Information You Provide
Some areas of the Site may ask you to submit personal information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, or order processing) 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.
We may combine the information you submit with other information we have collected from you, whether on- or offline, including, for example, your purchase history. We may also combine it with information we receive about you from other sources, such as other Johnson & Johnson Operating Companies, publicly available information sources (including information from your publicly available social media profiles), and other third parties.
Passive Information Collection and Use
As you navigate around the Site, certain information can be passively collected (that is, gathered without your actively providing the information), using various technologies. We and our third party service providers passively collect and use information in a variety of ways, including:
Through your browser: Certain information is collected by most browsers, such as your Media Access Control (MAC) address, computer type (Windows or Macintosh), screen resolution, operating system version, and Internet browser type and version. We may collect similar information, such as your device type and identifier, if you access the Site through a mobile device.
You can refuse to accept these cookies by following your browser’s instructions; however, if you do not accept them, you may experience some inconvenience in your use of the Site. You may also not receive advertising or other offers from us that are relevant to your interests and needs. To learn more about cookies, please visit http://www.allaboutcookies.org.
Using Flash cookies: Our use of Adobe Flash technology (including Flash Local Stored Objects (“Flash LSOs”)) allows us to, among other things, serve you with more tailored information, facilitate your ongoing access to and use of the Site, and collect and store information about your use of the Site. If you do not want Flash LSOs stored on your computer, you can adjust the settings of your Flash player to block Flash LSO storage using the tools contained in the Website Storage Settings Panel. You can also control Flash LSOs by going to the Global Storage Settings Panel and following the instructions (which may include instructions that explain, for example, how to delete existing Flash LSOs (referred to as “information” on the Macromedia site), how to prevent Flash LSOs from being placed on your computer without your being asked, and (for Flash Player 8 and later) how to block Flash LSOs that are not being delivered by the operator of the page you are on at the time). Please note that setting the Flash Player to restrict or limit acceptance of Flash LSOs may reduce or impede the functionality of some Flash applications, including, potentially, Flash applications used in connection with the Site or our online content.
Using pixel tags, web beacons, clear GIFs, or other similar technologies: These may be used in connection with some Site pages and HTML-formatted e-mail messages to, among other things, track the actions of Site users and e-mail recipients, measure the success of our marketing campaigns, and compile statistics about Site usage and response rates.
IP Address: Your IP Address is a number that is automatically assigned to the computer that you are using by your Internet Service Provider. An IP Address is identified and logged automatically in our server log files whenever a user visits the Site, along with the time of the visit and the page(s) that were visited. Collecting IP Addresses is standard practice on the Internet and is done automatically by many web sites. We use IP Addresses for purposes such as calculating Site usage levels, helping diagnose server problems, and administering the Site.
Device Information: We may collect information about your mobile device, such as a unique device identifier.
How We Use and Disclose Information
We use and disclose information you provide to us as described to you at the point of collection.
We also use information from or about you:
- to respond to your inquiries and fulfill your requests, such as to send you documents you request or e-mail alerts;
- to send you important information regarding our relationship with you or regarding the Site, changes to our terms, conditions, and policies and/or other administrative information; and
- for our business purposes, such as data analysis, audits, developing new products, enhancing our website, improving our products and services, identifying Site usage trends, personalizing your experience on the Site by presenting products and offers tailored to you, and determining the effectiveness of our promotional campaigns.
We also disclose information collected through the Site:
- to our third party partners with whom we offer a co-branded or co-marketed promotion;
- to our third party service providers who provide services such as website hosting and moderating, mobile application hosting, data analysis, payment processing, order fulfillment, infrastructure provision, IT services, customer service, e-mail and direct mail delivery services, credit card processing, auditing services, and other services, in order to enable them to provide services; and
- to a third party in the event of any reorganization, merger, sale, joint venture, assignment, transfer, or other disposition of all or any portion of our business, assets, or stock (including in connection with any bankruptcy or similar proceedings).
In addition, we use and disclose information collected through the Site as we believe to be necessary or appropriate: (a) as permitted by applicable law, including laws outside your country of residence; (b) to comply with legal process; (c) to respond to requests from public and government authorities, including public and government authorities outside your country of residence; (d) to enforce our terms and conditions; (e) to protect our operations or those of any of our affiliates; (f) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others; and (g) to allow us to pursue available remedies or limit the damages that we may sustain. We may also use and disclose information collected through the Site in other ways, with your consent.
We also use and disclose information we collect passively as described above, under “Passive Information Collection and Use,” and for any other purpose, except where we are required to do otherwise under applicable law (for example, if we are required to treat such information as personal information). In addition, we may use and disclose information that is not in personally identifiable form for any purpose. If we combine information that is not in personally identifiable form with information that is (such as combining your name with your geographical location), we will treat the combined information as personal information as long as it is combined.
THIRD PARTY SITES AND SERVICES
We use reasonable organizational, technical, and administrative measures to protect personal information under our control. Unfortunately, no data transmission over the Internet or data storage system can be guaranteed to be 100% secure. If you have reason to believe that your interaction with us is no longer secure (for example, if you feel that the security of any account you have with us has been compromised), please immediately notify us of the problem by contacting us in accordance with the “Contacting Us” section below.
CHOICES AND ACCESS
Your choices regarding our use and disclosure of your personal information
We give you choices regarding our use and disclosure of your personal information for marketing purposes. You may opt out from:
Receiving marketing communications from us: If you no longer want to receive marketing communications from us on a going-forward basis, you may opt out of receiving them by contacting us at
1-800-JANSSEN (526-7736)or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. In your response to us, please provide your name, identify the form(s) of marketing communications that you no longer wish to receive, and include the address(es) to which it/they are sent. For example, if you no longer wish to receive marketing e-mails or direct mail from us, tell us that, and provide your name and e-mail or postal address.
Receiving reminders from us: If you no longer want to receive medical reminders from us on a going-forward basis, you may opt out of receiving them by contacting us at
1-800-JANSSEN (526-7736)or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. In your response to us, please provide your name and the e-mail address or phone number at which you receive reminders from us.
Our sharing of your personal information with affiliates and third-party partners: If you would prefer that we not share your personal information on a going-forward basis with our affiliates and/or third-party partners for their marketing purposes, you may opt out of this sharing by contacting at
1-800-JANSSEN (526-7736)or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. In your response to us, please state that we should no longer share your personal information with our affiliates and/or third-party partners for their marketing purposes, and include your name and e-mail address.
We will seek to comply with your request(s) as soon as reasonably practicable. Please note that if you opt out as described above, we will not be able to remove your personal information from the databases of our affiliates with which we have already shared your information (i.e., as of the date that we implement your opt-out request). Please also note that if you opt out of receiving marketing-related messages from us, we may still send you important transactional and administrative messages, from which you cannot opt out.
How you can access, change, or delete your personal information
If you would like to review, correct, update, or delete the personal information that you have provided via the Site, please contact us at
USE OF SITE BY MINORS
The Site is not directed to individuals under the age of 18, and we request that these individuals not provide Personal Information through the Site.
Your personal information may be stored and processed in any country where we have facilities or service providers, and by using our Site or by providing consent to us (where required by law), you agree to the transfer of information to countries outside of your country of residence, including to the United States, which may provide for different data protection rules than in your country.
Unless we specifically request or invite it, we ask that you not send us, and you not disclose, any sensitive personal information (e.g., information related to racial or ethnic origin, political opinions, religion or other beliefs, health, criminal background or trade union membership) on or through the Site or otherwise to us. In those cases where we may request or invite you to provide sensitive information, we will do so with your express consent.
REMICADE® is indicated for:Crohn's Disease
- Reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease (CD) who have had an inadequate response to conventional therapy
- Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing CD
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age or older with moderately to severely active CD who have had an inadequate response to conventional therapy
- Reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy
- Reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active UC who have had an inadequate response to conventional therapy
- Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate (MTX)
- Reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis (PsA)
- Reducing signs and symptoms in patients with active ankylosing spondylitis (AS)
- The treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate
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:
- Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with REMICADE®.1,2 Treatment for latent infection should be initiated prior to treatment with REMICADE®.
- Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
- Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.
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.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including REMICADE®. Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.
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 or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.
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. (Requires Adobe® Reader®. Click here to download.)References:
1. American Thoracic Society, Centers for Disease Control and Prevention. Targeted tuberculin testing and treatment of latent tuberculosis infection. Am J Respir Crit Care Med. 2000;161:S221-S247.
2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.