TM Owner AVEO Pharmaceuticals
Tivozanib 1.34mg Capsule
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Indications & Clinical Uses
- Tivozanib 1.34 mg capsules, marketed as Fotivda, is a tyrosine kinase inhibitor that blocks vascular endothelial growth factor receptors to reduce the blood supply that kidney tumours need to grow.
- In the United States it is approved for adults with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies; it has been approved in Europe as Fotivda since 2017 for advanced renal cell carcinoma, with a somewhat broader label there covering first-line and later-line treatment.
- The standard dose is one 1.34 mg capsule taken by mouth once daily for 21 days, followed by 7 days off treatment, repeated in 28-day cycles; a lower 0.89 mg strength is used for people with moderate liver impairment.
- Fotivda is taken at home and is manufactured by AVEO Pharmaceuticals.
Side Effects
- Fotivda does not carry a boxed warning.
- Very common side effects, seen in 20% or more of patients, include tiredness, high blood pressure, diarrhoea, reduced appetite, nausea, hoarseness or voice changes, underactive thyroid, cough and mouth soreness.
- High blood pressure is common and can be severe, so blood pressure is checked regularly and treated if needed.
- Serious reactions include bleeding, heart failure, blood clots in the arteries or veins, protein in the urine, and gastrointestinal perforation, which can be fatal and needs urgent medical attention for severe abdominal pain.
- Wound healing can be slower than normal, and a rare reversible brain condition called RPLS, causing headache, confusion, seizures or vision loss, has been reported.
- Contact your care team urgently for chest pain, severe headache, black or bloody stools, or sudden vision changes.
Precautions & Warnings
- Blood pressure must be well controlled before starting Fotivda and is monitored throughout treatment; the dose is reduced or paused for severe or poorly controlled hypertension.
- Liver function, urine protein and signs of heart failure are checked periodically, and thyroid function is monitored because Fotivda commonly causes an underactive thyroid.
- Stop Fotivda and seek urgent care for signs of gastrointestinal perforation, unusual bleeding, or symptoms of RPLS such as sudden confusion or vision loss.
- Fotivda should be stopped at least 24 hours before planned surgery because it can slow wound healing, and restarted only once healing is adequate.
- It can harm an unborn baby, so effective contraception is required during treatment and for one week after the last dose for both women and men.
Avoid Interactions
- Tell your healthcare provider about every medicine and supplement you take.
- Avoid strong CYP3A inducers, such as rifampin, carbamazepine, phenytoin and St John's Wort, which can reduce tivozanib levels in the blood by roughly half and make Fotivda less effective; if a strong inducer cannot be avoided, the Fotivda dose may need to be increased.
- Strong CYP3A4 inhibitors, including certain antifungal and HIV medicines, may raise tivozanib exposure and the risk of side effects, so these combinations are used cautiously.
- Other blood-pressure-lowering medicines may need adjusting once you start Fotivda because it commonly raises blood pressure.
- Grapefruit and grapefruit juice should be used cautiously as they can affect drug levels; discuss this with your pharmacist.
References
Frequently Asked Questions
Tivozanib, brand name Fotivda, treats adults with advanced kidney cancer (renal cell carcinoma) that has come back or stopped responding after at least two other systemic treatments. It blocks the blood supply tumours need to grow, taken as a once-daily capsule at home.
Take one Fotivda 1.34 mg capsule by mouth once daily for 21 days, then stop for 7 days, repeating this 28-day cycle. It can be taken with or without food. A lower 0.89 mg capsule is used if you have moderate liver problems.
Common Fotivda side effects include tiredness, high blood pressure, diarrhoea, reduced appetite, nausea, hoarse voice and underactive thyroid. Seek urgent care for severe abdominal pain, black or bloody stools, chest pain, or sudden confusion or vision changes.
Avoid strong enzyme-inducing drugs like rifampin, carbamazepine, phenytoin and St John's Wort, which can make Fotivda (tivozanib) less effective. Certain antifungal and HIV medicines can raise its levels instead. Tell your care team about all medicines before starting.
You will have regular blood pressure checks, plus periodic blood tests for liver function, urine protein and thyroid hormones while taking Fotivda. Tell your care team about severe headache, swelling, or reduced urine output between visits.
Yes. Fotivda (tivozanib) should be stopped at least 24 hours before planned surgery because it can slow wound healing, and only restarted once your surgical wound has healed adequately. Effective contraception is needed during treatment and for one week after the last dose.

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