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Terms of Use

Welcome

This Web site (the "Site"), is owned by UCB, Inc. or its affiliates ("UCB"). We have drafted this Terms of Use Agreement ("Agreement") to help you understand the rules that govern your use of the Site. If you do not agree to abide by all of the provisions contained in this Agreement, you may not use or access the Site.

The most current version of the Agreement can be reviewed by clicking on the "Terms of Use" hypertext link located at the bottom of the Site. UCB reserves the right to modify this Agreement at any time at its sole discretion. You should check the Site from time to time to review the then current Agreement because it is binding on you. Your continued use of the Site constitutes your acceptance of any changes to the Agreement.

This Agreement was last updated on September 13, 2007.

  1. Scope

    We control and operate this Site from the United States of America. If you are a non-US resident, you may access this Site solely at your own risk and are responsible for compliance with local laws and regulations, if applicable. Any references to products or services on the Site do not imply that UCB intends to announce or offer these products or services in your country.

  2. Privacy

    Your use of the Site will be governed by UCB's Privacy Policy. By using the Site, you indicate that you understand and consent to the information collection, use, and disclosure practices described in our Privacy Policy.

  3. Registered Users

    UCB reserves the right to limit access to certain areas of the Site to certain users who register and meet the qualifications imposed by us. When registering, you must fill in all mandatory fields with true, accurate, current and complete information about yourself as prompted in the registration form and maintain and promptly update this information to keep it true, accurate, current and complete by contacting us . We reserve the right to discontinue access to any restricted area of the Site at any time, without notice to you, for any reason.

  4. Security

    If you are or become a registered user, you are responsible for maintaining the confidentiality of your User ID and password, and you are fully responsible for all activities that occur under your password or account. If you become aware of unauthorized use of your User ID and password, you agree to immediately notify UCB.

  5. Modifications to Site

    UCB reserves the right to modify or discontinue the Site (or any portion of the Site), temporarily or permanently, with or without notice to you, and is not obligated to support or update the Site. UCB shall not be liable to you or any third party in the event that UCB exercises its right to modify or discontinue the Site (or any portion of the Site). Unless explicitly stated otherwise, any new features that augment or enhance the current Site shall be subject to this Agreement.

  6. No Medical Advice

    The information on this Site is provided for general informational purposes only and is not intended or recommended as a substitute for professional medical advice. Always seek the advice of your physician or other qualified healthcare provider regarding any medical condition or treatment.

  7. Intellectual Property rights

    The entire content included in the Site, including without limitation, the text, design, graphics, interface, sounds, music, video, interactive features and the like and the selection and arrangement thereof ("Content") and the trademarks, service marks and logos contained therein ("Marks"), are owned by or licensed to UCB, its affiliates or subsidiaries, and are subject to copyright, trademark and other intellectual property rights under United States and foreign laws and international conventions.

    All Content on the Site is provided to you AS IS for your information and personal use only. You may download, view, copy and print Content, subject to the following conditions:

    1. the Content may be used solely for personal, informational, or internal business purposes;
    2. any and all copyright, trademark and other proprietary rights notices must appear on all copies, including the copyright notice at the bottom of the page;
    3. the Content may not be modified or altered in any way; and
    4. no graphics may be used separate from accompanying text.

    Except as provided above, you may not use, download, upload, copy, print, display, perform, reproduce, publish, license, post, transmit, frame, mirror on another Web service, use any meta tags, inline any graphics or distribute any Content or information from the Site in whole or in part without the express permission of UCB. Requests for such permission should be made by contacting us . Any rights not expressly granted herein are reserved. Please be advised that UCB enforces its intellectual property rights to the fullest extent of the law.

  8. User Submissions

    To the extent that you add, upload, transmit, post, communicate, or store any content on the Site or otherwise submit any content for use by UCB ("User Submissions"), you are solely responsible for all of the information, statements, facts, and material contained in such User Submissions.

    In connection with any User Submission you may submit, you agree not to transmit, distribute, post, communicate or store information or other material on, to, or through the Site that:

    1. is copyrighted, unless you are the copyright owner;
    2. infringes on any other intellectual property rights of others or on the privacy or publicity rights of others;
    3. reveals a trade secret, unless you own it;
    4. contains falsehoods or misrepresentations that could damage UCB (its successors and assigns) or any third party;
    5. is obscene, libelous, defamatory, threatening, harassing, abusive, hateful, sexually-explicit, or embarrassing to any other person or entity as determined by UCB, in its sole discretion;
    6. is illegal or otherwise objectionable;
    7. constitutes advertisements or solicitations of business, surveys, contests, chain letters or pyramid schemes.

    You understand that UCB does not guarantee that it will publish or maintain your User Submissions on the Site. UCB may remove User Submissions at any time, without prior notice and at its sole discretion. Moreover, UCB does not guarantee any confidentiality with respect to any User Submissions that you choose to add, upload, transmit, post, communicate or store on the Site or that UCB otherwise may receive from you.

    UCB does not claim ownership of your User Submissions. However, by adding, uploading, transmitting, posting, communicating, or storing such User Submissions on the Site or by otherwise submitting such User Submissions to UCB, you agree to and hereby grant UCB, its successors and assigns, and the operators of the Site a worldwide, non-exclusive, royalty free, perpetual, irrevocable, transferable, and sub-licensable license to use, edit, modify, copy, reproduce, distribute, transmit, broadcast, display, create derivative works of, publish, perform, adapt, and display such User Submissions on or in connection with the Site and for such other purposes as UCB (its successors and assigns) may deem appropriate, in all media formats and in all media channels now known or later developed. You also hereby grant each user of the Site a non-exclusive license to access your User Submissions through the Site, and to use, reproduce, distribute, prepare derivative works of, display and perform such User Submissions.

  9. Prohibited Uses Generally

    You agree not to:

    1. delete or revise any material or other information of any other user or UCB;
    2. harvest or otherwise collect information about others, including e-mail addresses, without their consent;
    3. take any action that imposes an unreasonable or disproportionately large load on the Site's infrastructure;
    4. use any device, software or routine to interfere or attempt to interfere with the proper working of the Site or any activity being conducted on the Site;
    5. use or attempt to use any engine, software, tool, agent or other device or mechanism (including, without limitation, browsers, spiders, robots, avatars or intelligent agents) to navigate or search the Site other than the search engine and search agents available from UCB on the Site and other than generally available third-party Web browsers (e.g., Netscape Navigator and Microsoft Internet Explorer);
    6. attempt to decipher, decompile, disassemble or reverse-engineer any of the software comprising or in any way making up a part of the Site;
    7. solicit UCB members and guests to join outside sites or online services or organizations; or
    8. disrupt the normal flow of dialogue, cause a screen to "scroll" faster than other users are able to type, or otherwise act in a manner that negatively affects other users' abilities to engage in real time exchanges.

    You further agree not to violate or attempt to violate the security of the Site, including, without limitation:

    1. accessing data not intended for you or logging into a server or account that you are not authorized to access;
    2. attempting to probe, scan or test the vulnerability of a system or network or to breach security or authentication measures without proper authorization; or
    3. attempting to interfere with service to any user, host, or network.

    Violations of system or network security may result in civil or criminal liability. In accordance with this Agreement, UCB will investigate and work with law enforcement authorities to prosecute users who are involved in such violations.

  10. Third-Party Content and Links to Third-Party Web Sites

    The Site may provide links to other Web sites operated by UCB as well as Web sites operated by third parties. Please refer to the separate terms of use, privacy policies, and other rules posted on these linked sites before you use them. Third-party links are provided merely as a convenience to you, and the inclusion of any link does not imply affiliation or endorsement by UCB. UCB does not review, monitor or check the accuracy of content published on third-party sites, and is not responsible for the availability of, and content provided on, third-party sites. If you choose to purchase any products or services from a third party, your relationship is directly with the third party and UCB is not responsible for any loss or damage of any sort you may incur from dealing with any third party.

  11. Notice of Copyright Infringement

    If you believe that your work has been copied and is accessible on the Site in a way that constitutes copyright infringement, please provide UCB's Copyright Agent with the following information:

    1. identification of the copyrighted work claimed to have been infringed;
    2. identification of the allegedly infringing material on the Site that is requested to be removed;
    3. your name, address, and daytime telephone number, and an e-mail address if available, so that UCB may contact you if necessary;
    4. a statement that you have a good faith belief that the use of the copyrighted work is not authorized by the copyright owner, its agent, or the law;
    5. a statement that the information in the notification is accurate and, under penalty of perjury, that the signatory is authorized to act on behalf of the owner of an exclusive copyright right that is allegedly infringed; and
    6. an electronic or physical signature of the copyright owner or someone authorized on the owner's behalf to assert infringement of copyright and to submit the statement.

    UCB's Copyright Agent for notice of claims of copyright infringement on the Site can be reached by contacting us.

    UCB will remove any content that infringes upon the copyright of any person under the laws of the United States upon receipt of such a statement (or, more specifically, any statement in conformance with 17 U.S.C. § 512(c)(3)). United States law provides significant penalties for submitting such a statement falsely. Please note that UCB may notify the individual who submitted the allegedly infringing material, and such person has the right to send UCB a counter-notification under applicable law and, if valid, the law requires the removed material to be restored. UCB will not be a party to disputes over alleged copyright infringement.

  12. Disclaimer of Warranties

    THE SITE AND ALL CONTENT, MATERIALS, INFORMATION, PRODUCTS AND SERVICES PROVIDED ON THE SITE, ARE PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS. UCB EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT, AND SECURITY AND ACCURACY, AS WELL AS ALL WARRANTIES ARISING BY USAGE OF TRADE, COURSE OF DEALING, OR COURSE OF PERFORMANCE. UCB MAKES NO WARRANTY THAT: (A) THE SITE WILL MEET YOUR REQUIREMENTS; (B) THE SITE WILL BE AVAILABLE ON AN UNINTERRUPTED, TIMELY, SECURE, OR ERROR-FREE BASIS; (C) THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE SITE OR ANY SERVICES OFFERED THROUGH THE SITE WILL BE ACCURATE OR RELIABLE; OR (D) THE QUALITY OF ANY PRODUCTS, SERVICES, INFORMATION, OR OTHER MATERIAL OBTAINED BY YOU THROUGH THE SITE WILL MEET YOUR EXPECTATIONS.

    ANY CONTENT, MATERIALS, OR INFORMATION DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THE SITE IS DONE AT YOUR OWN DISCRETION AND RISK. UCB SHALL HAVE NO RESPONSIBILITY FOR ANY DAMAGE TO YOUR COMPUTER SYSTEM OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF ANY CONTENT, MATERIALS, OR INFORMATION.

    NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM UCB OR THROUGH THE SITE SHALL CREATE ANY WARRANTY NOT EXPRESSLY MADE HEREIN.

  13. Limitation of Liability

    IN NO EVENT SHALL UCB BE LIABLE FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR DAMAGES FOR LOSS OF PROFITS, REVENUE, DATA OR USE, INCURRED BY YOU OR ANY THIRD PARTY, WHETHER IN AN ACTION IN CONTRACT OR TORT, ARISING FROM YOUR ACCESS TO, OR USE OF, THE SITE OR ANY SERVICES PROVIDED THROUGH THE SITE, OR IN CONNECTION WITH ANY FAILURE OF PERFORMANCE, ERROR, OMISSION, INTERRUPTION, DEFECT, DELAY IN OPERATION OR TRANSMISSION, COMPUTER VIRUS, OR LINE OR SYSTEM FAILURE. IN THE EVENT THAT YOU HAVE A DISPUTE WITH ANOTHER USER RELATED TO, ARISING FROM, OR IN ANY WAY CONNECTED WITH USE OF THE SITE, YOU RELEASE UCB FROM ANY CLAIMS, DEMANDS, AND DAMAGES OF EVERY KIND AND NATURE ARISING OUT OF OR IN ANY WAY CONNECTED WITH SUCH A DISPUTE

    These limitations apply whether the alleged liability is based on contract, tort, negligence, strict liability, or any other basis, even if UCB has been advised of the possibility of such damage. Because some jurisdictions do not allow the exclusion or limitation of incidental or consequential damages, UCB's liability in such jurisdictions shall be limited to the extent permitted by law.

  14. No Resale of the Site

    Your right to use the Site is personal to you. You agree not to reproduce, duplicate, copy, sell or resell the Site, without the express written consent of UCB.

  15. Indemnity

    You agree to indemnify, defend and hold UCB, its parents, subsidiaries, affiliates, shareholders, directors, officers, employees and agents, harmless from any claim, demand, liability, expense, or loss, including reasonable attorneys' fees, made by any third party due to or arising out of, or in any way connected with your use of or access to the Site or your violation of this Agreement.

  16. Export Restrictions/Legal Compliance

    UCB controls this Site from within the United States of America. You may not access, download, use or export the Site or the Content in violation of US export laws or regulations, or in violation of any other applicable laws or regulations.

  17. Choice of Law and Forum

    These Terms shall be governed by and construed in accordance with the laws of the State of Georgia without regard to its choice of law provisions. If there is any dispute between us concerning the Agreement or your access to or use of the Site, we both agree to submit the dispute to non-binding mediation. The mediation will be governed under the rules of the American Arbitration Association, and the venue will be in Georgia.

  18. Termination

    UCB reserves the right, in its sole discretion, to terminate your access to and use of the Site, with or without notice. Otherwise applicable sections of the Agreement shall survive termination.

  19. No Waiver

    The failure of UCB to enforce any provisions of the Agreement or respond to a breach by you or other parties shall not in any way waive its right to enforce subsequently any terms or conditions of the Agreement or to act with respect to similar breaches.

  20. Miscellaneous

    You agree that no joint venture, partnership, employment, or agency relationship exists between you and UCB as a result of the Agreement or your access to and use of the Site. A printed version of the Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. Unless otherwise specified herein, the Agreement constitutes the entire agreement between you and UCB and governs your use of the Site. If any portion of the Agreement is held invalid or unenforceable, that portion shall be construed in a manner consistent with applicable law to reflect, as nearly as possible, the original intention of the parties, and the remaining portions shall remain in full force and effect.

    UCB may assign its rights and duties under these Terms without such assignment being considered a change to the Terms and without notice to you. You may not assign these Terms without the prior written consent of UCB.

  21. Contact Information

    If you have any questions regarding this Agreement or the Site, please contact us .

  22. CIMplicity® Medication Reminders Terms and Conditions

    CIMplicity® Medication Reminders are sponsored by UCB. Your privacy is important to us. We have privacy and security policies in place to help us protect your information. Please read our PRIVACY POLICY for more details.

    CIMplicity Medication Reminders – Through the sign up process, you have authorized us to send you automatic medication reminders. There is no charge for participation in the CIMplicity Medication Reminder program, and your participation is not contingent on any purchase. Message frequency depends on user. Message and data rates may apply. (Contact your mobile carrier for further details on message and data rates under your phone plan.)

    You can opt-out of CIMplicity Medication Reminders at any time by texting STOP to 7707286162 or going to http://www2.cimzia.com/cimplicity/ .

    When opting out, you will need to provide your mobile phone number in order to be removed from the program. It may take up to 10 days to process your stop request.

    CIMplicity Medication Reminders service is available on the following carriers: Alltel AWCC; Associated Carrier Group (ACG); at&t Mobility; Boost; Cincinnati Bell; Cricket; Google Voice; MetroPCS; Rural Carrier Group; Sprint; Tier 2/3 Carrier Group; Tmobile; U.S. Cellular; Verizon; and Virgin Mobile. Cellular phone carriers’ instructions for text messaging may be different. Check your user’s manual for phone capabilities and specific instructions. Please consult the applicable wireless service agreement for your individual pricing plan.

    Alerts sent via SMS may not be delivered to you if your phone is not in range of a transmission site, or if sufficient network capacity is not available at a particular time. Even within a coverage area, factors beyond the control of your wireless carrier may interfere with message delivery, including the customer's equipment, terrain, proximity to buildings, foliage, and weather. You acknowledge that urgent alerts may not be timely received and that your wireless carrier does not guarantee that alerts will be delivered.

Indications

  • CIMZIA is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis
  • CIMZIA is indicated for the treatment of adults with active psoriatic arthritis
  • CIMZIA is indicated for the treatment of adults with active ankylosing spondylitis
  • CIMZIA is indicated for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adults with moderately to severely active disease who have had an inadequate response to conventional therapy
  • CIMZIA is indicated for the treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy

Important Safety Information

contraindications

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria.

serious infections

Patients treated with CIMZIA 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 CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start CIMZIA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.

malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

  • Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
  • In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
  • Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
  • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
  • Cases of acute and chronic leukemia were reported with TNF blocker use.

heart failure

  • Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

hypersensitivity

  • Angioedema, anaphylactoid reaction, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a plastic derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

hepatitis b virus reactivation

  • Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Test patients for HBV infection before initiating treatment with CIMZIA.
  • Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
  • Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

neurologic reactions

  • TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

hematologic reactions

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
  • Consider stopping CIMZIA if significant hematologic abnormalities occur.

drug interactions

  • Do not use CIMZIA in combination with other biological DMARDS.

autoimmunity

  • Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

immunizations

  • Patients on CIMZIA should not receive live or live-attenuated vaccines.

adverse reactions

  • The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

Please see full Prescribing Information.


General References

  1. CIMZIA® [prescribing information], Smyrna, GA: UCB, Inc.; 2018.
  2. Keystone E, van der Heijde D, Mason D Jr, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty‐two–week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008;58:3319-3329.
  3. Schwartzman S, Morgan GJ Jr. Does route of administration affect the outcome of TNF antagonist therapy? Arthritis Res Ther. 2004;6(Suppl 2):S19-S23.
  4. Sheikhzadeh A, Yoon J, Formosa D, et al. The effect of a new syringe design on the ability of rheumatoid arthritis patients to inject a biological medication. Appl Ergon. 2012;43:368-375.
  5. Data on file. UCB, Inc.; Smyrna, GA.

Rheumatology References

  1. Veronese FM, Mero A. The impact of PEGylation on biologic therapies. Biodrugs. 2008;22:315-329.
  2. Weir N, Athwal D, Brown D, et al. A new generation of high-affinity humanized PEGylated Fab' fragment anti-tumor necrosis factor-alpha monoclonal antibodies. Therapy. 2006;3:535-545.
  3. Chapman AP. PEGylated antibodies and antibody fragments for improved therapy: a review. Adv Drug Deliv Rev. 2002;54:531-545.
  4. Harris JM, Chess RB. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov. 2003;2:214-221.
  5. Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a phase 3 double-blind randomised placebo-controlled study (RAPID-PsA). Ann Rheum Dis. 2014;73:48-55.
  6. Landewe R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled phase 3 study. Ann Rheum Dis. 2014;73(1):39-47.
  7. Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology. 2012;51:2204-2214.
  8. Gladman D, Fleischmann R, Coteur G, Woltering F, Mease PJ. Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study. Arthritis Care Res. 2014;66(7):1085-1092.

Gastroenterology References

  1. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239-250.
  2. Schreiber S, Colombel JF, Bloomfield R, et al. Increased response and remission rates in short-duration Crohn’s disease with subcutaneous certolizumab pegol: an analysis of PRECiSE 2 randomized maintenance trial data. Am J Gastroenterol. 2010;105(7):1574-1582.
  3. Feagan BG, Coteur G, Tan S, Keininger DL, Schreiber S. Clinically meaningful improvement in health-related quality of life in a randomized controlled trial of certolizumab pegol maintenance therapy for Crohn’s disease. Am J Gastroenterol. 2009;104(8):1976-1983.
  4. Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004;10(3):261-269.

Dermatology References

  1. Gottlieb AB, Blauvelt A, Thaçi D, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks from two phase 3, multicenter, randomized, double-blinded, placebo-controlled studies (CIMPASI-1 and CIMPASI-2). J Am Acad Dermatol. 2018;79(2):302-314.e6.
  2. Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT). J Am Acad Dermatol. 2018;79(2):266-276.e5.
  3. Nesbitt A, Fossati G, Bergin M, et al. Mechanism of action of certolizumab pegol (CDP870): in vitro comparison with other anti-tumor necrosis factor alpha agents. Inflamm Bowel Dis. 2007;13(11):1323-1332.
  4. Pasut G. Pegylation of biological molecules and potential benefits: pharmacological properties of certolizumab pegol. BioDrugs. 2014;28 (suppl 1):S15-S23.
  5. Porter C, Armstrong-Fisher S, Kopotsha T, et al. Certolizumab pegol does not bind the neonatal Fc receptor (FcRn): consequences for FcRn-mediated in vitro transcytosis and ex vivo human placental transfer. J Reprod Immunol. 2016;116:7-12.
  6. Humira [prescribing information]. North Chicago, IL: Abbvie Inc.; 2018.
  7. Enbrel [prescribing information]. Thousand Oaks, CA: Amgen Inc.; 2017.
  8. Remicade [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2018.
  9. Stelara [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2018.
  10. Cosentyx [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018.
  11. Taltz [prescribing information]. Indianapolis, IN: Eli Lilly and Company; 2017.
  12. Tremfya [prescribing information]. Horsham, PA: Janssen Biotech, Inc.; 2017.
  13. Siliq [prescribing information]. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2017.
  14. Ilumya [prescibing information]. Whitehouse Station, NJ: Merck & Co., Inc.; 2018.
  15. van der Heijde D, Deodhar A, FitzGerald O, et al. 4-year results from the RAPID-PsA phase 3 randomised placebo-controlled trial of certolizumab pegol in psoriatic arthritis. RMD Open. 2018;4(1):e000582.
  16. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheumatol. 1995;38(6)727-735.
  17. Mahadevan U, Wolf DC, Dubinsky M, et al. Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013;11(3):286-292.
  18. Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77(2):228-233.
  19. Clowse MEB, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017;76(11):1890-1896.

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Full Important Safety Information & Indications

Important Safety Information You Should Know About CIMZIA® (certolizumab pegol) Serious and sometimes fatal side effects have been reported with CIMZIA, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens (such as Legionella or Listeria). Patients should be closely monitored for the signs and symptoms of infection during and after treatment with CIMZIA. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.
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Important Safety Information

contraindications

CIMZIA is contraindicated in patients with a history of hypersensitivity reaction to certolizumab pegol or to any of the excipients. Reactions have included angioedema, anaphylactoid reaction, serum sickness, and urticaria.

serious infections

Patients treated with CIMZIA 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 CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before CIMZIA use and during therapy. Initiate treatment for latent TB prior to CIMZIA use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

Carefully consider the risks and benefits of treatment with CIMZIA prior to initiating therapy in the following patients: with chronic or recurrent infection; who have been exposed to TB; with a history of opportunistic infection; who resided in or traveled in regions where mycoses are endemic; with underlying conditions that may predispose them to infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with CIMZIA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.

  • Do not start CIMZIA during an active infection, including localized infections.
  • Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection.
  • If an infection develops, monitor carefully and initiate appropriate therapy.

malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which CIMZIA is a member. CIMZIA is not indicated for use in pediatric patients.

  • Consider the risks and benefits of CIMZIA treatment prior to initiating or continuing therapy in a patient with known malignancy.
  • In clinical trials, more cases of malignancies were observed among CIMZIA-treated patients compared to control patients.
  • In CIMZIA clinical trials, there was an approximately 2-fold higher rate of lymphoma than expected in the general U.S. population. Patients with rheumatoid arthritis, particularly those with highly active disease, are at a higher risk of lymphoma than the general population.
  • Malignancies, some fatal, have been reported among children, adolescents, and young adults being treated with TNF blockers. Approximately half of the cases were lymphoma, while the rest were other types of malignancies, including rare types associated with immunosuppression and malignancies not usually seen in this patient population.
  • Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including CIMZIA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn’s disease or ulcerative colitis, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treating with CIMZIA in these patient types.
  • Cases of acute and chronic leukemia were reported with TNF blocker use.

heart failure

  • Worsening and new onset congestive heart failure (CHF) have been reported with TNF blockers. Exercise caution and monitor carefully.

hypersensitivity

  • Angioedema, anaphylactoid reaction, dyspnea, hypotension, rash, serum sickness, and urticaria have been reported following CIMZIA administration. If a serious allergic reaction occurs, stop CIMZIA and institute appropriate therapy. The needle shield inside the removable cap of the CIMZIA prefilled syringe contains a plastic derivative of natural rubber latex which may cause an allergic reaction in individuals sensitive to latex.

hepatitis b virus reactivation

  • Use of TNF blockers, including CIMZIA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal.
  • Test patients for HBV infection before initiating treatment with CIMZIA.
  • Exercise caution in patients who are carriers of HBV and monitor them before and during CIMZIA treatment.
  • Discontinue CIMZIA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatment.

neurologic reactions

  • TNF blockers, including CIMZIA, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, seizure disorder, optic neuritis, peripheral neuropathy, and Guillain-Barré syndrome.

hematologic reactions

  • Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with CIMZIA.
  • Consider stopping CIMZIA if significant hematologic abnormalities occur.

drug interactions

  • Do not use CIMZIA in combination with other biological DMARDS.

autoimmunity

  • Treatment with CIMZIA may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop.

immunizations

  • Patients on CIMZIA should not receive live or live-attenuated vaccines.

adverse reactions

  • The most common adverse reactions in CIMZIA clinical trials (≥8%) were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).

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