Tivozanib

Tivozanib is a prescription medication used for the treatment of relapsed or refractory advanced renal cell carcinoma in patients previously treated with two or more systemic therapies.

• Tivozanib is available under the following different brand names: Fotivda

Common side effects of Tivozanib include:

• fatigue
• high blood pressure (hypertension)
• diarrhea
• decreased appetite
• nausea
• hoarseness
• hypothyroidism
• cough
• inflammation of the mouth and lips
• bleeding
• vomiting
• shortness of breath
• back pain
• rash
• weight loss
• decreased sodium
• increased lipase
• decreased phosphate

Serious side effects of Tivozanib include:

• unusual bruising or bleeding
• bloody or black and tarry stools
• blood in the urine
• vomiting or coughing up blood
• bleeding from gums
• seizures, headaches, vision changes, or confusion
• redness, swelling, and pain in hands and/or feet
• confusion, headache, dizziness, chest pain, or shortness of breath
• shortness of breath or swelling of ankles

Rare side effects of Tivozanib include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsule

• 0.89 mg
• 1.34 mg

Renal cell carcinoma

Adult dosage

• 1.34 mg orally once a day on Days 1 to 21 of repeated 28-day cycles
• Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Tivozanib has severe interactions with no other drugs.
• Tivozanib has serious interactions with at least 25 other drugs
• Tivozanib has moderate interactions with the following drugs:
  • armodafinil
  • bexarotene
  • brigatinib
  • clobazam
  • elagolix
  • encorafenib
  • eslicarbazepine acetate
  • lorlatinib
  • pexidartinib
  • ponesimod
  • siponimod
  • telotristat ethyl
• Tivozanib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tivozanib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tivozanib?”

Cautions

• May cause fetal harm
• Imprint ink on 0.89-mg capsule contains FD&C yellow No.5 (Tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients; sensitivity is commonly seen in patients who also have aspirin hypersensitivity
• RPLS can occur; evaluate for RPLS in any patient presenting with seizures, headaches, visual disturbances, confusion, or altered mental function
• May cause thyroid dysfunction; monitor thyroid function before initiation of, and periodically throughout, treatment; treat hypothyroidism and hyperthyroidism to maintain euthyroid state before and during treatment
• Can cause serious, sometimes fatal, cardiac ischemia and arterial thromboembolic events; not studied in patients with significant bleeding or who have had an arterial thrombotic event, myocardial infarction, or unstable angina within the preceding 6 months before initiating
• Proteinuria reported; monitor for proteinuria before initiating, and periodically during treatment; discontinue if nephrotic syndrome develops
• Hypertension and hypertensive crisis
  • May cause severe hypertension and hypertensive crisis
  • Median time to onset of hypertension was 2 weeks
  • Not studied in patients with systolic blood pressure (BP) above 150 mmHg or diastolic BP above 100 mmHg
  • Control BP before treatment
  • Monitor BP after 2 weeks and at least monthly thereafter during treatment
  • Treat with antihypertensive therapy when hypertension occurs
  • If therapy is interrupted, monitor patients receiving antihypertensive medications for hypotension
• Cardiac failure
  • Serious, sometimes fatal, cardiac failure may occur
  • Not studied in patients with symptomatic cardiac failure within the preceding 6 months before initiating
  • Periodically monitor for symptoms of cardiac failure throughout treatment
• Risk of impaired wound healing
  • Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway, such as tivozanib
  • Withhold for at least 24 days before elective surgery
  • Do not administer for at least 2 weeks following major surgery and until adequate wound healing
  • Safety of resumption after resolution of wound healing complications has not been established
• Drug interaction overview
  • CYP3A4 substrate; inhibits BCRP
  • Strong CYP3A4 inducers
  • Avoid coadministration
  • Strong CYP3A4 inducers may decrease exposure and efficacy of tivozanib

Pregnancy and Lactation

• No data is available for use
• Verify the pregnancy status of women of reproductive potential before starting treatment
• Contraception
  • Women’s reproductive potential: Use effective contraception during treatment and for 1 month after the last dose
  • Men with women partners of reproductive potential: Use effective contraception during treatment and for 1 month after the last dose
• Fertility
  • Women’s and men’s reproductive potential: Can impair fertility
• Lactation
  • There is no data on the presence of human milk, its effects on breastfed children, or milk production
  • Advise not to breastfeed during treatment and for 1 month after the last dose