Generic drug: tivozanib
Brand name: Fotivda
What is Fotivda (tivozanib), and how does it work?
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.
What are the side effects of Fotivda?
Fotivda may cause serious side effects, including:
- High blood pressure (hypertension). High blood pressure is common with Fotivda and may sometimes be severe. Fotivda may also cause 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 during treatment with Fotivda. Your healthcare provider may prescribe medicine to treat your high blood pressure if you develop blood pressure problems. You should check your blood pressure regularly during treatment with Fotivda Â and tell your healthcare provider if you have increased blood pressure. Tell your healthcare provider right away if you get any of the following signs or symptoms:
- Heart failure. Fotivda can cause heart failure which can be serious, and sometimes lead to death. Your healthcare provider should check you for symptoms of heart failure regularly during treatment with Fotivda. Call your healthcare provider right away if you get symptoms of heart problems, such as shortness of breath or swelling of your ankles.
- Heart attack and blood clots in your veins or arteries. Fotivda can cause blood clots which can be serious, and sometimes lead to death. Tell your healthcare provider or get emergency medical help right away if you get any of the following symptoms:
- Bleeding problems. Fotivda can cause bleeding which can be serious, and sometimes lead to death. Tell your healthcare provider or get medical help right away if you develop any of the following signs or symptoms:
- unusual bleeding from the gums
- red or black stools (looks like tar)
- menstrual bleeding or vaginal bleeding that is heavier than normal
- bruises that happen without a known cause or get larger
- headaches, feeling dizzy or weak
- bleeding that is severe or you cannot control
- coughing up blood or blood clots
- pink or brown urine
- vomiting blood or your vomit looks like “coffee grounds”
- unexpected pain, swelling, or joint pain
- Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with Fotivda.
- Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with Fotivda. Your healthcare provider may prescribe medicine if you develop thyroid gland problems.
- Risk of wound healing problems. Wounds may not heal properly during Fotivda treatment. Tell your healthcare provider if you plan to have surgery before starting or during treatment with Fotivda, including dental surgery.
- You should stop taking Fotivda at least 24 days before planned surgery.
- Your healthcare provider should tell you when you may start taking Fotivda again after surgery.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with Fotivda. Tell your healthcare provider right away if you get:
- Allergic reactions to tartrazine (FD&C Yellow No.5). Fotivda 0.89 mg capsules contain a dye called FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions, including bronchial asthma, in certain people. This allergic reaction is most often seen in people who also have an allergy to aspirin.
The most common side effects of Fotivda include:
- decreased appetite
- low levels of thyroid hormones
- mouth sores
- decreased levels of salt (sodium) and phosphate in the blood
- increased levels of lipase in the blood (a blood test done to check your pancreas)
Fotivda may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Fotivda?
- The recommended dosage of Fotivda is 1.34 mg taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28-day cycle.
- Continue treatment until disease progression or until unacceptable toxicity occurs.
- Take Fotivda with or without food. Swallow the Fotivda capsule whole with a glass of water. Do not open the capsule.
- If a dose is missed, the next dose should be taken at the next scheduled time. Do not take two doses at the same time.
Dose Modifications For Adverse Reactions
- Initiate medical management for diarrhea, nausea, or vomiting prior to dose interruption or reduction.
- If dose modifications are required for adverse reactions, reduce the dosage of Fotivda to 0.89 mg for 21 days on treatment followed by 7 days off treatment for a 28-day cycle.
- Recommendations for dosage modifications are provided in Table 1.
Table 1: Dosage Modifications for Adverse Reactions
|Adverse Reaction||Severity*||Dosage Modifications for Fotivda|
|Cardiac Failure||Grade 3||
|Arterial Thromboembolic Events||Any Grade||
|Hemorrhagic Events||Grade 3 or 4||
|Proteinuria||2 grams or greater proteinuria in 24 hours||
|Reverse Posterior Leukoencephalopathy Syndrome||Any Grade||
|Other Adverse Reactions||Persistent or intolerable Grade 2 or 3 adverse reaction Grade 4 laboratory abnormality||
|Grade 4 adverse reaction||
|*Grades are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE).|
Dosage Modifications For Moderate Hepatic Impairment
- Reduce the recommended dosage of Fotivda to 0.89 mg capsule taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28-day cycle for patients with moderate hepatic impairment.
What drugs interact with Fotivda?
Effect Of Other Drugs On Fotivda
Strong CYP3A Inducers
- Concomitant use of Fotivda with a strong CYP3A inducer decreases tivozanib exposure, which may reduce Fotivda anti-tumor activity.
- Avoid concomitant use of strong CYP3A inducers with Fotivda.
Is Fotivda safe to use while pregnant or breastfeeding?
- Based on findings in animal studies and its mechanism of action, Fotivda can cause fetal harm when administered to a pregnant woman.
- There are no available data on Fotivda use in pregnant woman to inform the drug-associated risk.
- There are no data on the presence of tivozanib in human milk, or the effects of tivozanib on the breastfed child, or on milk production.
- Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during treatment with Fotivda and for one month after the last dose.
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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. Serious side effects include high blood pressure, heart failure, heart attack and blood clots in the veins or arteries, bleeding problems, protein in urine, thyroid gland problems, wound healing problems, and others.
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Related Disease Conditions
Kidney (Renal) Failure
Kidney failure can occur from an acute event or a chronic condition or disease. Prerenal kidney failure is caused by blood loss, dehydration, or medication. Some of the renal causes of kidney failure include sepsis, medications, rhabdomyolysis, multiple myeloma, and acute glomerulonephritis. Post renal causes of kidney failure include bladder obstruction, prostate problems, tumors, or kidney stones.Treatment options included diet, medications, or dialysis.
Kidney pain has a variety of causes and symptoms. Infection, injury, trauma, bleeding disorders, kidney stones, and less common conditions may lead to kidney pain. Symptoms associated with kidney pain may include fever, vomiting, nausea, flank pain, and painful urination. Treatment of kidney pain depends on the cause of the pain.
Kidney Stones (Nephrolithiasis)
Kidney stones are solid masses of crystalline material that form in the kidneys. Symptoms and signs of kidney stones can include pain, nausea, vomiting, and even fever and chills. Kidney stones are diagnosed via CT scans and specialized X-rays. Treatment of kidney stones involves drinking lots of fluids and taking over-the-counter pain medications to medical intervention including prescription medications, lithotripsy, and sometimes even surgery.
Kidney Infection (Pyelonephritis)
Kidney infection (pyelonephritis) usually is caused by E. coli and other bacteria that have spread from the bladder from a UTI (urinary tract infection), poor hygiene, sexual intercourse, pregnancy, catheter, cystoscope exam, surgery, kidney stones, or prostate enlargement. Symptoms of kidney infection include back pain, frequent urination, pain during urination, fever, and or pus or blood in the urine. Kidney infection can be cured with antibiotic treatment. Cranberry juice may prevent UTIs, but that hasn’t been proven in all research studies.
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Renal Artery Stenosis
Renal artery stenosis is a narrowing of the diameter of the renal arteries. When the renal arteries narrow, the result is restricted blood flow to the kidneys, which may lead to impaired kidney function and high blood pressure (referred to as renovascular hypertension (RVHT). Renal artery stenosis can occur in one or both kidneys. The primary cause of renal artery stenosis is atherosclerosis. Symptoms of renal artery stenosis include high blood pressure that does not respond to treatment and severe high blood pressure in individuals younger than 30 or greater than 50 years of age. Renal artery stenosis is diagnosed with imaging and functional tests. Treatment for renal artery stenosis include medication or surgery.
Kidney Pain vs. Back Pain
The signs and symptoms of kidney pain and back pain depend upon the underlying cause. Doctors may use blood tests, X-rays, CT, and/or MRI to diagnose kidney pain and back pain. Treatment may include rest, ice, stretching, muscle strengthening, and pain-relieving medications.
Hypertension-Induced Chronic Kidney Disease
Hypertension-induced chronic kidney disease (CKD) is a long-standing kidney condition that develops over time due to persistent or uncontrolled high blood pressure (hypertension).
Signs of a Kidney Disease
Most of the signs of kidney diseases are unnoticed, ignored, or appear very late in the disease. Over 37 million American adults have kidney diseases, and most are not aware of it.
What Are the 5 Stages of Chronic Kidney Disease?
The doctor will take your complete medical history along with your family history, such as if anyone in your family has or had diabetes, whether you are on any medications (that can cause kidney damage), and so on. They will perform a thorough physical examination to see if you have any signs or symptoms of chronic kidney disease (CKD).
Why Are Calcium Levels Low in Renal Failure?
Renal failure usually causes calcium imbalance. During renal failure, the kidneys may no longer filter out extra phosphorus and remove it from the body or from urine. Over time, phosphorus may increase in the blood. Calcium and phosphorous usually keep each other in check.
Is Kidney Cancer Curable?
Kidney cancer is an uncontrolled division of cells (cancer) that begins in the kidney. How curable is a particular cancer depends on its stage, its cell type, and the stage at which it is diagnosed.
How Can I Improve My Kidney Health? Nine Tips
Kidneys are vital organs involved in performing several important functions in the body. Almost a third of the adults in the United States are at risk of developing kidney diseases. People who are on long-term medications or suffering from conditions such as diabetes and hypertension have a higher risk of kidney diseases.
What Is RCC Stand For?
Renal cell carcinoma (RCC) is the most common type of kidney cancer that accounts for 90% of all cases. Cancerous cells typically develop in the lining of very small filtering tubes in the kidney called tubules. Cancer cells start multiplying and grow out of control forming a tumor in one or both kidneys.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.