Legal Statement

Introduction

This page states the Terms and Conditions under which you may use www.serostim.com (the "Web Site"). Please read this page carefully. If you do not accept these Terms and conditions, do not use this Web Site. By using this Web Site, you are indicating your acceptance to be bound by these Terms and Conditions. EMD Serono may revise these Terms and Conditions at any time by posting an update to this page. You should visit this page periodically, because your continued use of the Web Site following the posting of changes to these Terms and Conditions will mean you accept those changes. The terms "you" and "user" as used herein refer to all individuals and/or entities accessing the Web Site for any reason.

Use of Material

The site contains information intended for U.S. residents only. Products described may or may not be available in other countries or regions of the world, may be available under different trademarks in different countries and, where applicable, may be approved or cleared by a government regulatory body for sale or use with different indications and restrictions in different countries.

The contents of this Web Site, such as text, graphics, images and other material ("Material"), are owned by EMD Serono and its licensors and vendors, and are protected by United States and foreign intellectual property laws. Unauthorized use of the Material may violate copyright, trademark and other laws.

EMD Serono authorizes you to view and download a single copy of the material on the Web Site solely for your personal use, provided you retain all copyright and other proprietary notices contained in the original Material on any copy you make of the Material. You may not sell or modify the Material or reproduce, display, publicly perform, distribute, or otherwise use the Material in any way for any public or commercial purpose. The use of the Material on any other web site or in a networked computer environment for any purpose is prohibited.

You may not copy or adapt the HTML or other code that EMD Serono uses to generate its pages. This code is also protected by EMD Serono's copyright.

Acceptable Site Use

General Rules: You may not use the Web Site in order to transmit, distribute, store or destroy material (a) in violation of any applicable law or regulation, (b) in a manner that will infringe the copyright, trademark, trade secret or other intellectual property rights of others or violate the privacy, publicity or other personal rights of others, or (c) that is defamatory, obscene, threatening, abusive or hateful.

Security Rules: You are prohibited from violating or attempting to violate the security of the Web Site and from using the Web Site to violate the security of other web sites by any method, including, without limitation, (a) accessing data not intended for you or logging into a server or account which you are not authorized to access, (b) attempting to probe, scan or test the vulnerability of a system or network or to breach security or authentication measurers without proper authorization, (c) attempting to interfere with service to any user of the Web Site, host or network, including, without limitation, via means of submitting a virus to the Web Site, overloading, "flooding", "spamming", "mailbombing" or "crashing", (d) sending unsolicited e-mail, including promotions and/or advertising of products or services, or (e) forging any EMD Serono packet header or any part of the header information in any e-mail or newsgroup posting. Violations of system or network security may result in civil or criminal liability. EMD Serono may investigate violations of these Terms and Conditions and may involve and cooperate with law enforcement authorities in prosecuting users of the Web Site who are involved in such violations.

Specific Prohibited Uses: EMD Serono specifically prohibits any use of the Web Site, and you agree not to use the Web Site, for any of the following: distributing or otherwise publishing, without EMD Serono's approval, any material containing any solicitation of funds, promotion, advertising, or solicitation for goods or services; soliciting other users of the Web Site to join or become members of any commercial online service; or deleting or revising any material posted by any other person or entity.

EMD Serono's Liability

The Material may contain inaccuracies or typographical errors. EMD Serono makes no representations about the accuracy, reliability, completeness, or timeliness of the Web Site or the Material. The use of the Web Site and the Material is at your own risk. We reserve the right, at our discretion, to modify, add, or remove portions of the Web Site at anytime without notice.

You acknowledge and agree that you are solely responsible for the form, content and accuracy of any material placed by you on the Web Site.

EMD SERONO DOES NOT WARRANT THAT THE WEB SITE WILL OPERATE ERROR-FREE OR THAT THE WEB SITE AND ITS SERVER ARE FREE OF COMPUTER VIRUSES OR OTHER HARMFUL MECHANISMS. IF YOUR USE OF THE WEB SITE OR THE MATERIAL RESULTS IN THE NEED FOR SERVICING OR REPLACING EQUIPMENT OR DATA, EMD SERONO IS NOT RESPONSIBLE FOR THOSE COSTS.

THE WEB SITE AND MATERIAL ARE PROVIDED ON AN "AS IS" BASIS WITHOUT ANY WARRANTIES OF ANY KIND. EMD SERONO, TO THE FULLEST EXTENT PERMITTED BY LAW, DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING THE WARRANTY OF MERCHANTABILITY, FITNESS FOR PARTICULAR PURPOSE AND NON-INFRINGEMENT. EMD SERONO MAKES NO WARRANTIES ABOUT THE ACCURACY, RELIABILITY, COMPLETENESS, OR TIMELINESS OF THE MATERIAL, SERVICES, SOFTWARE, TEXT, GRAPHICS OR LINKS.

Disclaimer of Consequential Damages

IN NO EVENT WILL EMD SERONO, ITS SUPPLIERS, OR ANY THIRD PARTIES MENTIONED ON THE WEB SITE BE LIABLE FOR ANY DAMAGES WHATSOEVER (INCLUDING, WITHOUT LIMITATION, INCIDENTAL, RELIANCE OR CONSEQUENTIAL DAMAGES, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION) RESULTING FROM THE USE OR INABILITY TO USE THE WEB SITE OR THE MATERIAL, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR ANY OTHER LEGAL THEORY, AND WHETHER OR NOT EMD SERONO IS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Links to Other Sites

The Web Site may contain links to third party web sites. These links are provided solely as a convenience to you and not as an endorsement by EMD Serono of the contents on such third-party web sites. EMD Serono is not responsible for the content of linked third-party sites and does not make any representations regarding the content or accuracy of materials on such third-party sites. If you decide to access linked third-party sites, you do so at your own risk.

EMD Serono cannot ensure that you will be satisfied with any products or services that you purchase from a third-party site that links to or from EMD Serono, since these sites are owned and operated by independent retailers. EMD Serono does not endorse any of the merchandise, nor has EMD Serono taken any steps to confirm the accuracy or reliability of any of the information contained in such third-party sites. EMD Serono does not make any representations or warranties as to the security of any information (including, without limitation, credit card and other personal information) you might be requested to give any third party, and you hereby irrevocably waive any claim against us with respect to such sites. We strongly encourage you to make whatever investigation you feel necessary or appropriate before proceeding with any online or off-line transaction with any of these third parties.

Limitation of Liability

The aggregate liability of EMD Serono to you for all claims arising from the use of the Materials is limited to $100.

Termination

EMD Serono reserves the right, at its sole discretion, to immediately terminate your ability to access the Web Site and/or any other service provided to you by EMD Serono, upon any breach by you of these Terms and Conditions.

Indemnity

You agree to defend, indemnify, and hold harmless EMD Serono, its officers, directors, employees and agents, from and against any claims, actions or demands, including without limitation reasonable legal and accounting fees, alleging or resulting from your use of the Material or your breach of the terms of these Terms and Conditions. EMD Serono will provide notice to you promptly of any such claim, suit, or proceeding and will assist you, at your expense, in defending any such claim, suit or proceeding.

General

EMD Serono makes no claims that the Materials may be lawfully viewed or downloaded outside of the United States. Access to the Materials may not be legal by certain persons or in certain countries. If you access the Web Site from outside of the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction. These Terms and Conditions are governed by the internal substantive laws of the Commonwealth of Massachusetts, without respect to its conflict of laws principles. Jurisdiction of any claims arising under these Terms and Conditions will lie exclusively with the state or federal courts within Boston, Massachusetts. If any provision of these Terms and Conditions is found to be invalid by any court having competent jurisdiction, the invalidity of such provision will not affect the validity of the remaining provisions of these Terms and Conditions, which will remain in full force and effect. No waiver of any provision of these Terms and Conditions will be deemed a further or continuing waiver of such provision or any other provision. Except as expressly provided in an end user software license, or in a "Legal Notice" or other statement by EMD Serono on the Web Site, these Terms and Conditions constitute the entire agreement between you and EMD Serono with respect to the use of Web Site. No changes to these Terms and Conditions may be made except by a revised posting on this page.













Important Risk Information and IndicationToggle Button

What is Serostim®?

Serostim® is an injectable prescription medicine used for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Treatment with antiretroviral therapy at the same time is necessary.

You Should not take Serostim® if you have:

  • A critical illness due to complications after open heart surgery, abdominal surgery, serious injuries or have severe breathing problems
  • Cancer or undergoing treatment for cancer
  • Certain types of eye diseases caused by diabetes
  • Allergies to growth hormone or benzyl alcohol, an ingredient in the liquid used to mix Serostim®

What should I tell my healthcare provider before using Serostim®? Before using Serostim®, tell your doctor if you have or are:

  • A critical illness due to complications after open heart surgery, abdominal surgery or serious injuries or have severe breathing problems
  • Cancer or history of cancer
  • Skin lesions
  • Diabetes, a family history of diabetes or have been told by your doctor that you are at risk for diabetes
  • Multiple hormone deficiencies
  • Pregnant or nursing
  • Taking any medications, especially cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizure
  • Liver or kidney disease
  • Over 65 years of age
  • Have any other medical condition

What are the possible side effects of Serostim®? Serostim® may cause serious side effects including:

Concomitant Antiretroviral Therapy:
In some experimental systems, somatropin has been shown to increase HIV replication in vitro.
Because of this possibility for acceleration of virus replication, it is recommended that you continue on your antiretroviral therapy for the duration of Serostim® treatment.

Impaired Glucose Tolerance/Diabetes:
Cases of new onset impaired glucose tolerance (pre-diabetes), new onset type 2 diabetes mellitus and worsening of current diabetes mellitus have been reported in patients receiving Serostim®. Some patients developed diabetic complications (ketoacidosis and diabetic coma). In some patients, these conditions improved when Serostim® was discontinued, while in others, the glucose intolerance persisted.

Intracranial Hypertension:
Intracranial hypertension, a rise in the pressure inside the skull, associated visual changes, headache, nausea, and/or vomiting has been reported.

Fluid Retention/Carpal Tunnel Syndrome:
Water retention may occur in adults during Serostim® therapy. Increased swelling, particularly in the hands and feet, muscle or joint pain may occur during treatment with Serostim®. Often these reactions resolve with analgesic therapy, or after decreasing the number of doses.
Carpal tunnel syndrome may occur during treatment with Serostim®. If the symptoms of carpal tunnel syndrome do not resolve by decreasing the weekly number of doses of Serostim®, it is recommended that treatment be discontinued.

Kaposi's sarcoma, Lymphoma and other Malignancies:
Kaposi's sarcoma (KS), lymphoma, and other malignancies are more common in HIV+ individuals. There was no increase in the incidence of Kaposi's sarcoma, lymphoma, or in the progression of cutaneous Kaposi's sarcoma in clinical studies of Serostim®. Patients with internal KS lesions were excluded from the studies. Potential effects on other malignancies are unknown.

Local and Systemic Reactions:
Injection sites should be changed (rotated) to avoid tissue atrophy. Patients should be informed that local and systemic reactions are possible and that prompt medical attention should be sought if allergic reactions occur.

Pancreatitis:
Inflammation of the pancreas has been reported rarely in adults receiving growth hormone.

The most common side effects of Serostim® include:

  • In clinical trials the most common adverse reactions included swelling (particularly of the hands or feet), muscle pain, joint pain, numbness, and pain in extremities.
  • Injection site reactions (pain, numbness, redness, swelling). Change (rotate) your injection site to help lower your risk for injection site reactions.
  • Fluid retention
  • Bone, joint or muscle pain
  • Swelling of the extremities
  • Carpal tunnel syndrome
  • Breast enlargement
  • Nausea
  • Fatigue
  • Increase in blood glucose
  • Increase in triglycerides

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono at 1-800-283-8088 ext. 5563.

This information is not intended to replace discussions with your doctor. For additional information about Serostim®, please consult the Prescribing Information and talk to your doctor. You can also visit www.serostim.com. Serostim® is available by prescription only.

Please see the full Prescribing Information for a complete discussion of Serostim®'s risks.

Reference:

  1. Moyle GJ, Daar ES, Gertner JM, et al. Growth hormone improves lean body mass, physical performance, and quality of life in subjects with HIV-associated weight loss or wasting on highly active antiretroviral therapy. J Acquir Immune Defic Syndr. 2004;35:367-375.

Indication

Serostim®[somatropin (rDNA origin) for injection] is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance. Concomitant antiretroviral therapy is necessary.