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Ipsen is pleased to announce that the US Food and Drug Administration (FDA) has approved a new device to deliver Somatuline® Depot for patients with acromegaly. The enhanced device with Safe’n’Sound® syringe technology will continue to offer a streamlined injection process with its prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.

The syringe is available in 60-mg, 90-mg, and 120-mg doses and will offer several benefits:

The updated design has been available in the European Union since January 2012 and will be available in the US beginning January 2015.

This new device incorporating Safe’n’Sound® syringe technology should be administered by a healthcare professional.

Ipsen is continually looking for ways to improve delivery of the medications that are critical to your patients' care. The enhanced device is one example of this commitment.

Click here for Important Safety Information about Somatuline Depot.

About Somatuline® Depot

Somatuline® Depot Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

The active substance in Somatuline® Depot is lanreotide acetate, a somatostatin analog that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides.

Please click here for additional information about the Somatuline Depot device.

To read the Ipsen Press Release, please click here.

For Healthcare Providers

Somatuline Depot -- Start Right & Stay Right

Acromegaly is a rare disease caused by the oversecretion of growth hormone (GH) from the pituitary gland. It is typically caused by a noncancerous tumor called a pituitary adenoma.1

Living with acromegaly can be difficult and presents challenges for patients.1 For many, just getting diagnosed with the disease may have taken years. After diagnosis, patients often face surgery to reduce or remove the tumor. For patients who can’t have surgery—and even for many patients who do—additional pharmacologic treatment is often needed to reduce GH secretion and normalize insulin-like growth factor (IGF-1) levels. Many receive long-term therapy with a somatostatin analog (SSA) such as Somatuline® Depot (lanreotide) Injection to manage their acromegaly.

The Patient Perspective

 

This is an actual patient and his experience may not be representative of all patients.

Somatuline Depot–Proven Effective in the Treatment of Acromegaly

Somatuline Depot is a long-term treatment for acromegaly that may help your patients move forward on their journey. With Somatuline Depot, patients get an acromegaly treatment that offers:

  • Proven GH and IGF-1 reduction2,3
  • A streamlined injection process with prefilled, ready-to-inject syringes
  • FDA-approved extended dosing intervals for controlled patients*2
  • 1-on-1 support services through IPSEN CARES, the Coverage, Access, Reimbursement & Education Support program 

*“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 provider. Patients who are controlled on Somatuline Depot 60 mg or 90 mg every 4 weeks may be considered for extended dosing intervals of Somatuline Depot 120 mg every 6 or 8 weeks.

Indication

Somatuline® Depot (Ianreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Somatuline may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed
  • Patients may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly
  • Somatuline may decrease heart rate. In cardiac studies, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension. Dose adjustment of coadministered drugs that decrease heart rate may be necessary
  • Somatuline may decrease bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted

ADVERSE REACTIONS

The most common adverse reactions (incidence >5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%).

USE IN SPECIAL POPULATIONS

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment: Initial dose is 60 mg every 4 weeks.

Click here for Full Prescribing Information.

SOMATULINE DEPOT is a registered trademark of Ipsen Pharma S.A.S.
All other trademarks are the property of their respective owners.
© 2014 Ipsen Biopharmaceuticals, Inc.

Expand Safety Information

Indication and Important Safety Information

Indication

Somatuline® Depot (Ianreotide) Injection is a somatostatin analog indicated for the long-term treatment of patients with acromegaly who had an inadequate response to or cannot be treated with surgery and/or radiotherapy.

Important Safety Information

WARNINGS AND PRECAUTIONS

  • Somatuline may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed
  • Patients may experience hypoglycemia or hyperglycemia. Glucose level monitoring is recommended and antidiabetic treatment adjusted accordingly
  • Somatuline may decrease heart rate. In cardiac studies, the most common cardiac adverse reactions were sinus bradycardia, bradycardia, and hypertension. Dose adjustment of coadministered drugs that decrease heart rate may be necessary
  • Somatuline may decrease bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted

ADVERSE REACTIONS

The most common adverse reactions (incidence >5%) were diarrhea (37%), cholelithiasis (20%), abdominal pain (19%), nausea (11%), injection-site reaction (9%), constipation (8%), flatulence (7%), headache (7%), arthralgia (7%), vomiting (7%), and loose stools (6%).

USE IN SPECIAL POPULATIONS

Patients with moderate and severe renal impairment or moderate and severe hepatic impairment: Initial dose is 60 mg every 4 weeks.

Click here for Full Prescribing Information.

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