FULL PRESCRIBING INFORMATION
Privacy

Thank you for visiting our website. Dendreon Pharmaceuticals LLC (“Dendreon”) respects the individual privacy of the visitors to our website and is committed to protecting personal information in conformity with applicable legal and ethical standards. This Privacy Policy sets forth Dendreon’s practices regarding the collection, use and disclosure of information that you may provide through this website. Please read this entire Privacy Policy before using this website or submitting information to Dendreon through this website. By using this website and whenever you submit information through this website to Dendreon, you agree with the terms of this Privacy Policy.

We will only collect personal information such as names, addresses, and the like, only when voluntarily provided to us at this website. We, or companies we hire will only use this information to comply with your request for information or as otherwise disclosed to you at the location where you submit the information. We may from time to time refer to that information in an effort to understand your needs and better serve you by improving our products and or services. We may also use that information to contact you. We will not sell or transfer your personal information to any third party unless disclosed to you when you submit your information.

While you are browsing this website, your IP address will be automatically logged so that we can track your session on this website and thus serve you better. When analyzing our traffic, we also look at where our visitors have been referred from (the last URL you visited before visiting this website), your domain, and what browser and operating system you are using.

This website may deposit information commonly referred to as "cookies" in a visitor's computer. A cookie is a token that a server gives to your browser when you access a website. They store many types of data, and help provide additional functionality to our website. Our cookies do not collect personal information. You may turn off all cookies or you can have your computer warn you whenever cookies are being used. For both options, you have to adjust your browser settings. Please be aware, however, that when you choose to reject cookies, this choice may limit the functionality of this website and you may lose access to some of its features. In addition, if you turn off cookies, web beacon and other technologies will still detect visits to our website, but the information they generate cannot be associated with other non-identifiable cookie information and are disregarded. Should Dendreon merge with, acquire or be acquired by another business entity, some or all of your information could be transferred to the other entity.

If you provide personal information to us through this website, we may combine such information with other actively collected information unless we specify otherwise at the point of collection. We may disclose personal information you provide via this website to other Dendreon affiliates worldwide that agree to treat it in accordance with this Privacy Policy and use it for the same purposes. While Dendreon makes every reasonable effort to protect the personal information collected through this website, please be aware that there is always some risk involved when submitting data over the Internet. We cannot guarantee that its website is 100% safe from illegal tampering or "hacking." Any data transmitted over the Internet may be at risk. All information that Dendreon collects will be stored in Dendreon databases (including local storage), affiliated company databases, or databases managed by third party service providers, which are located within and outside of the United States. Such data will be automatically transferred to these databases, which may be located in countries where privacy rules differ and may be less stringent than those of the country in which you reside. If you visit our website from a country in the European Union, you consent to such cross-border transfers of personal data to the United States. We also may disclose personal information you provide via this website to third parties that are not Dendreon affiliates, but only:

(i) to contractors we use to support our business (such as fulfillment services, technical support, delivery services, and financial institutions), in which case we will require such third parties to agree to treat it in accordance with this Privacy Policy and use it for the same purposes;

(ii) in connection with the sale, assignment, or other transfer of the product or business of this website to which the information relates, in which case we will require any such buyer to agree to treat it in accordance with this Privacy Policy and use it for the same purposes; or

(iii) in response to a court order, subpoena, search warrant, applicable law, regulation or government request.

We do not sell or rent our customers’ email addresses. We will not exchange our customers’ email addresses with other marketing partners. We may share your email address with third parties who perform services for Dendreon.

Dendreon also contracts with third-party service providers to place our advertising messages on other websites and digital properties. No personal information is collected or used in this process. These providers may collect anonymous information about your visits to our digital properties, and your interaction with our products and services such as pages and products you viewed. They may also use information about your visits to our and other digital properties to target advertisements for goods and services. This anonymous information is collected through the use of a cookie and a pixel tag, which is industry standard technology used by most major websites.

You have the right to ensure that your personal data is always up-to-date. In some jurisdictions you have the legal right to require us to correct or delete your personal data. In addition, you can always tell us to stop contacting you and to opt out of receiving certain information from Dendreon. If you wish to contact us regarding our use of your personal data, or to unsubscribe from our email list, please e-mail us at corporate.communications@dendreon.com. If you contact us, please note the name of the website where you provided the information, as well as the specific information you would like us to correct, update or delete. Your requests will be dealt with in a prompt and proper manner. Requests to delete personal data will be subject to any applicable legal and ethical reporting or document filing or retention obligations imposed on us.

The Dendreon website is not intended or designed to attract children under the age of thirteen. To ensure compliance with federal law, Dendreon does not knowingly collect or maintain personal information from, nor does it actively market its products to, any person under the age of thirteen.

This website may contain links or references to other websites. These other websites have their own privacy policies. If you visit another website, you should review the privacy policy of that website.

We reserve the right, at any time, to modify, alter, or update this Privacy Policy, and any such modifications, alterations, or updates will be effective upon posting. In the event we modify this Privacy Policy, your continued use of this website will signify your acceptance of the modified Privacy Policy. If a change to this Privacy Policy results in a materially different use of your personal information provided prior to the date of the change, you may opt out of such use by providing notice to Dendreon.

California Residents Under the Age of 18

If you are a California resident under age 18 then you may request that we remove any of your personal information that you may have provided to Dendreon. To request removal of your personal information, please send a request with a detailed description of the specific personal information legal@dendreon.com. Dendreon reserves the right to request that you provide information that will enable us to confirm that the personal information that you want removed was provided by you.

California Consumer Privacy Act - Notice for California Residents

If you are a California resident, this notice supplements the information above regarding the collection, use, and disclosure of your personal information. California Civil Code Section 1798.83 permits individual California residents to request certain information regarding Dendreon’s disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please write or send an email to the address below.

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.  The CCPA gives California consumers the right to request access to and deletion of their personal information, and the right to request that their personal information not be sold to the extent applicable under the CCPA.

The purpose of this notice is to describe our practices regarding the collection, use, disclosure, and sale of personal information and instructions for submitting CCPA data privacy requests. 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.

We collect personal information from you when you interact with us online (through our Site, our other websites, and services) or offline (such as through your health care providers, if you are a patient, with your authorization as applicable.)

Your Rights

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 process for exercising this right is describe below under How to Submit a Data Privacy Request
  • 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 process for exercising this right is describe below under How to Submit a Data Privacy Request     
  • 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.
How to Submit a Data Privacy Request

You may exercise your Right to Know and Right to Deletion by clicking on the “Data Request” link at the end of this paragraph. By doing so, you acknowledge that you will be redirected to a site hosted by OneTrust, which processes data requests for us.  OneTrust has different terms of service and a different privacy policy than Dendreon. To submit a request pursuant to your rights under the CCPA, please click here.

To process your request for access or deletion, we must be able to verify your identity to a reasonable degree of certainty. We use a third-party verification service, Lexis Nexis, for that purpose. To verify your identity, you must provide the required information when completing the online request form or making a request including the last 4 digits of your social security number. We will ask you to provide your contact information and additional identifiers based on your relationship with us. Before we process your request, we will match these data points with a third-party identity verification service and data points we currently maintain to verify your identity and your relationship with us.

You may designate an authorized agent to make a request to access, delete, or opt-out of the sale of your information on your behalf. When you use an authorized agent to submit a request for access or deletion, you must provide the authorized agent with written permission to do so, and, in certain circumstances, we may ask you to verify your own identity directly with us. We may deny a request from an authorized agent that does not submit proof that they have been authorized by you to act on your behalf.  

Right to Know

Please note that we may not be required to provide you access to the specific pieces of information we have collected about you or delete information if we are unable to verify your identity. 

Right to Delete

We may not be required to delete information under certain circumstances. Specifically, the CCPA includes exemptions that provide that we do not have to delete data that, for example, is necessary to comply with legal obligations including those pertaining to the quality, safety or effectiveness of a product or activity regulated by the Food and Drug Administration (FDA), complete a transaction, detect security incidents, or for certain other internal purposes.

Sale or Disclosure of Personal Information

The CCPA defines “sale” broadly to include sharing, transferring, disclosing or otherwise communicating personal information with a third party for monetary or other valuable consideration. We share personal information with service providers who work on our behalf and agree not to use or sell your personal information for other purposes or if you have intentionally directed us to share information with a third party. In addition, we do not sell customer data for the purpose of delivering online advertising that is more tailored to our customer’s interests or share internet tracking data, including cookies and the IP address used to access our websites.

Nevada Privacy of Information Collected on the Internet from Consumers Act - Notice to Nevada Residents

Dendreon does not sell Covered Information as defined under Nevada law (NRS 603A.300- 603A.360). If you would like to make a further inquiry regarding the sale of your Covered Information, as defined under Nevada law, please send an email to legal@dendreon.com.

This Privacy Policy was last updated June 4, 2020. Please refer to this page from time to time to review updates to this Privacy Policy.

INDICATION

PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer.

IMPORTANT SAFETY INFORMATION

Acute Infusion Reactions: Acute infusion reactions (reported within 1 day of infusion) may occur and include nausea, vomiting, fatigue, fever, rigor or chills, respiratory events (dyspnea, hypoxia, and bronchospasm), syncope, hypotension, hypertension, and tachycardia.

Thromboembolic Events: Thromboembolic events, including deep venous thrombosis and pulmonary embolism, can occur following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events. PROVENGE should be used with caution in patients with risk factors for thromboembolic events.

Vascular Disorders: Cerebrovascular events (hemorrhagic/ischemic strokes and transient ischemic attacks) and cardiovascular disorders (myocardial infarctions) have been reported following infusion of PROVENGE. The clinical significance and causal relationship are uncertain. Most patients had multiple risk factors for these events.

Handling Precautions: PROVENGE is not tested for transmissible infectious diseases.

Concomitant Chemotherapy or Immunosuppressive Therapy: Chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. Concurrent use of immune-suppressive agents may alter the efficacy and/or safety of PROVENGE.

Adverse Reactions: The most common adverse reactions reported in clinical trials (≥ 15% of patients receiving PROVENGE) were chills, fatigue, fever, back pain, nausea, joint ache, and headache.

Click here for full Prescribing Information.