Tivozanib
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]
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Overview
Tivozanib is a tyrosine kinase inhibitor that is FDA approved for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.. Common adverse reactions include • Hypertension and Hypertensive Crisis. • Cardiac Failure. • Cardiac Ischemia and Arterial Thromboembolic Events. • Venous Thromboembolic Events . • Hemorrhagic Events. • Proteinuria. • Gastrointestinal Perforation and Fistula Formation. • Thyroid Dysfunction. • Risk of Impaired Wound Healing. • Reversible Posterior Leukoencephalopathy Syndrome.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.
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.
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.
Capsules:
1.34 mg: bright yellow opaque cap imprinted with "TIVZ" in dark blue ink and a bright yellow opaque body imprinted with "SD" in dark blue ink. 0.89 mg: dark blue opaque cap imprinted with "TIVZ" in yellow ink and a bright yellow opaque body imprinted with "LD" in dark blue ink.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tivozanib in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tivozanib in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Tivozanib FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Tivozanib in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Tivozanib in pediatric patients.
Contraindications
There is limited information regarding Tivozanib Contraindications in the drug label.
Warnings
There is limited information regarding Tivozanib Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Tivozanib Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Tivozanib Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Tivozanib Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Tivozanib in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Tivozanib in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Tivozanib during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Tivozanib in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Tivozanib in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Tivozanib in geriatric settings.
Gender
There is no FDA guidance on the use of Tivozanib with respect to specific gender populations.
Race
There is no FDA guidance on the use of Tivozanib with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Tivozanib in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Tivozanib in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Tivozanib in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Tivozanib in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Tivozanib Administration in the drug label.
Monitoring
There is limited information regarding Tivozanib Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Tivozanib and IV administrations.
Overdosage
There is limited information regarding Tivozanib overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Tivozanib Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Tivozanib Mechanism of Action in the drug label.
Structure
There is limited information regarding Tivozanib Structure in the drug label.
Pharmacodynamics
There is limited information regarding Tivozanib Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Tivozanib Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Tivozanib Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Tivozanib Clinical Studies in the drug label.
How Supplied
There is limited information regarding Tivozanib How Supplied in the drug label.
Storage
There is limited information regarding Tivozanib Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Tivozanib Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Tivozanib interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Tivozanib Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Tivozanib Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.