Supplemental Privacy Notices
Privacy Notice for California Residents
Privacy Notice for Nevada Residents
Janssen Biotech, Inc. respects your privacy and wants you to be familiar with how we collect, use, and disclose information. This Privacy Policy describes our practices in connection with information that we or our service providers collect through the website or application (hereinafter the “Service”) operated and controlled by us from which you are accessing this Privacy Policy. We encourage you to read the full Privacy Policy before using this Service or providing any personal information. By providing personal information to us or by using the Service, you acknowledge that you have read and understand this Privacy Policy.
USE BY MINORS
The Service is not directed to individuals under the age of 18, and we request that these individuals not provide personal information through the Service. If your child has submitted Personal Information and you would like to request that such Personal Information be removed, please contact us as explained below under “Contacting Us.”
INFORMATION COLLECTION
We may ask you to submit personal information in order for you to benefit from certain 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 Affiliates, publicly available information sources (including information from your publicly available social media profiles), and other third-party information providers.
If you submit any personal information relating to another individual to us, you represent that you have the authority to do so and to permit us to use the information in accordance with this Privacy Policy.
SENSITIVE INFORMATION
Unless we specifically request or invite it, we ask that you not send us, and you not disclose, any sensitive personal information (e.g., Social Security numbers, information related to racial or ethnic origin, political opinions, religion or philosophical beliefs, health or medical condition, sex life or sexual orientation, criminal background, or trade union membership, or biometric or genetic data) on or through the Service or otherwise directly to us.
AUTOMATIC INFORMATION COLLECTION AND USE
We and our service providers may automatically collect and use information in the following ways as you navigate around the Service:
Through your browser: Certain information is collected by most browsers, such as your Media Access Control (MAC) address, computer type (Windows or Mac), screen resolution, operating system name and version, and Internet browser type and version. We may collect similar information, such as your device type and identifier, if you access the Service through a mobile device. We use this information to ensure that the Service functions properly.
Using cookies: Cookies are pieces of information stored directly on the computer you are using. Cookies allow us to collect information such as browser type, time spent on the Service, pages visited, and language preferences. We and our service providers use the information for security purposes, to facilitate navigation, display information more effectively, and to personalize your experience while using the Service. We also use cookies to recognize your computer or device, which makes your use of the Service easier, such as to remember what is in your shopping cart. In addition, we use cookies to gather statistical information about Service usage in order to continually improve its design and functionality, understand how individuals use it, and to assist us with resolving questions regarding it. Cookies further allow us to select which of our advertisements or offers are most likely to appeal to you and display them while you are on the Service. We may also use cookies in online advertising to track consumer responses to our advertisements.
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 Service. 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 Service, and collect and store information about your use of the Service. 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. 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.
Using pixel tags, web beacons, clear GIFs, or other similar technologies: These may be used in connection with some Service pages and HTML formatted e-mail messages to, among other things, track the actions of users and e-mail recipients, measure the success of our marketing campaigns, and compile statistics about Service usage.
Interest-based advertising: We may use third-party advertising companies to serve advertisements regarding goods and services. that may be of interest to you when you access and use the Service and other online services, based on information relating to your access and use of the Service and other online services on any of your devices. To do so, these companies may place or recognize a unique cookie on your browser (including through the use of pixel tags). They may also use these technologies, along with information they collect about your online use, to recognize you across the devices you use, such as a mobile phone and a laptop.
If you would like more information about this practice, and to learn how to opt-out of it, in desktop and mobile browsers on the particular device on which you are accessing this Privacy Policy, please visit http://optout.aboutads.info/#/ and http://optout.networkadvertising.org/#/. You may download the AppChoices app at www.aboutads.info/appchoices to opt-out in mobile apps.
IP address: Your IP address is a number that is automatically assigned to your computer by your Internet Service Provider. An IP address is identified and logged automatically in our server log files whenever a user visits the Service, along with the time of the visit and the pages visited. Collecting IP addresses is standard practice and is done automatically by many online services. We use IP addresses for purposes such as calculating Service usage levels, diagnosing server problems, and administering the Service. We may also derive your approximate location from your IP address.
Device Information: We may collect information about your mobile device, such as a unique device identifier, to understand how you use the Service.
HOW WE USE AND DISCLOSE INFORMATION
We use and disclose information you provide to us as described to you at the point of collection. Please see the section entitled “Choices and Access” below to learn how you may opt-out of certain of our uses and disclosures.
Where required by applicable law, we will obtain your consent to our use of your personal information at the point of information collection. We may also rely on other legal bases, specifically for:
We will engage in these activities to manage our contractual relationship with you and/or to comply with a legal obligation.
We will engage in these activities to manage our contractual relationship with you, to comply with a legal obligation, and/or because we have a legitimate interest.
We will provide personalized services either with your consent or because we have a legitimate interest.
We also disclose information collected through the Service:
In addition, we may use and disclose your information as we believe to be necessary or appropriate: (a) to comply with legal process or applicable law which may include laws outside your country of residence; (b) as permitted by applicable law to respond to requests from public and government authorities, which may include authorities outside your country of residence; (c) to enforce our terms and conditions; and (d) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others. We may also use and disclose your information in other ways after obtaining your consent to do so.
We may use and disclose information we collect automatically as described above under “Automatic Information Collection and Use.”
In addition, where allowed by applicable law, 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 identifiable (such as combining your name with your geographical location), we will treat the combined information as personal information as long as it is combined.
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:
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 may not be able to directly 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). However, we will make reasonable efforts to inform our affiliates of your 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, restrict, or delete your personal information, or if you would like to request an electronic copy of your personal information for purposes of transmitting it to another company (to the extent these rights are provided to you by applicable law), please contact us via 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO BOX 200 Titusville, NJ 08560. We will respond to your request as soon as reasonably practicable and no later than one month after receipt. If circumstances cause any delay in our response, you will be promptly notified and provided a date for our response.
CROSS-BORDER TRANSFER
Your personal information may be stored and processed in any country where we have facilities or service providers, and by using our Service or by providing consent to us (where required by law), your information may be transferred 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 of residence. Nonetheless, appropriate contractual and other measures are in place to protect personal information when it is transferred to our affiliates or third parties in other countries.
SECURITY
We seek to use reasonable organizational, technical, and administrative measures designed to protect personal information under our control. However, 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 in accordance with the “Contacting Us” section below.
RETENTION PERIOD
We will retain your personal information for as long as needed or permitted in light of the purpose(s) for which it was obtained. The criteria used to determine our retention periods include: (i) the length of time we have an ongoing relationship with you and provide the Service to you; (ii) whether there is a legal obligation to which we are subject; and (iii) whether retention is advisable in light of our legal position (such as, in regard to applicable statutes of limitations, litigation or regulatory investigations).
THIRD PARTY SITES AND SERVICES
This Service may contain links to sites of third parties. This Privacy Policy does not address, and we are not responsible for, the privacy, information, or practices of any third parties, including any third party operating any site or online service (including, without limitation, any application) that is available through this Service or to which this Service contains a link. The availability of, or inclusion of a link to, any such site or property on the Service does not imply endorsement of it by us or by our affiliates.
CONTACTING US
Janssen Biotech, Inc. is the company responsible for collection, use, and disclosure of personal information under this Privacy Policy.
If you have any questions about this Privacy Policy, please contact us via 1-800-JANSSEN (526-7736), or please write to the following address:
Janssen Medical Information
PO Box 200
Titusville, NJ 08560
UPDATES TO THIS PRIVACY POLICY
We may change this Privacy Policy. Any changes to this Privacy Policy will become effective when we post the revised Privacy Policy on the Service. Your use of the Service following these changes means that you accept the revised Privacy Policy. We recommend that you regularly review the Privacy Policy when you visit the Service. This policy was last updated on November 2019.
Effective: January 1, 2020
This Privacy Notice for California Residents supplements the information contained in the Johnson & Johnson Global Privacy Policy (above), and applies only to California residents (“You,” “your” or “consumer”).
Personal Information Collection and Purposes of Use
We collect and use information that identifies, relates to, describes, references, is capable of being associated with, or could reasonably be linked, directly or indirectly, to you or your devices when you visit this website, provide us your personal information, or have a contractual or business relationship with us or any of our affiliates, (“Personal Information”). Such Personal Information includes direct identifiers like a name, postal address, email address, social security number or other government identifier, and indirect identifiers that may identify, relate to, or be associated with a particular individual, such as a telephone number, device identifier, IP address and browsing history, credit card information, or inferences about consumer preferences or characteristics.
We collect this Personal Information for the following purposes:
Our Personal Information Handling Practices
In the preceding 12 months, we have collected the following categories of Personal Information from California residents who have visited this website, provided us their Personal Information, or had or have a contractual or business relationship with us or any of our affiliates:
We have collected such Personal Information from one or more of the following categories of sources:
We collected such Personal Information for the purposes noted above (see “Personal Information Collection and Purposes of Use”) and in the J&J Global Privacy Policy (see “How We Use and Disclose Information”):
We may have shared such Personal Information with the following categories of third parties:
We collected one or more of the following specific pieces of personal information:
Unless specifically stated, we do not share, disclose or sell personal information to third parties for their own use, but we do share your personal information with our affiliates and trusted partners in arrangements that may meet the broad definition of “sale” under California law. In these arrangements, use of the information we share is limited by policies, contracts, or similar restrictions.
In the preceding 12 months we may have disclosed, shared or sold, as defined by California law, one or more of the above categories of personal information.
Your Privacy Rights
You have the following rights regarding our collection and use of your personal information. To exercise those rights, you must submit a request by either calling us at 1-800-JANSSEN (526-7736) or through https://www.janssen.com/us/privacy-request/. We may ask you to provide additional information to verify your request. We may not discriminate against you if you exercise your rights as described in this notice. For example, we may not deny goods or services to you, or charge you different prices or rates, or provide a different level of quality of products or services.
Right to Information
You have the right to request the following information regarding the personal information we have collected about you:
You have the right to request the following information regarding the personal information we have sold or disclosed about you:
Right to Opt Out of Sharing, Disclosure, or Sale of Personal Information
You have the right to direct us to not share, disclose, or sell your personal information. To exercise this right, you or your authorized representative may submit a request by clicking on the following link:
Right to Request Deletion
You have the right to request that we delete the personal information we have about you. However, we are not required to delete information if it is necessary to retain your information to:
Contact Us
You can contact us with questions about this Privacy Notice for California Residents or to exercise your rights as described in this Notice.
|
Telephone number: |
1-800-JANSSEN (526-7736) |
|
Email or Web address: |
|
|
Postal address: |
Janssen Medical Information |
Contact Title: Privacy Manager
Effective: October 1, 2019
This Supplemental Privacy Notice for Nevada Residents adds to the information contained in the Johnson & Johnson Global Privacy Policy (above), and applies only to Nevada residents (“You,” “your” or “consumer”).
Personal Information Collection and Purposes of Use
We collect certain personal information of Nevada consumers through our Internet websites or other online service. This information includes one or more of the following elements of personally identifiable information:
We collect this personal information for the following purposes:
Your Privacy Rights
Right to access and/or correct your personal information, or opt out of sale of personal information
If you would like to review, correct, or update your personal information, you or your authorized representative may submit your request to https://www.janssen.com/us/privacy-request/. We will respond to your verified request as soon as reasonably practicable, but no later than sixty (60) days after receipt. If circumstances cause any delay in our response, you will be promptly notified and provided a date for our response.
We generally do not disclose or share personal information for profit. Under Nevada law, you have the right to direct us to not sell or license your personal information to third parties. To exercise this right, if applicable, you or your authorized representative may submit a request to https://www.janssen.com/us/privacy-request/. We will respond to your verified request as soon as reasonably practicable, but no later than sixty (60) days after receipt. If circumstances cause any delay in our response, you will be promptly notified and provided a date for our response.
Contact Us
You can contact us with questions about this Privacy Notice for Nevada Residents or to exercise your rights as described in this Notice.
Via web: https://www.janssen.com/us/privacy-request/
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, who are on treatment for latent TB, or who were previously treated for TB infection.
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. The majority of reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost 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 blockers, 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 blockers, 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 blockers 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.
A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with REMICADE® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE®.
The use of REMICADE® at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. REMICADE® is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE® or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).
TNF blockers, 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 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.
In a randomized, placebo-controlled study in patients with moderate or severe heart failure (NYHA Functional Class III/IV), higher mortality rates and a higher risk of hospitalization were observed at Week 28 at a dose of 10 mg/kg and higher rates of cardiovascular events were observed at both 5 mg/kg and 10 mg/kg. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking REMICADE® (≤5 mg/kg) or patients with mild heart failure should be closely monitored and treatment should be discontinued if new or worsening symptoms appear.
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. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Medications for the treatment of hypersensitivity reactions should be available.
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE® infusion. Cases of transient visual loss have been reported during or within 2 hours of REMICADE® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.
TNF blockers, including REMICADE®, have been associated 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.
Concurrent 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.
Treatment with REMICADE® may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
Prior to initiating REMICADE®, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.
At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE®.
In clinical trials, the most common adverse reactions occurring in >10% of REMICADE®-treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
For more information, please see the full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion.
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.
cp-62063v2
REMICADE® is indicated for:
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, who are on treatment for latent TB, or who were previously treated for TB infection.
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. The majority of reported REMICADE® cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost 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 blockers, 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 blockers, 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 blockers 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.
A population-based retrospective cohort study found a 2- to 3-fold increase in the incidence of invasive cervical cancer in women with rheumatoid arthritis treated with REMICADE® compared to biologics-naïve patients or the general population, particularly those over 60 years of age. A causal relationship between REMICADE® and cervical cancer cannot be excluded. Periodic screening should continue in women treated with REMICADE®.
The use of REMICADE® at doses >5 mg/kg is contraindicated in patients with moderate or severe heart failure. REMICADE® is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab or any of the inactive ingredients of REMICADE® or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness).
TNF blockers, 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 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.
In a randomized, placebo-controlled study in patients with moderate or severe heart failure (NYHA Functional Class III/IV), higher mortality rates and a higher risk of hospitalization were observed at Week 28 at a dose of 10 mg/kg and higher rates of cardiovascular events were observed at both 5 mg/kg and 10 mg/kg. There have been postmarketing reports of new onset and worsening heart failure, with and without identifiable precipitating factors. Patients with moderate or severe heart failure taking REMICADE® (≤5 mg/kg) or patients with mild heart failure should be closely monitored and treatment should be discontinued if new or worsening symptoms appear.
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. Anaphylaxis, acute urticaria, dyspnea, and hypotension have occurred in association with infusions of REMICADE®. Medications for the treatment of hypersensitivity reactions should be available.
Serious cerebrovascular accidents, myocardial ischemia/infarction (some fatal), hypotension, hypertension, and arrhythmias have been reported during and within 24 hours of initiation of REMICADE® infusion. Cases of transient visual loss have been reported during or within 2 hours of REMICADE® infusion. Monitor patients during infusion and if a serious reaction occurs, discontinue infusion. Manage reactions according to signs and symptoms.
TNF blockers, including REMICADE®, have been associated 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.
Concurrent 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.
Treatment with REMICADE® may result in the formation of autoantibodies and in the development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.
Prior to initiating REMICADE®, update vaccinations in accordance with current vaccination guidelines. Live vaccines or therapeutic infectious agents should not be given with REMICADE® due to the possibility of clinical infections, including disseminated infections.
At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to REMICADE®.
In clinical trials, the most common adverse reactions occurring in >10% of REMICADE®-treated patients included infections (eg, upper respiratory, sinusitis, and pharyngitis), infusion-related reactions, headache, and abdominal pain.
For more information, please see the full Prescribing Information and Medication Guide for REMICADE®. Provide the Medication Guide to your patients and encourage discussion.
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.
cp-62063v2
REMICADE® is indicated for:
Targan et al conducted a multicenter, randomized, double-blind trial in 108 patients with moderately to severely active CD (baseline CDAI ≥220 and ≤400) unresponsive to conventional therapy. Patients were randomized to receive a single infusion of placebo (n=25) or REMICADE® 5 mg/kg IV (n=27), 10 mg/kg IV (n=28), or 20 mg/kg IV (n=28). The primary endpoint was clinical response at Week 4.5
Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn’s disease.1
ACCENT I is a 1-year, multicenter, randomized, double-blind trial of REMICADE® in 545 patients with moderately to severely active CD (CDAI ≥220 and ≤400). All patients received an initial dose of REMICADE® 5 mg/kg IV. Patients were then randomized based on clinical response at Week 2 to 1 of 3 treatment groups through Week 541,6:
The coprimary endpoints of the trial were the proportion of patients responding at Week 2 who were in remission at Week 30 and time to loss of response through Week 54.1,6
Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2, and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adults with moderately to severely active Crohn’s disease.1
Results from SONIC, a multicenter, randomized, double-blind, controlled, phase IIIb trial of 508 patients with moderately to severely active CD (baseline CDAI ≥220 and ≤450). At baseline, mean CDAI score for all patients was 287; median duration of CD ranged from 2.2 to 2.4 years. Patients were randomly assigned to 1 of 3 treatment groups through Week 30. In the primary study phase, patients received REMICADE® 5 mg/kg or placebo infusions at Weeks 0, 2, 6, 14, and 22; patients also received AZA capsules at a dose of 2.5 mg/kg/day or placebo capsules daily through Week 30. Patients completing treatment through Week 30 (main study) were eligible to enter the study extension if, in the opinion of the investigator, the patient could benefit from continued treatment. Patients eligible for participation in the extension (N=280) continued to receive their initial treatment through Week 50. The Week-50 analysis included patients who did not enter the study extension. These patients were assumed nonresponders and not to be in steroid-free remission at Week 50. The primary endpoint of the study was the proportion of patients in corticosteroid-free remission at Week 26. Secondary endpoints included mucosal healing at Week 26 and corticosteroid-free remission at Week 50. Monitoring for adverse events was performed through Week 54.
REACH (A Randomized, multicenter, open-label study to Evaluate the safety and efficacy of Anti-TNF-α Chimeric monoclonal antibody in pediatric subjects with moderate to severe Crohn's disease) was a controlled trial that evaluated the safety and efficacy of REMICADE® in 112 pediatric patients aged 6 to 17 years with moderately to severely active CD. All patients received induction dosing of 5 mg/kg IV REMICADE® at Weeks 0, 2, and 6. At Week 10, 103 patients were randomized to a maintenance regimen of REMICADE® 5 mg/kg IV given either every 8 weeks or every 12 weeks. Induction of clinical response, the primary endpoint, was evaluated 10 weeks after the 3-dose induction regimen (Weeks 0, 2, and 6). At Week 54, clinical response, clinical remission, and change from baseline in average daily corticosteroid use were evaluated as secondary efficacy endpoints.5
Note: REMICADE® 5 mg/kg IV every 12 weeks is not an approved maintenance dose for REMICADE®.1
The safety and efficacy of REMICADE® were evaluated in the Active Ulcerative Colitis Trial (ACT 1) (N=364), a randomized, double-blind, placebo-controlled, multicenter trial conducted in patients with moderately to severely active ulcerative colitis who had an inadequate response or were intolerant to conventional therapy. Patients presented with a Mayo score between 6 and 12, and an endoscopy subscore of ≥2. Prior failed or intolerable therapies in ACT 1 included oral corticosteroids, 6-mercaptopurine (6-MP), or azathioprine (AZA). Patients were randomized to the following treatment groups: REMICADE® 5 mg/kg IV (n=121), REMICADE® 10 mg/kg IV (n=122), or placebo (n=121). Infusions were administered at Weeks 0, 2, and 6, and every 8 weeks thereafter through Week 46.5
Final efficacy evaluations were completed 8 weeks following the last infusion. Concomitant treatment with stable doses of aminosalicylates, corticosteroids, and/or immunomodulators was permitted throughout the study. Of patients receiving steroids at baseline, tapering was allowed beginning at Week 8. The primary efficacy endpoint was clinical response at Week 8; secondary endpoints included clinical remission and mucosal healing.5
Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.1
The safety and efficacy of REMICADE® were evaluated in ACT 2 (N=364) (ACT=Active Ulcerative Colitis Trial), a randomized, double-blind, placebo-controlled, multicenter trial conducted in patients with moderately to severely active ulcerative colitis who had an inadequate response or were intolerant to conventional therapy. Patients presented with a Mayo score between 6 and 12, and an endoscopy subscore of ≥2. Prior failed or intolerable therapies in ACT 2 included oral corticosteroids, 6-mercaptopurine (6-MP), or azathioprine (AZA) and/or aminosalicylates. Patients were randomized to the following treatment groups: REMICADE® 5 mg/kg IV (n=121), REMICADE® 10 mg/kg IV (n=120), or placebo (n=123). Infusions were administered at Weeks 0, 2, and 6, and every 8 weeks thereafter through Week 22.5
Final efficacy evaluations were completed 8 weeks following the last infusion. Concomitant treatment with stable doses of aminosalicylates, corticosteroids, and/or immunomodulators was permitted throughout the study. Of patients receiving steroids at baseline, tapering was allowed beginning at Week 8. The primary efficacy endpoint was clinical response at Week 8; secondary endpoints included clinical remission and mucosal healing.5
Note: The recommended dose of REMICADE® is 5 mg/kg given as an IV induction regimen at 0, 2 and 6 weeks followed by a maintenance regimen of 5 mg/kg IV every 8 weeks thereafter for the treatment of adult patients with moderately to severely active ulcerative colitis.1
The REMICADE® Pediatric Ulcerative Colitis (UC) trial was a multicenter, phase 3, randomized, open-label, parallel-group trial to evaluate the safety and efficacy of REMICADE® in pediatric patients aged 6 to 17 years with moderately to severely active UC (N=60; Mayo score of 6 to 12; endoscopic subscore ≥2) and an inadequate response to conventional therapies. The primary objectives of the study were to evaluate clinical response after a 3-dose induction regimen of REMICADE® 5 mg/kg IV and the safety of REMICADE® during induction and maintenance regimens. Secondary objectives included the evaluation of 2 REMICADE® maintenance dosing regimens (every 8 weeks and every 12 weeks) in maintaining remission, as measured on the Pediatric Ulcerative Colitis Activity Index (PUCAI); the efficacy of a 3-dose regimen of REMICADE® in the induction of clinical remission, as measured by the Mayo score; and the induction of remission, as measured on the PUCAI.1,5
All patients received induction dosing of REMICADE® 5 mg/kg IV at Weeks 0, 2, and 6. Patients who did not respond to REMICADE® at Week 8 received no further REMICADE® and returned for safety follow-up. At Week 8, 45 patients were randomized to a maintenance regimen of REMICADE® 5 mg/kg IV given either every 8 weeks through Week 46 or every 12 weeks through Week 42.1,5
Note: REMICADE® 5 mg/kg IV every 12 weeks is not an FDA-approved maintenance dosing regimen for REMICADE® in the treatment of pediatric patients with moderately to severely active UC.1
EXPRESS evaluated 378 patients with moderate to severe plaque psoriasis. These patients had ≥10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of ≥12, and were candidates for systemic or phototherapy. Patients were randomized to placebo or REMICADE® (infliximab) at a dose of 5 mg/kg IV at Weeks 0, 2, and 6 (induction therapy), followed by maintenance therapy (5 mg/kg IV) every 8 weeks. At Week 24, the placebo group crossed over to REMICADE® induction (5 mg/kg IV), followed by maintenance therapy (5 mg/kg IV) every 8 weeks. Patients randomized to REMICADE® continued to receive REMICADE® 5 mg/kg IV every 8 weeks through Week 46. The primary endpoint was the proportion of patients achieving ≥75% improvement in PASI from baseline to Week 10.
EXPRESS II evaluated 835 patients with moderate to severe plaque psoriasis. These patients had ≥10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of ≥12, and were candidates for systemic therapy or phototherapy. Patients were randomized to placebo or REMICADE® (infliximab) at doses of 3 mg/kg IV or 5 mg/kg IV at Weeks 0, 2, and 6 (induction therapy). At Week 14, patients in the REMICADE® arms continued on their original dose but were randomized to either an every 8 week scheduled maintenance therapy or an as needed (PRN) maintenance therapy through Week 46. Patients randomized to the PRN maintenance therapy group received their original REMICADE® dose when baseline improvement in PASI was <75% and received placebo if PASI improvement was ≥75%. Maintenance visits occurred monthly. At Week 16, the placebo group crossed over to REMICADE® induction therapy (5 mg/kg IV), followed by a maintenance therapy every 8 weeks. The primary endpoint was proportion of patients achieving PASI 75 at Week 10.
SPIRIT evaluated 249 patients with plaque psoriasis. These patients had ≥10% body surface area (BSA) involvement, a Psoriasis Area and Severity Index (PASI) score of ≥12, and had previously received either psoralen plus ultraviolet A treatment (PUVA) or other systemic therapy for their psoriasis. Patients were randomized to either placebo or REMICADE® (infliximab) at doses of 3 mg/kg IV or 5 mg/kg IV at Weeks 0, 2, and 6 (induction therapy). At Week 26, patients with a static physician’s global assessment (sPGA) score of moderate or worse (≥3 on a scale of 0 to 5) received an additional dose of the randomized treatment. The primary endpoint was the proportion of patients achieving ≥75% improvement in PASI from baseline at Week 10.
ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy), a 24-week, multicenter, double-blind, placebo-controlled, randomized, phase 3 study in 279 adult patients with active ankylosing spondylitis according to the modified New York criteria for ≥3 months, with Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4, and spinal pain assessment score ≥4 on a Visual Analog Scale (VAS), each on a scale of 0-10. The primary endpoint was the proportion of patients with a 20% improvement response according to the criteria of the ASAS International Working Group. Patients were randomized to 1 of 2 treatment groups in a 3:8 ratio: placebo (n=78) or REMICADE® 5 mg/kg (n=201) infused at Weeks 0, 2, 6, 12, and 18. Concurrent stable treatment with nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and tramadol was permitted during the study. Patients were not permitted to be on any disease-modifying antirheumatic drugs (DMARDs) or systemic corticosteroids.
IMPACT 2 (Induction and Maintenance Psoriatic Arthritis Clinical Trial 2): a randomized, double-blind, placebo-controlled, multicenter, phase 3, parallel-group study of REMICADE® in 200 adult patients with active PsA for at least 6 months who had an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or nonsteroidal anti-inflammatory drugs (NSAIDs). Patients had active articular disease (≥5 swollen and tender joints each), psoriatic target skin lesion (≥2 cm in diameter), and either C-reactive protein (CRP) ≥1.5 mg/dL or morning stiffness lasting ≥45 minutes. Stable methotrexate (MTX) doses of ≤25 mg/week at study entry and stable oral corticosteroid doses equivalent to ≤10 mg/day of prednisone were permitted. During the 24-week, double-blind phase, patients received either REMICADE® 5 mg/kg IV (n=100) or placebo (n=100) at Weeks 0, 2, 6, 14, and 22. At Week 16, placebo patients with <10% improvement in swollen and tender joint counts were switched to active treatment and received REMICADE® 5 mg/kg IV at Weeks 16, 18, 22, 30, 38, and 46. At Week 24, all patients receiving placebo crossed over to active treatment and received REMICADE® 5 mg/kg IV (n=91) at Weeks 24, 26, 30, 38, and 46. Primary endpoints included the proportion of patients with ACR20 response at Week 14 and the change from baseline in total modified van der Heijde-Sharp (vdH-S) score at Week 24. Improvement in Psoriasis Area and Severity Index (PASI) was evaluated in psoriatic arthritis patients with baseline body surface area (BSA) ≥3% (n=87, placebo; n=83, REMICADE®).
START (Safety Trial for Rheumatoid Arthritis with REMICADE® Therapy): a 54-week, randomized, multicenter, double-blind, 3-arm, parallel-group, phase 3 study of the safety of REMICADE® in combination with methotrexate (MTX) in adult patients with moderately to severely active RA. Moderately to severely active RA was defined as ≥6 swollen (out of 66 total) and ≥6 tender joints (out of 68 total) for ≥3 months prior to screening. Patients were receiving MTX for ≥3 months before randomization and at a stable dose (≤25 mg/week) for ≥4 weeks before randomization. Patients could continue receiving other conventional disease-modifying antirheumatic drugs (DMARDs) as long as doses had been stable for ≥4 weeks. Doses of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids must have been stable for ≥4 weeks prior to screening.
The primary objective was to assess the relative risk of serious infection within 22 weeks of initiating therapy with REMICADE® + MTX in subjects matching clinical practice demographics (including severity of disease, background DMARD use, and concomitant disease). Secondary objectives measured the safety and efficacy of dose-escalation regimens in patients with an incomplete response to the initial dose of REMICADE® 3 mg/kg every 8 weeks and the safety of REMICADE® + MTX after 1 year.
Patients (N=1084) were randomized in a 1:1:1 ratio to 1 of 3 treatment groups: placebo infusions through Week 14, followed by REMICADE® 3 mg/kg infusions every 8 weeks through Week 46 (Group 1, n=363); REMICADE® 3 mg/kg infusions every 8 weeks through Week 46, with dose escalation from Week 22 to 46 by 1.5 mg/kg increments, if the patient had an inadequate response (Group 2, n=360); and REMICADE® 10 mg/kg infusions every 8 weeks through Week 46 (Group 3, n=361). At Week 26, Group 2 and Group 3 patients received a placebo infusion in order to maintain treatment blind. The median dose of MTX was 15 mg/week.
ATTRACT (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy): a 2-year, multicenter, double-blind, placebo-controlled, randomized, phase 3 study of REMICADE® with methotrexate (MTX) in 428 patients with moderately to severely active MTX-refractory established RA (MTX use ≥3 months). Moderately to severely active RA was defined as ≥6 swollen joints (out of 66 total) and ≥6 tender joints (out of 68 total) and ≥2 of the following:
Primary endpoints: reduction of signs and symptoms at 30 weeks, inhibition of structural damage at 54 weeks, and improvement in physical function at 102 weeks. Nearly 50% of patients had advanced disease. Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids (≤10 mg/day) permitted at stable doses; no other disease-modifying antirheumatic drugs (DMARDs) allowed. There were 4 REMICADE® groups: 3 mg/kg IV q8 weeks + MTX (n=86), 3 mg/kg IV q4 weeks + MTX (n=86), 10 mg/kg IV q8 weeks + MTX (n=87), and 10 mg/kg IV q4 weeks + MTX (n=81); patients randomized to placebo + MTX (n=88).
ASPIRE (Active-controlled Study of Patients Receiving Infliximab for the Treatment of Rheumatoid Arthritis of Early Onset): a 54-week, multicenter, double-blind, active treatment-controlled, randomized, phase 3 study of REMICADE® with methotrexate (MTX) in 1004 MTX-naïve adult patients with moderately to severely active early RA (≥3 months and ≤3 years from date of diagnosis). Moderately to severely active RA was defined as ≥10 swollen joints (out of 66 total) and ≥12 tender joints (out of 68 total) and ≥1 of the following:
Concurrent stable treatment with corticosteroids (equivalent to ≤10 mg prednisone per day) and usual doses of nonsteroidal anti-inflammatory drugs (NSAIDs) were permitted. The coprimary endpoints were reduction of signs and symptoms, inhibition of structural damage, and improvement in physical function from baseline to Week 54. Patients were randomized into 1 of 3 treatment groups in a 5:5:4 ratio: REMICADE® 3 mg/kg IV + MTX (n=359), REMICADE® 6 mg/kg IV + MTX (n=363), and placebo + MTX (n=282). REMICADE® or placebo was infused at Weeks 0, 2, and 6, and every 8 weeks thereafter. MTX was started at 7.5 mg/week and gradually increased to 20 mg/week by Week 8. All patients were to maintain a target MTX dose of 20 mg/week for the duration of the trial, whenever possible.
Infusions every 8 weeks after 3 induction doses. REMICADE® is
administered by intravenous (IV) infusion over a period of not
less than
5 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
5 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
If response is lost, consider treatment with 10 mg/kg
IV1
Patients who do not respond by Week 14 are unlikely to
respond, and consideration should be given to discontinuing
REMICADE® in these patients1
Infusions every 8 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1
5 mg/kg IV given at 0, 2, and 6 weeks
as
an induction regimen
5 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
Infusions every 8 weeks after 3 induction doses. REMICADE® is
administered by intravenous (IV) infusion over a period of not
less than
5 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
5 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
Infusions every 8 weeks after 3 induction doses. REMICADE® is
administered by intravenous (IV) infusion over a period of not
less than
5 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
5 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
Infusions every 8 weeks after 3 induction doses. REMICADE® is
administered by intravenous (IV) infusion over a period of not
less than
5 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
5 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
Infusions every 8 weeks after 3 induction doses. REMICADE® is
administered by intravenous (IV) infusion over a period of not
less than
3 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
3 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
REMICADE® should be given in combination with methotrexate.
For patients who have an incomplete response,
consideration may be given to adjusting the dose up to 10
mg/kg IV or treating as often as every 4 weeks, bearing in
mind that risk of serious infections is increased at higher
doses.
Infusions every 8 weeks after 3 induction doses. REMICADE® is
administered by intravenous (IV) infusion over a period of not
less than
5 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
5 mg/kg IV given every 8 weeks thereafter
as a maintenance regimen
REMICADE® can be used with or without methotrexate in active PsA.
Infusions every 6 weeks after 3 induction doses. REMICADE® is administered by intravenous (IV) infusion over a period of not less than 2 hours.1
5 mg/kg IV given at 0, 2, and 6 weeks
as an induction regimen
5 mg/kg IV given every 6 weeks thereafter
as a maintenance regimen
cp-129778v1
