Somatuline® Depot(lanreotide) Injection

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 & 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.

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.

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/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

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.

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

References:

1. Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; June 2019.

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. Medical progress: Acromegaly. N Engl J Med. 2006 Dec 14;355(24):2558-73. Review. No abstract available. Erratum in: N Engl J Med. 2007 Feb 22;356(8):879.

6. Burton T, Le Nestour E, Neary M, Ludlam WH. Incidence and prevalence of acromegaly in a large US health plan database. Pituitary. 2016;19:262-267.

7. Katznelson L, Atkinson JL, Cook DM, Ezzat SZ, Hamrahian AH, Miller KK; American Association of Clinical Endocrinologists. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the diagnosis and treatment of acromegaly–2011 update. Endocr Pract. 2011 Jul-Aug;17 Suppl 4:1-44.

8. Katznelson L, Laws ER Jr, Melmed S, et al. Acromegaly: an endocine society clinical practice guideline. J Clin Endocrinol Metab. 2014;99:3933-3951.

9. Melmed S, Bronstein MD, Chanson P, Klibanski A, Casanueva FF, Wass JAH, Strasburger CJ, Luger A, Clemmons DR, Giustina A. A Consensus Statement on acromegaly therapeutic outcomes. Nat Rev Endocrinol. 2018 Sep;14(9):552-561.

10. Jane JA Jr, Starke RM, Elzoghby MA, Reames DL, Payne SC, Thorner MO, Marshall JC, Laws ER Jr, Vance ML. Endoscopic transsphenoidal surgery for acromegaly: remission using modern criteria, complications, and predictors of outcome. J Clin Endocrinol Metab. 2011 Sep;96(9):2732-40.

11. Starke RM, Raper DM, Payne SC, Vance ML, Oldfield EH, Jane JA Jr. Endoscopic vs microsurgical transsphenoidal surgery for acromegaly: outcomes in a concurrent series of patients using modern criteria for remission. J Clin Endocrinol Metab. 2013 Aug;98(8):3190-8.

12. Adelman DT, Truong Thahn X-M, Mégret C. Enhancing patient care: co-creation and validation of a new and improved delivery system for lanreotide autogel/depot and its evaluation by US healthcare professionals. Presented at: 101st Annual Meeting and Expo of the Endocrine Society. New Orleans, LA; March 23-26, 2019.

13. Knappe U, Petroff D, Quinkler M, et al. Fractionated radiotherapy and radiosurgery in acromegaly: analysis of 352 patients from the German Acromegaly Registry. Eur. J. Endocrinol. 2020;182(3):275-284.