Janssen Consent

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Welcome to JanssenConsent.com. Based on the email you have received your physician has requested for you to provide your consent to the offerings selected by your physician. The information below is being requested from you to verify your identity and to proceed with your consent to receive these offerings.

The information you provide will be used by Janssen Pharmaceuticals, Inc., affiliates, and service providers for the registration, fulfillment, and administration of the Janssen CarePath and other offerings you may select. Our Privacy Policy governs the use of information you provide. You may withdraw from the program by calling 1-877-524-3579. By providing the information and selecting the Continue button, you indicate that you read, understand, and agree to these terms.

INDICATION

INVEGA TRINZA® (3-month paliperidone palmitate) is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been treated with INVEGA SUSTENNA® (1-month paliperidone palmitate) for at least 4 months.

INVEGA SUSTENNA® (In-VEY-guh Suss-TEN-uh) (paliperidone palmitate) is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used to treat schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about INVEGA TRINZA® and INVEGA SUSTENNA®?

INVEGA TRINZA® and INVEGA SUSTENNA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss, and have lost touch with reality (dementia-related psychosis). INVEGA TRINZA®and INVEGA SUSTENNA® are not for treating dementia-related psychosis.

Do not receive INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA TRINZA® and INVEGA SUSTENNA® ingredients.

Before you receive INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you:


Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls.

What should I avoid while receiving INVEGA TRINZA® or INVEGA SUSTENNA®?


INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including:


The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk.

The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes.

Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist.

Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088.

General information about the safe and effective use of INVEGA TRINZA® or INVEGA SUSTENNA®

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. Do not give INVEGA TRINZA® or INVEGA SUSTENNA® to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare professional for information about INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals.

This Patient Information leaflet summarizes the most important information about INVEGA TRINZA® and INVEGA SUSTENNA®. If you would like more information, talk with your healthcare professional.

You can ask your healthcare professional or pharmacist for more information that is written for healthcare professionals. For more information, go to www.invegatrinza.com or www.invegasustenna.com or call 1 800-526-7736.


Click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA TRINZA®.
Click here to read the full Prescribing Information, including Boxed WARNING, for INVEGA SUSTENNA®.

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RISPERDAL CONSTA® (risperidone) is used for the treatment of schizophrenia and for the longer-term treatment of Bipolar I Disorder.

IMPORTANT SAFETY INFORMATION FOR RISPERDAL CONSTA®

RISPERDAL CONSTA® can cause serious side effects, including an increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). RISPERDAL CONSTA® is not for treating dementia-related psychosis.

Do not receive RISPERDAL CONSTA® if you are allergic to paliperidone, risperidone, or any of the ingredients in RISPERDAL CONSTA®.

Cerebrovascular problems (stroke) that can lead to death have been reported in elderly patients with dementia-related psychosis.

Neuroleptic Malignant Syndrome (NMS) is a rare but very serious problem that can happen in people who receive RISPERDAL CONSTA®. NMS can cause death and must be treated in a hospital. Call your healthcare provider right away if you become severely ill and have any of these symptoms: high fever, severe muscle stiffness, confusion, loss of consciousness, or changes in your breathing, heartbeat and blood pressure.

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. Elderly female patients appear to be at increased risk for TD, although it is impossible to predict which patients will develop the syndrome. This condition can develop after a brief period of therapy at low doses, although this is much less common. Symptoms may go away partially or completely if therapy is stopped.

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

High blood sugar and diabetes have been reported with RISPERDAL CONSTA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your healthcare professional if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.

Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your healthcare professional while on treatment.

Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.

RISPERDAL CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and problems with erection.

Some people taking RISPERDAL CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional's dosing instructions, this side effect can be reduced.

Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long- term therapy should be evaluated by their healthcare professional for the potential risk of falls.

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your healthcare professional may choose to test your blood as you start therapy with RISPERDAL CONSTA®.

RISPERDAL CONSTA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how RISPERDAL CONSTA® affects you.

RISPERDAL CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

RISPERDAL CONSTA® may increase difficulty in swallowing that may cause food or liquid to get into your lungs.

Painful, long lasting erections have been reported with the use of RISPERDAL CONSTA®. Call your healthcare professional immediately if you think you are having this problem.

Tell your healthcare professional if you are pregnant or plan to become pregnant. It is not known if RISPERDAL CONSTA® will harm your unborn baby. If you become pregnant while taking RISPERDAL CONSTA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry. Infants born to women who are treated with RISPERDAL CONSTA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. Tell your healthcare professional if you are breastfeeding or plan to breastfeed. RISPERDAL CONSTA® can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive RISPERDAL CONSTA®.

RISPERDAL CONSTA® may impair fertility, which is reversible. Speak to your healthcare provider if you plan to become pregnant.

RISPERDAL CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Some medications interact with RISPERDAL CONSTA®. Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL CONSTA®.

In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of schizophrenia were headache, slow movements (including tremor [shaking], stiffness, and a shuffling walk), dizziness; feeling of inner restlessness or needing to be constantly moving; tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

In studies of people taking RISPERDAL CONSTA®, the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and slow movements (including with tremor [shaking], stiffness, and a shuffling walk) and tremor (when used with lithium or valproate).

This is not a complete list of all possible side effects. Ask your healthcare professional or treatment team if you have any questions or want more information.

If you have any questions about RISPERDAL CONSTA® or your therapy, talk with your healthcare professional.

Please read the full Prescribing Information including Boxed WARNING for RISPERDAL CONSTA®.

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Janssen Pharmaceuticals, Inc. is concerned about privacy issues and wants you to be familiar with how we collect, use, and disclose information. This Privacy Policy describes our practices in connection with information that we or our service providers collect through the Web site or Web property (including, for example, a mobile Web site or application) operated and controlled by us from which you are accessing this Privacy Policy (each, the “Site”). By providing personal information to us or by using the Site, you agree to the terms and conditions of this Privacy Policy.

INFORMATION COLLECTION

Information You Provide

Some areas of the Site may ask you to submit personal information in order for you to benefit from the specified features (such as newsletter subscriptions, tips/pointers, or order processing) or to participate in a particular activity (such as sweepstakes or other promotions). You will be informed what information is required and what information is optional.

We may combine the information you submit with other information we have collected from you, whether on- or offline, including, for example, your purchase history. We may also combine it with information we receive about you from other sources, such as other Johnson & Johnson Operating Companies, publicly available information sources (including information from your publicly available social media profiles), and other third parties.

Passive Information Collection and Use

As you navigate around the Site, certain information can be passively collected (that is, gathered without your actively providing the information), using various technologies. We and our third party service providers passively collect and use information in a variety of ways, including:

Through your browser: Certain information is collected by most browsers, such as your Media Access Control (MAC) address, computer type (Windows or Macintosh), screen resolution, operating system version, and Internet browser type and version. We may collect similar information, such as your device type and identifier, if you access the Site through a mobile device.

Using cookies: Cookies are pieces of information stored directly on the computer you are using. Cookies allow us to collect information such as browser type, time spent on the Site, pages visited, and language preferences. We and our service providers use the information for security purposes, to facilitate navigation, display information more effectively, and to personalize your experience while using the Site. We also use cookies to recognize your computer or device, which makes your use of the Site easier, such as to remember what is in your shopping cart. In addition, we use cookies to gather statistical information about Site usage in order to continually improve its design and functionality, understand how individuals use it, and to assist us with resolving questions regarding it. Cookies further allow us to select which of our advertisements or offers are most likely to appeal to you and display them while you are on the Site. We may also use cookies in online advertising to track consumer responses to our advertisements.

You can refuse to accept these cookies by following your browser’s instructions; however, if you do not accept them, you may experience some inconvenience in your use of the Site. You may also not receive advertising or other offers from us that are relevant to your interests and needs. To learn more about cookies, please visit http://www.allaboutcookies.org.

Using Flash cookies: Our use of Adobe Flash technology (including Flash Local Stored Objects (“Flash LSOs”)) allows us to, among other things, serve you with more tailored information, facilitate your ongoing access to and use of the Site, and collect and store information about your use of the Site. If you do not want Flash LSOs stored on your computer, you can adjust the settings of your Flash player to block Flash LSO storage using the tools contained in the Website Storage Settings Panel. You can also control Flash LSOs by going to the Global Storage Settings Panel and following the instructions (which may include instructions that explain, for example, how to delete existing Flash LSOs (referred to as “information” on the Macromedia site), how to prevent Flash LSOs from being placed on your computer without your being asked, and (for Flash Player 8 and later) how to block Flash LSOs that are not being delivered by the operator of the page you are on at the time). Please note that setting the Flash Player to restrict or limit acceptance of Flash LSOs may reduce or impede the functionality of some Flash applications, including, potentially, Flash applications used in connection with the Site or our online content.

Using pixel tags, web beacons, clear GIFs, or other similar technologies: These may be used in connection with some Site pages and HTML-formatted e-mail messages to, among other things, track the actions of Site users and e-mail recipients, measure the success of our marketing campaigns, and compile statistics about Site usage and response rates.

Online behavioral advertising: The use of cookies, pixel tags, web beacons, clear GIFs, or other similar technologies allows our third-party vendors to deliver advertisements about our products and services when you visit the Site or other web sites or web properties across the Internet. These vendors may place pixel tags, web beacons, clear GIFs, or similar technologies on the Site and other websites or web properties, and also place or recognize third-party cookies when you visit the Site or other sites or web properties. They may use information about your visits to the Site and other web sites or web properties to provide advertisements about goods and services that may be of interest to you.

IP Address: Your IP Address is a number that is automatically assigned to the computer that you are using by your Internet Service Provider. An IP Address is identified and logged automatically in our server log files whenever a user visits the Site, along with the time of the visit and the page(s) that were visited. Collecting IP Addresses is standard practice on the Internet and is done automatically by many web sites. We use IP Addresses for purposes such as calculating Site usage levels, helping diagnose server problems, and administering the Site.

Device Information: We may collect information about your mobile device, such as a unique device identifier.

How We Use and Disclose Information

We use and disclose information you provide to us as described to you at the point of collection.

We also use information from or about you:

We also disclose information collected through the Site:

In addition, we use and disclose information collected through the Site as we believe to be necessary or appropriate: (a) as permitted by applicable law, including laws outside your country of residence; (b) to comply with legal process; (c) to respond to requests from public and government authorities, including public and government authorities outside your country of residence; (d) to enforce our terms and conditions; (e) to protect our operations or those of any of our affiliates; (f) to protect our rights, privacy, safety, or property, and/or that of our affiliates, you, or others; and (g) to allow us to pursue available remedies or limit the damages that we may sustain. We may also use and disclose information collected through the Site in other ways, with your consent.

We also use and disclose information we collect passively as described above, under “Passive Information Collection and Use,” and for any other purpose, except where we are required to do otherwise under applicable law (for example, if we are required to treat such information as personal information). In addition, we may use and disclose information that is not in personally identifiable form for any purpose. If we combine information that is not in personally identifiable form with information that is (such as combining your name with your geographical location), we will treat the combined information as personal information as long as it is combined.

THIRD PARTY SITES AND SERVICES

This Privacy Policy does not address, and we are not responsible for, the privacy, information, or other practices of any third parties, including any third party operating any site or web property (including, without limitation, any application) that is available through this Site or to which this Site contains a link. The availability of, or inclusion of a link to, any such site or property on the Site does not imply endorsement of it by us or by our affiliates.

SECURITY

We use reasonable organizational, technical, and administrative measures to protect personal information under our control. Unfortunately, no data transmission over the Internet or data storage system can be guaranteed to be 100% secure. If you have reason to believe that your interaction with us is no longer secure (for example, if you feel that the security of any account you have with us has been compromised), please immediately notify us of the problem by contacting us in accordance with the “Contacting Us” section below.

CHOICES AND ACCESS

Your choices regarding our use and disclosure of your personal information

We give you choices regarding our use and disclosure of your personal information for marketing purposes. You may opt out from:

We will seek to comply with your request(s) as soon as reasonably practicable. Please note that if you opt out as described above, we will not be able to remove your personal information from the databases of our affiliates with which we have already shared your information (i.e., as of the date that we implement your opt-out request). Please also note that if you opt out of receiving marketing-related messages from us, we may still send you important transactional and administrative messages, from which you cannot opt out.

How you can access, change, or delete your personal information

If you would like to review, correct, update, or delete the personal information that you have provided via the Site, please contact us at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. We will try to comply with your request as soon as reasonably [email protected]@

RETENTION PERIOD

We retain your personal information for the period necessary to fulfill the purposes outlined in this Privacy Policy, unless a longer retention period is required or allowed by law or to otherwise fulfill a legal obligation.

USE OF SITE BY MINORS

The Site is not directed to individuals under the age of 18, and we request that these individuals not provide Personal Information through the Site.

CROSS-BORDER TRANSFER

Your personal information may be stored and processed in any country where we have facilities or service providers, and by using our Site or by providing consent to us (where required by law), you agree to the transfer of information to countries outside of your country of residence, including to the United States, which may provide for different data protection rules than in your country.

SENSITIVE INFORMATION

Unless we specifically request or invite it, we ask that you not send us, and you not disclose, any sensitive personal information (e.g., information related to racial or ethnic origin, political opinions, religion or other beliefs, health, criminal background or trade union membership) on or through the Site or otherwise to us. In those cases where we may request or invite you to provide sensitive information, we will do so with your express consent.

UPDATES TO THIS PRIVACY POLICY

We may change this Privacy Policy. Any changes to this Privacy Policy will become effective when we post the revised Privacy Policy on the Site. Your use of the Site following these changes means that you accept the revised Privacy Policy. This Privacy Policy was last updated September 2013.

CONTACTING US

If you have any questions about this Privacy Policy, please contact us at 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560.

For US Residents:

Call our Customer Communications Center at 1-800-JANSSEN (1-800-526-7736), 9 AM to 8 PM (ET) Monday through Friday or contact your Janssen representative.