Privacy Policy

Janssen Therapeutics, Division of Janssen Products, LP 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:

  • to respond to your inquiries and fulfill your requests, such as to send you documents you request or e-mail alerts;
  • to send you important information regarding our relationship with you or regarding the Site, changes to our terms, conditions, and policies and/or other administrative information; and
  • for our business purposes, such as data analysis, audits, developing new products, enhancing our website, improving our products and services, identifying Site usage trends, personalizing your experience on the Site by presenting products and offers tailored to you, and determining the effectiveness of our promotional campaigns.

We also disclose information collected through the Site:

  • to our affiliates for the purposes described in this Privacy Policy. A list of our affiliates is available here (click on the link for Form 10K, Exhibit 21, under “SEC Filings”). PREZISTA® is the party responsible for the management of the jointly-used Personal Information;
  • to our third party partners with whom we offer a co-branded or co-marketed promotion;
  • to our third party service providers who provide services such as website hosting and moderating, mobile application hosting, data analysis, payment processing, order fulfillment, infrastructure provision, IT services, customer service, e-mail and direct mail delivery services, credit card processing, auditing services, and other services, in order to enable them to provide services; and
  • to a third party in the event of any reorganization, merger, sale, joint venture, assignment, transfer, or other disposition of all or any portion of our business, assets, or stock (including in connection with any bankruptcy or similar proceedings).

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:

  • Receiving marketing communications from us: If you no longer want to receive marketing communications from us on a going-forward basis, you may opt out of receiving them by contacting us at Janssen Therapeutics, Division of Janssen Products, LP, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA. In your response to us, please provide your name, identify the form(s) of marketing communications that you no longer wish to receive, and include the address(es) to which it/they are sent. For example, if you no longer wish to receive marketing e-mails or direct mail from us, tell us that, and provide your name and e-mail or postal address.You may also opt out of receiving marketing communications from us by visiting the Site to update your online profile. In addition, you may opt out of receiving marketing e-mails from us by following the unsubscribe instructions provided in any such message.
  • Receiving reminders from us: If you no longer want to receive medical reminders from us on a going-forward basis, you may opt out of receiving them by contacting us at Janssen Therapeutics, Division of Janssen Products, LP, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA. In your response to us, please provide your name and the e-mail address or phone number at which you receive reminders from us.
  • Our sharing of your personal information with affiliates and third-party partners: If you would prefer that we not share your personal information on a going-forward basis with our affiliates and/or third-party partners for their marketing purposes, you may opt out of this sharing by contacting at Janssen Therapeutics, Division of Janssen Products, LP, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA. In your response to us, please state that we should no longer share your personal information with our affiliates and/or third-party partners for their marketing purposes, and include your name and e-mail address.

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 Janssen Therapeutics, Division of Janssen Products, LP, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA. We will try to comply with your request as soon as reasonably practicable.

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 Janssen Therapeutics, Division of Janssen Products, LP, 1125 Trenton-Harbourton Rd, Titusville, NJ 08560, USA.

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Indication:

PREZISTA® (darunavir), coadministered with ritonavir (PREZISTA®/r), in combination with other antiretroviral agents (ARVs), is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

Important Safety Information

Contraindications

  • Coadministration of PREZISTA®/r is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. Coadministration is also contraindicated with drugs that may result in reduced plasma concentrations of darunavir, which may result in loss of therapeutic effect and development of resistance.
    • Drugs that are contraindicated with PREZISTA®/r are: alfuzosin, cisapride, colchicine (in patients with renal and/or hepatic impairment), dihydroergotamine, dronedarone, elbasvir/grazoprevir, ergotamine, lomitapide, lovastatin, lurasidone, methylergonovine, oral midazolam, pimozide, ranolazine, rifampin, St. John’s wort (Hypericum perforatum), sildenafil (for the treatment of pulmonary arterial hypertension), simvastatin, and triazolam.
  • Warnings & Precautions

    • PREZISTA® must be coadministered with ritonavir and food to achieve the desired antiviral effect. Failure to administer PREZISTA® with ritonavir and food may result in a loss of efficacy of darunavir.
    • Hepatotoxicity: Drug-induced hepatitis has been reported with PREZISTA®/r. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA®/r. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse reactions.
    • Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA®/r therapy has not been established.

      Appropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA®/r and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA®/r treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA®/r should prompt consideration of interruption or discontinuation of treatment.

    • Severe Skin Reactions: Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, and Stevens-Johnson Syndrome (<0.1%) have been reported in patients receiving PREZISTA®/r. During post-marketing experience, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis have been reported in patients receiving PREZISTA®/r. Discontinue PREZISTA®/r immediately if signs or symptoms of severe skin reactions develop (including, but not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia).
    • In clinical trials (N=3063), rash (all grades, generally mild to moderate, regardless of causality) occurred in 10.3% of patients receiving PREZISTA®/r. Discontinuation due to rash was 0.5%.

      Rash occurred more commonly in treatment-experienced subjects receiving regimens containing PREZISTA®/r + raltegravir compared to subjects receiving either drug regimen alone. However, rash that was considered drug related occurred at similar rates. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.

    • Sulfa Allergy: PREZISTA® should be used with caution in patients with known sulfonamide allergy.
    • Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PREZISTA®/r, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PREZISTA®/r, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PREZISTA®/r, respectively. These interactions may lead to:
      • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
      • Clinically significant adverse reactions from greater exposures of PREZISTA®/r
      • Loss of therapeutic effect of PREZISTA®/r and possible development of resistance

      Consider the potential for drug interactions prior to and during PREZISTA®/r therapy, review concomitant medications during PREZISTA®/r therapy, and monitor for the adverse reactions associated with the concomitant drugs.

    • Diabetes Mellitus/Hyperglycemia and Hemophilia: New-onset or exacerbations of preexisting diabetes mellitus, hyperglycemia, and increased bleeding in hemophiliacs have been reported in patients receiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. A causal relationship between protease inhibitors and these events has not been established.
    • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established.
    • Immune Reconstitution Syndrome has been reported in patients treated with combination ARV therapy, including PREZISTA®. Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time of onset is more variable and can occur many months after the initiation of treatment.

    Adverse Reactions

    • In treatment-naïve adult patients, the most common adverse drug reactions (≥5%) reported of at least moderate intensity (≥Grade 2) in the PREZISTA®/r arm through 192 weeks were diarrhea (9%), headache (7%), abdominal pain (6%), and rash (6%).
    • In treatment-experienced adult patients, the most common adverse drug reactions (≥5%) reported of at least moderate intensity (≥Grade 2) in the PREZISTA®/r arm through 96 weeks were diarrhea (14%), nausea (7%), rash (7%), abdominal pain (6%), and vomiting (5%).

    This is not a complete list of all adverse drug reactions reported with the use of PREZISTA®/r.

    Drug Interactions

    • Consult the full Prescribing Information for PREZISTA® for information on potentially significant drug interactions, including clinical comments.

    Use in Specific Populations

    • Hepatic Impairment: PREZISTA®/r is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment.

    This list of uses in specific populations is not complete.

    Please refer to the ritonavir prescribing information for additional safety information.

    Please read the full Prescribing Information for PREZISTA® for more details.

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