A cookie is a piece of information contained in a very small text file that is stored on your computer. Cookies allow a website to identify a user’s device whenever that user returns to the website and are commonly used in order to make websites work more efficiently and enrich the user experience, as well as to provide information to the owners of the site.
We may also use third-party cookies. Third-party cookies are created by domains that are not the sites (or domain) that you are visiting. These cookies are used for our marketing efforts, as well as to understand your browsing of the sites, for example, which page you visit or how long you stay on each page. These types of cookies are set by AVEO affiliates and/or vendors we are working with to enhance end-user experience or may be used to identify visitors to our sites.
We may also use internet tags such as “pixel tags,” which are small graphic files that allow us to monitor the use of our websites. A pixel tag can collect additional information such as IP address, URL, timestamp, browser type and the cookie identification number.
“Do-Not-Track” is an optional browser setting that you can use to express your preferences regarding tracking by advertisers and other third parties. Please note, however, that our website does not have the capability to respond to “Do Not Track” signals received from web browsers at this time. We commit to user privacy by honoring Do Not Track (“DNT”) browser settings.
You can control, opt-out, reject and/or delete cookies as you wish. You can delete all cookies that are already on your computer, and you can set most browsers to prevent them from being placed. If you do this, however, you may have to manually adjust some preferences every time you visit a site and some services and functionalities may not work. For more information about how to manage cookies, please visit https://www.aboutcookies.org/.
You may also control your online behavioral advertising preferences and opt-out from having your data processed by certain marketing companies by visiting http://www.youronlinechoices.com/ and http://optout.aboutads.info/. Please note, however, that managing these preferences will not turn off internet advertisements in general. You will still receive the same number of advertisements, but those advertisements will be less reflective of your interests, as indicated by your web browsing habits. In addition, please note that the opt-out preferences that you set using these tools may be nullified if you delete your cookies after setting them.
Main Cookies AVEO Uses
The table below is a list of the main cookies set by AVEO websites. Please note that we may from time to time modify or update our cookies. When that happens, we will update this list accordingly.
Purpose Classifications and Descriptions for each cookie in the chart below are provided by AVEO’s IT Department.
AVEO Pharmaceuticals, Inc.
Attention: Legal Department
30 Winter Street
Boston, MA 02108
Please allow up to four (4) weeks for us to reply.
Effective on: December 28, 2022
Last Modified on: April 18, 2023
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
Hypertension and Hypertensive Crisis: Hypertension was reported in 45% of FOTIVDA-treated patients with 22% of the events ≥Grade 3. Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.
Cardiac Failure: Cardiac failures were reported in 1.6% of FOTIVDA-treated patients, with 1% of events reported as ≥Grade 3; 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.
Cardiac Ischemia and Arterial Thromboembolic Events: Cardiac ischemia in FOTIVDA-treated patients were reported in 3.2%; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of FOTIVDA-treated patients, including death due to ischemic stroke (0.1%). Closely monitor patients who are at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.
Venous Thrombotic Events: Venous thromboembolic events were reported in 2.4% of FOTIVDA-treated patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue FOTIVDA in patients who develop serious venous thromboembolic events.
Hemorrhagic Events: Hemorrhagic events were reported in 11% of FOTIVDA-treated patients; 0.2% of events were fatal. FOTIVDA should be used with caution in patients who are at risk for or who have a history of bleeding.
Proteinuria: Proteinuria was reported in 8% of FOTIVDA-treated patients, with 2% Grade 3. Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment with FOTIVDA. Discontinue FOTIVDA in patients who develop nephrotic syndrome.
Thyroid Dysfunction: Thyroid dysfunction events were reported in 11% of FOTIVDA-treated patients, with 0.3% of events reported as ≥Grade 3. Monitor thyroid function before initiation and throughout treatment with FOTIVDA.
Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery. Do not administer FOTIVDA for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by MRI, can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue FOTIVDA if signs or symptoms of RPLS occur.
Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.
Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) as an imprint ink which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.
The most commonly reported (≥20%) adverse reactions were: fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. Serious adverse reactions reported in >2% of patients included bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).
Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.
Lactation: Advise women not to breastfeed during FOTIVDA treatment and for at least 1 month after the last dose.
Renal Impairment: The recommended dosage for patients with end-stage renal disease has not been established.
Hepatic Impairment: Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.
To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for FOTIVDA® (tivozanib).