Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
August 9, 2013
Health Canada has issued information concerning the use of pazopanib. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abnormal heart rhythms: Pazopanib may cause a heart rhythm problem called QT prolongation. If you have a history of QT prolongation, slow or irregular heart beat, irregular heart rhythm, heart failure, heart attack, heart disease, taking other medications known to cause QT prolongation, or a family history of sudden cardiac death at less than 50 years of age, discuss with your doctor how this medication may affect your medical condition, or how your medical condition may affect the dosing and effectiveness of this medication. Your doctor will perform tests at regular intervals to monitor for any changes in your heart rhythm.
Bleeding problems: Pazopanib may increase your risk of bleeding. If you have a history of coughing up blood, brain bleeds, or bleeding from the stomach, discuss with your doctor how this medication may affect your medical condition. If you notice signs of serious bleeding, such as vomiting blood or a coffee grounds-like substance, or bleeding from the rectum, get immediate medical attention.
Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking, contact your doctor immediately.
Blood counts: This medication can decrease the number of neutrophils (a type of white blood cell that helps fight infection) and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.
Congestive heart failure (CHF): Pazopanib may make the heart less effective at pumping blood through the body, causing congestive heart failure and reduced heart function. If you have a history of heart disease or you are at risk of developing heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Gastrointestinal (stomach and bowel) problems: Rarely, pazopanib can cause perforation (holes) in the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or black and tarry stools, contact your doctor immediately.
Grapefruit juice: Grapefruit juice affects how pazopanib is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. People should not drink grapefruit juice or eat grapefruit at anytime while taking this medication for treatment.
High blood pressure : Pazopanib can cause increased blood pressure. People with uncontrolled high blood pressure should be closely monitored closely by their doctor.
If you experience symptoms of a severe increase in blood pressure, such as severe chest pain, headache with confusion, nausea, vomiting, or shortness of breath, contact your doctor immediately.
Reversible Posterior Leukoencephalopathy Syndrome (RPLS): This is a rare condition of the brain where the covering that protects the nerves is destroyed, affecting how the nerves in the brain transmit messages. Signs and symptoms of leukoencephalopathy include unusual clumsiness, gradually worsening weakness, visual, speech or personality changes, or possibly seizures. If you experience any of these, contact your doctor immediately.
Liver function: Pazopanib has been reported to cause liver failure, which has in cases, caused death. This medication may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Your doctor may want to test your liver function regularly with blood tests while you are taking this medication. This often allows reduced liver function to be identified before it becomes too severe.
Reproduction: Pazopanib may decrease the fertility of both males and females. Discuss with your doctor any concerns you have about having children in the future. Women of childbearing age who are taking this medication should use an effective method of birth control (e.g., birth control pill, condoms) during treatment.
Thyroid function: This medication may reduce the function of the thyroid gland. If you have thyroid disease, discuss with your doctor how this medication may affect your medical condition. Your doctor may want to test your thyroid function regularly with blood tests while you are taking this medication.
Pregnancy: This medication may cause harm to an unborn fetus if taken by the mother while she is pregnant. It should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if pazopanib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about breast-feeding, as it is recommended that breast-feeding be stopped while using this medication.
Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age and is not recommended for this age group. Do not give this medication to children less than 2 years of age as it severely affects body weight gain, organ growth and maturation and may cause serious problems with a child's growth.