somatuline depot logo Somatuline Depot full Prescribing Information

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.

Somatuline® Depot (lanreotide) 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.

sustained control with the only SSA with FDA-approved extended dosing intervals for controlled* patients

Clinically proven control of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) at Week 42†

  • 63% of patients experienced a >50% decline in GH levels from baseline (P<0.001)
  • 25% of patients demonstrated normalized IGF-1 levels

Clinically proven control of GH and IGF-1 at Week 522†§

  • 82% of patients experienced >50% decline in GH levels from baseline
  • 59% of patients demonstrated normalized IGF-1 levels

The only SSA with FDA-approved extended dosing intervals for controlled patients1,3

  • Dosing can be extended to 120 mg every 6 or 8 weeks when patients are controlled with 60 or 90 mg every 4 weeks
    • 83% of patients remained controlled after the third 120-mg extended dose at 6-week intervals
    • 89% of patients remained controlled after the third 120-mg extended dose at 8-week intervals
  • Patients may receive up to 46% fewer injections per year with 8-week dosing

Enhanced device with Safe’n’Sound® syringe
technology delivers multiple benefits:

  • Prefilled, low-volume syringe supports full-dose delivery
  • Does not require a reconstitution process
  • Helps guard against needle stick injuries
  • Manufactured without latex or natural dry rubber

Patients receiving Somatuline Depot can get 1-on-1 personal
support through the IPSEN CARES (IPSEN 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 professional.

Study design: In a 1-year study including a 4-week, double-blind, placebo-controlled phase (N=107); a 16-week, single-blind, fixed-dose phase (N=105); and a 32-week, open-label, dose-titration phase (N=99), injections of 60, 90, or 120 mg were given at 4-week intervals. During the dose-titration phase of the study, the dose was titrated twice, if needed, according to individual GH
and IGF-1 levels.

IGF-1 data analyses were secondary endpoints of the pivotal trial.

§IGF-1 and GH data analyses at Week 52 were secondary endpoints of the pivotal trial.

Study design: In an open-label, comparative, multicenter, Phase 3 trial, Somatuline Depot 120 mg was administered every 4, 6, or 8 weeks in patients previously receiving lanreotide microparticles every 5-7, 8-11, or 12-16 days, respectively. Of patients whose levels were controlled (GH ≤2.5 ng/mL and normalized IGF-1) when switched to extended dosing intervals (n=32), 5 out of 6 remained controlled after 3 injections at 6-week intervals and 23 out of 26 remained controlled after 3 injections at 8-week intervals.

Targeted affinity for the receptors that affect GH and IFG-1

  • Lanreotide acts as a specific and potent type 2 and type 5 somatostatin receptor (SSTR) agonist with a reduced binding affinity for SSTRs 1, 3, and 41,6
  • Human SSTRs 2 and 5 are believed to be the primary receptor sites responsible for GH inhibition1
    • By reducing GH, IGF-1 levels are also reduced4,5

affinity diagram

the nanotube formulation of Somatuline Depot

INDICATION

Somatuline® Depot (lanreotide) Injection is a somatostatin analog (SSA) 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

CONTRAINDICATIONS

Somatuline 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 may reduce gallbladder motility and lead to gallstone formation. Periodic monitoring may be needed
  • Hypoglycemia or Hyperglycemia: Pharmacological studies show that Somatuline, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Blood glucose levels should be monitored when Somatuline treatment is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly
  • Thyroid Function: Slight decreases in thyroid function have been seen in acromegalic patients during treatment, though clinical hypothyroidism is rare (<1%). Thyroid function tests are recommended where clinically indicated
  • Cardiac Abnormalities: Somatuline 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 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
  • Drug Interactions: The pharmacological gastrointestinal effects of Somatuline may reduce the intestinal absorption of concomitant drugs. Concomitant administration of Somatuline may decrease the relative bioavailability of cyclosporine and may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels

ADVERSE REACTIONS

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

USE IN SPECIFIC POPULATIONS

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

You may report suspected adverse reactions to FDA at 1-800-FDA-1088 or to
Ipsen Biopharmaceuticals, Inc. at 1-888-980-2889.

Click here for full Prescribing Information.

 

ipsen logo

Somatuline Depot is a registered trademark of Ipsen Pharma S.A.S.
Safe'n'Sound is a registered trademark of NEMERA LA VERPILLIERE SAS.
IPSEN CARES is a trademark of Ipsen S.A.S.
All other trademarks are the property of their respective owners.
©2015 Ipsen Biopharmaceuticals, Inc. May 2015. DEP00436

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