SAFETY PROFILE

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

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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.
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  • 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

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Important Safety Information and Indication

CONTRAINDICATIONS

Somatuline® Depot (lanreotide) Injection 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. 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
  • Thyroid Function: Slight decreases in thyroid function have been seen in acromegalic patients during treatment, though clinical hypothyroidism is rare (<1%). Thyroid function tests are recommended where clinically indicated
  • Cardiac 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
  • Drug Interactions: The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline Depot may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels

ADVERSE REACTIONS

The most common adverse reactions (incidence >5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reactions (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%).

USE IN SPECIFIC POPULATIONS

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment: Initial dose is 60 mg every 4 weeks.

Indication

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

Click here for Full Prescribing Information.

Somatuline Depot is available in 60 mg, 90, mg and 120 mg

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.

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Indication

CONTRAINDICATIONS

Somatuline® Depot (lanreotide) Injection is contraindicated in patients with hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide.

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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

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