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  • ADMINISTRATION
  • Formulation

SOMATULINE® DEPOT PROVIDES ONCE-MONTHLY DOSING VIA DEEP SUBCUTANEOUS INJECTION FROM A PREFILLED AND READY-TO-USE SYRINGE1,2

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The formulation of Somatuline Depot enables steady release without the need for polymers or additives.2

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High density of lanreotide nanotubes allows for low injection volume.2

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Lanreotide is injected into the deep subcutaneous layer of the tissue. After injection, the formulation is thought to form a depot – or drug reservoir, for fast-acting (peak serum concentration of 7 hours) and sustained-release (half-life of 23 to 30 days) drug delivery.1,2

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Lanreotide is slowly released, enabling delivery every 4 weeks.2

See the Pharmacokinetic profile of Somatuline Depot below

Discover more about the Somatuline Depot formulation and mechanism of action – watch now

Rapid onset of action and sustained-release formulation1,2

Somatuline Depot has been shown to reach peak serum concentration in 7 hours, followed by a steady and sustained release (half-life of 23 to 30 days)1,2

Serum concentrations achieved in healthy subjects following deep SC administration of Somatuline Depot2

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SC=subcutaneous.

REFERENCES:

  • Somatuline Depot (lanreotide) Injection [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; February 2023.
  • Wolin EM, Manon A, Chassaing C, et al. Lanreotide depot: an antineoplastic treatment of carcinoid or neuroendocrine tumors. J Gastrointest Cancer. 2016;47(4):366-374.

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.

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.

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 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.

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

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Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S.
IPSEN CARES is a registered trademark of Ipsen S.A.
All other trademarks and registered trademarks are the property of their respective owners.

© 2023 Ipsen Biopharmaceuticals Inc. All rights reserved. September 2023. SMD-US-003607 v3.0.