Welcome to SIMPONI.com! This site is owned by Janssen Biotech, Inc. This Privacy Policy is designed to tell you about our practices regarding collection, use, and disclosure of information that you may provide via this site. Please be sure to read this entire Privacy Policy before using or submitting information to this site. This site is intended for use by residents of the United States.
By using this site, you agree to the terms of this Privacy Policy. Whenever you submit information via this site, you consent to the collection, use, and disclosure of that information in accordance with this Privacy Policy.
This site is not intended for children under the age of 13. We will not knowingly collect personally identifiable information via this site from visitors in this age group. We encourage parents to talk to their children about their use of the Internet and the information they disclose to websites.
Some areas of this site may ask you to submit personally identifiable information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, order processing, or resume submission) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.
As you navigate through this site, certain anonymous information can be passively collected (that is, gathered without your actively providing the information) using various technologies, such as cookies, Internet tags or Web beacons, and navigational data collection (log files, server logs, clickstream). Your Internet browser automatically transmits to this site some of this anonymous information, such as the URL of the website you just came from and the Internet Protocol (IP) address and the browser version your computer is currently using. This site may also collect anonymous information from your computer through cookies and Internet tags or Web beacons. You may set your browser to notify you when a cookie is sent or to refuse cookies altogether, but certain features of this site might not work without cookies.
This site may use and combine such passively collected anonymous information to provide better service to site visitors, customize the site based on your preferences, compile and analyze statistics and trends, and otherwise administer and improve the site for your use. Such information is not combined with personally identifiable information collected elsewhere on the site unless you have consented.
A "cookie" is a bit of information that a Website sends to your Web browser that helps the site remember information about you and your preferences.
"Session" cookies are temporary bits of information that are used to improve navigation, block visitors from providing information where inappropriate (the site “remembers” previous entries of age or country of origin that were outside the specified parameters and blocks subsequent changes), and collect aggregate statistical information on the site. They are erased once you exit your Web browser or otherwise turn off your computer.
"Persistent" cookies are more permanent bits of information that are placed on the hard drive of your computer and stay there unless you delete the cookie. Persistent cookies store information on your computer for a number of purposes, such as retrieving certain information you have previously provided (such as passwords), helping to determine what areas of the website visitors find most valuable, and customizing the website based on your preferences on an ongoing basis. Persistent cookies placed by this site on your computer may hold personally identifiable information, but only if you have registered or have otherwise consented to the retention of personally identifiable information you have provided at the site. Otherwise, our site’s server only knows that an unidentified visitor with your cookie has returned to the site.
You can set your browser to accept all cookies, to reject all cookies, or to notify you whenever a cookie is offered so that you can decide each time whether to accept it. To learn more about cookies and how to specify your preferences, please search for "cookie" in the "Help" portion of your browser.
A site may use Internet Protocol (IP) addresses. An IP address is a number assigned to your computer by your Internet service provider so you can access the Internet and is generally considered to be non-personally identifiable information, because in most cases an IP address is dynamic (changing each time you connect to the Internet), rather than static (unique to a particular user's computer). The IP address can be used to diagnose problems with a server, report aggregate information, determine the fastest route for your computer to use in connecting to a site, and administer and improve the site.
"Internet tags" (also known as single-pixel GIFs, clear GIFs, invisible GIFs, and 1-by-1 GIFs) are smaller than cookies and tell the website server information such as the IP address and browser type related to the visitor's computer. Tags may be placed both on online advertisements that bring people to the site and on different pages of the site. Such tags indicate how many times a page is opened and which information is consulted.
"Navigational data" (log files, server logs, and clickstream data) are used for system management, to improve the content of the site, market research purposes, and to communicate information to visitors.
Except as otherwise stated, we may use information collected via this site to improve the content of our site, to customize the site to your preferences, to communicate information to you (if you have requested it), for our marketing and research purposes, and for any other purpose specified. In addition, we may make full use of all information acquired through this site that is not in personally identifiable form.
If you provide personally identifiable information to this site, we may combine such information with other actively collected information unless we specify otherwise at the point of collection. We also may disclose personally identifiable information you provide via this site to third parties, but only:
The collection, use, and disclosure of information contemplated in this Privacy Policy may involve a transfer of the information to jurisdictions located outside your country of residence that may not have equivalent laws and rules regarding personally identifiable information. In these cases, you will be asked to consent to such transfers and disclosures in accordance with this Privacy Policy.
To keep personally identifiable information that you provide via this site accurate, current, and complete, please contact us as specified below and we will take appropriate steps to update or correct such information in our possession, or to delete your information from our contact list.
This site takes reasonable steps to protect personally identifiable information as you transmit it to our site and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever completely secure or error-free. In particular, e-mail sent to or from this site may not be secure.
This site may contain links or references to other websites to which this Privacy Policy does not apply. We encourage you to read the Privacy Policy of every website you visit.
If you have any questions, comments, requests, or concerns related to this Privacy Policy or the information practices of this site, or if you would like to opt out of future communications, please contact us as follows:
Janssen Biotech, Inc.
850 Ridgeview Drive
Horsham, PA 19044
Medical Information
1-800-JANSSEN (1-800-526-7736)
If this Privacy Policy changes, the revised policy will be posted on this site. Please check back periodically, and especially before you provide any personally identifiable information. This Privacy Policy was last updated on April 14, 2009.
INDICATION
SIMPONI® (golimumab) is indicated for the treatment of1:
DOSING AND ADMINISTRATION
SIMPONI® is administered by 50 mg subcutaneous injection once a month.1
IMPORTANT SAFETY INFORMATION
SERIOUS INFECTIONS
Patients treated with SIMPONI® (golimumab) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI® if a patient develops a serious infection.
Reported infections with TNF blockers, of which SIMPONI® is a member, include:
The risks and benefits of treatment with SIMPONI® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI® in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.
Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI® included sepsis, pneumonia, cellulitis, abscess and hepatitis B infection.
MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers of which SIMPONI® is a member. Approximately half the cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI®, more cases of lymphoma have been observed among patients receiving TNF-blocking treatment compared with control patients. In clinical trials, the incidence of lymphoma per 100 patient-years of follow-up was 0.21 (95% CI: 0.03, 0.77) in the combined SIMPONI® group compared with an incidence of 0 (95% CI: 0, 0.96) in the placebo group. In clinical trials, the incidence of malignancies other than lymphoma was not increased with exposure to SIMPONI® and was similar to what would be expected in the general population. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.
HEPATITIS B REACTIVATION
The use of TNF-blocking agents including SIMPONI® has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants.
All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing SIMPONI® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI®. Discontinue SIMPONI® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI®, and monitor patients closely.
HEART FAILURE
Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported. Exercise caution and monitor patients with heart failure. Discontinue SIMPONI® if new or worsening symptoms of heart failure appear.
DEMYELINATING DISORDERS
TNF-blocking agents, of which SIMPONI® is a member, have been associated with rare cases of new-onset or exacerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported with SIMPONI®. Exercise caution in considering the use of SIMPONI® in patients with these disorders. Consider discontinuation if these disorders develop.
HEMATOLOGIC CYTOPENIAS
There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving SIMPONI® in clinical trials. Additionally, aplastic anemia has been reported in patients receiving TNF-blocking agents, of which SIMPONI® is a member. Exercise caution when using SIMPONI® in patients who have or had significant cytopenias.
USE WITH OTHER DRUGS
The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections, therefore the use of SIMPONI® in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker.
VACCINATIONS
People receiving SIMPONI® can receive vaccinations, except for live vaccines. Administration of live vaccines to infants exposed to SIMPONI® in utero is not recommended for 6 months following the mother’s last SIMPONI® injection during pregnancy due to an increased risk of infection.
HYPERSENSITIVITY REACTIONS
Serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported with SIMPONI®, some occurring after the first dose. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI® immediately and institute appropriate therapy.
ADVERSE REACTIONS
The most serious adverse reactions were serious infections and malignancies.
Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 trials through Week 16, occurring in 7% and 6% of patients treated with SIMPONI® as compared with 6% and 5% of patients in the control group, respectively. The rate of injection-site reactions was 6% with patients treated with SIMPONI® compared with 2% of patients in the control group.
Please see accompanying full Prescribing Information and Medication Guide for SIMPONI®. Provide the Medication Guide to your patients and encourage discussion. (Requires Adobe® Reader®. Click here to download.)