This website is provided to you under these “Terms of Use” and any amendments or supplements to them (collectively referred to as this “Agreement”) that may be posted by or one of its affiliated companies (collectively, “Site Owner,” “we”, “us”) from time to time. Your use of this Website, or any other services or content provided through the Website [or Mobile Software], shall be deemed to constitute your consent to be legally bound by the terms and conditions of the Agreement, which shall be enforceable in the same way as if you had signed the Agreement. If you are not willing to accept the terms and conditions in the Agreement, we ask that you not access or use the Website or post or submit any materials on it.
This Website is intended for and directed to residents of the United States and its territories. This Website is not intended for anyone under the age of 18.
THE INFORMATION INCLUDING ANY, ADVICE AND RECOMMENDATIONS ON THE WEBSITE IS INTENDED SOLELY AS A GENERAL EDUCATIONAL AID. IT IS NOT INTENDED AS MEDICAL OR HEALTHCARE ADVICE, OR TO BE USED FOR MEDICAL DIAGNOSIS OR TREATMENT, FOR ANY INDIVIDUAL PROBLEM. IT IS ALSO NOT INTENDED AS A SUBSTITUTE FOR PROFESSIONAL ADVICE AND SERVICES FROM A QUALIFIED HEALTHCARE PROVIDER FAMILIAR WITH YOUR UNIQUE FACTS. ALWAYS SEEK THE ADVICE OF YOUR DOCTOR OR OTHER QUALIFIED HEALTHCARE PROVIDER REGARDING ANY MEDICAL CONDITION AND BEFORE STARTING ANY NEW TREATMENT. YOUR USE OF THE SITE IS SUBJECT TO THE ADDITIONAL DISCLAIMERS AND CAVEATS THAT MAY APPEAR THROUGHOUT THE WEBSITE.
WE ASSUME NO RESPONSIBILITY FOR ANY CONSEQUENCE RELATING DIRECTLY OR INDIRECTLY TO ANY ACTION OR INACTION YOU TAKE BASED ON THE INFORMATION, SERVICES, OR OTHER MATERIAL ON THE WEBSITE. WHILE WE STRIVE TO KEEP THE INFORMATION ON THE WEBSITE ACCURATE, COMPLETE, AND UP-TO-DATE, WE DO NOT GIVE ANY ASSURANCES, AND WILL NOT BE RESPONSIBLE FOR, ANY DAMAGE OR LOSS RELATED TO THE ACCURACY, COMPLETENESS, OR TIMELINESS OF THE INFORMATION ON THE WEBSITE.
You understand that the Website is available for your personal, non-commercial use only. You agree that the Website is the property of the Site Owner; including all intellectual property rights in it and that you have no right to use them other than as set out in these Terms of Use. We are not responsible for any harm or loss that you suffer in relation to any use you make of the Website for any business purposes or other purposes not authorized under these Terms of Use. We reserve the right to refuse or terminate access to the Website at our discretion. The Website are provided free of charge and on that basis we have no obligation to provide any maintenance or support services in relation to them and we are not responsible for any loss or damage you may suffer as a result of any failure to maintain or update the Website.
You may not copy, change or reuse the Website, any updates to them or any part of them including the software incorporated in them. You may use this Website only for lawful purposes and in accordance with these Terms of Use. You are granted a nonexclusive, nontransferable, revocable, limited license to view, print and distribute content retrieved from the Website for your personal, noncommercial purposes, provided that you do not remove or obscure the copyright notice or other notices displayed on the content. You may not copy, reprint, modify, display, perform, translate, distribute, adapt, broadcast, communicate to the public by telecommunication, circulate, or sell the content retrieved from the Website in any way, for any commercial use or provide it to any commercial source, including other websites, without the prior written permission of Site Owner.
In addition, you agree not to: (i) use this Website in any manner that could disable, overburden, damage, or impair this Website, or interfere with any other use of this Website, including, any user's ability to engage in real-time activities through this Website; (ii) use any robot, spider or other automatic device, process or means to access this Website for any purpose, including to scrape, data mine, monitor or copy any of the material on this Website; (iii) use any manual process to monitor or copy any of the material on this Website, or to engage in any other unauthorized purpose without the express prior written consent of Site Owner; (iv) otherwise use any device, software or routine that interferes with the proper working of this Website; or (v) otherwise attempt to interfere with the proper working of this Website. We reserve all rights not expressly granted to you.
The information that we obtain through your use of the Website, whether through the registration process or otherwise, is subject to our Privacy Policy. Our Privacy Policy addresses our collection and use of the data you provide to us, including your rights relative to that information.
The information communicated on the Website constitutes an electronic communication. When you communicate with us through the Website or via other forms of electronic media, such as e-mail, you are communicating with us electronically. You agree that we may communicate electronically, subject to local privacy laws, and that such communications, as well as notices, disclosures, agreements, and other communications that we provide to you electronically, are equivalent to communications in writing and shall have the same force and effect as if they were in writing and signed by the party sending the communication.
We have created, or may create in the future, certain areas, such as message boards and chat rooms, within the Website where members can upload and share their thoughts, comments, product reviews, pictures, videos and the like with other members (collectively, "Forums"). These Forums may be available to registered members of the Website only. To help ensure that the text, graphics, software, music, sound, photographs, videos, messages, posts, data, information, or other materials posted by users (collectively, the "User Content") is beneficial for the greater community, we have established some basic rules for everyone to follow.
In addition, if a Forum is provided within the Website, it may allow users to post questions to be answered by experts engaged by us. Where applicable, these experts are paid by us for their time in responding to members’ questions, but the opinions they express are their own. We are providing access to the experts and their guidance in the Forum solely as an informational and educational service to members of the Website.
Our policy for this Website is to review User Content, as far as practical, either before or after such User Content is posted. Pre-moderation means that the User Content will not be posted to the Forum and cannot be accessed or viewed by other Website members until we have reviewed it and determined that the User Content is suitable for posting to the Forum. This process also means that User Content submitted for posting will not be posted in real time and may never be posted if we determine that it is unsuitable for the Website. Post-moderation means that User Content will be reviewed by us once it is already posted on the Website. Post-moderated User Content that Site Owner determines does not comply with these Terms or is otherwise unsuitable for the Website will be removed from the Website, without notice to the User.
User Content must be appropriate for the Forum. Without limiting the reasons for which User Content may be rejected by us, we may reject, edit or remove any User Content that does not comply with any Community Guidelines that we provide, which you must read prior to posting any User Content on the Website. By submitting User Content for posting at a Forum, you also (1) confirm that you are entitled to post or transmit User Content; (2) agree that you are solely responsible for all User Content that you submit for posting; and (3) grant to Site Owner and its affiliated entities an irrevocable, worldwide, nonexclusive, perpetual, fully sub-licensable, transferable, royalty-free right and license to use, your User Content in any way on the Website and on any other Website owned or operated by Site Owner or its affiliates (as well as on any social media sites associated with the Site Owner or its affiliates). We are free to use any ideas, concepts, know-how, or techniques contained in or derived from any User Content for any purpose whatsoever, including developing, manufacturing, and marketing products. Therefore please do not submit or send to us any ideas, suggestion or materials that you wish to keep confidential or for which you expect to receive compensation. You will not have any claim against us with respect to any use or non-use of User Content. When you submit User Content, you understand that we will have the right, but not the obligation, to use, display and publish your name, photograph, likeness, voice, performance, biographical information and/or statements, throughout the world in perpetuity on the Website and on any affiliate or successor Website or social media channels owned or operated by us or our affiliates. If we make use of any of these rights, you understand and agree that you shall not receive any other consideration, payment, notification or credit, nor will you have any approval over how Site Owner uses them.
You acknowledge that the Forums contain the opinions and views of other users. You acknowledge further that we are not responsible for the accuracy of any User Content on the Website. You understand and agree that all User Content is the sole responsibility of the person who posted the Content. You understand and agree that you will evaluate, and bear all risks associated with, the use of any User Content, including any reliance on the accuracy, completeness, or usefulness of such User Content.
We reserve the right at any time to discontinue, temporarily or permanently, your ability to upload User Content and/or your ability to access User Content with or without notice, at our sole discretion. You agree that we shall not be liable to you or to any third party for any suspension or discontinuance of acceptance of User Content.
Remember that all User Content you submit to the Website through a mobile device will be stored on that mobile device. The security and safety of your mobile device, and the information and materials contained on it, as well as any password you use on your device and to access the Website are your sole responsibility.
We may impose a maximum amount of storage for User Content on the Website. We are not responsible for any loss or harm you may suffer as a result of any deletion or failure to store any messages, communications or other User Content associated with maintaining the maximum amount of storage.
Additional terms may govern certain features or content on the Website, such as offers, prize draws, competitions, contests and sweepstakes. By participating in any activity on the Website governed by additional terms, such as a prize draw, competition, contest or sweepstakes with Official Rules, you agree that you will be subject to those additional terms in addition to these Terms of Use.
THE WEBSITE IS PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS. EXCEPT AS SPECIFICALLY PROVIDED HEREIN, TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, SITE OWNER EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS, LEGAL OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT.
SITE OWNER DOES NOT MAKE ANY WARRANTY THAT THE WEBSITE WILL MEET YOUR REQUIREMENTS, OR THAT ACCESS TO THE WEBSITE WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE, OR THAT DEFECTS, IF ANY, WILL BE CORRECTED. SITE OWNER MAKES NO WARRANTIES AS TO THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE WEBSITE OR AS TO THE ACCURACY, QUALITY, OR RELIABILITY OF ANY INFORMATION OBTAINED THROUGH THE WEBSITE.
YOU UNDERSTAND AND AGREE THAT ANY MATERIAL AND/OR DATA DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THE WEBSITE IS USED AT YOUR OWN RISK AND THAT YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER SYSTEM OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF SUCH MATERIAL AND/OR DATA. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM SITE OWNER OR THROUGH THE WEBSITE SHALL CREATE ANY WARRANTY NOT EXPRESSLY MADE HEREIN.
YOU EXPRESSLY UNDERSTAND AND AGREE THAT UNDER NO CIRCUMSTANCES WILL SITE OWNER, ITS AFFILIATES AND ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, AGENTS, MANDATARIES OR OTHER REPRESENTATIVES BE LIABLE FOR DIRECT, INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR AGGRAVATED DAMAGES, INCLUDING, WITHOUT LIMITATION, ANY LOSS OF USE, LOSS OF INCOME, SAVING OR PROFITS, LOSS OF DATA, LOSS OF GOODWILL, COST OF PROCUREMENT OF SUBSTITUTE SERVICES, OR ANY OTHER INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, HOWSOEVER CAUSED, AND ON ANY THEORY OF LIABILITY, WHETHER FOR BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY), OR OTHERWISE RESULTING FROM (1) THE USE OF, OR THE INABILITY TO USE, THE WEBSITE; (2) THE COST OF PROCUREMENT OF SUBSTITUTE SERVICES, ITEMS, OR WEBSITES; (3) UNAUTHORIZED ACCESS TO OR ALTERATION OF YOUR TRANSMISSIONS OR DATA (INCLUDING PERSONAL INFORMATION); (4) THE STATEMENTS OR CONDUCT OF ANY THIRD PARTY ON THE WEBSITE; OR (5) ANY OTHER MATTER RELATING TO THE WEBSITE. THESE LIMITATIONS WILL APPLY WHETHER OR NOT SITE OWNER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. THIS EXCLUSION OF LIABILITY SHALL APPLY TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAWS.
The trademarks and brand names displayed on this Website are the property of Site Owner, its affiliates or third party owners. You may not use or display any trademarks or service marks owned by Site Owner without our prior written consent. You may not use or display any other trademarks or service marks displayed on this Website without the permission of their owners.
We will make reasonable efforts to make the Website available but we may from time to time need to interrupt, restrict, modify or discontinue, temporarily or permanently the Website or parts of it without notice. We will not be responsible for any harm or loss you may suffer as a result of such actions.
We may at any time terminate your use of or access to the Website and may delete any or all of your User Content without prior notice if we have a good reason to do so which includes any breach by you of these Terms of Use and the Community Guidelines. We will not be responsible for any loss or harm you may suffer as a result of termination of your use of the Website in these circumstances. In the event of any termination you must stop using the Website and you agree that the provisions of the Agreement regarding Ownership, Trademark Notices, Indemnification, Disclaimer or Warranties, Limitations of Liability, and Applicable Law shall survive any such termination.
This Website may contain links or references to third party websites. These links are provided for your convenience only. No endorsement of any third party products, services or information is expressed or implied by any information, material or content of any third party contained in, referred to, included on, or linked from or to this Website. Any information, data, opinions, recommendations, products or services provided by such third parties through links to other websites or otherwise made available through their websites are solely those of such third parties and not of Site Owner. Your use of such third party websites is subject to the terms of use and the privacy policies of such websites.
You agree to indemnify and hold harmless Site Owner and its affiliates and their respective directors, officers, employees, agents, or other representatives from and against all claims, liability, damages and expenses, including without limitation all legal fees and costs arising from or relating to (a) your breach of these Terms of Use; (b) your use of this Website including without limitation transmission or placement of information or material by you on this Website; and (c) any claim or allegation that any of your User Content infringes the intellectual property or other proprietary rights, or privacy rights, of any third party.
We may make changes to the Terms of Use from time to time in our sole discretion, by updating these Terms of Use on this Website, and specifying the effective date of the new version of the Terms of Use. The "Last Modified" date at the top of these Terms of Use will indicate when the latest changes were made. Your continued use of the Website following the posting of a new version of the Terms of Use constitutes your acceptance of any such changes. Accordingly, whenever you visit this Website, you should check to see if a new version of the Agreement has been posted.
If you have any questions or concerns with respect to these Terms of Use or the Website you may contact us as identified in the Privacy Policy or the “Contact Us” section of this Website.
Should any part or provision of these Terms of Use be held unlawful, void, invalid, or unenforceable that portion shall be deemed severable from these Terms of Use and shall not affect the validity and enforceability of any remaining provisions.
All Sections shall survive the termination of the right to use the Website.
The information on the Website is intended only for use by residents of the United States and its territories. Other countries may have laws, regulatory requirements, or medical practices that differ from those in the United States. The Agreement and the resolution of any dispute related to the Agreement, the Website, or items you purchase through the Website, and any non-contractual obligations arising out of or in connection with these Terms of Use, shall be governed by and construed in accordance with the laws of New Jersey, USA, without giving effect to any principles of conflicts of law. Any legal action or proceeding between Site Owner and you related to the Agreement shall be brought exclusively in a court of competent jurisdiction sitting in New Jersey, USA, and you agree to submit to the personal and exclusive jurisdiction of such courts.
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 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.
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®.
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 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. 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 inhibitors, 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.
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.
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®. 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®.
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(suppl 3):S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.
cp-62063v1
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 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.
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®.
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 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. 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 inhibitors, 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.
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.
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®. 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®.
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(suppl 3):S221-S247. 2. See latest Centers for Disease Control guidelines and recommendations for tuberculosis testing in immunocompromised patients.
cp-62063v1
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
