Generic Name: pazopanib (paz-OH-pa-nib)
Brand Name: Votrient
Severe and sometimes fatal liver problems have occurred in patients using Votrient. Your doctor will monitor your liver function while you are using Votrient. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent stomach pain, nausea, vomiting, or loss of appetite; severe or persistent tiredness; easy bruising).
Votrient is used for:
Treating patients with advanced kidney cancer. It is also used to treat patients with certain types of advanced soft tissue cancer who have received chemotherapy in the past. It may also be used for other conditions as determined by your doctor.
Votrient is a tyrosine kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Votrient if:
- you are allergic to any ingredient in Votrient
- you have severe liver problems
- you have had bleeding in the brain, bleeding in the stomach or bowels, or coughing up blood in the past 6 months
- you have had an angina attack, heart attack, stroke, or transient ischemic attack (TIA) ("mini-stroke") in the past 6 months
- you are taking carbamazepine, cimetidine, dexamethasone, dexlansoprazole, esomeprazole, famotidine, hydantoins (eg, phenytoin), lansoprazole, nevirapine, nizatidine, omeprazole, oxcarbazepine, pantoprazole, phenobarbital, primidone, rabeprazole, ranitidine, rifamycins (eg, rifampin), or St. John's wort
Contact your doctor or health care provider right away if any of these apply to you.
Before using Votrient:
Some medical conditions may interact with Votrient. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of angina, irregular heartbeat (eg, QT prolongation), or other heart problems (eg, congestive heart failure), or if you are at risk of heart problems
- if you have high blood pressure, abnormal electrolyte levels (eg, potassium, calcium, magnesium), thyroid problems, vision problems, or a wound that has not fully healed
- if you have a history of stomach or bowel problems (eg, ulcer, tearing, fistula, bleeding) or blood clots (eg, in your legs or lungs), or you are at risk of developing these problems
- if you have a history of angina attacks, heart attack, stroke, or TIA, or you are at risk of developing these problems
- if you have a history of liver problems or abnormal liver function tests, seizures, bleeding in the brain, or coughing up blood
- if you have an infection or if you are taking another cancer medicine
- if you will be having surgery, or you have recently had surgery (eg, within the last 7 days)
- if you have had previous therapy with a certain type of chemotherapy called an anthracycline (eg, doxorubicin)
- if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Some MEDICINES MAY INTERACT with Votrient. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Antiarrhythmics (eg, amiodarone, dofetilide, propafenone, sotalol), arsenic, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), romidepsin, tacrolimus, toremifene, tricyclic antidepressants (eg, amitriptyline), or ziprasidone because they may increase the risk of a severe and possibly fatal irregular heartbeat
- Simvastatin because the risk of liver problems may be increased
- Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), cobicistat, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, or protease inhibitors (eg, boceprevir, ritonavir) because they may increase the risk of Votrient's side effects
- Carbamazepine , cimetidine, dexamethasone, dexlansoprazole, esomeprazole, famotidine, hydantoins (eg, phenytoin), lansoprazole, nevirapine, nizatidine, omeprazole, oxcarbazepine, pantoprazole, phenobarbital, primidone, rabeprazole, ranitidine, rifamycins (eg, rifampin), or St. John's wort because they may decrease Votrient's effectiveness
This may not be a complete list of all interactions that may occur. Ask your health care provider if Votrient may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Votrient:
Use Votrient as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Votrient comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Votrient refilled.
- Take Votrient by mouth on an empty stomach at least 1 hour before or 2 hours after eating.
- Swallow Votrient whole. Do not break, crush, or chew before swallowing.
- Do not eat grapefruit or drink grapefruit juice while you use Votrient.
- If you take an antacid while taking Votrient, ask your doctor or pharmacist how to take it with Votrient.
- Take Votrient on a regular schedule to get the most benefit from it.
- Continue to take Votrient even if you feel well. Do not miss any doses.
- If you miss a dose of Votrient, take it as soon as possible. If there are less than 12 hours before your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Votrient.
Important safety information:
- Votrient may cause dizziness. This effect may be worse it you take it with alcohol or certain medicines. Use Votrient with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not change your dose or stop taking Votrient without checking with your doctor.
- Tell your doctor or dentist that you take Votrient before you receive any medical or dental care, emergency care, or surgery. Votrient may need to be stopped at least 7 days before having surgery as directed by your doctor.
- Mild diarrhea is common with Votrient. Check with your doctor if moderate to severe diarrhea occurs.
- Women who may become pregnant should use effective birth control while they are taking Votrient. Check with your doctor if you have questions about effective birth control.
- Votrient may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
- Severe and sometimes fatal bleeding has rarely occurred in patients taking Votrient. Contact your doctor right away if you develop blood in the urine, coughing or spitting up blood, severe or persistent nosebleed, or other unusual bruising or bleeding.
- Severe and sometimes fatal stomach or bowel problems (eg, tearing, fistula) have rarely occurred in patients taking Votrient. Contact your doctor right away if you develop severe or persistent stomach pain, black tarry or bloody stools, or vomiting blood or a substance that looks like coffee grounds.
- A serious and sometimes fatal brain problem called reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in patients taking Votrient. Contact your doctor right away if you experience severe headaches, seizures, sluggishness, confusion, problems thinking, or vision changes (eg, loss of vision).
- Tell your doctor if you have a wound that does not heal or if you have a surgical wound that has split apart.
- Lab tests, including liver and thyroid function, urine protein levels, blood pressure, blood electrolytes, and heart function, may be performed while you use Votrient. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Votrient with caution in the ELDERLY; they may be more sensitive to its effects, especially liver problems.
- Votrient is not approved for use in CHILDREN; safety and effectiveness in children have not been confirmed. Votrient may cause serious side effects in children, especially in children younger than 2 years old.
- PREGNANCY and BREAST-FEEDING: Votrient may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Votrient is found in breast milk. Do not breast-feed while you are taking Votrient.
Possible side effects of Votrient:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dry skin; hair loss; headache; indigestion; lightening of hair or skin color; loss of appetite; mild stomach pain; muscle or bone pain; nausea; taste changes; tiredness; trouble sleeping; tumor pain; vomiting; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry, or bloody stools; blood in the urine; blurred vision or other vision changes (eg, loss of vision); calf, leg, or arm pain, swelling, redness, or tenderness; chest pain or pressure; confusion; cool or pale arm or leg; coughing or spitting up blood; dizziness; fainting; fast or irregular heartbeat; mouth or tongue sores; one-sided numbness or weakness; pain in your arms, back, neck, or jaw; problems thinking; seizures; severe anxiety; severe or persistent headache, diarrhea, stomach pain, or tiredness; severe or persistent nosebleed; shortness of breath; sluggishness; speech problems; stomach swelling; sudden, severe nausea or vomiting; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet; symptoms of infection (eg, fever, chills, or persistent cough or sore throat; cold symptoms, such as runny nose; flu-like symptoms, such as cough, unusual tiredness, or body aches; painful urination; red, warm, swollen, or painful cuts, scrapes, or wounds); symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, severe or persistent stomach pain or tiredness, yellowing of the skin or eyes); tingling, pain, or tenderness of the palms of the hands or soles of the feet; unusual bruising or bleeding; unusual sweating; vomiting blood or a substance that looks like coffee grounds.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Votrient:
Store Votrient between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Votrient out of the reach of children and away from pets.
- If you have any questions about Votrient, please talk with your doctor, pharmacist, or other health care provider.
- Votrient is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Votrient or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Votrient. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Votrient. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Votrient.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.