Fotivda

Fotivda 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.

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  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:
  • confusion
  • headaches
  • dizziness
  • chest pain
  • shortness of breath
• 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:
  • new chest pain or pressure
  • numbness or weakness on one side of your body
  • pain in your arms, back, neck or jaw
  • trouble talking
  • shortness of breath
  • sudden severe headache
  • vision changes
  • swelling in the arms or legs
• 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:
  • headaches
  • seizures
  • confusion
  • blindness or change in vision
  • difficulty thinking
• 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:

• tiredness
• diarrhea
• decreased appetite
• nausea
• hoarseness
• low levels of thyroid hormones
• cough
• 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)

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. 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.

Recommended Dosing

• 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

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.

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.

• 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.