Terms of Use

The aim of this website is to introduce you to the activities of Ipsen Biopharmaceuticals, Inc. and the website is available for your information, interest, and education. Access to and use of the information presented on this website is subject to the following Terms of Usage, as may be amended from time to time. By accessing and using this website, you accept, without limitation or qualification, the Terms of Usage described below.

Content

The content on this website is designed to provide a general overview of our Company, and is presented solely for informational purposes. The website may contain general information relating to various medical conditions and their treatment. Such information is provided for informational purposes and is not meant to be a substitute for advice provided by qualified healthcare professionals. You should consult a qualified healthcare provider if you have or suspect you have any health problems.

Ipsen Biopharmaceuticals, Inc. reserves its right to alter, modify, substitute, or delete any content of, or may restrict access to, or discontinue distribution of, this site at any time and at its sole discretion.

No Warranties

THE INFORMATION ON THIS SITE IS PROVIDED "AS IS" AND IPSEN MAKES NO REPRESENTATIONS OR WARRANTIES EITHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT. IPSEN MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND AS TO THE COMPLETENESS, ACCURACY, TIMELINESS, AVAILABILITY, FUNCTIONALITY, AND COMPLIANCE WITH APPLICABLE LAWS, AS IT RELATES TO THE INFORMATION CONTAINED IN THIS WEBSITE. BY USING THIS WEBSITE YOU ACCEPT THE RISK THAT THE INFORMATION MAY BE INCOMPLETE OR INACCURATE OR MAY NOT MEET YOUR NEEDS OR REQUIREMENTS.

Disclaimed Liability

IPSEN SHALL NOT BE LIABLE FOR ANY DAMAGES OR INJURY ARISING OUT OF YOUR ACCESS TO, OR INABILITY TO ACCESS, THIS SITE OR FROM YOUR RELIANCE ON ANY INFORMATION PROVIDED HEREIN. IPSEN DISCLAIMS ANY AND ALL LIABILITY FOR DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, AND SPECIAL OR OTHER DAMAGES, LOST OPPORTUNITIES, LOST PROFIT, OR ANY OTHER LOSS OR DAMAGES OF ANY KIND. THIS LIMITATION INCLUDES DAMAGES OR ANY VIRUSES, WHICH MAY AFFECT YOUR COMPUTER EQUIPMENT.

Indemnification

Any person who accesses or uses this website hereby agrees to indemnify, defend, and hold harmless Ipsen, its officers, directors, employees, agents, suppliers, and third-party partners from and against all losses, expenses, damages, and costs, including reasonable attorneys' fees, resulting from any violation of the Terms of Use by such person.

Third-Party Links to Other Websites

Any links to other Internet sites are provided as a convenience. Ipsen has no responsibility or control over the content or operation of such sites and shall not be liable for any damages or injuries arising from that content or its operation. Inclusion of a third-party link does not imply an endorsement or recommendation by Ipsen.

Copyright and Use of Content

Ipsen will enforce its intellectual property rights to the fullest extent permitted under law. The content of this website is the property of Ipsen and is protected by copyright laws. The trademarks, service marks, trade names, logos, and products displayed on this site are protected worldwide, and no use of any of these may be made without the prior written consent of Ipsen. You are welcome to download the content of this website, however, only for your personal and noncommercial use. No modification or further reproduction of the contents is permitted. The content may otherwise not be copied or used in any other manner without the prior written consent of Ipsen. Nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any patent, trademark, or copyright of Ipsen. Privacy and Use of Questions and Comments

Any questions, comments, suggestions, or any other communications, including any ideas, inventions, concepts, techniques, or knowhow you may forward to this site or otherwise to Ipsen, electronically or by any other means, are on a nonconfidential basis and will become the property of Ipsen, which Ipsen without restriction may use in any fashion and for any purposes whatsoever including developing, manufacturing, and/or marketing goods or services.

Governing Law

This website is operated by Ipsen Biopharmaceuticals, Inc. from its office in Basking Ridge, New Jersey. Your access and use of this website and the contents hereof shall be governed by and interpreted in accordance with the laws of New Jersey. Ipsen makes no representation that the information contained in this website is appropriate or available in other locations where the content and access thereto may be illegal. Any legal action or proceeding related to this website shall be brought exclusively in a federal or state court of competent jurisdiction situated in New Jersey.

Indication and Important Safety Information

  • Somatuline® Depot (lanreotide) 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.

CONTRAINDICATIONS

  • None.

WARNINGS & PRECAUTIONS

  • Somatuline Depot may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically.
  • Somatuline Depot and other somatostatin analogs can inhibit the secretion of insulin and glucagon. Patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia.
  • Antidiabetic treatment may need to be adjusted when Somatuline Depot treatment is initiated or when the dose is altered.
  • Slight decreases in thyroid function have been seen during treatment with Somatuline Depot. Thyroid function tests are recommended where clinically indicated.
  • The most common cardiac adverse reactions observed in patients in 3 pooled cardiac studies were sinus bradycardia (5.5%), bradycardia (2.8%), and hypertension (5.6%).
    • 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 Somatuline Depot treatment, sinus bradycardia may occur. Care should be taken when initiating Somatuline Depot treatment in patients with bradycardia.
  • The pharmacological gastrointestinal effects of Somatuline Depot may reduce the intestinal absorption of concomitant drugs.
  • Somatuline Depot may decrease the relative bioavailability of cyclosporine. Cyclosporine dose may need to be adjusted to maintain levels.

SPECIAL POPULATIONS

  • Patients with moderate and severe renal impairment or moderate and severe hepatic impairment should begin treatment with Somatuline Depot 60 mg. Caution should be exercised when considering these patients for an extended dosing interval of Somatuline Depot 120 mg every 6 or 8 weeks.
  • There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human responses, Somatuline Depot should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.
  • A decision should be made whether to discontinue nursing or discontinue Somatuline Depot taking into account the importance of the drug to the mother.
  • Patients receiving beta-blockers, calcium channel blockers, or other drugs that affect heart rate may need dose adjustments to those drugs. Somatuline Depot may reduce the intestinal absorption of coadministered drugs. Caution should be used.

ADVERSE EVENTS

  • In pooled studies (N = 416), 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%), headaches (7%), arthralgia (7%),vomiting (7%), and loose stools (6%).
  • Gastrointestinal adverse reactions were mild to moderate and typically resolved within 8 to 10 weeks.
    • 1% of patients in the pooled studies with Somatuline Depot discontinued treatment due to gastrointestinal adverse events.
  • Occasional cases of pancreatitis have been reported.
  • Injection-site pain (4.1%) and injection-site mass (1.7%) were the most frequently reported local adverse reactions.
  • Local side effects were more common at the start of treatment and less common as treatment continued.
    • Injection–site reactions were usually mild to moderate but did lead to withdrawal from clinical studies in two patients.
For Full Prescribing Information, click here.