Tivozanib

What is Tivozanib?

• Tivozanib (Fotivda) is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

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What are the uses of this medicine?

• Tivozanib (Fotivda) medicine is 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.

How does this medicine work?

• Tivozanib is a tyrosine kinase inhibitor.
• In vitro cellular kinase assays demonstrated that tivozanib inhibits phosphorylation of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2 and VEGFR-3 and inhibits other kinases including c-kit and PDGFR β at clinically relevant concentrations.
• In tumor xenograft models in mice and rats, tivozanib inhibited angiogenesis, vascular permeability, and tumor growth of various tumor cell types including human renal cell carcinoma.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant use of strong CYP3A inducers with Fotivda. which may reduce Fotivda anti-tumor activity.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

Recommended dosage

• 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.

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.

Administration

• Take Fotivda exactly as your healthcare provider tells you to take it.
• Take Fotivda 1 time each day for 21 days on treatment, followed by 7 days off treatment. This is 1 cycle of treatment. You will repeat this cycle for as long as your healthcare provider tells you to.
• Fotivda can be taken with or without food.
• Swallow the Fotivda capsule whole with a glass of water. Do not open the capsule.
• If you miss a dose of Fotivda, take your next dose at your next scheduled time. Do not take 2 doses in the same day.
• If you take too much Fotivda, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 1.34 mg and 0.89 mg

This medicine is available in fallowing brand namesː

• Fotivda

What side effects can this medication cause?

The most common side effects of this medicine 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)

Fotivda may cause serious side effects, including:

• High blood pressure (hypertension). High blood pressure is common with Fotivda and may sometimes be severe
• Heart failure
• Heart attack and blood clots in your veins or arteries
• Bleeding problems
• Protein in your urine
• Thyroid gland problems
• Risk of wound healing problems
• Reversible Posterior Leukoencephalopathy Syndrome (RPLS)
• Allergic reactions to tartrazine (FD&C Yellow No.5)

What special precautions should I follow?

• Control blood pressure prior to initiating Fotivda. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the Fotivda dose.
• Monitor for signs or symptoms of cardiac failure throughout treatment with Fotivda.
• Closely monitor patients who are at increased risk cardiac ischemia and arterial thromboembolic events. Permanently discontinue Fotivda for severe arterial thromboembolic events, such as myocardial infarction and stroke.
• Closely monitor patients who are at increased risk for these thromboembolic events. Permanently discontinue Fotivda for severe venous thromboembolic events.
• Closely monitor patients for hemorrhagic events who are at risk for or who have a history of bleeding.
• This medicine may cause Proteinuria. Monitor throughout treatment with Fotivda. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with Fotivda.
• This medicine may cause thyroid dysfunction. Monitor before initiation and throughout treatment with Fotivda.
• Withhold Fotivda for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of Fotivda after resolution of wound healing.
• Discontinue Fotivda if signs or symptoms of reversible posterior leukoencephalopathy syndrome (RPLS) occur.
• This medicine Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

• Overdosage with Fotivda can cause severe hypertension and hypertensive crisis.

Management of Overdose

• There is no specific treatment or antidote for Fotivda overdose.

In cases of suspected overdose, withhold Fotivda, closely monitor patients for hypertension and hypertensive crisis and other potential adverse reactions. Immediately manage signs or symptoms of hypertension and provide other supportive care as clinically indicated.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• The safety and effectiveness of Fotivda in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: tivozanib hydrochloride
• Inactive ingredients: mannitol and magnesium stearate. The capsule contains gelatin, titanium dioxide, FDA yellow iron oxide, and Blue SB-6018 (ink). The 0.89 mg capsule also contains FD&C Blue #2 and Yellow SB-3017 (ink). The Yellow SB-3017 ink contains FD&C Yellow No.5 (tartrazine).

Who manufactures and distributes this medicine?

• Manufactured by: Catalent CTS, Inc.
• Packager: AVEO Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

Storage and Handling

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Keep out of reach of children.

• Dailymed label info on Tivozanib
• FDA Tivozanib

Tivozanib Resources
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