Exelixis® Internet Privacy Statement

Thank you for visiting our website. This is the Exelixis, Inc. ("Exelixis®") Internet Privacy Statement for this website, www.exelixis.com (the "Site"). We provide this Internet Privacy Statement to help website visitors understand our practices with respect to the collection, use, sharing and retention of the information we collect about them through the Site.

You can write to us at Exelixis, Inc., 210 East Grand Avenue, So. San Francisco, CA 94080, U.S.A. or at [email protected]. Or you can call us at 1 (650) 837-7000.

Please be sure to read this entire Internet Privacy Statement before using or submitting information to the Site. By using the Site, you agree with the terms of this Internet Privacy Statement. Whenever you submit information via the Site, you consent to the collection, use and the disclosure of that information in accordance with this Internet Privacy Statement. Your use of the Site is also subject to the Terms of Use for the Site, into which this Internet Privacy Statement is incorporated by reference.

DATA WE COLLECT AND HOW WE USE AND SHARE IT

Personally Identifiable Information

Personally identifiable information includes your name, address, e-mail, telephone number, survey information, website registrations or any other information which might reasonably be used to identify you individually. Exelixis® collects personally identifiable information from Site visitors when they submit it to us through the "Contact Us" form provided on the Site, or if they otherwise provide it to us. Exelixis also collects information identifiable to an individual Site visitor if that visitor enters the Site through a link in an e-mail received from us. We may use this information to respond to an e-mail or other inquiry or request, to help improve the Site and our services, or to send updates or notices about our company and the products we offer that we think may be of interest to Site visitors.

We may share personally identifiable information with unaffiliated third parties who provide us with services, such as the designer of the Site and others who assist us with technology, data management and analysis, communications with site visitors, or similar services. We do not share personally identifiable information with unaffiliated third parties for their own marketing purposes. In the event of a reorganization, merger, sale, joint venture, assignment, transfer or other disposition of all or any portion of Exelixis® or its assets, we may transfer any and all information that we collect from Site users to the acquiring party or assignee.

We may disclose personally identifiable information that we collect about you to others as we believe to be appropriate in the following circumstances: (i) when required by applicable law, including laws outside your country of residence; (ii) to comply with legal process; (iii) to respond to requests from public and government authorities; (iv) to enforce the terms and conditions for use of the Site, including this Internet Privacy Statement; (v) to protect and defend our rights and property; (vi) to protect the interests and safety of Exelixis® or others; and (vii) to permit us to pursue available remedies or limit the damages that we may sustain. We have no obligation to notify you of such disclosures, except as required by applicable law.

Exelixis® may also combine the personally identifiable information you provide with other generally or publicly available information to help us identify visitors' preferences or interests. We may use the information to improve the content of the Site or our products and services.

Non-Personally Identifiable Information

The Exelixis® web server captures the Internet Protocol (IP) addresses of each connection to the Site and the specific web pages visited during that connection. An IP address is a number assigned to your computer by your Internet Service Provider so you can access the Internet. It is generally considered to be non-personally identifiable information because in most cases it changes each time you connect to the Internet. IP addresses may be used to diagnose problems with our server, report aggregate information, determine the fastest route for your computer to use in connecting to the Site, and to administer and improve the Site. We may also use this information to help improve the Site and our services by better understanding our audience. Exelixis® may also collect non-personally identifiable information in aggregate form to track data such as the total number of visitors to each page of the Site, and the domain names of our visitors' Internet service providers. We may use this information to understand how our visitors use the Site and thereby to improve the Site.

We do not currently allow others to collect the PII of visitors to our Site by tracking the usage of either our Site or other websites.

Children

Exelixis® does not knowingly collect any personally identifiable information from children under 13 years old through this website. If you are under age 13, please do not submit any PII to us. If you believe that a child under age 13 has provided us with personally identifiable information, please contact us at [email protected]. Anyone age 13 to 17 should seek their parent's or guardian's permission prior to using or disclosing any personal information on this website.

HOW YOU CAN CONTROL AND UPDATE DATA ABOUT YOU

Updating Contact Information

If we collect any of your personally identifiable information, we want to keep that information accurate and up-to-date in our records. Therefore, if you believe that your contact information needs to be updated, please contact us at [email protected] to correct or update your contact information. You may choose at any time to remove your name, telephone number and postal and e-mail addresses from the list we use to send notices or updates and elect not to receive correspondence from us by contacting us at [email protected].

Data Integrity and Security

Exelixis® takes reasonable steps to protect your personally identifiable information as you transmit your information from your computer to our website and to protect your information from loss, misuse and unauthorized access, disclosure, alteration or destruction. All information transmitted to this website is secure to the extent possible using existing technology. You should keep in mind, however, that no Internet transmission is ever 100% secure or error free. In particular, e-mail sent to or from this website may not be secure, and you should therefore take special care in deciding what information you send to us via e-mail. Moreover, where you use passwords, ID numbers, or other special access features on this website, it is your responsibility to safeguard them.

HYPERLINKS

This website may provide links to other websites as a service to our visitors. These are websites we believe may have helpful information. However, Exelixis® does not endorse and is not responsible for the content of third-party websites. Nor does Exelixis® have any control over information you may choose to provide to those websites.

The privacy policy described here does not apply to third-party websites, even if they are linked to Exelixis® websites. Other Internet websites you visit may have their own privacy policies or no policy at all. Other websites might use personal information differently than our policy permits. We strongly encourage you to review the privacy policies of any website before providing any personal information.

INTERNATIONAL TRANSFERS OF INFORMATION

By using the website, you are deemed to understand and unambiguously consent to the collection and processing of your personally identifiable information in the United States, with the awareness that the laws of the United States may not provide as much protection for personally identifiable information as the laws of certain other countries or territories.

CHANGES

We may update this Internet Privacy Statement at any time. Any changes to the Internet Privacy Statement will become effective upon the date of our posting of the revised Statement on the website. If you use the website following the effective date of the revised Statement, you will be deemed to have accepted the Statement's updated terms. Accordingly, you should check this Internet Privacy Statement regularly for any changes.

QUESTIONS

Questions about the Exelixis® Internet Privacy Statement may be directed to [email protected].

Indication

CABOMETYX® (cabozantinib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In RCC trials, the incidence of Grade ≥3 hemorrhagic events was 3% in CABOMETYX patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.
  • Gastrointestinal (GI) Perforations and Fistulas: In RCC trials, GI perforations were reported in 1% of CABOMETYX patients. Fatal perforations occurred in patients treated with CABOMETYX. In RCC studies, fistulas were reported in 1% of CABOMETYX patients. Monitor patients for symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a GI perforation or a fistula that cannot be appropriately managed.
  • Thrombotic Events: Thrombotic events increased with CABOMETYX. In RCC trials, venous thromboembolism occurred in 9% (including 5% pulmonary embolism) and arterial thromboembolism occurred in 1% of CABOMETYX patients. Fatal thrombotic events occurred in the cabozantinib clinical program. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or any other arterial thromboembolic complication.
  • Hypertension and Hypertensive Crisis: Treatment-emergent hypertension, including hypertensive crisis, increased with CABOMETYX. In RCC trials, hypertension was reported in 44% (18% Grade ≥3) of CABOMETYX patients. Monitor blood pressure prior to initiation and regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume CABOMETYX at a reduced dose. Discontinue CABOMETYX if there is evidence of hypertensive crisis or for severe hypertension that cannot be controlled with antihypertensive therapy or medical management.
  • Diarrhea: In RCC trials, diarrhea occurred in 74% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 diarrhea or Grade 3-4 diarrhea that cannot be managed with standard antidiarrheal treatments until improvement to Grade 1; resume CABOMETYX at a reduced dose.
  • Palmar-Plantar Erythrodysesthesia (PPE): In RCC trials, PPE occurred in 42% of CABOMETYX patients. Grade 3 PPE occurred in 8% of CABOMETYX patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPE or Grade 3 PPE until improvement to Grade 1; resume CABOMETYX at a reduced dose.
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.
  • Embryo-fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during CABOMETYX treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most commonly reported (≥25%) adverse reactions were: diarrhea, fatigue, nausea, decreased appetite, hypertension, PPE, weight decreased, vomiting, dysgeusia, and stomatitis.

DRUG INTERACTIONS

  • Strong CYP3A4 Inhibitors: If concomitant use with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage.
  • Strong CYP3A4 Inducers: If concomitant use with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage.

USE IN SPECIFIC POPULATIONS

  • Lactation: Advise women not to breastfeed while taking CABOMETYX and for 4 months after the final dose.
  • Hepatic Impairment: In patients with mild to moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information by clicking here.

IMDC=International Metastatic Renal Cell Carcinoma Database Consortium; TKI=tyrosine kinase inhibitor.

Reference: 1. CABOMETYX® (cabozantinib) Prescribing Information. Exelixis Inc., 2017.

+

Indication and Important Safety Information

Indication

CABOMETYX® (cabozantinib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Hemorrhage: Severe and fatal hemorrhages have occurred with CABOMETYX. In RCC trials, the incidence of Grade ≥3 hemorrhagic events was 3% in CABOMETYX patients. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.