Fotivda (tivozanib)

Fotivda may cause serious side effects, including:

• High blood pressure(hypertension).High blood pressureis common with Fotivda and may sometimes be severe.Fotivda may also cause a sudden, severe increase in your官网地址bwin(hypertensive crisis) that canlead to death.
• Your healthcare provider should check your blood pressure after 2 weeks and at least monthly duringtreatment with Fotivda. Your healthcare provider may prescribe medicine to treat yourhigh blood pressureif youdevelop 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
• 心failure.Fotivda can causeheartfailure 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.
• 心attackandblood clotsin 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:
  • newchest painor pressure
  • numbness orweaknesson one side of your body
  • painin your arms, back, neck or jaw
  • trouble talking
  • shortness of breath
  • sudden severeheadache
  • 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
  • 红色或black stools(looks like tar)
  • menstrual bleeding or阴道提单eedingthat is heavier than normal
  • bruisesthat happen without a known cause or get larger
  • headaches, feeling dizzy or weak
  • bleeding that is severe or you cannot control
  • coughing up bloodor blood clots
  • pink or brown urine
  • vomiting bloodor your vomit looks like “coffee grounds”
  • unexpectedpain, swelling, orjoint 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 ofwoundhealing 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, includingdental 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
  • blindnessor change in vision
  • difficulty thinking
• Allergicreactions 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 bronchialasthma, in certain people. Thisallergic reactionis most often seen in people who also have anallergytoaspirin.

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 includevomitingand weakness orlack of energy.

Fotivda may causefertilityproblems 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 fordiarrhea,nausea, orvomitingprior 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.

Fotivda其他药物的效果

Strong CYP3A Inducers

• Concomitant use of Fotivda with a strong CYP3A inducer decreases tivozanib exposure, which may reduce Fotivda anti-tumoractivity.
• 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 apregnantwoman.
• 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 inhuman milk, or the effects of tivozanib on thebreastfedchild, 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.