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

INCRELEX^® (mecasermin [rDNA origin] injection) is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency, or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Severe primary IGF-1 deficiency (IGFD) is defined by height standard deviation score ≤ -3.0 and basal IGF-1 standard deviation score ≤ -3.0 and normal or elevated growth hormone (GH). Severe Primary IGFD includes classical and other forms of growth hormone insensitivity. Patients with Primary IGFD may have mutations in the GH receptor (GHR), post-GHR signaling pathway including the IGF-1 gene. They are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.

INCRELEX is not intended for use in subjects with secondary forms of IGF-1 deficiency, such as GH deficiency, malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids. Thyroid and nutritional deficiencies should be corrected before initiating INCRELEX treatment.

Limitations of use: INCRELEX is not a substitute to GH for approved GH indications.

INCRELEX is contraindicated in the presence of active or suspected malignancy, and therapy should be discontinued if evidence of malignancy develops. INCRELEX should not be used by patients who are allergic to mecasermin (rhIGF-1) or any of the inactive ingredients in INCRELEX, or who have experienced a severe hypersensitivity to INCRELEX [see Warnings and Precautions and Adverse Reactions]. Intravenous administration of INCRELEX is contraindicated. INCRELEX should not be used for growth promotion in patients with closed epiphyses.

INCRELEX has insulin-like hypoglycemic effects and should be administered 20 minutes before or after a meal or snack. Hypersensitivity and allergic reactions have been reported, including a low number of cases indicative of anaphylaxis requiring hospitalization. Intracranial hypertension has occurred in patients treated with INCRELEX. Funduscopic examination is recommended at the initiation of and periodically during the course of therapy. Patients should have periodic examinations to rule out potential complications from tonsillar/adenoidal hypertrophy and receive appropriate treatment if necessary. Children with onset of limp or hip/knee pain should be evaluated for possible slipped capital femoral epiphysis. Monitor any child with scoliosis for progression of the spine curve.

In clinical studies of 71 pediatric subjects with severe Primary IGFD representing 274 patient-years of treatment, no subjects discontinued due to adverse events. Hypoglycemia was reported by 30 subjects (42%) at least once during their course of therapy with INCRELEX. Most cases of hypoglycemia were mild or moderate in severity. Five subjects had severe hypoglycemia (requiring assistance and treatment) on one or more occasion and four subjects experienced hypoglycemic seizures/loss of consciousness on one or more occasion. Symptomatic hypoglycemia was generally avoided when a meal or snack was consumed either shortly (i.e., 20 minutes) before or after the administration of INCRELEX. Tonsillar hypertrophy was noted in 11 (15%) subjects in the first 1 to 2 years of therapy with lesser tonsillar growth in subsequent years. Intracranial hypertension occurred in three subjects. In two subjects the events resolved without interruption of INCRELEX treatment. INCRELEX treatment was discontinued in the third subject and resumed later at a lower dose without recurrence.

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