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Privacy Policy

Janssen Biotech, 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.

Online behavioral advertising opt out: As outlined in this Policy, we may use information stored in cookies and similar technologies, including cookies stored directly by this site and cookies previously stored by another web site (such as a statistical analysis provider or advertising network), together to better understand your usage of this site and to deliver more relevant advertisements. If you do not want this information to be used by those service providers to tailor advertising to your interests, you may opt out at http://www.networkadvertising.org/choices/ and https://www.aboutads.info/choices. If you opt out, information about your visit to this site may still be collected by third parties but will not be used to tailor advertisements for you. Further, if you opt out, you may continue to see advertisements related to this site, but those ads would be selected based on criteria not related to your usage of this site.

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”). Janssen Biotech, Inc.  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 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. 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.
  • 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 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. 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 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560. 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 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 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 1-800-JANSSEN (526-7736) or send a written request to Janssen Medical Information, PO Box 200 Titusville, NJ 08560.

 

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Important Safety Information

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS- None

WARNINGS AND PRECAUTIONS

Infusion Reactions DARZALEX® can cause severe infusion reactions. Approximately half of all patients experienced a reaction, most during the first infusion. Infusion reactions can also occur with subsequent infusions. Nearly all reactions occurred during infusion or within 4 hours of completing an infusion. Prior to the introduction of post-infusion medication in clinical trials, infusion reactions occurred up to 48 hours after infusion. Severe reactions have occurred, including bronchospasm, hypoxia, dyspnea, hypertension, laryngeal edema and pulmonary edema. Signs and symptoms may include respiratory symptoms, such as nasal congestion, cough, throat irritation, as well as chills, vomiting and nausea. Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus, and hypotension.

Pre-medicate patients with antihistamines, antipyretics, and corticosteroids. Frequently monitor patients during the entire infusion. Interrupt infusion for reactions of any severity and institute medical management as needed. Permanently discontinue therapy for life-threatening (Grade 4) reactions. For patients with Grade 1, 2, or 3 reactions, reduce the infusion rate when re-starting the infusion.

To reduce the risk of delayed infusion reactions, administer oral corticosteroids to all patients following DARZALEX® infusions. Patients with a history of chronic obstructive pulmonary disease may require additional post-infusion medications to manage respiratory complications. Consider prescribing short-and long-acting bronchodilators and inhaled corticosteroids for patients with chronic obstructive pulmonary disease.

Interference with Serological Testing Daratumumab binds to CD38 on red blood cells (RBCs) and results in a positive Indirect Antiglobulin Test (Indirect Coombs test). Daratumumab-mediated positive indirect antiglobulin test may persist for up to 6 months after the last daratumumab infusion. Daratumumab bound to RBCs masks detection of antibodies to minor antigens in the patient’s serum. The determination of a patient’s ABO and Rh blood type are not impacted. Notify blood transfusion centers of this interference with serological testing and inform blood banks that a patient has received DARZALEX®. Type and screen patients prior to starting DARZALEX®.

Neutropenia DARZALEX® may increase neutropenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. Monitor patients with neutropenia for signs of infection. DARZALEX® dose delay may be required to allow recovery of neutrophils. No dose reduction of DARZALEX® is recommended. Consider supportive care with growth factors.

Thrombocytopenia DARZALEX® may increase thrombocytopenia induced by background therapy. Monitor complete blood cell counts periodically during treatment according to manufacturer’s prescribing information for background therapies. DARZALEX® dose delay may be required to allow recovery of platelets. No dose reduction of DARZALEX® is recommended. Consider supportive care with transfusions.

Interference with Determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.

Adverse Reactions The most frequently reported adverse reactions (incidence ≥20%) in clinical trials were: infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy and upper respiratory tract infection.

In patients who received DARZALEX® in combination with lenalidomide and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: upper respiratory tract infection (65%), infusion reactions (48%), diarrhea (43%), fatigue (35%), cough (30%), muscle spasms (26%), nausea (24%), dyspnea (21%) and pyrexia (20%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions were pneumonia (12%), upper respiratory tract infection (7%), influenza (3%) and pyrexia (3%). DARZALEX® in combination with lenalidomide and dexamethasone: treatment-emergent Grade 3-4 hematology laboratory abnormalities > 20% were neutropenia (36%) and lymphopenia (42%).

In patients who received DARZALEX® in combination with bortezomib and dexamethasone, the most frequently reported adverse reactions (incidence ≥20%) were: peripheral sensory neuropathy (47%), infusion reactions (45%), upper respiratory tract infection (44%), diarrhea (32%), cough (27%), peripheral edema (22%), and dyspnea (21%). The overall incidence of serious adverse reactions was 42%. Serious adverse reactions were upper respiratory tract infection (5%), diarrhea (2%) and atrial fibrillation (2%). DARZALEX® in combination with bortezomib and dexamethasone: treatment-emergent Grade 3-4 hematology laboratory abnormalities > 20% were lymphopenia (41%) and thrombocytopenia (28%).

In patients who received DARZALEX® as monotherapy, the most frequently reported adverse reactions (incidence ≥20%) were: infusion reactions (48%), fatigue (39%), nausea (27%), back pain (23%), pyrexia (21%), cough (21%), and upper respiratory tract infection (20%). Serious adverse reactions were reported in 51 (33%) patients. The most frequent serious adverse reactions were pneumonia (6%), general physical health deterioration (3%), and pyrexia (3%). DARZALEX® as monotherapy: treatment-emergent Grade 3-4 hematology laboratory abnormalities > 20% was lymphopenia (30%).

In patients who received DARZALEX® in combination with pomalidomide and dexamethasone, the most frequent adverse reactions (>20%) were fatigue (50%), infusion reactions (50%), upper respiratory tract infection (50%), cough (43%), diarrhea (38%), constipation (33%), dyspnea (33%), nausea (30%), muscle spasms (26%), back pain (25%), pyrexia (25%), insomnia (23%), arthralgia (22%), dizziness (21%), and vomiting (21%). The overall incidence of serious adverse reactions was 49%. Serious adverse reactions reported in ≥ 5% patients included pneumonia (7%). DARZALEX® in combination with pomalidomide and dexamethasone: treatment-emergent hematology Grade 3-4 laboratory abnormalities > 20% were anemia (30%), neutropenia (36%, 46%), and lymphopenia (45%, 26%).

DRUG INTERACTIONS

Effect of Other Drugs on Daratumumab: The coadministration of lenalidomide, pomalidomide or bortezomib with DARZALEX® did not affect the pharmacokinetics of daratumumab.

Effect of Daratumumab on Other Drugs: The coadministration of DARZALEX® with bortezomib did not affect the pharmacokinetics of bortezomib.

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Please see full Prescribing Information.

 

Indication

DARZALEX® is a CD38-directed cytolytic antibody indicated:

  • in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy

  • in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor

  • as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.