Privacy Policy

General

EMD Serono respects the privacy of every individual who visits www.serostim.com (the "Web Site"). This Privacy Policy outlines the information EMD Serono will collect and how we will use that information.

Personally-Identifiable Information

There may be cases where EMD Serono will ask you for personally-identifiable information such as your name, mailing address, and email address. For example, we may request personally-identifiable information when you participate in a survey, contest, or other service that requires registration or subscription. EMD Serono will not collect any personally-identifiable information about you unless you provide it to us voluntarily.

When you view the website, we may store some information on your computer. This information will be in the form of a "cookie" or similar file and will help us to offer increased personalization and functionality. With most internet browsers, you can erase cookies from your computer hard drive, block all cookies, or receive a warning before a cookie is stored. Please refer to your browser instructions or help screen to learn more about these functions.

Except as stated in this Privacy Policy, or as otherwise stated at the time personally-identifiable information is gathered, we will not provide personally-identifiable information to third parties who are not under the direction and control of EMD Serono.

Children

The Web Site is not directed at individuals under thirteen years of age, and EMD Serono does not intend to collect any personally-identifiable information from such individuals, unless otherwise stated at the time such information is collected.

Information Collected Automatically

EMD Serono may also automatically collect non-personally-identifiable information about your use of the Web Site, such as the domain from which you access the Internet (for example, aol.com, if you are connecting from an America Online account), the date and time you access the Web Site, and the Internet address of the website from which you linked directly to our Web Site. This information will not be linked to personally-identifiable information. EMD Serono may use this information to analyze and enhance the Web Site, and may aggregate this information and share such aggregated information with business partners, sponsors and other third parties.

Links to Other Web Sites

The Web Site may allow links to various other web sites. EMD Serono assumes no responsibility for the information practices of sites you are able to access through the Web Site. These links to other sites do not imply affiliation or endorsement of a linked site.

Security

The importance of security for all personally-identifiable information associated with visitors to the Web Site is of utmost concern to us. Unfortunately, no data transmission over the Internet can be guaranteed to be secure. As a result, EMD Serono cannot ensure or warrant the security of any information you transmit to us, and you do so at your own risk. Once we receive your personally-identifiable information, we will take reasonable efforts to ensure its security on our systems.

Your Acceptance of These Terms

By using the Web Site, you signify your assent to the EMD Serono Privacy Policy. If you do not agree to this Policy, please do not use the Web Site. Your continued use of the Web Site following the posting of changes to these terms will mean you accept those changes. EMD Serono will, however, use personally-identifiable information only in accordance with the version of the Privacy Policy under which the information was collected.

Terms and Conditions of Use

Use of the Web Site is governed by the EMD Serono Legal Statement.

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.