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Privacy Policy

Welcome

This Web site ( "Web site" or "Site") is owned by UCB, Inc. As used in this Privacy Policy, "You" or "Your" refers to users of this Web site. "We" or "Us" includes UCB, Inc. ("UCB") and its related companies.

Your privacy is important to us. This Privacy Policy explains our online information practices regarding the collection, use, and disclosure of information that You may provide via this Web site. Please be sure to read this entire Privacy Policy before using or submitting information to this Web site. This Privacy Policy applies only to data collected through this Web site and does not apply to any other data collected by UCB online or offline.

Your consent

By using this Web site, You agree with the terms of this Privacy Policy. Whenever You submit information via this Web site, You consent to the collection, use, and disclosure of that information in accordance with this Privacy Policy.

About children

This Web site is not intended for persons under the age of 18. We will not knowingly collect information from Web site visitors unless You have indicated that You are above the age of 18 by submitting information to Us. We encourage parents to talk to their children about their use of the Internet and the information they disclose via the Internet.

Active information collection

In general. We receive and store any information You enter on our Web site. This includes information that can identify You ("personal information"), including Your first and last name, telephone number, postal address and e-mail address. We also may request information about Your age, gender, and medical condition, such as the date of Your diagnosis and medications taken. In the course of requesting this information, we also may ask You to identify Your relationship to a particular disease (e.g., as a diagnosed patient, a friend or relative of such a patient, or as a healthcare provider). You can choose not to provide this or other information through our Web site, but in general, some information about You is required in order for You to register as a member; request to subscribe to a newsletter; ask a question; or initiate other transactions on our Web site.

Information from other sources. We also may periodically obtain information about You from other sources and add it to Your account information. Examples of information We may receive includes updated delivery and address information, which We use to correct and update our records; and demographic information, which We use to better understand Your potential purchasing preferences.

Information collected automatically. We automatically collect some information about Your computer when You visit our Web site. For example, we will collect Your IP address, Web browser software (such as Internet Explorer), and referring Web site. We also may collect information about Your online activity within our Web site, such as the pages You visited. One of our goals in collecting this automatic information is to help customize Your user experience.

Cookies. We also may assign Your computer a "cookie" (a small, unique identifier text file). For example, whenever You sign into the Web site, we record Your member ID and name on Your member account in a cookie file on Your computer. We also may record Your password in this cookie file, if You check "Remember me." You can always choose not to receive a cookie file by enabling Your Web browser to refuse cookies or to prompt You before accepting a cookie. Please note that if You refuse to accept cookies from our Web site, You may not be able to access some of the tools we offer.

Information collected by third-party advertising companies. We may allow third-party advertising companies, including ad networks, to display advertisements on our site. These companies may use tracking technologies, such as cookies, to collect anonymous information about users who view or interact with their advertisements. Our Web site does not provide any personal information to these third parties, but they may collect information about where You, or others who are using Your computer, saw and/or clicked on the advertisements they deliver, and possibly associate this information with Your subsequent visits to the advertised Web sites. They also may combine this information with personal information they collect from You. This allows them to deliver targeted advertisements and gauge their effectiveness.

Use of information

Except as otherwise stated, We may use Your personal information for the following general purposes: to provide You with the services You request; to manage Your account; to respond to Your questions and comments; to measure interest in and improve the content of our Web site; to customize this Web site to Your preferences; to send You information about products in which You may be interested; to solicit information from You, including through surveys; to resolve disputes or troubleshoot problems; to enforce our Terms of Use; and for other purposes specified in this Privacy Policy or described to You at the point of collection. For information regarding Your choices about such uses, please review the "Your choices" section of this Privacy Policy below.

Disclosure of information

We may disclose Your personal information to other UCB affiliates worldwide that agree to treat it in accordance with this Privacy Policy. In addition, We may disclose Your personal information in the following circumstances:

  1. to third-party vendors We use to support our business (e.g., Internet service providers, hosting companies, financial institutions, and companies that provide business analytics, fulfillment services, technical support, and delivery services), in which case We will require such third parties to agree to treat it in accordance with this Privacy Policy;
  2. to trusted third-party businesses with which We partner to offer You products and services;
  3. in connection with a corporate transaction, such as the sale, assignment, or other transfer of the business of this Web site to which the information relates;
  4. in response to subpoenas, court orders, or other legal process; to establish or exercise our legal rights; to defend against legal claims; or as otherwise required by applicable laws or government regulations;
  5. to protect and defend the rights of UCB, this Web site or the users of this Web site;
  6. under circumstances We believe reasonably necessary to protect the personal safety of users of UCB, Inc.'s products and services, this Web site or the public; or
  7. as is otherwise described in this Privacy Policy or at the point of collection.

We also may share aggregate or anonymous information with third parties, including advertisers and investors. This information does not contain any personal information and is used to develop content and services we believe You will find of interest.

Access and correction

You can access the personal information You have provided through this Web site by contacting us at the address listed in the "How to Contact Us" section of the Privacy Policy. We will take reasonable steps to update or correct personal information in our possession that You have submitted via this Web site, so long as You notify Us of any changes.

Your choices

You may choose:

  1. not to provide personal information, but that may result in Your inability to obtain certain services or use certain features of our Web site;
  2. to stop receiving commercial e-mails from Us in any such message we send or by sending an e-mail to the contact address at the bottom of this policy;
  3. to delete or decline cookies by changing Your browser settings. (Click "Help" in the toolbar of most browsers for instructions.) If You do so, some of the features and services of our Web site may not function properly;
  4. to review and update Your personal information by contacting us at the link below and, if You have an online account on our Web site, by logging into that account.

Security

We take reasonable steps to protect Your personal information as You transmit Your information from Your computer to our site and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no Internet transmission is ever 100% secure or error–free. Therefore, although we take steps to secure Your information, we do not promise, and You should not expect, that Your personal information or other communications will always remain private.

Links to other Web sites

This Web site may contain links or references to other Web sites. Please be aware that We do not control other Web sites and that, in any case, this Privacy Policy does not apply to those Web sites. We encourage You to read the privacy policy of every Web site You visit.

Other terms

Your use of this Web site is subject to our Terms of Use.

International users

This Web site is intended for use only by U.S. residents and You have indicated that You are a U.S. resident by entering this Web site. Personal information that You have voluntarily entered electronically may be delivered to servers located in the United States and other countries outside of the country in which You reside. By using the Web site, You consent to the transfer of any and all personal information that You provide to Us and to our use and disclosure of such personal information as outlined in this Privacy Policy.

Your California privacy rights

California Civil Code Section 1798.83 permits customers of UCB who are California residents to request certain information regarding its disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please contact us .

How to contact us

If You have any questions, comments, or concerns about this Privacy Policy or the information practices of this Web site, You can contact us at UCB, Inc., 1950 Lake Park Drive, Smyrna, GA 30080, or contact us .

Changes to this privacy policy

UCB may, from time to time in its sole discretion, change or modify this Privacy Policy. Any changes or modification will be effective upon posting of the revisions on this Web site. At any given time, Your access and use of this Web site and provision of information is governed by the Privacy Policy then in effect. We will notify You about material changes to this Privacy Policy by sending a notice to the e-mail address You provided to us or by placing a prominent notice on our Web site.

This Privacy Policy was last updated on September 13, 2007.

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.

This site is intended for US healthcare professionals.

UCBCares® 1-844-599-CARE (2273)

Monday - Thursday 8:00 am - 8:00 pm ET

Friday 8:00 am - 5:00 pm ET

CIMZIA®, CIMplicity®, cimplicity®, and UCBCares® are registered trademarks of the UCB Group of Companies. All other trademarks and registered trademarks are the property of their respective holders.
©2018 UCB, Inc., Smyrna, GA 30080. All rights reserved. USP-CZ1015-0298(6)a

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.
Click to open Full Prescribing Information.

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.