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Votrient 200mg Tablet
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Indications & Clinical Uses
- Votrient 200 mg tablets contain pazopanib, a kinase inhibitor taken by mouth.
- In the US, Votrient is approved for adults with advanced renal cell carcinoma (kidney cancer) and for adults with advanced soft tissue sarcoma who have had prior chemotherapy; it is not effective for adipocytic soft tissue sarcoma or gastrointestinal stromal tumours.
- In the EU it is used in adults for advanced or metastatic renal cell carcinoma (first-line, or after cytokine therapy) and selected soft tissue sarcoma subtypes after prior chemotherapy.
- The usual dose is 800 mg once daily, which is four 200 mg tablets (or two 400 mg tablets), taken without food, at least 1 hour before or 2 hours after a meal; people with moderate liver impairment take 200 mg once daily.
- Treatment is started and supervised by a cancer specialist.
Side Effects
- In the US label, the most common side effects in kidney cancer (at least 20 in 100 people) are diarrhoea (52%), high blood pressure (40%), hair colour changes (38%), nausea (26%), loss of appetite (22%) and vomiting (21%); in soft tissue sarcoma tiredness (65%), weight loss (48%) and reduced appetite (40%) are also very common.
- BOXED WARNING (US label): severe and fatal hepatotoxicity (liver damage) has been observed in clinical trials, so liver function must be monitored and dosing interrupted, reduced or stopped as directed; the EU product information has no boxed warning but gives the same monitoring advice.
- Report yellow skin or eyes, dark urine, unusual bleeding, severe stomach pain, chest pain, breathlessness, or severe headache with confusion or vision changes to your healthcare provider urgently.
Precautions & Warnings
- Liver blood tests are required before treatment, at weeks 3, 5, 7 and 9, at months 3 and 4, and periodically afterwards.
- Heart function (LVEF), ECG and electrolytes, blood pressure, thyroid function and urine protein are also monitored, and high blood pressure should be controlled before starting.
- Pazopanib can prolong the QT interval, cause bleeding, gastrointestinal perforation and reversible posterior leukoencephalopathy syndrome (PRES); treatment is withheld at least 1 week before elective surgery, and should not be started with recent haemoptysis or cerebral haemorrhage.
- It causes fetal harm: use effective contraception during treatment and for at least 2 weeks after the last dose, and men (including after vasectomy) should use condoms.
- Do not breastfeed.
- Avoid driving if you feel dizzy or weak.
- No contraindications are listed in the US label; the EU label contraindicates hypersensitivity.
Avoid Interactions
- Medicines that increase pazopanib exposure or toxicity: strong CYP3A4 inhibitors such as ketoconazole or clarithromycin (avoid, or reduce the dose to 400 mg if unavoidable), P-glycoprotein and BCRP inhibitors (EU label), grapefruit and grapefruit juice (do not consume), and food, which roughly doubles absorption.
- Simvastatin increases liver enzyme (ALT) elevations, so liver tests need closer monitoring.
- Avoid QT-prolonging medicines and narrow-margin CYP3A4, CYP2D6 or CYP2C8 substrates.
- Medicines that reduce efficacy: strong CYP3A4 inducers such as rifampin or St. John's wort (avoid chronic use), and proton pump inhibitors and H2 blockers, which lower absorption; if acid control is needed, use a short-acting antacid separated by several hours.
- Tell your healthcare provider about all medicines and supplements.
References
Frequently Asked Questions
Votrient (pazopanib) 200 mg tablets treat adults with advanced kidney cancer (renal cell carcinoma) and certain advanced soft tissue sarcomas after earlier chemotherapy. It is not for fatty-tissue (adipocytic) sarcoma or gastrointestinal stromal tumours. It is taken as tablets by mouth and prescribed by a cancer specialist.
Take Votrient (pazopanib) by mouth once daily, at least 1 hour before or 2 hours after a meal, because food roughly doubles the amount absorbed. The usual 800 mg dose is four 200 mg tablets. Swallow the tablets whole; do not crush them.
Common Votrient side effects include diarrhoea, high blood pressure, hair colour changes, nausea, vomiting and loss of appetite; tiredness and weight loss are also common in sarcoma. Get urgent help for yellow skin or eyes, dark urine, unusual bleeding, severe stomach pain, chest pain or breathlessness.
Do not eat grapefruit or drink grapefruit juice while taking Votrient (pazopanib); it can raise the amount of drug in your body. Avoid strong CYP3A4 inhibitors such as ketoconazole unless your dose is reduced, and proton pump inhibitors or H2 blockers. Tell your provider if you take simvastatin.
No. Votrient (pazopanib) can cause fetal harm. Use effective contraception during treatment and for at least 2 weeks after your last dose. Men, including those who have had vasectomies, should use condoms with female partners of reproductive potential for the same period. Do not breastfeed.
Yes. The US Votrient label carries a boxed warning: severe and fatal liver damage (hepatotoxicity) has occurred. Liver tests are done before treatment and regularly afterwards, and the dose may be paused, reduced or stopped. Report yellow skin or eyes, dark urine or severe tiredness promptly.
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