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);
Professional 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

Important Safety Information you should know about NAYZILAM^® (midazolam) nasal spray, CIV

What is the most important information I should know about NAYZILAM?

NAYZILAM is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.

Get emergency medical help right away if any of the following happens:

shallow or slowed breathing
breathing stops (which may lead to the heart stopping)
excessive sleepiness (sedation)

Do not drive or operate heavy machinery until you know how taking NAYZILAM with opioids may affect you.

Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including NAYZILAM, which can lead to overdose and serious side effects including coma and death.

Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including midazolam (the active ingredient in NAYZILAM). These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of these serious side effects.
You can develop an addiction even if you use NAYZILAM as prescribed by your healthcare provider.
Use NAYZILAM exactly as your healthcare provider prescribed.
Do not share your NAYZILAM with other people.
Keep NAYZILAM in a safe place and away from children.

Physical Dependence and withdrawal reactions. Benzodiazepines, including NAYZILAM, can cause physical dependence and withdrawal reactions, especially if you continue to use NAYZILAM daily. NAYZILAM is not intended for daily use.

Do not suddenly stop using NAYZILAM without talking to your healthcare provider. Stopping NAYZILAM suddenly can cause serious and life-threatening side effects, including, unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of these symptoms.
Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including, anxiety, trouble remembering, learning, or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
Physical dependence is not the same as drug addiction. Your healthcare provider can tell you more about the differences between physical dependence and drug addiction.
Do not use more NAYZILAM than prescribed or use NAYZILAM more often than prescribed.

NAYZILAM can make you sleepy or dizzy and can slow your thinking and motor skills.

Do not drive, operate heavy machinery, or do other dangerous activities until you know how NAYZILAM affects you.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while using NAYZILAM without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, NAYZILAM may make your sleepiness or dizziness worse.

Like other antiepileptic medicines, NAYZILAM may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying
feeling agitated or restless
acting aggressive, being angry, or violent
attempts to commit suicide
panic attacks
acting on dangerous impulses
new or worse depression

trouble sleeping (insomnia)
an extreme increase in activity and talking (mania)
new or worse anxiety
new or worse irritability
other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts or actions?

Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is NAYZILAM?

NAYZILAM is a prescription medicine used for the short-term treatment of seizure clusters (also known as “acute repetitive seizures”) in patients 12 years of age and older.
NAYZILAM is a federally controlled substance (CIV) because it contains midazolam that can be abused or lead to dependence. Keep NAYZILAM in a safe place to prevent misuse and abuse. Selling or giving away NAYZILAM may harm others and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription drugs, or street drugs.
It is not known if NAYZILAM is safe and effective in children under 12 years of age.

Do not use NAYZILAM if you:

are allergic to midazolam.
have an eye problem called acute narrow-angle glaucoma.

Before you use NAYZILAM, tell your healthcare provider about all your medical conditions, including if you:

have a history of depression, mood problems or suicidal thoughts or behavior.
have asthma, emphysema, bronchitis, chronic obstructive pulmonary disease, or other breathing problems.
have kidney or liver problems.
have congestive heart failure.
have a history of drug or alcohol abuse.
are pregnant or plan to become pregnant. Taking NAYZILAM late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
are breastfeeding or plan to breastfeed. Breastfeeding during treatment with NAYZILAM may cause your baby to have sleepiness, feeding problems, and decreased weight gain.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.

How should I use NAYZILAM?

Use NAYZILAM in the nose only.
Use NAYZILAM exactly as your healthcare provider tells you to use it and follow the Instructions for Use.
Your healthcare provider has prescribed NAYZILAM to treat a type of seizure called a “seizure cluster”.
If the seizure cluster is continuing 10 minutes after the first dose of NAYZILAM, a second dose of NAYZILAM may be used if you have been told to do so by your healthcare provider.
If a second dose of NAYZILAM is used, give the second dose in the other nostril.
Do not give more than 2 doses of NAYZILAM to treat a seizure cluster.
If the seizures do not stop after NAYZILAM is used, get emergency medical help right away.
Do not use NAYZILAM for more than 1 seizure cluster episode every 3 days. Do not use NAYZILAM for more than 5 seizure cluster episodes per month.
If benzodiazepines are stopped after a person takes them daily, they can cause withdrawal symptoms. Stopping benzodiazepines suddenly can cause seizures that will not stop (status epilepticus), hearing or seeing things that are not there (hallucinations), shaking, nervousness, and stomach and muscle cramps. NAYZILAM is not intended to be used daily.
If you use too much NAYZILAM, call your healthcare provider or go to the nearest emergency room right away.

What should I avoid while using NAYZILAM?

See “What is the most important information I should know about NAYZILAM?”

What are the possible side effects of NAYZILAM?

NAYZILAM may cause serious side effects, including:

See “What is the most important information I should know about NAYZILAM?”
Increase in eye pressure in people with acute narrow-angle glaucoma. See “Do not use NAYZILAM if you:”

The most common side effects of NAYZILAM include:

sleepiness
headache
runny nose

nasal discomfort
throat irritation

These are not all the possible side effects of NAYZILAM. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or you may contact UCBCares^® at 1-844-599-CARE.

Please see additional patient information in the Medication Guide. This information does not take the place of talking with your healthcare provider about your condition or your treatment. For more information, go to www.NAYZILAM.com or call 1-844-599-2273.

Please talk to your healthcare provider if you have any questions or concerns about NAYZILAM.

SELECT IMPORTANT SAFETY INFORMATION

NAYZILAM is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. There is a risk of abuse, misuse, and addiction with benzodiazepines, including NAYZILAM, which can lead to overdose and serious side effects including coma and death. Benzodiazepines, including NAYZILAM can cause physical dependence and withdrawal reactions, especially if you continue to use NAYZILAM daily. NAYZILAM is not intended for daily use. NAYZILAM may cause serious breathing problems and excessive sleepiness (sedation). Like other antiepileptic drugs, NAYZILAM may cause suicidal thoughts or actions. Do not use NAYZILAM if you have an eye problem called acute narrow-angle glaucoma. Taking NAYZILAM late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone), and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems). Breastfeeding during treatment with NAYZILAM may cause your baby to have sleepiness, feeding problems, and decreased weight gain. Do not drive, operate machinery, or do other activities that require mental alertness until you know how NAYZILAM affects you. The most common side effects of NAYZILAM include sleepiness, nasal discomfort, headache, throat irritation and runny nose.