Fotivda
Fotivda (tivozanib) is a targeted therapy for treating advanced kidney cancer (renal cell carcinoma). Fotivda (tivozanib) isn't a first-choice treatment, but typically only prescribed if the cancer comes back after or didn’t respond well to previous treatments. Fotivda (tivozanib) is taken by mouth once a day. Some of the more common side effects of this medication include tiredness, diarrhea, and a lowered appetite.
What is Fotivda (tivozanib)?
What is Fotivda (tivozanib) used for?
Advanced renal cell carcinoma (kidney cancer) that has come back or didn’t respond well to 2 or more prior anticancer treatments
How Fotivda (tivozanib) works
Fotivda (tivozanib) is a targeted therapy known as a tyrosine kinase inhibitor (TKI). More specifically, it blocks vascular endothelial growth factor receptors (VEGFRs). These are proteins in cancer cells that provide blood supply to the tumor. By blocking these proteins, Fotivda (tivozanib) prevents blood vessels from forming and supplying blood to the tumor. This helps to slow and stop cancer growth.
Drug Facts
What are the side effects of Fotivda (tivozanib)?
Common Side Effects
- Feeling tired (67%)
- Higher creatinine levels (50%)
- Higher blood sugar levels (50%)
- High blood pressure (44%)
- Diarrhea (43%)
- Lowered appetite (39%)
- Lower phosphate levels (38%)
- Lower sodium levels (36%)
- Higher lipase levels (32%)
- Nausea (30%)
- Higher liver enzyme levels (up to 30%)
- Hoarseness (27%)
- Higher potassium levels (26%)
- Lower magnesium levels (26%)
Other Side Effects
- Hypothyroidism
- Cough
- Mouth sores
- Back pain
- Vomiting
- Rash
- Bleeding
- Weight loss
- Hand-foot syndrome
- Trouble catching your breath
Serious Side Effects
- Heart failure: chest pounding, chest pain, trouble catching your breath, feeling faint or lightheaded, swelling in the legs
- Serious bleeding (general): unusual bleeding, bleeding that’s difficult to stop, easy bruising, blood in urine or stool
- Blood clot in the lungs: cough, chest pain, trouble breathing, racing heart
- Blood clot in the heart: chest pain, stomach discomfort, sweating, nausea, dizziness
- Blood clot in the leg: leg cramp, swelling, pain, muscle tightness
- Dangerously high blood pressure: anxiety, blurry vision, confusion, chest pain, nausea, vomiting, headache
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
- High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
- Increase in blood pressure
- Kidney injury (glomerulonephritis)—decrease in the amount of urine, red or dark brown urine, foamy or bubbly urine, swelling of the ankles, hands, or feet
- Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
- Stomach pain that is severe, does not go away, or gets worse
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Sudden and severe headache, confusion, change in vision, seizures, which may be signs of posterior reversible encephalopathy syndrome (PRES)
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Fotivda (tivozanib)
Pros
Taken by mouth
Taken once daily
Possible option for treating advanced kidney cancer that didn't respond well to other anticancer treatments
Cons
Must remember to take for 3 weeks on, then 1 week off
Raises risks of bleeding, blood clots, and heart failure
Not safe to take while pregnant or breastfeeding
Pharmacist tips for Fotivda (tivozanib)
Take Fotivda (tivozanib) capsules once a day with or without food. Swallow capsules whole with water, don't open, break, or chew the capsules.
If you miss a dose of Fotivda (tivozanib), take your next dose at the next scheduled time. Don't take 2 doses at the same time.
Fotivda (tivozanib) can raise your blood pressure. You should check your blood pressure regularly while taking Fotivda (tivozanib). If your blood pressure starts to rise, your healthcare provider will likely prescribe medications to help lower your blood pressure to a safer range.
If you experience mouth sores or inflammation of the mouth while taking Fotivda (tivozanib), talk to your provider. They can recommend home remedies, such as sucking on ice chips, to help with the pain.
You should let your healthcare provider know if you are planning to have surgery or other types of procedures. Because Fotivda (tivozanib) can make it more difficult for your body to heal from wounds, your provider will typically ask you to stop this medication for 24 days before and at least 2 weeks after your procedure, or until the wounds are fully healed.
Let your provider know if your urine looks cloudy in color. This can be a symptom of kidney problems, a rare side effect of Fotivda (tivozanib). Your provider might need to order lab tests to check your kidney health.
Taking Fotivda (tivozanib) can raise your risk for bleeding. Let your provider know if you have a fall or get injured and they can help check to see if you have any bleeding inside your body. Also, let your provider know if you notice bruises that don’t go away or bleeding that’s difficult to stop because you might need more medical attention.
If you or your partner can have children, use effective birth control while taking Fotivda (tivozanib) and for at least 1 month after stopping the medication.
Fotivda (tivozanib) can harm an unborn baby. If you think you or your partner has become pregnant while you’re taking this medication, tell your healthcare provider right away.
Frequently asked questions about Fotivda (tivozanib)
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What are the risks and warnings for Fotivda (tivozanib)?
Fotivda (tivozanib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Dangerously high blood pressure
Fotivda (tivozanib) can raise your blood pressure, sometimes to dangerously high levels. Some people experienced this within 2 weeks of starting treatment. Your provider will only let you start Fotivda (tivozanib) after your blood pressure is under control. Once you start treatment, they’ll check your blood pressure 2 weeks later and then monthly after that. If your blood pressure starts to rise, your provider might ask you to start blood pressure-lowering medications. If your blood pressure becomes dangerously high, your provider will likely ask you to stop Fotivda (tivozanib) or lower your dosage. Let your provider know if you notice symptoms of dangerously high blood pressure, such as dizziness, confusion, and headaches.
Heart failure
Rarely, Fotivda (tivozanib) can cause heart failure. If so, your provider might recommend that you stop taking this medication (temporarily or permanently) or lower your dosage, depending on how severe it is. To lower your risk of a serious problem, your provider might order an echocardiogram before you start Fotivda (tivozanib) and check you for heart failure symptoms regularly during treatment. Let your provider know right away if you have symptoms like chest pain, trouble breathing, swelling in lower legs or feet, feeling faint or lightheaded, or tiredness.
Blood clots in veins or arteries
Fotivda (tivozanib) can raise your risk for blood clots. Blood clots can form anywhere in your body, including brain (stroke) and heart (heart attack). If you develop a blood clot, your healthcare provider might ask you to stop treatment with Fotivda (tivozanib), depending on how serious. Symptoms of a blood clot might be different depending on the location of the clot. Get medical attention right away if you have any symptoms of blood clots, including trouble walking, blurry vision, breathing problems, chest pain, and swelling in the leg.
Serious bleeding
Fotivda (tivozanib) can raise the risk of serious bleeding, which can be life-threatening. Bleeding can happen in any area of the body, including in the lungs, stomach, and brain. If you experience serious bleeding, your healthcare provider might ask you to stop Fotivda (tivozanib) completely.
Get medical help right away if you experience any serious or unusual bleeding, especially bleeding that’s difficult to stop. Also, get medical attention immediately if you have symptoms of bleeding on the inside of your body, such as nausea, sudden or painful headache, changes in your vision, stomach pain, or are coughing or spitting up blood.
Protein in the urine
Though not common, Fotivda (tivozanib) can raise the risk of kidney injuries. Most of the time, people don’t feel any symptoms, but their labs will show higher protein levels in the urine. To be safe your provider will monitor your kidney health through lab work and by taking urine samples before and while you’re receiving this medication. If you develop kidney problems, your provider might pause or lower your dosage of Fotivda (tivozanib) until your kidney gets better, or permanently discontinue the medication, depending on the severity. Talk to your provider if you notice any changes in how often you urinate (more or less) or any blood in your urine so they can check for kidney issues.
Thyroid problems
Fotivda (tivozanib) can cause thyroid problems like hypothyroidism and hyperthyroidism. Symptoms of thyroid gland problems can include weight loss or weight gain, feeling nervous or anxious, depression, eye or neck swelling, feeling hot or cold, sweating, or changes in menstruation.
Let your healthcare provider know if you have symptoms of thyroid gland problems. They will order lab tests before and during treatment to check your thyroid health. If appropriate, they might start you on thyroid replacement medication.
Surgery and wound healing problems
Fotivda (tivozanib) can make it more difficult for your wound to heal. Let your provider know if you’re planning to have a surgery or procedure, including dental surgery. You shouldn’t take Fotivda (tivozanib) for 24 days before and at least 2 weeks after surgery, and until surgical wounds have fully healed.
Posterior reversible encephalopathy syndrome (PRES)
PRES is a very rare side effect of Fotivda (tivozanib). If you develop symptoms, your provider will order a brain scan called a magnetic resonance imaging (MRI) to check for RPLS. If you do have this condition, then it’s very likely that your provider will ask you to stop Fotivda (tivozanib) treatment. Let your provider know if you have any symptoms of RPLS, like headache, seizures, confusion, vision changes, or difficulty thinking.
Harm to an unborn baby
Fotivda (tivozanib) can cause harm to an unborn baby. If you're a female who’s able to become pregnant, your provider might ask you to take a pregnancy test before you start treatment. Males and females who are taking Fotivda (tivozanib) should use effective birth control while taking Fotivda (tivozanib) and for 1 month after the last dose. Let your provider know right away if you or your partner become pregnant during this time.
Allergic reactions to tartrazine
The 0.89 mg capsule of Fotivda (tivozanib) contains a dye called tartrazine, also known as FD&C Yellow No.5. This dye can cause an allergic reaction, including trouble breathing, in some people. The risk of this is generally low, but might be higher in people who also have an allergy to aspirin.
Fotivda (tivozanib) dosage forms
Typical dosing for Fotivda (tivozanib)
The typical dose of Fotivda (tivozanib) is 1.34 mg by mouth once daily for 21 days out of a 28-day treatment cycle, followed by 7 days off treatment.
This dose might differ if you have liver problems.
What are alternatives to Fotivda (tivozanib)?
Advanced renal cell carcinoma (kidney cancer) that has come back or didn’t respond well to 2 or more prior anticancer treatments
Liver cancer that can’t be removed by surgery
Advanced kidney cancer
Advanced or metastatic differentiated thyroid cancer
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References
Best studies we foundAmerican Cancer Society. (2021). Mouth soreness and pain.
American Cancer Society. (2021). Targeted drug therapy for kidney cancer.
AVEO Pharmaceuticals, Inc. (2022). Fotivda- tivozanib capsule [package insert]. DailyMed.
Centers for Disease Control and Prevention. (2023). Know the risks, signs & symptoms of blood clots infographic.
International Association of Color Manufacturers. (n.d.). Tartrazine.
Kwakman, J. J. M., et al. (2020). Management of cytotoxic chemotherapy-induced hand-foot syndrome. Oncology Reviews.
MedlinePlus. (2023). Phosphate in blood.
Neighbors, C., et al. (2022). Dysphonia. StatPearls.
Sakellakis, M., et al. (2023). Current status of tivozanib in the treatment of patients with advanced renal cell carcinoma. Cureus.
Shibuya, M. (2011). Vascular endothelial growth factor (VEGF) and its receptor (VEGFR) signaling in angiogenesis: A crucial target for anti- and pro-angiogenic therapies. Genes & Cancer.
Sudulagunta, S. R., et al. (2017). Posterior reversible encephalopathy syndrome (PRES). Oxford Medical Case Reports.
Thomson, R. J., et al. (2023). Tyrosine kinase inhibitors. StatPearls.
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