Tuesday, 6 March 2012

Votrient


Pronunciation: paz-OH-pa-nib
Generic Name: Pazopanib
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, or loss of appetite; severe or persistent tiredness).





Votrient is used for:

Treating patients with advanced kidney cancer.


Votrient is a tyrosine kinase inhibitor. It works by blocking certain substances in the body, which kills certain 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 have a surgical wound that has split apart

  • you are taking barbiturates (eg, phenobarbital, primidone), carbamazepine, dexamethasone, halofantrine, hydantoins (eg, phenytoin), nevirapine, 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 taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have high blood pressure, irregular heartbeat (eg, QT prolongation) or other heart problems, abnormal electrolyte levels (eg, potassium, calcium, magnesium), thyroid 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 transient ischemic attack (TIA; "mini-stroke") or you are at risk of developing these problems

  • if you have a history of liver problems, bleeding in the brain, or coughing up blood

  • if you are or will be having surgery, or you have recently had surgery (eg, within the last 7 days)

  • if you take medicine for depression

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, propafenone, sotalol), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, haloperidol, iloperidone, maprotiline, methadone, paliperidone, pentamidine, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), romidepsin, tacrolimus, terfenadine, toremifene, tricyclic antidepressants (eg, amitriptyline), ziprasidone, or any other 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

  • Azole antifungals (eg, ketoconazole), macrolide antibiotics (eg, clarithromycin), nefazodone, or protease inhibitors (eg, boceprevir, ritonavir) because they may increase the risk of Votrient's side effects

  • Barbiturates (eg, phenobarbital, primidone), carbamazepine, dexamethasone, hydantoins (eg, phenytoin), nevirapine, 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 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:


  • Do not take more than the recommended dose 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.

  • 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.

  • Tell your doctor if you have a wound that does not heal.

  • 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 should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: Do not use Votrient if you are pregnant. It 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:



Diarrhea; hair loss; headache; indigestion; lightening of hair or skin color; loss of appetite; mild stomach pain; nausea; taste changes; tiredness; vomiting; weakness; weight loss.



Seek medical attention right away if any of these SEVERE side effects occur:

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; calf or leg pain, swelling, or tenderness; chest pain; coughing or spitting up blood; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; severe or persistent headache, dizziness, or stomach pain; severe or persistent nosebleed; shortness of breath; stomach swelling; symptoms of heart attack or stroke (eg, chest pain, confusion, numbness of an arm or leg, one-sided weakness, speech problems, sudden severe headache or vomiting, vision problems); symptoms of liver problems (eg, dark urine, loss of appetite, nausea, pale stools, severe or persistent stomach pain, severe or persistent 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; 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.


See also: Votrient side effects (in more detail)


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. Symptoms may include severe or persistent headache or tiredness.


Proper storage of Votrient:

Store Votrient between 59 and 86 degrees F (15 and 30 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.


General information:


  • 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 is a summary only. It does not contain all information about Votrient. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Votrient resources


  • Votrient Side Effects (in more detail)
  • Votrient Use in Pregnancy & Breastfeeding
  • Votrient Drug Interactions
  • Votrient Support Group
  • 7 Reviews for Votrient - Add your own review/rating


  • Votrient Prescribing Information (FDA)

  • Votrient Consumer Overview

  • Votrient Monograph (AHFS DI)

  • Votrient Advanced Consumer (Micromedex) - Includes Dosage Information

  • Pazopanib Professional Patient Advice (Wolters Kluwer)



Compare Votrient with other medications


  • Renal Cell Carcinoma

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