Tivozanib (Fotivda)

Medicine at a glance

Tivozanib, also called Fotivda, is a targeted cancer medicine taken as a capsule. A usual cycle consists of one capsule daily for 21 days followed by seven days without capsules. Food is optional. Your prescribed dose and calendar may be different if side effects or liver problems require adjustment.

Tivozanib blocks signals that help cancers develop a blood supply. This can also affect normal blood vessels, so blood-pressure checks, urine tests and attention to bleeding and wound healing are central parts of treatment. Fatigue, diarrhoea, appetite changes, a hoarse voice and thyroid changes are other important concerns.

Follow your prescription and oncology team’s instructions; do not change treatment from an online example.

What tivozanib is and how it works

Tivozanib is a tyrosine kinase inhibitor. It mainly blocks vascular endothelial growth factor receptors, called VEGF receptors or VEGFRs. These receptors receive signals involved in forming new blood vessels. By interfering with this process, the medicine can reduce the blood-vessel support a cancer needs to grow.

It is targeted therapy rather than conventional chemotherapy or an immune-checkpoint medicine. The word “targeted” does not mean harmless: normal blood vessels and other tissues can also be affected. Benefit varies and cannot be predicted from side effects alone.

You will usually have repeated cycles while the treatment is helping and side effects remain manageable. Scans, symptoms and your overall condition guide decisions about continuing, adjusting or changing treatment. The planned week off is part of the prescription.

How the team decides whether it is suitable

Your oncologist considers your diagnosis, previous cancer treatments, overall health, organ function and current prescribing information. Unlike some targeted treatments, the reviewed tivozanib labels do not require a particular mutation test as a condition of use. Other tests may still be relevant to understanding your cancer or choosing between treatments.

Tell the team about high blood pressure, angina, heart failure, abnormal heart rhythm, a previous heart attack or stroke, blood clots, significant bleeding, bowel problems and poorly healing wounds. An aneurysm, which is a weakened enlarged part of an artery, or a previous tear in an artery wall also matters.

Liver function can change the prescribed dose or schedule. US and European guidance use different adjustments for moderate liver impairment, so do not copy another patient's calendar. Severe liver impairment is a reason to avoid or not recommend treatment in the reviewed guidance. Kidney impairment and dialysis also require an individual assessment. Safety and effectiveness in children have not been established.

Before treatment starts

The team checks and, if necessary, treats high blood pressure before the first capsule. Ask whether you should use a home blood-pressure monitor, how often to measure and what reading should trigger contact. High blood pressure can be present without symptoms.

Baseline investigations include urine testing for protein, thyroid blood tests and assessment of liver and kidney function. Blood counts and salts help identify issues that may affect treatment. European information recommends baseline and periodic ECG checks and keeping calcium, magnesium and potassium within the normal range because heart-rhythm changes can occur.

Bring a complete medicine list, including blood thinners, epilepsy medicines, antibiotics, herbal products and supplements. Mention any planned operation or dental surgery before starting. Pregnancy testing is needed where relevant, and contraception and breastfeeding plans should be discussed.

The lower-strength 0.89 mg capsule contains tartrazine, a yellow dye also called E102 or FD&C Yellow No. 5, in its printing ink. Tell the team about dye reactions, aspirin allergy or asthma related to such reactions.

How to take tivozanib

Dose and the four-week calendar

A usual adult starting dose is 1.34 mg once daily for 21 days, followed by seven days off, making a 28-day cycle. European packaging expresses this as 1,340 micrograms; it is the same amount. A usual reduced strength is 0.89 mg, or 890 micrograms, on the same 21-days-on, seven-days-off pattern. Only your prescriber should change the dose.

You may see the higher capsule described as containing 1.5 mg of tivozanib hydrochloride, equivalent to 1.34 mg of tivozanib. The lower capsule contains 1 mg of the hydrochloride, equivalent to 0.89 mg of tivozanib. These are salt equivalents, not additional medicine to take. Confirm the capsule strength and calendar with the pharmacist.

Use a written cycle calendar showing the final capsule day, the seven rest days and the next planned start. Do not take leftover capsules during the break to catch up. If a side effect causes an extra interruption, ask for an updated calendar rather than calculating the restart yourself.

Taking the capsule

Take the capsule at approximately the same time on each treatment day, with or without food. Swallow it whole with a glass of water. Do not open, chew, crush or dissolve it. The reviewed labels do not provide a home dispersion or feeding-tube method. If swallowing becomes difficult, contact the pharmacist before the next dose.

For moderate liver impairment, US instructions reduce the dose to 0.89 mg daily during the treatment weeks. European instructions instead describe one 1,340-microgram capsule every other day. These are alternative regional prescribing approaches, not instructions to combine. Your team must supply the exact treatment and rest-day plan.

Missed doses, vomiting and accidental extra doses

If you miss a dose, skip it and take the next one at the next scheduled time. Do not take a late replacement or two doses on the same day. If you vomit after taking a capsule, do not repeat it; take the next scheduled dose. Report repeated vomiting or inability to keep fluids down.

If you accidentally take extra capsules, contact your treating team or the nearest emergency department immediately, even if you initially feel well. Overdose can cause severe, prolonged high blood pressure. Tell clinicians the strength, number of capsules and timing; do not take further tivozanib until advised.

Storage and disposal

Keep capsules in the supplied packaging, out of children's and pets' reach. Keep the bottle tightly closed to protect from moisture. US storage instructions specify 20–25°C (68–77°F), with short excursions to 15–30°C (59–86°F) permitted. Follow your own pack's instructions and avoid hot cars or damp bathrooms. Return unwanted capsules through a pharmacy; do not share them or put them down a drain.

Monitoring and checking whether treatment is working

Blood pressure needs ongoing attention. The US label specifies a check after two weeks and at least monthly thereafter; more frequent home or clinic checks may be appropriate. European guidance also requires monitoring and treatment of hypertension. Keep a record if your team asks, and report readings above your agreed threshold.

Urine protein and thyroid function are checked before and periodically during treatment. Liver tests, kidney function, blood counts and salts are followed according to your care plan. A urine dipstick may be followed by a more detailed measurement if protein is found. You may feel normal despite a result that needs a treatment change.

ECGs assess heart rhythm. Additional heart tests may be arranged if symptoms or medical history suggest a problem. Scans and appointments assess whether the cancer is responding or remaining controlled. Bring a record of doses, blood pressure, side effects and new medicines.

During the rest week or an unplanned interruption, continue agreed monitoring. Blood pressure may fall when tivozanib stops, particularly if you take blood-pressure medicines. Tell the team about dizziness or faintness; do not independently stop or double those medicines.

Common side effects and practical management

Raised blood pressure

Hypertension is common and may appear early. Taking any prescribed blood-pressure medicine consistently and attending checks can prevent serious complications. Report persistent headache, nosebleeds, blurred vision or unexpected breathlessness, but remember that high readings can occur without these symptoms.

A sudden severe headache, chest pain, confusion, marked breathing difficulty or new neurological symptoms needs emergency assessment. Do not simply take an extra blood-pressure tablet and wait. The oncology team may add treatment, pause tivozanib, reduce its dose or stop it if pressure remains dangerously high.

Tiredness and thyroid changes

Fatigue may improve with pacing, regular rest and manageable activity. Let the team know if you cannot carry out usual activities or tiredness is worsening. Thyroid changes, anaemia, poor intake and other causes may contribute.

An underactive thyroid may cause fatigue, feeling cold, constipation or weight change. An overactive thyroid can cause palpitations, sweating or feeling unusually restless. Blood tests help identify the cause, and thyroid medicine may be needed. Do not dismiss all these symptoms as an unavoidable part of cancer treatment.

Diarrhoea, nausea and appetite

Report diarrhoea early and follow the team's anti-diarrhoea plan. Keep track of stools compared with your usual pattern, or changes in stoma output. Take regular fluids as advised; people with heart or kidney problems need an individual target. Seek urgent help for dizziness, very little urine, fever, blood in stool or inability to drink.

Small meals, snacks and prescribed anti-sickness medicine can help nausea. Tell the team about weight loss, persistent vomiting or poor appetite. A dietitian can help you find manageable foods. Severe abdominal pain needs assessment rather than being assumed to be ordinary indigestion.

Mouth soreness and voice changes

Mouth soreness can make eating and drinking difficult. Use gentle mouth care and a soft toothbrush, and report ulcers or pain early. The team can provide mouth treatments and assess infection if necessary. Avoid foods or drinks that sting while your mouth is sore.

Dysphonia means a changed, weak or hoarse voice. It is a recognised tivozanib effect. Mention persistent or troublesome changes, particularly if your work depends on speaking. Difficulty swallowing or breathing is different and needs prompt assessment. Report a new or persistent cough, especially with breathlessness.

Hands, feet and other skin symptoms

Hand–foot skin reaction may cause tender, red or darker areas, tingling, calluses, peeling or cracks on palms and soles. Reduce friction, avoid excessive heat and use moisturiser recommended by the team. Comfortable shoes and early attention to painful areas can help prevent deterioration.

Report pain that affects walking, sleep or using your hands, and any blistering or infection. Treatment may require creams, a pause or a lower dose. Do not cut thickened skin yourself or continue painful activity to the point of skin breakdown.

Important risks that need medical assessment

Heart problems, clots and artery-wall problems

Tivozanib can cause heart failure, reduced blood supply to the heart and blood clots in arteries or veins. New ankle swelling, breathlessness on activity or when lying down, and an unexplained reduction in exercise tolerance need prompt review. Chest pressure, severe breathlessness or pain spreading to the arm, jaw or back needs emergency care.

A painful swollen limb may indicate a vein clot. Sudden weakness or numbness on one side, facial drooping, trouble speaking or sudden vision loss may indicate a stroke: seek emergency help immediately. A sudden severe chest, back or abdominal pain may also signal a serious artery problem. European guidance warns that VEGF-pathway medicines can promote aneurysms or artery dissections, including in people without high blood pressure.

European information also warns about QT prolongation, a change in the heart's electrical recovery time. Report palpitations or dizziness; fainting or collapse needs emergency assessment. Other medicines and abnormal blood salts can increase this risk.

US guidance requires permanent withdrawal for arterial clots and severe venous clots; life-threatening heart failure also requires permanent withdrawal. The treating team determines the diagnosis and treatment changes.

Bleeding

Minor nose or gum bleeding can occur, but serious internal bleeding is possible. Report unusual bruising, increasing nosebleeds, blood in urine or heavier menstrual bleeding. Vomiting blood, coffee-ground-looking vomit, black tar-like stools, coughing blood or bleeding that will not stop requires urgent medical care; heavy bleeding or weakness with bleeding is an emergency.

Tell the team about anticoagulants, aspirin and other medicines that affect bleeding. Do not stop prescribed blood thinners on your own, but have the combination reviewed. US guidance requires permanent withdrawal for severe bleeding; European guidance calls for an interruption when bleeding needs medical intervention.

Protein in urine and kidney problems

Proteinuria means protein leaking into urine. It may be detected before symptoms appear. Marked frothiness of urine, new swelling or reduced urine needs assessment. The team may measure the amount of protein, adjust treatment and check kidney function. A severe protein-loss condition called nephrotic syndrome requires permanently stopping tivozanib under US guidance.

Bowel perforation, fistula and pancreatic problems

A perforation is a hole in the stomach or bowel wall. A fistula is an abnormal connection between body structures. These can be serious, and fatal bowel perforation has been reported with tivozanib. Severe persistent abdominal pain or tenderness, especially with fever, vomiting, a swollen abdomen or rectal bleeding, needs immediate medical assessment. US guidance requires permanent withdrawal for severe or life-threatening gastrointestinal perforation.

Pancreatitis, inflammation of the pancreas, has also been reported. Upper abdominal pain spreading to the back, particularly with vomiting, should be assessed urgently. Pancreatic enzyme levels can rise on blood tests without proving pancreatitis; the team interprets the result alongside symptoms. Do not wait for your next routine appointment if pain is severe.

Brain symptoms and liver injury

Posterior reversible encephalopathy syndrome, or PRES, is a rare serious brain disorder also called reversible posterior leukoencephalopathy syndrome, or RPLS. It involves brain swelling and can cause severe headache, seizures, confusion or changes in vision. Despite the word “reversible” in its name, it needs emergency assessment, including an MRI to confirm the diagnosis. Do not take further capsules while urgent assessment is arranged. US guidance requires permanent withdrawal for confirmed RPLS. European guidance also requires stopping for signs or symptoms of PRES and states that restart safety is unknown.

Liver blood tests can become abnormal. Report yellow eyes or skin, dark urine, unusual bruising, right-sided upper abdominal pain or marked loss of appetite. The team may pause or change treatment while investigating.

Wound healing and surgery

Tivozanib can interfere with wound healing. Tell the oncologist about planned surgery, including dental surgery, well in advance. US instructions require withholding it for at least 24 days before elective surgery and not restarting for at least two weeks after major surgery and until the wound has healed adequately. A date alone is not sufficient clearance to restart.

European guidance recommends interruption for major procedures and a clinician's assessment of healing before restart, without specifying the same fixed intervals. Your oncologist and surgeon must coordinate your plan. Report a wound that opens, drains, becomes painful or fails to heal.

Other medicines, supplements and vaccines

Strong enzyme-inducing medicines can lower tivozanib levels and reduce its effect. Examples include rifampicin and some epilepsy medicines such as carbamazepine or phenytoin. US guidance advises avoiding strong CYP3A inducers; European guidance advises caution and specifically prohibits St John's wort. Its enzyme-inducing effect can persist after it is stopped, so tell the pharmacist about recent use as well as current use.

European information also advises caution with rosuvastatin and other selected medicines affected by a transport protein called BCRP. A pharmacist may choose an alternative or prescribe a timing gap for a relevant combination. Do not assume all cholesterol medicines need the same spacing or adjust doses yourself.

Have all new prescriptions, herbal remedies, supplements and over-the-counter pain medicines checked. Include drugs that affect heart rhythm or blood pressure. Current labels do not impose a general fasting requirement or routine acid-suppressant spacing rule; advice for a different cancer tablet may not apply here.

Ask your team about vaccines and their timing. Non-live vaccines may be suitable; live vaccines need assessment of your immune status and recent treatments. Do not assume a fixed long restriction based only on the medicine name.

Everyday life during treatment

Keep activities manageable and allow rest when fatigue is troublesome. If feet are sore, adjust walking and footwear rather than pushing through pain. Work changes or practical support may help with treatment weeks, blood tests and clinic visits.

Eat what you can tolerate and seek dietary advice if your weight is falling. Ask about alcohol in view of blood-pressure, liver and hydration concerns. Avoid driving or operating machinery when tired, weak, dizzy or visually impaired. New neurological or visual symptoms need assessment.

For travel, carry capsules in labelled packaging and take a copy of your cycle calendar. Arrange enough supply, planned tests and access to medical advice. Do not move the rest week or take extra capsules to fit travel plans. Tell your dentist and other clinicians about tivozanib before any procedure.

Ask for support with emotional strain, sleep or intimacy concerns.

Fertility, contraception, pregnancy and breastfeeding

Tivozanib can harm a developing baby. Pregnancy status should be checked before treatment where relevant. Tell the team promptly if you or your partner may be pregnant, and discuss future family plans before the first cycle.

Patients who can become pregnant, and male patients with partners who can become pregnant, should use effective contraception throughout treatment and for at least one month after the last dose. This includes rest weeks. European guidance advises an additional barrier method alongside hormonal contraception because its effectiveness with tivozanib is uncertain.

Do not breastfeed during treatment. US guidance extends this restriction for one month after the final dose. The European information prohibits breastfeeding during treatment but does not specify a fixed restart interval, so confirm the date with your team.

Animal evidence suggests fertility in both men and women may be affected. This does not establish whether an individual will become infertile or whether any change is permanent. Discuss preservation options before treatment if future parenthood matters to you.

After a pause or when treatment finishes

Continue follow-up for blood pressure, thyroid function, urine protein and any other abnormal results until the team is satisfied they are stable. If you take blood-pressure medicine, it may need review as tivozanib is interrupted or stopped. Report dizziness and faintness rather than changing it yourself.

Do not restart leftover capsules after a longer interruption without confirming the dose and calendar. Surgery-related restart additionally requires adequate healing. Continue contraception and breastfeeding precautions, return unused medicine safely and clarify your next scan and supportive-care appointment. New severe symptoms still need urgent assessment during a break or after treatment ends.

Frequently asked questions