ADMINISTRATION

Streamlined Delivery System

The Somatuline Depot delivery system was redesigned in 2019 to help streamline administration.^1,12

Prefilled deep subcutaneous injection needs no reconstitution¹
Somatuline Depot should be administered by a healthcare professional¹
Allow 30 minutes for product to come to room temperature¹
Product may be returned to the refrigerator for continued storage and used at a later time if left in its sealed pouch at room temperature (not to exceed 104℉ or 40℃) for up to 24 hours¹
Automatic needle guard is designed to retract the needle once the plunger is depressed and thumb is removed¹

Device not shown actual size

The Somatuline Depot delivery system was updated in 2019 to provide an improved ergonomic injection experience, based on user feedback. Through a series of 4 formative studies between 2015 and 2017, Ipsen sought feedback from acromegaly and NET patients, nurses and caregivers on the design and functionality of new delivery device prototypes. These culminated in a human factors validation study in 2017 in which the final delivery system prototype was tested to determine whether the product could be safely and effectively used by intended users in the intended use environment. Key changes between the prior delivery system and the current delivery system (updated in 2019) are: an overcap to improve the ergonomics (and needle shield removal); plunger support for the new delivery system; and improved version of the needle safety system.

How to Administer Somatuline Depot Using the 2019 Redesigned Syringe

Dosing Somatuline Depot

^*Controlled is defined as GH level from >1.0 ng/mL to ≤2.5 ng/mL, normalized IGF-1 level, and satisfactory management of clinical symptoms as determined by the healthcare professional.

SUPPORT & RESOURCES

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 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

Acromegaly: 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%).

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.

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 treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

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

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.