
- Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients.
- Thyroid function tests are recommended where clinically appropriate.
- Monitoring/Laboratory Tests: In acromegaly, serum GH and IGF-1 levels are useful markers of the disease and effectiveness of treatment.
Most Common Adverse Reactions
- Adverse reactions in >5% of patients who received SOMATULINE DEPOT were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reactions (9%), constipation (8%), flatulence (7%), vomiting (7%), arthralgia (7%), headache (7%), and loose stools (6%).
- SOMATULINE DEPOT may decrease the absorption of cyclosporine (dosage adjustment may be needed); increase the absorption of bromocriptine; and require dosage adjustment for bradycardia-inducing drugs (e.g., beta-blockers).
- Lactation: Advise women not to breastfeed during treatment and for 6 months after the last dose.
- Moderate to Severe Renal and Hepatic Impairment: See full prescribing information for dosage adjustment in patients with acromegaly.
To report SUSPECTED ADVERSE REACTIONS, contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
SOMATULINE® DEPOT (lanreotide) is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin growth factor-1 (IGF-1) levels to normal.
1. Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019.
2. Melmed S, Cook D, Schopohl J, Goth MI, Lam KSL, Marek J. 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;13:18-28.
3. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.
4. Valery C, Paternostre M, Robert B, et al. Biomimetic organization: octapeptide self-assembly into nanotubes of viral capsid-like dimension. PNAS. 2003;100(18):10258-10262.
5. Melmed S. Medical progress: Acromegaly. N Engl J Med. 2006 Dec 14;355(24):2558-73. Review. No abstract available. Erratum in: N Engl J Med. 2007 Feb 22;356(8):879.
6. Burton T, Le Nestour E, Neary M, Ludlam WH. Incidence and prevalence of acromegaly in a large US health plan database. Pituitary. 2016;19:262-267.
7. Katznelson L, Atkinson JL, Cook DM, Ezzat SZ, Hamrahian AH, Miller KK; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly–2011 update. Endocr Pract. 2011 Jul-Aug;17 Suppl 4:1-44.
8. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.
9. Melmed S, Bronstein MD, Chanson P, Klibanski A, Casanueva FF, Wass JAH, Strasburger CJ, Luger A, Clemmons DR, Giustina A. A Consensus Statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol. 2018 Sep;14(9):552-561.
10. Jane JA Jr, Starke RM, Elzoghby MA, Reames DL, Payne SC, Thorner MO, Marshall JC, Laws ER Jr, Vance ML. Endoscopic transsphenoidal surgery for acromegaly: remission using modern criteria, complications, and predictors of outcome. J Clin Endocrinol Metab. 2011 Sep;96(9):2732-40.
11. Starke RM, Raper DM, Payne SC, Vance ML, Oldfield EH, Jane JA Jr. Endoscopic vs microsurgical transsphenoidal surgery for acromegaly: outcomes in a concurrent series of patients using modern criteria for remission. J Clin Endocrinol Metab. 2013 Aug;98(8):3190-8.
12. Adelman DT, Truong Thahn X-M, Mégret C. Enhancing patient care: co-creation and validation of a new and improved delivery system for lanreotide autogel/depot and its evaluation by US healthcare professionals. Presented at: 101st Annual Meeting and Expo of the Endocrine Society. New Orleans, LA; March 23-26, 2019. 3. Data on file. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.