Privacy policy

Welcome

 

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

 

Your privacy is important to Us. UCB, Inc. is committed to maintaining the highest level of confidentiality regarding the personal information that We collect, use, maintain, and disclose. This Privacy Policy explains how We handle the personal information You provide to UCB within the United States. Please be sure to read this entire Privacy Policy before using or submitting Your information to this Website. This Privacy Policy applies only to data collected through this Website and does not apply to any other data collected by UCB online or offline.

 

UCB is not a healthcare provider (e.g., a doctor, hospital, pharmacist, etc.) and is generally not subject to the Privacy Rule under the Health Insurance Portability and Accountability Act, commonly known as HIPAA, which imposes additional requirements on healthcare providers relating to protected health information.

 

Your consent

 

By using this Website, You agree with the terms of this Privacy Policy. Whenever You submit information via this Website, You consent to the collection, use, disclosure and storage of Your information and other information received by Us as a result of such use in accordance with this Privacy Policy and the Terms of Use, and as permitted or required by applicable law.

 

About children

 

This Website is not intended for persons under the age of 18. We will not knowingly collect information from Website visitors unless You have indicated that You are age 18 or older 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 collect and store information You enter on our Website. This may include:

  • Direct Identifiers such as Your first and last name, telephone number, postal address, e-mail address, or Your NPI or other unique identification number for healthcare providers;
  • Personal Characteristics such as Your age, ethnicity, gender, or Your relationship to a disease (e.g., as a healthcare provider, a researcher, a diagnosed patient, a friend or relative of such a patient)
  • Health Information such as Your professional credentials (e.g., pharmacist), Your medical specialty, Your hospital or other affiliation(s), or Your educational background or expertise; and
  • If you are a diagnosed patient, Your Health Information such as the date of Your medical diagnosis or information related to medication(s) taken or other treatment(s) such as Your experience with certain therapies;
  • Other Information such as the name of Your treating physician(s) or information related to Your health insurance coverage.

You may choose not to provide this or other information through our Website, 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 Website.

 

Information from other sources. We also may periodically obtain information about You from other sources (for example, insurance companies) and add it to Your account information. Examples of information We may receive includes prescription histories or patterns, which We use to support Our strategic planning and operations; and (if, for example, you conduct research) Your published findings and analysis.

 

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

 

Cookies. We may assign Your computer a “cookie” (a small, unique identifier text file). For example, whenever You sign into the Website, 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 Website, You may not be able to access some of the tools We offer.

 

Analytics information. Our website also uses tools like Google Analytics to measure traffic to our site and how users interact with our site. Google Analytics employs cookies in order to facilitate an analysis of Your use of this site; the information generated by these cookies, such as time, place and frequency of Your visits to our Website, including Your IP address, is transmitted to Google’s location in the US and stored there.

 

Website users who do not want their data collected with Google Analytics can install the Google Analytics opt-out browser add-on. This add-on instructs the Google Analytics JavaScript running on websites to prohibit sending information to Google Analytics.

 

To opt-out of Analytics for the web, visit https://tools.google.com/dlpage/gaoptout/ and install the add-on for Your browser. For more details, please see the relevant help resources for Your specific browser.

 

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, including any follow-up activities;
  • to manage Your account;
  • to respond to Your questions and comments;
  • to measure interest in and improve the content of our Website;
  • to customize this Website to Your preferences;
  • to analyze and better understand Your needs, preferences, and interests;
  • 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. We will not sell Your name, address, e-mail address, or any other personal information to another party for their own marketing use.

 

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:

  • 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 Your personal information in accordance with this Privacy Policy;
  • to trusted third-party businesses with which We partner to offer You products and services;
  • in connection with a corporate transaction, such as the sale, assignment, or other transfer of the business of this Website to which the information relates;
  • 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;
  • to protect and defend the rights of UCB, this Website or the users of this Website;
  • under circumstances We believe reasonably necessary to protect the personal safety of users of UCB, Inc.’s products and services, this Website or the public; or
  • 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 deletion requests

 

If permitted by local laws, You have the right to request access to (or correction of) the personal information We have collected about You in a portable and readily usable format. In addition, You can request that We delete Your personal information in accordance with local laws. Please submit Your request(s) using the address listed in the “How to Contact Us” section below. We do not charge a fee to process or respond to Your verifiable request unless it is excessive, repetitive or manifestly unfounded. If We determine Your request warrants a fee, We will explain why We made that decision and provide You with a cost estimate before completing Your request.

 

California Consumer Privacy Act

 

The California Consumer Privacy Act of 2018 (CCPA) gives California consumers the right to know what personal information is collected about them, how it will be used and to whom it is disclosed. In addition, the CCPA provides You (as a California resident) with specific rights subject to certain exceptions.

  • The Right to Know. You have the right under the CCPA to request that We disclose what personal information We collect, use, disclose, and sell.
  • The Right to Deletion. You have the right under the CCPA to request deletion of any personal information about You that We have collected from You.
  • The Right to Opt-Out. You have the right under the CCPA to opt-out of the sale of Your personal information.
  • The Right to Non-Discrimination. You have the right under the CCPA not to be discriminated against for exercising Your rights.

Please note that some of the personal information that We collect, use, and disclose may be exempt from the CCPA because it is regulated by other federal and state laws that apply to Us.

 

Nevada Privacy Law

 

We do not sell Covered Information as defined under Nevada law.

 

Your choices

 

You may choose:

  • not to provide personal information, but that may result in Your inability to obtain certain services or use certain features of our Website;
  • 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;
  • 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 Website may not function properly; or
  • to review and update Your personal information by contacting Us at the link below and, if You have an online account on our Website, by logging into that account.

Security

 

We take reasonable steps to protect Your personal information as You transmit Your information from Your computer to Us and to protect such information from loss, misuse, and unauthorized access, disclosure, alteration, or destruction. You should keep in mind that no technology 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 Websites

 

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

 

Other terms

 

Your use of this Website is subject to our Terms of Use.

 

International users

 

This Website is intended for use only by U.S. residents and You have indicated that You are a U.S. resident by entering this Website. 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 Website, 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.

 

How to contact us

 

If You have any questions, comments, or concerns about this Privacy Policy or the information practices of this Website, You can contact Us at UCB, Inc., Attn: ucbCARES®, 1950 Lake Park Drive, Smyrna, GA 30080, or contact us by email or telephone.

 

Changes to this privacy policy

 

Without prejudice to Your rights under applicable law, We reserve the right to amend this Privacy Policy without prior notice to reflect technological advancements, legal and regulatory changes, and good business practices. If We change our privacy practices, an updated version of this Privacy Policy will reflect those changes and We will notify You of such changes by updating the effective date below.

 

This Privacy Policy was last updated January 6, 2020.

 

IMPORTANT SAFETY INFORMATION & INDICATIONS

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.

INDICATIONS

CIMZIA is indicated for:

  • Reducing signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy
  • Treatment of adults with moderately to severely active rheumatoid arthritis (RA)
  • Treatment of adult patients with active psoriatic arthritis (PsA)
  • Treatment of adults with active ankylosing spondylitis (AS)
  • Treatment of adults with moderate-to-severe plaque psoriasis (PSO) who are candidates for systemic therapy or phototherapy
  • Treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation

IMPORTANT SAFETY INFORMATION (CONT)

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, anaphylaxis, 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, anaphylaxis, 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 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 refer to full Prescribing Information.