SAFETY

SAFETY PROFILE

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

	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	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	5 (6)	0	3 (8)	5 (14)	8 (7)
Application site disorders (Injection site mass/pain/reaction/ inflammation)	0	5 (6)	3 (9)	4 (11)	8 (22)	15 (14)
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 and 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 and 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.¹

Adverse reactions of dysglycemia (hypoglycemia, hyperglycemia, diabetes) were reported by 14% (47/332) of patients and 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.¹

Learn about the
Somatuline formulation

REFERENCE:

Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc; July 2024.

IMPORTANT SAFETY INFORMATION & INDICATION

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.
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.

Steatorrhea and Malabsorption of Dietary Fats

New onset steatorrhea, stool discoloration and loose stools have been reported in patients receiving somatostatin analogs, including SOMATULINE DEPOT. Somatostatin analogs reversibly inhibit secretion of pancreatic enzymes and bile acids, which may result in malabsorption of dietary fats and subsequent symptoms of steatorrhea, loose stools, abdominal bloating, and weight loss.
If new occurrence or worsening of these symptoms are reported in patients receiving SOMATULINE DEPOT, evaluate patients for potential pancreatic exocrine insufficiency and manage accordingly.

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%).

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) 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.