Welcome to Remicade.com. This site is owned by Janssen Biotech, Inc. and its affiliates. 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 healthcare professionals in the United States and Puerto Rico.
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About ChildrenThis 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.
Active Information CollectionLike many websites, this site actively collects information from its visitors both by asking you specific questions and by permitting you to communicate directly with us via e-mail, feedback forms, and/or chat rooms. Some of the information that you submit may be personally identifiable information (that is, information that can be uniquely identified with you, such as your full name, address, e-mail address, phone number, and so forth).
Some areas of this site may require you to submit information in order for you to benefit from the specified features (such as resumes, newsletter subscriptions, tips/pointers, order processing) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed at each information collection point what information is required and what information is optional.
Passive Information CollectionAs 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.
Information about cookies and other passive tracking methods are described below.
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.
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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.
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, market research purposes, to improve the content of the site, and to communicate information to visitors.
Use and Disclosure of InformationExcept 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 may disclose personally identifiable information you provide via this site to other Johnson & Johnson affiliates worldwide that agree to treat it in accordance with this Privacy Policy and use it for the same purposes. We also may disclose personally identifiable information you provide via this site to third parties that are not Johnson & Johnson affiliates, 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.
Access and CorrectionTo 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.
SecurityThis 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.
Third Party Sites and ServicesThis Privacy Policy does not address, and we are not responsible for, the privacy, information, or other practices of any third parties, including any third party operating any site or web property (including, without limitation, any application) that is available through this site or to which this site contains a link. The availability of, or inclusion of a link to, any such site or property on the site does not imply endorsement of it by us or by our affiliates.
Other TermsYour use of this site is subject to our Legal Notice.
How to Contact UsIf 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:
Corporate Headquarters
Janssen Biotech, Inc. 800 Ridgeview Drive Horsham, PA 19044
Product Communications 215-325-6861
Medical Information 800-JANSSEN (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 July 2, 2012.
Patients treated with REMICADE® (infliximab) 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 REMICADE® if a patient develops a serious infection or sepsis.
Reported infections include:
The risks and benefits of treatment with REMICADE® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with REMICADE®, 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, pediatric patients, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with REMICADE® included pneumonia, cellulitis, abscess, and skin ulceration.
Postmarketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including REMICADE®. These cases have had a very aggressive disease course and have been fatal. All reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and the majority were in adolescent and young adult males. All of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with REMICADE® at or prior to diagnosis. Carefully assess the risks and benefits of treatment with REMICADE®, especially in these patient types.
In clinical trials of all TNF inhibitors, more cases of lymphoma were observed compared with controls and the expected rate in the general population. However, patients with Crohn’s disease, rheumatoid arthritis, or plaque psoriasis may be at higher risk for developing lymphoma. In clinical trials of some TNF inhibitors, including REMICADE®, more cases of other malignancies were observed compared with controls. The rate of these malignancies among patients treated with REMICADE® was similar to that expected in the general population whereas the rate in control patients was lower than expected. Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use. As the potential role of TNF inhibitors in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy or other risk factors such as chronic obstructive pulmonary disease (COPD).
Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocker therapy, including REMICADE®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
REMICADE® is contraindicated in patients with moderate to severe (NYHA Class III/IV) congestive heart failure (CHF) at doses greater than 5 mg/kg. Higher mortality rates at the 10 mg/kg dose and higher rates of cardiovascular events at the 5 mg/kg dose have been observed in these patients. REMICADE® should be used with caution and only after consideration of other treatment options. Patients should be monitored closely. Discontinue REMICADE® if new or worsening CHF symptoms appear. REMICADE® should not be (re)administered to patients who have experienced a severe hypersensitivity reaction or to patients with hypersensitivity to murine proteins or other components of the product.
TNF inhibitors, including REMICADE®, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating REMICADE®. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing REMICADE® for patients identified as carriers of HBV and monitor closely for active HBV infection during and following termination of therapy with REMICADE®. Discontinue REMICADE® in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of REMICADE® and monitor patients closely.
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis, and cholestasis have been reported rarely in patients receiving REMICADE® postmarketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, REMICADE® should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Cases of leukopenia, neutropenia, thrombocytopenia, and pancytopenia (some fatal) have been reported. The causal relationship to REMICADE® therapy remains unclear. Exercise caution in patients who have ongoing or a history of significant hematologic abnormalities. Advise patients to seek immediate medical attention if they develop signs and symptoms of blood dyscrasias or infection. Consider discontinuation of REMICADE® in patients who develop significant hematologic abnormalities.
REMICADE® has been associated with hypersensitivity reactions that differ in their time of onset. Acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Serious infusion reactions including anaphylaxis were infrequent. Medications for the treatment of hypersensitivity reactions should be available.
TNF inhibitors, including REMICADE®, have been associated in rare cases with CNS manifestation of systemic vasculitis, seizure, and new onset or exacerbation of CNS demyelinating disorders, including multiple sclerosis and optic neuritis, and peripheral demyelinating disorders, including Guillain-Barré syndrome. Exercise caution when considering REMICADE® in patients with these disorders and consider discontinuation if these disorders develop.
Treatment with REMICADE® may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
In clinical trials, the most common REMICADE® adverse reactions occurring in >10% of patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
Concomitant use of REMICADE® with anakinra, abatacept, tocilizumab, or other biologics used to treat the same conditions as REMICADE® is not recommended because of the possibility of an increased risk of infection. Care should be taken when switching from one biologic to another, since overlapping biological activity may further increase the risk of infection.
Live vaccines should not be given with REMICADE®. Bring pediatric patients up to date with all vaccinations prior to initiating REMICADE®. Exercise caution in the administration of live vaccines to infants born to female patients treated with REMICADE® during pregnancy.
For more information, please see full Prescribing Information and Medication Guide for REMICADE®.
Provide the Medication Guide to your patients and encourage discussion.
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