Carcinoid Syndrome | Somatuline® Depot 120mg Injection

EFFICACY
Carcinoid Syndrome

SOMATULINE^® DEPOT REDUCED THE NEED FOR RESCUE MEDICATION IN PATIENTS WITH CARCINOID SYNDROME VS PLACEBO^1,2

In ELECT, Somatuline Depot reduced the number of days a rescue SSA was needed by 15% (absolute reduction)^1,2

A measurable treatment difference

With Somatuline Depot, patients experienced approximately 15% fewer days on rescue medication compared with placebo¹
- ~4.4 fewer days of rescue therapy per month; or potentially ~53 fewer days per year^†2

^†Assuming the treatment difference in the 16-week intention-to-treat population could be maintained in the longer term.²

31% relative reduction in patients’ need to use rescue medication¹

Secondary endpoints: Average daily frequencies¹

The average daily frequencies of diarrhea and flushing events in patients treated with Somatuline Depot (and rescue medication) were numerically lower relative to patients treated with placebo (and rescue medication) but were not statistically significantly different via hierarchical testing.

Adverse reactions reported in the ELECT study¹

Adverse events occurring by Week 16 in ELECT in ≥5% of Somatuline Depot-treated patients and occurring at least 5% more than in placebo-treated patients were headache (12% vs 5%), dizziness (7% vs 0%), and muscle spasm (5% vs 0%).

Please also see ELECT trial study design and Patient Information below.

STUDY DESIGN AND PATIENT INFORMATION

ELECT:* A phase 3, 16-week, randomized, placebo-controlled, double-blind, pivotal trial²

Patients were excluded if they had:²

History of carcinoid syndrome refractory to treatment with conventional doses of SSA
Treatment with interferon, chemotherapy, and/or peptide receptor radionuclide therapy, and/or tumor debulking <3 months before study entry
History of hepatic arterial embolization, hepatic arterial chemoembolization, and/or selective internal radiation therapy <6 months before study entry

Do not administer an additional dose if patient is already being treated with Somatuline Depot.

*ELECT=Evaluating Lanreotide Efficacy and safety as a Carcinoid-syndrome Treatment.²

^†Administered every 28 days by deep subcutaneous injection, with access to short-acting octreotide as rescue medication.²

^‡Analysis of variance and ANCOVA models were applied using Statistical Analysis System (SAS^®) version 8 or higher.²

GEP-NET=gastroenteropancreatic neuroendocrine tumor; LS=least squares; SSA=somatostatin analog.

REFERENCES:

Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; July 2024.
Vinik AI, Wolin EM, Liyanage N, et al.; on behalf of the ELECT Study Group. Evaluation of lanreotide depot/autogel efficacy and safety as a carcinoid syndrome treatment (ELECT): a randomized, double-blind, placebo-controlled trial. Endocr Pract. 2016;22(9):1068-1080.

IMPORTANT SAFETY
INFORMATION & INDICATIONS

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 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.

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

GEP-NETs: Adverse reactions in >10% of patients who received SOMATULINE DEPOT were abdominal pain (34%), musculoskeletal pain (19%), vomiting (19%), headache (16%), injection site reaction (15%), hyperglycemia (14%), hypertension (14%), and cholelithiasis (14%).

Carcinoid Syndrome: Adverse reactions occurring in the carcinoid syndrome trial were generally similar to those in the GEP-NET trial. Adverse reactions in ≥5% of patients who received SOMATULINE DEPOT and at least 5% greater than placebo were headache (12%), dizziness (7%) and muscle spasm (5%).

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.

INDICATIONS

SOMATULINE^® DEPOT (lanreotide) is a somatostatin analog indicated for: the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival; and

the treatment of adults with carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy.

SOMATULINE® DEPOT REDUCED THE NEED FOR RESCUE MEDICATION IN PATIENTS WITH CARCINOID SYNDROME VS PLACEBO1,2