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.

patients maintained biochemical control with 120 mg administered every 6 or 8 weeks

patients maintained GH less than 2.5 ng/mL and normalized IGF-1

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.

*SSA=somatostatin analog.

Patients who are controlled with Somatuline Depot 60 mg or 90 mg administered every 4 weeks can be considered for treatment with 120 mg administered every 6 or 8 weeks. GH and IGF-1 levels should be obtained 6 weeks after this change in dosing regimen to evaluate persistence of patient response. Continued monitoring of patients’ response with dose adjustments for biochemical and clinical symptom control, as necessary, is recommended.

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.

Proven to maintain an effective pharmacokinetics profile for extended dosing intervals

effective serum concentrations were maintained through 6 and 8 week dosing intervals

Study design: In open-label, comparative, multicenter, Phase 3 trials, eligible patients who responded to SSAs received 3 to 5 injections of Somatuline Depot 120 mg. Somatuline Depot 120 mg was injected every 4, 6, or 8 weeks in patients previously receiving lanreotide microparticles every 5-7, 8-11, or 12-16 days, respectively. There was no washout period or dose titration.

the patient perspective

 

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

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.
©2017 Ipsen Biopharmaceuticals, Inc. October 2016. SMD-US-000654

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