Tivozanib
Tivozanib is a kinase inhibitor (a targeted cancer pill) used to treat adult patients with advanced kidney cancer (renal cell carcinoma) that has come back or stopped responding after other treatments.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Tivozanib (Fotivda) is a kinase inhibitor that blocks the VEGF receptors tumors use to grow new blood vessels. It is reserved for adults with advanced kidney cancer (renal cell carcinoma) that has returned or resisted two or more earlier treatments, and it has been on the U.S. market for several years. Among drugs of its type it is often considered easier to tolerate, though tiredness, diarrhea, poor appetite and a hoarse voice are common. The one thing to watch is blood pressure, which can climb sharply and should be checked at two weeks and at least monthly, alongside heart, thyroid, bleeding and urine protein checks.
Clinical pearls
- It runs in 28-day cycles, 21 days on and 7 days off, so mark the off-week rather than taking it continuously.
- Tell any surgeon, because it must be stopped at least 24 days before elective surgery and restarted only once wounds heal.
- Strong CYP3A inducers (drugs that speed up a liver enzyme) lower tivozanib levels, so have new medicines and supplements checked first.
- Both women and men need effective contraception during treatment and for one month after the last dose.
Patient information guide A plain-language walkthrough of Tivozanib, written from its FDA label.
What Tivozanib is used for
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Tivozanib is used for one type of cancer:
- Fotivda (capsule, by mouth) treats adults with relapsed or refractory advanced renal cell carcinoma (kidney cancer) after two or more prior systemic therapies.
How Tivozanib works
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Tivozanib is a tyrosine kinase inhibitor. It blocks VEGF receptors 1, 2 and 3, along with other kinases such as c-kit and PDGFR beta. These signals help tumors form blood vessels and grow.
In animal tumor models, tivozanib reduced new blood vessel growth, vessel leakiness and tumor growth, including human kidney cancer.
Tivozanib dosage
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Fotivda is a capsule taken by mouth once a day, with or without food. The usual pattern is 21 days on, then 7 days off, making a 28-day cycle.
- Swallow it whole with water. Do not open the capsule.
- If you miss a dose, take the next one at the regular time. Do not double up.
- Your doctor may pause or lower your dose to manage side effects.
- Your dose is lowered if you have moderate liver impairment.
Follow your prescriber and the label for your exact dose.
Dosing details from the FDA-approved label
From the Tivozanib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosing (general)
- 1.34 mg taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28-day cycle, with or without food, until disease progression or unacceptable toxicity
- Swallow capsule whole with a glass of water; do not open the capsule. If a dose is missed, take the next dose at the next scheduled time; do not take two doses at the same time
- Dose modification for adverse reactions
- 0.89 mg for 21 days on treatment followed by 7 days off treatment for a 28-day cycle
- Initiate medical management for diarrhea, nausea, or vomiting prior to dose interruption or reduction
- Moderate hepatic impairment
- 0.89 mg capsule taken orally once daily for 21 days on treatment followed by 7 days off treatment for a 28-day cycle
- Reduced dose for moderate hepatic impairment
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended Dose: 1.34 mg once daily with or without food for 21 days on treatment followed by 7 days off treatment (28-day cycle) until disease progression or unacceptable toxicity. ( 2.1 ) Dose interruptions and/or dose reduction may be needed to manage adverse reactions. ( 2.2 ) For patients with moderate hepatic impairment, reduce the dose to 0.89 mg for 21 days on treatment followed by 7 days off treatment (28-day cycle). ( 2.3 ) 2.1 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. 2.2 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 Adverse Reaction Severity Grades are based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). Dosage Modifications for FOTIVDA Hypertension [see Warnings and Precautions (5.1) ] Grade 3 Withhold for Grade 3 that persists despite optimal anti-hypertensive therapy. Resume at reduced dose when hypertension is controlled at less than or equal to Grade 2. Grade 4 Permanently discontinue. Cardiac Failure [see Warnings and Precautions (5.2) ] Grade 3 Withhold until improves to Grade 0 to 1 or baseline. Resume at a reduced dose or discontinue depending on the severity and persistence of adverse reaction. Grade 4 Permanently discontinue. Arterial Thromboembolic Events [see Warnings and Precautions (5.3) ] Any Grade Permanently discontinue. Hemorrhagic Events [see Warnings and Precautions (5.5) ] Grade 3 or 4 Permanently discontinue.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Tivozanib side effects
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The most common side effects (in at least 1 in 5 people) include:
Common side effects
- Fatigue
- High blood pressure
- Diarrhea
- Decreased appetite
- Nausea
- Hoarse or weak voice (dysphonia)
- Underactive thyroid (hypothyroidism)
- Cough and mouth sores (stomatitis)
When to get medical help
- Call your doctor right away if you have severe headaches, seizures, vision changes, confusion or altered thinking. These can be signs of reversible posterior leukoencephalopathy syndrome (RPLS).
- Get help for signs of a heart attack or stroke, such as chest pain or sudden weakness.
- Get help for signs of heart failure or blood clots in the veins or arteries.
- Report serious or unusual bleeding.
- Report severe stomach pain, which could signal a gastrointestinal perforation (a hole in the gut wall).
- Tell your doctor about very high blood pressure readings.
- Tell your doctor if you develop significant protein in the urine or kidney problems.
- Tell your doctor if you notice thyroid problems.
Serious reactions can include dangerous blood pressure, heart failure, heart attack, stroke, blood clots, bleeding, gut perforation and RPLS. Contact your care team right away if you notice warning signs.
Tivozanib warnings and precautions
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- High blood pressure: can be severe, including hypertensive crisis. Control it before starting and monitor it throughout.
- Heart failure, heart ischemia and clots: can be serious and sometimes fatal. Tell your doctor about any history of these.
- Bleeding: can be serious. Tell your doctor about any bleeding history.
- Protein in the urine: your urine is monitored. Kidney injury has occurred.
- Gut perforation and fistulas: report severe stomach pain.
- Thyroid problems: thyroid function is checked before and during treatment.
- Wound healing: Fotivda must be stopped before and after surgery.
- RPLS: seizures, headache, vision changes or confusion need prompt evaluation.
- Pregnancy: can harm an unborn baby.
Tivozanib interactions
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One interaction is highlighted:
- Strong CYP3A inducers lower tivozanib levels, which may reduce its anti-cancer effect. Avoid using them together.
Interactions listed in the FDA-approved label
From the Tivozanib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A inducers: Concomitant use decreases tivozanib exposure, which may reduce FOTIVDA anti-tumor activity. Avoid concomitant use of strong CYP3A inducers with FOTIVDA.
Read the label’s full interactions text
7 DRUG INTERACTIONS CYP3A Inducers: Avoid concomitant use of strong CYP3A inducers. ( 7.1 ) 7.1 Effect of Other Drugs on FOTIVDA Strong CYP3A Inducers Concomitant use of FOTIVDA with a strong CYP3A inducer decreases tivozanib exposure [see CLINICAL PHARMACOLOGY (12.3) ], which may reduce FOTIVDA anti-tumor activity. Avoid concomitant use of strong CYP3A inducers with FOTIVDA.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Tivozanib
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- There are no listed contraindications.
- Pregnancy: it can cause fetal harm. Pregnancy status is checked before treatment. Use effective contraception during treatment and for one month after the last dose.
- Breastfeeding: do not breastfeed during treatment and for one month after the last dose.
- Fertility may be affected in women and men.
- Liver: the dose is lowered for moderate impairment. Avoid it in severe impairment.
- Kidneys: no dose change for mild to severe impairment. The dose for end-stage kidney disease has not been established.
- Children: safety and effectiveness have not been established.
- Older adults: no overall differences in safety or effectiveness.
- Tartrazine: the 0.89 mg capsule contains it, which may trigger allergic-type reactions.
Tivozanib overdose
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Too much Fotivda can cause severe high blood pressure and hypertensive crisis, which may be fatal. There is no specific antidote. If an overdose is suspected, the medicine is stopped, blood pressure is closely monitored and treated, and supportive care is given.
What Tivozanib does in the body
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The relationship between tivozanib levels and its effects has not been fully characterized. At the recommended dose, no large average increases in QTc interval (a heart rhythm measure) were seen.
How your body processes Tivozanib
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Tivozanib is absorbed slowly, peaking at a median of about 10 hours. A high-fat meal did not make a clinically significant difference. It has a long half-life of about 111 hours, and steady levels build up over about 14 days.
It is mostly broken down by the liver enzyme CYP3A4. Most of a dose leaves in the stool, and little leaves in the urine. Levels rise in moderate liver impairment, which is why the dose is lowered.
How to store Tivozanib
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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.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Tivozanib
288 supplements and herbal products have documented interactions with Tivozanib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 239
- Minor · 42
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Tivozanib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Tivozanib — the kind of thing our pharmacy team would talk through with you at the counter.
What is Fotivda for?
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How do I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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Do I need to watch my blood pressure?
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What about pregnancy and surgery?
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Is Tivozanib available over the counter?
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When was Tivozanib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Tivozanib on HelloPharmacist
Tivozanib forms and strengths (how it comes)
Tivozanib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Fotivda is used for adults with relapsed or refractory advanced renal cell carcinoma after two or more prior systemic therapies.
- Fotivda is taken by mouth once daily for 21 days, followed by 7 days off.
- Fotivda can be taken with or without food.
- Swallow Fotivda whole with a glass of water and do not open the capsule.
- If you miss a Fotivda dose, take the next dose at the next scheduled time. Do not take two doses together.
Tivozanib on the U.S. market: products, makers and brands
How Tivozanib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 2 Tivozanib product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 2017. Brand names on the directory include Fotivda; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Tivozanib is used (Medicaid data)
A general measure of how commonly Tivozanib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tivozanib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tivozanib prescribed? Of the 1,601 medications we measure, Tivozanib ranks #1,535 by Medicaid prescriptions — more than 4% of them.
Utilization by Tivozanib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tivozanib 1.34 MG Oral Capsule
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2534247
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tivozanib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Tivozanib NDCs with Medicaid activity.
Compare Tivozanib products
A representative set of FDA-listed product records for Tivozanib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 0.89 mg | Oral | AVEO Pharmaceuticals, Inc. | NDA | View NDC → |
| 1.34 mg | Oral | AVEO Pharmaceuticals, Inc. | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Tivozanib NDCs →
Tivozanib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tivozanib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tivozanib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Tivozanib FDA approval history
How Tivozanib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Tivozanib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Tivozanib recalls since July 2021.
✅No Tivozanib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2534233 1 dose form · 2 strengths
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Dose form (SCDF) Oral Capsule RxCUI 2534237In current FDA listings
Look up RxCUI 2534233 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Tivozanib supply and shortage status
Whether Tivozanib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Tivozanib brand names
Tivozanib is sold under one brand name in the FDA directory — Fotivda. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Tivozanib: manufacturers and labelers
One company lists Tivozanib products with the FDA. By number of product records, the largest are AVEO Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Tivozanib drug class (RxNorm)
Tivozanib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Tivozanib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AVEO Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →