In the study, 175 people took FOTIVDA and 175 people took sorafenib.
Remember that no 2 treatment experiences are the same—you may not get all of these side effects while taking FOTIVDA. Please call your healthcare provider right away if you experience any side effect.
|Possible serious side effects|
|High blood pressure (hypertension)||Heart failure|
|Heart attack and blood clots in your veins or arteries||Bleeding problems|
|Protein in your urine||Thyroid gland problems|
|Risk of wound healing problems||Reversible Posterior Leukoencephalopathy Syndrome (RPLS)|
|Allergic reactions to tartrazine (FD&C Yellow No. 5)|
|Most common side effects|
|Tiredness||Low levels of thyroid hormones|
|Decreased appetite||Mouth sores|
|Nausea||Decreased levels of salt (sodium) and phosphate in the blood|
|Hoarseness||Increased levels of lipases in the blood (a blood test done to check your pancreas)|
More details about these side effects can be found in the Important Safety Information section and the Patient Information in the full Prescribing Information for FOTIVDA.
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).