SAFETY PROFILE

Most common adverse events occurring at an incidence >5% and at a higher rate than placebo in pivotal trial 11*

Scroll Table
Placebo-controlled double-blind phase Weeks 0-4 Fixed-dose phase double-blind + single-blind Weeks 0-20
Placebo Lanreotide overall Lanreotide
(N=25) n (%) (N=83) n (%) 60 mg (N=34) n (%) 90 mg (N=36) n (%) 120 mg (N=37) n (%) Overall (N=107) n (%)
Gastrointestinal system disorders 1 (4) 30 (36) 12 (35) 21 (58) 27 (73) 60 (56)
Diarrhea 0 (0) 26 (31) 9 (26) 15 (42) 24 (65) 48 (45)
Abdominal pain 1 (4) 6 (7) 3 (9) 6 (17) 7 (19) 16 (15)
Flatulence 0 (0) 5 (6) 0 (0) 3 (8) 5 (14) 8 (7)
Application site disorders 0 (0) 5 (6) 3 (9) 4 (11) 8 (22) 15 (14)
(Injection site mass/pain/reaction/inflammation)
Liver and biliary system disorders 1 (4) 3 (4) 9 (26) 7 (19) 4 (11) 20 (19)
Cholelithiasis 0 2 (2) 5 (15) 6 (17) 3 (8) 14 (13)
Heart rate & rhythm disorders 0 8 (10) 7 (21) 2 (6) 5 (14) 14 (13)
Bradycardia 0 7 (8) 6 (18) 2 (6) 2 (5) 10 (9)
Red blood cell disorders 0 6 (7) 2 (6) 5 (14) 2 (5) 9 (8)
Anemia 0 6 (7) 2 (6) 5 (14) 2 (5) 9 (8)
Metabolic & nutritional disorders 3 (12) 13 (16) 8 (24) 9 (25) 4 (11) 21 (20)
Weight decrease 0 7 (8) 3 (9) 4 (11) 2 (5) 9 (8)
A patient is counted only once for each body symptom and preferred term.
Scroll Table
  • 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.

DOSING & ADMINISTRATION

NEXT

IMPORTANT SAFETY INFORMATION

Contraindications

  • 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.
  • Hypoglycemia or Hyperglycemia
    • Pharmacological studies show that SOMATULINE DEPOT, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. 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 occurring in greater than or equal to 9% of patients who received SOMATULINE DEPOT in the overall pooled safety studies in acromegaly were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), and injection-site reactions (9%).

Drug Interactions: 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).

Special Populations

  • 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.

INDICATIONS

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 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.

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/medwatch.

Please click here for the full Prescribing Information and Patient Information.

References:

  1. Somatuline Depo (lanreotide) Injection [US Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc.
  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. Acromegaly. N Engl J Med. 2006;355:2558-2573.
  6. National Endocrine and Metabolic Diseases Information Service. Acromegaly. National Institute of Diabetes and Digestive and Kidney Diseases. www.endocrine.niddk.nih.gov/pubs/acro/acromegaly_508/pdf. Accessed September 20, 2016
  7. 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. 2005;63:514-519.

Are you a healthcare provider?

This site is intended for U.S. healthcare professionals only. By clicking Yes, you attest that you are a healthcare professional licensed in the U.S.

Indication

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 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.

Contraindications

Leaving Website

NOTE: You are about to leave an Ipsen Biopharmaceuticals, Inc., website. This link is provided as a service to our website visitors. It will take you to another site maintained by a third party who is solely responsible for its content.

Ipsen Biopharmaceuticals, Inc., does not control or endorse this site. Ipsen is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.

Thank you! You'll be hearing from us shortly!

Ipsen Biopharmaceuticals, Inc.

PRIOR TREATMENT STATUS (refers to medication only)

Study included a diverse range of patient types2

NOTE: Patients either were not candidates for surgery or had had surgery and required further control.

The procedure for injecting Somatuline® Depot (lanreotide) Injection used for treating acromegaly is explained in this illustration.

Device not shown at actual size

Sign Up for updates &information