Many medicines are available to treat kidney cancer. If one treatment doesn’t help or stops working, your health care provider may recommend another option. If you or a loved one has kidney cancer and already tried multiple treatments, your health care provider may recommend a medicine called Fotivda (tivozanib).
Fotivda is commonly used for certain people with advanced renal cell carcinoma (RCC), the most common type of kidney cancer. RCC starts in the lining of the small tubes in the kidney and can be challenging to treat, especially when the cancer comes back or has not improved with other medicines.
Fotivda belongs to a group of medicines called tyrosine kinase inhibitors (TKIs). TKIs are a type of targeted therapy that block signals cancer cells use to grow. By interfering with these signals, Fotivda can help slow down the growth and spread of RCC.
Fotivda may also be used in other situations, as determined by your health care provider. Below are frequently asked questions and answers about Fotivda for RCC.
Is Fotivda Right for Me?
When recommending a treatment plan, your health care provider will consider factors like the type of kidney cancer you have, how much it has spread, and which cancer treatments you have already used. They will also review your medical history to see if Fotivda is right for you.
Fotivda is FDA-approved to treat renal cell carcinoma (RCC) in adults whose cancer meets all of the following requirements.
- The cancer has returned (relapsed) or has not improved with other treatments (refractory).
- The cancer has already been treated with two or more cancer medicines that affect the whole body (such as pills or injections).
Fotivda is only approved for use in adults. It is not known if this medicine is safe or effective for children.
How Does Fotivda Work for RCC?
Fotivda is a type of medicine called a tyrosine kinase inhibitor (TKI). Tyrosine kinases are proteins that play an important role in normal cell functions, such as sending signals and controlling growth. In some cancers, these proteins can become overactive or appear in higher amounts, which helps cancer cells grow and survive.
One group of kinases, called VEGF receptors (VEGFRs), is involved in a signaling pathway that triggers the growth of new blood vessels. Tumors use these blood vessels to bring in oxygen and nutrients that support their growth.
Fotivda blocks VEGFRs that control this blood vessel growth, including VEGFR-1, VEGFR-2, and VEGFR-3. By shutting down these signals, Fotivda can help slow or stop the supply lines that feed the tumor. It also blocks other growth-related signals inside cancer cells.
While Fotivda does not cure kidney cancer, it can help manage the disease by slowing its growth and spread.
How Do I Take Fotivda?
Fotivda comes as a capsule that’s taken by mouth, with or without food. Fotivda can cause nausea as a side effect, so some people may find it easier on the stomach if they take it with food. Swallow the capsule whole with a glass of water. Do not open the capsule.
Fotivda is usually given in a 28-day cycle. You probably will repeat this 28-day treatment cycle for as long as the medicine is helping your cancer and the side effects are manageable. If you have severe side effects, your health care provider may pause treatment and/or lower your dose of Fotivda.
Take Fotivda exactly as prescribed. The recommended dosage of Fotivda is 1.34 milligrams (mg) once daily for 21 days in a row, followed by seven days without any doses. In some cases, your health care provider may adjust your dose. For example, if you have liver problems, your dosage may be 0.89 mg once daily for 21 days, followed by seven days off, for each 28-day cycle.
How Was Fotivda Studied for RCC?
Fotivda was studied in a clinical trial called TIVO-3, which compared Fotivda to another medicine called sorafenib (Nexavar). The goal was to see how well Fotivda works and how safe it is for adults with advanced renal cell carcinoma (RCC) whose cancer had come back (relapsed) or had not responded to earlier treatments (refractory).
To join the study, people had to have relapsed or refractory advanced RCC that had already been treated with two or three other medicines, including at least one VEGF-targeted treatment before (but not sorafenib or Fotivda). In addition, people could not join the study if they already tried more than three treatments or if their cancer had spread to their brain or spinal cord (central nervous system).
A total of 350 adults took part in the study. They ranged in age from 30 to 90 years, with a median age of 63. Most were male (73%) and the rest were female (27%). Most were White (95%), 1% were Asian, less than 1% were Black or African American, and 4% identified as other or unknown races.
Before joining the trial, all participants had already tried different types of treatment:
- Some had taken two other tyrosine kinase inhibitors (TKIs) (45%)
- Some had taken a TKI plus an immune checkpoint inhibitor (26%)
- Some had taken a TKI plus another type of cancer medicine that affects the whole body (29%)
At the start of the trial, risk scores showed that about 20% of people had a favorable outlook, 61% had an intermediate outlook, and 19% had a poor outlook.
People who joined the study were randomly placed into two groups. One group took Fotivda, and the other group took sorafenib. Everyone stayed on treatment as long as it was working and side effects were manageable.
The main goal of the TIVO-3 trial was to measure progression-free survival (PFS) — the length of time people lived without their cancer getting worse. To assess this, an independent group of experts reviewed scans and test results without knowing which treatment people received.
What Are the Main Benefits of Fotivda Based on the Study?
The main benefit of Fotivda is that it can help people with advanced kidney cancer live longer without their cancer getting worse. Results from the TIVO-3 clinical trial showed that Fotivda worked better than sorafenib when comparing progression-free survival (PFS).
- People who took Fotivda went 5.6 months before their cancer got worse or they died, compared to 3.9 months for those who took sorafenib. Note that these are median values, meaning the middle point when looking at everyone’s results from shortest to longest.
Your results may be different from what was seen in the study. Talk to your health care provider about how they will track your progress and what to expect during Fotivda treatment.
Does Fotivda Work for People Who Have Tried Inlyta (axitinib) for RCC?
You may wonder if Fotivda could be helpful for your cancer if you have already tried a medicine called Inlyta (axitinib).
Out of 350 people in the trial, about half (172 people) had been treated with Inlyta in the past. As explained above, progression-free survival was longer among people in this study who took Fotivda as compared with those who took sorafenib.
So, Fotivda may be a treatment option for people who took Inlyta in the past. You and your health care provider can decide if Fotivda is a good option for you.
What Can I Do to Prevent or Manage Side Effects of Fotivda?
The information below includes some of the common side effects of Fotivda seen in studies and possible ways to manage them. This is not a complete list of side effects. Tell your health care provider if these side effects bother you or do not go away. They may let you know about other ways to prevent or manage Fotivda side effects.
Fatigue or lack of energy. Fatigue was the most common side effect, seen in nearly 70% of people taking Fotivda during the clinical trial. For most people it was mild, while for others it was more severe and sometimes led to their health care provider adjusting their dose or pausing or stopping the medicine.
- Strategies to help manage this side effect: Try to stay active with light exercise like walking or stretching, and follow a daily routine. Focus on important tasks when you have the most energy. Aim for seven to eight hours of sleep, and take short naps when needed. Eat a balanced diet with enough calories and nutrients to energize your body.
High blood pressure. In the clinical trial, high blood pressure was common, affecting nearly half of people taking Fotivda. In rare cases, blood pressure became dangerously high. Because of this, careful monitoring and early management are very important. If necessary, your doctor may prescribe blood pressure medicines or adjust your Fotivda dose or treatment plan.
- Strategies to help manage this side effect: Your health care provider probably will check and control your blood pressure before you start Fotivda and continue to monitor it regularly during treatment. You can also check your blood pressure at home, keep track of your numbers, and report any significant changes. Lifestyle changes can support healthy blood pressure. This includes following a heart-healthy diet, staying active, managing stress, limiting alcohol, and avoiding smoking.
Diarrhea. Diarrhea was one of the more common side effects for people taking Fotivda in the clinical trial. It can lead to dehydration if not addressed.
- Strategies to help manage this side effect: To manage diarrhea, stay hydrated by drinking clear fluids such as water, broth, or electrolyte drinks. Eating bland foods like bananas, rice, applesauce, and toast may also help. Keep track of how often it happens and let your health care team know if it is frequent, severe, or does not improve. They may recommend antidiarrheal medicine or adjust your treatment if needed.
Low appetite. Nearly 40% of people taking Fotivda in the trial had decreased appetite. For most people, this side effect was manageable, but for others it was more severe and sometimes led to their health care provider lowering their dose or pausing the medicine.
- Strategies to help manage this side effect: You can support your body by focusing on high-calorie, nutrient-rich foods that are easy to eat, such as yogurt or smoothies. Drinking most of your fluids between meals instead of during them may help you feel less full at mealtime. If appetite loss continues, your doctor may refer you to a dietitian and/or prescribe medicines to help stimulate your appetite.
Nausea. About a third of people who took Fotivda in the clinical trial reported nausea. For most people, it was mild, while for some it was more severe and sometimes led to their health care provider pausing the medicine.
- Strategies to help manage nausea: Eating small, frequent meals and sipping cool, clear liquids slowly throughout the day may ease nausea. Choose bland foods that are gentle on the stomach, such as crackers, toast, or broth. Sucking on sour candies or mints can sometimes help with queasiness. If needed, your doctor may prescribe anti-nausea medicines.
Other, more serious side effects are possible while taking Fotivda. If you are having new or worsening symptoms that bother you or feel severe, tell your health care provider or get medical care right away.
Is There Any Cost Assistance Available?
A cost assistance program is available from Aveo Pharmaceuticals, the drugmaker of Fotivda. It may reduce the amount you pay. Whether you qualify to enroll may depend on what type of insurance you have or if you are uninsured. Visit www.fotivda.com/patient-support for more information about Fotivda costs and copay savings.
You can also contact the drugmaker at 833-368-4832 to connect with a representative for financial support information and other resources.
