Exelixis® Terms of Use

Last Updated: February 22, 2016

Welcome to our Sites. We are pleased to provide you with information and links to information regarding our company, products and other topics.

Access and use of any information and/or materials from our website requires that you acknowledge certain of our intellectual property rights and agree to the following terms and conditions ("Terms of Use") and all applicable laws in using the information and materials. These Terms of Use supersede any other agreement between you and Exelixis®, Inc. ("Exelixis®" or "we") covering Exelixis®' Sites located at www.exelixis.com/ and any of our other websites, their respective subdomains, and software applications containing a link to these Terms of Use (collectively, our "Sites") or the contents of any Site. We may change these Terms of Use at any time without notice. If any modification is unacceptable to you, your only recourse is to terminate your use of our Sites. Your continued use of our Sites following our posting or emailing of a change notice or revised Terms of Use as provided in this section will constitute your binding acceptance of the change.

The product and other information provided on our Sites is intended for residents of the United States who are eighteen years of age or older.

ATTENTION: PLEASE READ THESE TERMS OF USE CAREFULLY BEFORE USING THIS SITE. BY USING THIS SITE YOU INDICATE THAT YOU HAVE READ AND UNDERSTAND, AND ACCEPT, WITHOUT LIMITATION OR QUALIFICATION, THESE TERMS OF USE (WHETHER OR NOT YOU CONFIRM YOUR AGREEMENT, SUCH AS BY CLICKING "I AGREE"). IF YOU DO NOT ACCEPT THESE TERMS OF USE, YOU ARE NOT PERMITTED TO USE ANY OF OUR SITES.

IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL 911 IMMEDIATELY.

The Site Content (defined below) is provided for informational purposes only and should not be construed as medical, legal, financial, investment, or other professional advice or opinion. We do not offer personalized medical advice or patient-specific treatment advice. If you are a patient, you should consult a doctor or other qualified health care professional regarding any questions you have about your health or before making any treatment decisions. If you are a doctor or other qualified health care professional, you should not allow the content of this website to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.

YOU SHOULD NEVER DISREGARD OR DELAY SEEKING MEDICAL ADVICE BECAUSE OF SOMETHING THAT YOU HAVE SEEN OR HEARD ON THIS SITE. PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL, BEFORE USING ANY PRODUCT DISCUSSED ON THIS SITE.

Privacy

Our policies concerning the use of your personal information are set forth in the Internet Privacy Statement available here and incorporated by reference herein. By using this Site, you agree to waive and release Exelixis® from any claim or liability in connection with the collection, use, or disclosure of information consistent with the Internet Privacy Statement.

Additional Terms

Some of our Sites, or portions of our Sites, may be subject to additional terms ("Additional Terms"), which will be described in separate policies posted on the applicable Sites. The Additional Terms will supplement these Terms of Use and will control over any conflict between the Additional Terms and these Terms of Use with respect to the specific Site(s), or portions thereof, subject to the Additional Terms.

Limited License

As between you and Exelixis®, Exelixis® its affiliates or partners or other individuals or organizations own all content developed or acquired by us that is on or made available through our Sites, including, but not limited to, pictures, illustrations, designs, icons, text, audio clips, and video clips, as well as any materials accessed through or made available for use or download through any of our Sites (collectively, the "Site Content") and all intellectual property rights therein. Site Content is protected under United States and international copyright laws and is subject to other intellectual property and proprietary rights and Applicable Laws (as defined below). You may view and copy a reasonable amount of the Site Content on the public portions of our Sites solely for non-commercial, personal and informational use. You must abide by all rights notices, information, or restrictions contained in or attached to any Site Content. Any copy of the Site Content you copy shall retain all copyright and other proprietary notices in the same form and manner as on the original. Nothing contained herein shall be construed as conferring any license or right under any Exelixis® copyright or the copyright of the owner other than as expressly set forth herein. No other use of the information is authorized without the express written permission of Exelixis® or the copyright owner. All other rights reserved.

Trademark Information

All trademarks, logos, trade names, trade dress, service marks and products of Exelixis® ("Marks") displayed on our Sites are the property of Exelixis® or third parties and are protected in the United States and internationally. You are not permitted to use these Marks without our prior written consent or the prior written consent of the third party that owns the Mark. Ownership of the Marks and the goodwill associated with them remains with us or those other entities.

Third Party Content Including User Content

Under no circumstances will Exelixis® be liable in any way for any content or materials of any third parties, including, but not limited to, for any errors or omissions in any content, or for any loss or damage of any kind incurred as a result of the use of any such content (collectively, "Third Party Content") on our Sites. We do not control any Third Party Content on our Sites and do not guarantee the availability or display of any Third Party Content. We reserve the right to remove any Third Party Content at any time in our sole discretion. Any opinions, advice, statements, views, positions, services, offers, or other Third Party Content expressed or made available on our Sites are solely those of the respective authors or distributors, and do not necessarily reflect our opinions, views, or position. We do not endorse any particular products, services or treatments. We take no responsibility and assume no liability for any Third Party Content. You use or rely on Third Party Content at your own risk.

Users are solely responsible for all the content including, but not limited to text, photographs, caricatures, illustrations, designs, icons, articles, audio clips, and video clips (collectively, "User Content") that they post, e-mail, or otherwise transmit via this Site. We do not control User Content posted or otherwise transmitted via this Site. We do not guarantee the accuracy, integrity, or quality of such User Content.

Although Exelixis® may from time to time monitor or review discussions, postings, transmissions, bulletin boards, and the like on the Sites, if any, Exelixis® is under no obligation to do so and assumes no responsibility or liability arising from the content of any such elements nor for any error, defamation, libel, slander, omission, falsehood, obscenity, pornography, profanity, danger, or inaccuracy contained in any information within such elements.

Any communications you send to this Site or otherwise to Exelixis® by electronic mail, with the exception of personally identifiable information as defined in the Internet Privacy Statement, shall be deemed to be non-confidential. If your User Content includes any suggestions, ideas, concepts, know how, techniques (including feedback about us, our Sites, or our products) (collectively your "Feedback"): (i) you grant us all necessary rights to use your Feedback; (ii) you acknowledge and agree that we are free to use, disclose, distribute and otherwise act on your Feedback with no financial, credit, or other obligation whatsoever to you, but we are not obligated to use your Feedback in any way; (iii) you acknowledge and agree that we are not obligated to keep your Feedback confidential other than as set forth in the Internet Privacy Statement; and (iv) you represent that your Feedback is entirely your original work.

We have a policy of removing Third Party Content that violates copyright, trademark, or other intellectual property Laws. If you believe your copyright, trademark, or other intellectual property right is being infringed by a user of any of our Sites, please provide written notice to us at info@exelixis.com.

If you believe any materials accessible on or from any of our Sites infringe your copyright, you may request removal of those materials (or access thereto) from any of our Sites by contacting our copyright agent (identified above) and providing the following information:

  • Identification of the copyrighted work that you believe to be infringed.
  • Identification of the material that you believe to be infringing and its location. Please describe the material, and provide us with its URL or any other pertinent information that will allow us to locate the material. Your name, address, telephone number and (if available) e-mail address.
  • A statement that you have a good faith belief that the complained of use of the materials is not authorized by the copyright owner, its agent, or the law.
  • A statement that the information that you have supplied is accurate, and indicating that "under penalty of perjury," you are the copyright owner or are authorized to act on the copyright owner's behalf.
  • A signature or the electronic equivalent from the copyright holder or authorized representative. Our agent for copyright issues relating to this website is the contact indicated at the end of these Terms of Use.
  • If any content that you submitted has been removed as a result of a notification as described above and you believe that such content was posted lawfully, please contact us about our counter-notification procedure through which you can dispute the allegation and request re-posting of the content at issue.

Disclaimers

Although we have attempted to provide accurate information on our Sites, we do not warrant or assume any responsibility for the accuracy or completeness of the Site Content. In particular, we may not update our Sites on a daily or other regular basis. As such, the Site Content may be out of date or include omissions or other errors. We may change the Site Content provided on our Sites at any time without notice.

YOU UNDERSTAND AND AGREE THAT USE OF ANY OF OUR SITES, OUR CONTENT, ANY THIRD PARTY CONTENT, OR ANY THIRD PARTY SERVICES IS AT YOUR SOLE RISK. TO THE MAXIMUM EXTENT PERMITTED BY LAW, THE EXELIXIS® PARTIES DISCLAIM ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, OR STATUTORY, WITH RESPECT TO OUR SITES, OUR SITE CONTENT, ANY THIRD PARTY CONTENT, OR ANY THIRD PARTY SERVICES (INCLUDING, BUT NOT LIMITED TO, THE IMPLIED OR STATUTORY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, TITLE, QUIET ENJOYMENT, AND NON-INFRINGEMENT AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING, USAGE, OR TRADE). IN PARTICULAR, THE EXELIXIS® PARTIES (AS DEFINED BELOW) DO NOT REPRESENT OR WARRANT THAT ANY INFORMATION OR OTHER CONTENT OBTAINED OR VIEWED BY YOU AS A RESULT OF YOUR USE OF OUR SITES WILL BE ACCURATE OR RELIABLE, OR THAT YOUR ACCESS TO OUR SITES OR SITE CONTENT WILL BE UNINTERRUPTED, SECURE OR ERROR-FREE. THE EXELIXIS® PARTIES DO NOT WARRANT THAT THE SITES OR FILES AVAILABLE FOR DOWNLOAD WILL BE FREE OF VIRUSES, WORMS, TROJAN HORSES OR OTHER DESTRUCTIVE PROGRAMMING. THE EXELIXIS® PARTIES DISCLAIM ALL EQUITABLE INDEMNITIES.

ALL SITE CONTENT IS PROVIDED ON AN "AS IS" AND "AS AVAILABLE" BASIS WITHOUT WARRANTY OF ANY KIND.

You assume the entire risk as to the results and performance of this Site.

Use of This Site

You agree not to do any of the following while visiting or using this Site or any functionality provided by or through this Site:

Impersonate or misrepresent your affiliation with any person or entity;

Except as expressly permitted by the rules of this Site, post or transmit any unsolicited advertising, promotional materials, junk mail, spam, or any other form of solicitation on this Site;

Post or transmit any information or material that is defamatory, invasive of another's privacy, offensive, abusive, indecent, obscene, tortious, discriminatory, hateful, unlawful or otherwise objectionable;

Post or transmit any information or software which contains a virus, Trojan horse, worm, adware, malware, spyware, or other harmful components;

Post or transmit any information or software to infringe any copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy of any party;

Post or transmit any unsolicited or unauthorized advertising or promotional materials;

Post or upload information or content that is false, inaccurate, or misleading;

Interfere with or disrupt any Sites or any software, hardware, telecommunications equipment or networks used by Exelixis®;

Further or promote any criminal activity or enterprise or provide instructional information about illegal activities;

Violate the Terms of Use or any applicable law, rule, order or regulation, including without limitation any local, state, provincial national or international law, any export control laws, or any regulations promulgated by any state or federal authority (collectively "Applicable Law");

Access or use or attempt to access or use password protected, secure or non-public areas of this Site without authorization;

Frame, repackage, or otherwise re-distribute any portion of this Site; or

Interfere with others' use and enjoyment of our Sites (for example, by spamming, soliciting or overly promoting personal interests).

Exelixis® may, at its sole discretion, take any action we deem necessary, including, but not limited to, removal of content from our Sites, suspension or termination of access of violators to this Site and reporting violations to the law enforcement authorities, if we believe, in our sole discretion, that a user's conduct or content violates the terms and conditions provided in these Terms of Use or may create liability for Exelixis®, its affiliates, partners, suppliers or other users. Exelixis® will not be liable to you or any third party as a result of any such actions. The terms and conditions provided in the Terms of Use will survive any such termination.

You agree that you will release, indemnify and hold harmless us, our affiliates (if any), and our or their respective content providers, collaborators, suppliers, distributors, or customers, and any of our or their respective officers, directors, employees, contractors, representatives, or agents (collectively, the "Exelixis® Parties") for any and all claims, actions, losses, damages and expenses (including attorneys' fees) arising out of or resulting from: (i) your use of our Sites or any Site Content; (ii) Your User Content; (iii) your connection to our Site; (iv) your violation of these Terms of Use; or (v) your violation of any rights of another. If you are a California resident, you waive California Civil Code Section 1542, which says: "A general release does not extend to claims which the creditor does not know or suspect to exist in his favor at the time of executing the release, which if known by him must have materially affected his settlement with the debtor." If you are a resident of another jurisdiction, you waive any comparable statute or doctrine.

Limitation of Liability

YOU UNDERSTAND AND AGREE THAT TO THE EXTENT PERMITTED UNDER APPLICABLE LAW, IN NO EVENT WILL ANY OF THE EXELIXIS® PARTIES BE LIABLE UNDER ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT, STATUTORY, OR OTHERWISE) FOR ANY DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, PERSONAL INJURY/WRONGFUL DEATH, PUNITIVE OR EXEMPLARY DAMAGES, OR LOST PROFITS, (EVEN IF SUCH PARTIES WERE ADVISED OF, KNEW OF OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES), INCLUDING BUT NOT LIMITED TO AS A RESULT OF: (A) YOUR USE OF OR INABILITY TO USE ANY OF OUR SITES, (B) ANY OF OUR SITE CONTENT, ANY THIRD PARTY CONTENT, OR ANY THIRD PARTY SERVICES AVAILABLE THROUGH ANY OF OUR SITES OR (C) ANY LOSS OF DATA. SHOULD ANY EXELIXIS® BE FOUND TO BE LIABLE TO YOU OR ANY THIRD PARTY NOTWITHSTANDING THE FOREGOING, SUCH LIABILITY WILL NOT EXCEED $100.00 IN THE AGGREGATE.

Some jurisdictions do not allow the exclusion of certain warranties or the limitation or exclusion of liability for incidental or consequential damages. Accordingly, some of the above limitations and disclaimers may not apply to you. To the extent that we may not, as a matter of Applicable Law, disclaim any implied warranty or limit our liabilities, the scope and duration of such warranty and the extent of liability of the Exelixis® Parties will be the minimum permitted under such Applicable Law.

Forward-Looking Statements

This Site may contain forward-looking statements within the meaning of the federal securities laws, specifically the Securities Litigation Reform Act of 1995, including without limitation, statements related to: the continued development and clinical, therapeutic and commercial potential of, and opportunities for, cabozantinib or any other compounds; the continued development and clinical, therapeutic and commercial potential of, and opportunities for, Exelixis®' partnered compounds and programs; future periods; future events; and future operating and financial plans and performance. Any statements contained in this Site that are not statements of historical fact may be deemed to be forward-looking statements. Words such as "anticipates," "believes," "continue," "demonstrate," "estimates," "expects," "forecast," "goal," "intends," "may," "objective," "outlook," "plans," "potential," "should," "will" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Exelixis®' current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Exelixis®' actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: risks related to the potential failure of cabozantinib or any other compounds to demonstrate safety and efficacy in clinical testing; Exelixis®' ability to conduct clinical trials of cabozantinib or any other compounds sufficient to achieve a positive completion; the availability of data at the referenced times; the sufficiency of Exelixis®' capital and other resources; the uncertain timing and level of expenses associated with the development of cabozantinib or any other compounds; the uncertainty of the FDA approval process; risks related to the potential failure of Exelixis®' partnered compounds and programs to demonstrate safety and efficacy in clinical testing; Exelixis®' dependence on its relationships with its collaboration partners with respect to its partnered compounds and programs; Exelixis®' ability to maintain its rights under its collaborative agreements; timely receipt of potential reimbursements, milestones, royalties and profits under Exelixis®' collaborative agreements; Exelixis®' ability to enter into new collaborations; market competition; and changes in economic and business conditions. These and other risk factors are discussed under "Risk Factors" and elsewhere in Exelixis®' periodic reports filed with the Securities and Exchange Commission (SEC), including Exelixis®' most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and Exelixis®' other filings with the SEC. Exelixis® expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained in this Site to reflect any change in Exelixis®' expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Third Party Services and Sites

Portions of our Sites may allow you to use third party products and services, e.g., social networking services, and our Sites may contain hyperlinks to websites owned and/or controlled by other parties (such products, services and websites, collectively "Third Party Services"). Access to any other website is at your own risk; we are not responsible for the accuracy or reliability of any information accessible from these websites or any other aspect of Third Party Services and we do not make any representations or warranties about them. Third party linked websites and their contents should not be attributed to Exelixis® in any manner. We provide these hyperlinks merely as a convenience and we do not approve or endorse any Third Party Services, their content, or any views expressed on any Third Party Service, nor are our Sites approved or endorsed by any Third Party Services. Your use of Third Party Services is subject to the license agreements, terms and conditions, privacy policies, and other policies and agreements applicable to such Third Party Services.

Governing Law and Jurisdiction

We reserve our right to any remedy available at law or equity in the event of your breach of these Terms of Use. All matters relating to your access to, or use of, our Sites shall be governed by U.S. federal law and the laws of the State of California without regard to conflicts of laws principles. Any legal action or proceeding relating to your access to, or use of, our Sites shall be instituted in a state court in San Mateo County, California or the U.S. district court for the Northern District of California. We and you hereby irrevocably submit to the exclusive personal jurisdiction of such courts for such purpose and waive any objection to such courts on any basis, including without limitation improper venue or inconvenience of the forum. You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to use of our Sites or these Terms of Use must be filed within one (1) year after such claim or cause of action arose or be forever barred. You may only resolve disputes with us on an individual basis and may not bring and expressly waive bringing a claim as a plaintiff or a class member in a class, consolidated, or representative action. Class arbitrations, class actions, private attorney general actions, and consolidation with other arbitrations are not allowed. YOU HEREBY WAIVE YOUR RIGHT TO A JURY TRIAL IN ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF YOUR USE OF OUR SITES OR THESE TERMS OF USE.

Refusal of Service; Modification of Sites; Termination

We reserve the right to refuse service, disable or prohibit logins, remove or edit content (including Third Party Content), limit access to content, or modify or discontinue any of our Sites or features on any of our Sites in our sole discretion. We may terminate, suspend, or modify your access to all or part of any of our Sites, without notice, if you violate these Terms of Use or you engage in any conduct that we, in our sole and absolute discretion, believe is in violation of any Applicable Law or is otherwise harmful to the interests of us, any other user of any of our Sites, or any third party.

Electronic Communications Notice

When you use our Sites or send emails to us, you are communicating with us electronically. You consent to receiving communications from us electronically. We may communicate with you by email or posting notices on the applicable Site. You agree that all agreements and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing. In order to access any such communications, you must have a computer or other Internet-enabled device. In order to retain copies of any such communications, you must have a printer or data storage device. If you have a printer, you may print paper copies of any such communications for your own use. If you wish to withdraw your consent for us to communicate with you electronically, you may not use our Sites.

Mobile Site

Our Sites may include certain services that are available via a mobile device, including (i) the ability to upload content to our Sites via a mobile device and (ii) the ability to browse our Sites from a mobile device (collectively, the "Mobile Site"). To the extent you access our Service through a mobile device, your wireless service carrier's standard charges, data rates and other fees may apply. In addition, downloading, installing, or using certain elements of the Mobile Site may be prohibited or restricted by your carrier, and not all aspects of the Mobile Site may work with all carriers or devices. By using the Mobile Site, you agree that we may communicate with you regarding Exelixis® by electronic means and that certain information about your usage of the Mobile Site may be communicated to us.

Miscellaneous

These Terms of Use, together with the Internet Privacy Statement and any Additional Terms constitute the entire and exclusive agreement between us with respect to their subject matter, and govern your use of our Sites, superseding any prior agreements or negotiations between us with respect to that subject matter. Our failure to exercise or enforce any right or provision of these Terms of Use will not constitute a waiver of such right or provision. If any provision of these Terms of Use is found by a court of competent jurisdiction to be invalid, you nevertheless agree that the court should endeavor to give effect to our intentions as reflected in the provision, and that the other provisions of these Terms of Use remain in full force and effect. The section titles in these Terms of Use are for convenience only and have no legal or contractual effect.

Access to and use of this Site is subject to the above terms and conditions. This information is intended only for residents of the United States.

© 2016 Exelixis®, Inc. All rights reserved.

Indication

CABOMETYX™ (cabozantinib) is indicated for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.

Important Safety Information

Hemorrhage: Severe hemorrhage occurred with CABOMETYX™. The incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also occurred in the cabozantinib clinical program. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.

Gastrointestinal (GI) Perforations and Fistulas: Fistulas were reported in 1.2% (including 0.6% anal fistula) of CABOMETYX-treated patients and 0% of everolimus-treated patients. GI perforations were reported in 0.9% of CABOMETYX-treated patients and 0.6% of everolimus-treated patients. Fatal perforations occurred in the cabozantinib clinical program. Monitor patients for symptoms of fistulas and perforations. Discontinue CABOMETYX in patients who experience a fistula that cannot be appropriately managed or a GI perforation.

Thrombotic Events: CABOMETYX treatment results in an increased incidence of thrombotic events. Venous thromboembolism was reported in 7.3% of CABOMETYX-treated patients and 2.5% of everolimus-treated patients. Pulmonary embolism occurred in 3.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated patients. Events of arterial thromboembolism were reported in 0.9% of CABOMETYX-treated patients and 0.3% of everolimus-treated 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: CABOMETYX treatment results in an increased incidence of treatment-emergent hypertension. Hypertension was reported in 37% (15% Grade ≥3) of CABOMETYX-treated patients and 7.1% (3.1% Grade ≥3) of everolimus-treated 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 for severe hypertension that cannot be controlled with anti-hypertensive therapy. Discontinue CABOMETYX if there is evidence of hypertensive crisis or severe hypertension despite optimal medical management.

Diarrhea: Diarrhea occurred in 74% of patients treated with CABOMETYX and in 28% of patients treated with everolimus. Grade 3 diarrhea occurred in 11% of CABOMETYX-treated patients and in 2% of everolimus-treated 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. Dose modification due to diarrhea occurred in 26% of patients.

Palmar-Plantar Erythrodysesthesia Syndrome (PPES): PPES occurred in 42% of patients treated with CABOMETYX and in 6% of patients treated with everolimus. Grade 3 PPES occurred in 8.2% of CABOMETYX-treated patients and in <1% of everolimus-treated patients. Withhold CABOMETYX in patients who develop intolerable Grade 2 PPES or Grade 3 PPES until improvement to Grade 1; resume CABOMETYX at a reduced dose. Dose modification due to PPES occurred in 16% of patients.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in the cabozantinib clinical program. Perform an evaluation for RPLS in any patient 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 when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the last dose.

Adverse Reactions: The most commonly reported (≥25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting, weight decreased, and constipation.

Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.

Lactation: Advise a lactating woman not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose.

Reproductive Potential: Contraception―Advise females of reproductive potential to use effective contraception during treatment with CABOMETYX and for 4 months after the final dose. Infertility―CABOMETYX may impair fertility in females and males of reproductive potential.

Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-Pugh score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information by clicking here.

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Indication and Important Safety Information

Indication

CABOMETYX™ (cabozantinib) is indicated for the treatment of advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.

Important Safety Information

Hemorrhage: Severe hemorrhage occurred with CABOMETYX™. The incidence of Grade ≥3 hemorrhagic events was 2.1% in CABOMETYX-treated patients and 1.6% in everolimus-treated patients. Fatal hemorrhages also occurred. Do not administer CABOMETYX to patients that have or are at risk for severe hemorrhage.