The effectiveness and safety of FOTIVDA was proven in the largest clinical study of people (350 people in total) with relapsed or refractory advanced kidney cancer where at least 2 medicines stopped working. These medicines included an immunotherapy and other treatments, including vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs). During the study, 175 people with advanced RCC were randomly chosen to take FOTIVDA and 175 were chosen to take sorafenib.
FOTIVDA® (tivozanib) is a prescription medicine used to treat adults with advanced kidney cancer (advanced renal cell carcinoma or RCC) that has been treated with 2 or more prior medicines and has come back or did not respond to treatment.
It is not known if FOTIVDA is safe and effective in children.
Possible serious side effects can occur with FOTIVDA. Call or see your healthcare provider right away if you develop:
High blood pressure (hypertension). High blood pressure may be severe, including a sudden, severe increase in your blood pressure (hypertensive crisis) that can lead to death. Your healthcare provider should check your blood pressure after 2 weeks and at least monthly, and may prescribe medicine to treat high blood pressure. You should check your blood pressure regularly and tell your healthcare provider if you have increased blood pressure or experience confusion, headaches, dizziness, chest pain, or shortness of breath.
Heart failure. Heart failure may be serious and sometimes lead to death. Your healthcare provider should check for symptoms of heart failure regularly, such as shortness of breath or swelling of your ankles.
Heart attack and blood clots in your veins or arteries. Blood clots may be serious and sometimes lead to death. Tell your healthcare provider or get emergency medical help right away if you have:
Bleeding problems. Bleeding may be serious and sometimes lead to death. Report or get medical help right away if you have:
Protein in your urine. Your healthcare provider should check your urine for protein before and during treatment.
Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment, and may prescribe medicine if you develop thyroid gland problems.
Risk of wound-healing problems. Wounds may not heal properly during treatment. Tell your healthcare provider if you plan to have surgery before starting or during treatment, including dental surgery.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS). RPLS is a condition that can happen. Tell your healthcare provider right away if you have headaches, seizures, confusion, blindness or changes in vision, or difficulty thinking.
Allergic reactions to tartrazine (FD&C Yellow No. 5). FOTIVDA contains a dye called FD&C Yellow No. 5 (tartrazine) that may cause allergic-type reactions, including bronchial asthma, in certain people. This occurs most often in people who also are allergic to aspirin.
The most common side effects of FOTIVDA include:
Other side effects include vomiting and weakness or lack of energy. FOTIVDA may cause fertility problems in males and females, which may affect your ability to have a child.
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with FOTIVDA if you have certain side effects.
These are not all of the possible side effects of FOTIVDA.
Before taking FOTIVDA, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicine you take and any new medicine, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FOTIVDA with certain other medicines may affect how FOTIVDA works.
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 the Patient Information in the full Prescribing Information for FOTIVDA® (tivozanib).