MEDICATION GUIDE

What is the most important information I should know about pazopanib tablets?

Pazopanib tablets can cause severe liver problems, including death. Your healthcare provider will do blood tests to check your liver before you start and while you take pazopanib tablets.

Tell your healthcare provider right away if you get any of these signs of liver problems during treatment with pazopanib tablets:

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Pazopanib tablets may affect the way other medicines work and other medicines may affect how pazopanib tablets work.

Especially, tell your healthcare provider if you:

take medicines that can affect how your liver enzymes work, such as:

What are the possible side effects of pazopanib tablets?

Pazopanib tablets may cause serious side effects, including:

• See “What is the most important information I should know about pazopanib tablets?”
• irregular or fast heartbeat or fainting
• heart failure. This is a condition where your heart does not pump as well as it should and may cause you to have shortness of breath.
• bleeding problems. These bleeding problems may be severe and cause death.
  Symptoms may include: unusual bleeding, bruising, or wounds that do not heal.
• heart attack or stroke. Heart attack and stroke can happen with pazopanib tablets and may cause death. Symptoms may include: chest pain or pressure, pain in your arms, back, neck or jaw, shortness of breath, numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
• blood clots. Blood clots may form in a vein, especially in your legs (deep vein thrombosis or DVT). Pieces of a blood clot may travel to your lungs (pulmonary embolism). This may be life-threatening and cause death.

  Symptoms may include: new chest pain, trouble breathing or shortness of breath that starts suddenly, leg pain, and swelling of the arms and hands, or legs and feet, a cool or pale arm or leg.

• Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenia purpura (TTP) and hemolytic uremic syndrome (HUS). TMA is a condition involving blood clots that can happen while taking pazopanib tablets. TMA is accompanied by a decrease in red blood cells and cells that are involved in clotting. TMA may harm organs, such as the brain and kidneys.
• tear in your stomach or intestinal wall (perforation) or an abnormal connection between two parts of your gastrointestinal tract (fistula).
  Symptoms may include: pain, swelling in your stomach area, vomiting blood, and black sticky stools.
• lung problems. Pazopanib tablets may cause lung problems that may lead to death. Tell your healthcare provider right away if you get a cough that will not go away or shortness of breath.
• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a condition that can happen while taking pazopanib tablets that may cause death.
  Symptoms may include: headaches, seizures, lack of energy, confusion, high blood pressure, loss of speech, blindness or changes in vision, and problems thinking.
• high blood pressure. High blood pressure can happen with pazopanib tablets, including a sudden and severe rise in blood pressure which may be life-threatening. These blood pressure increases usually happen in the first several months of treatment. Your blood pressure should be well controlled before you start taking pazopanib tablets. Your healthcare provider should begin checking your blood pressure within 1 week of you starting pazopanib tablets and often during treatment to make sure that your blood pressure is well controlled.
  Have someone call your healthcare provider or get medical help right away for you, if you get symptoms of a severe increase in blood pressure, including: severe chest pain, severe headache, blurred vision, confusion, nausea and vomiting, severe anxiety, shortness of breath, seizures, or you pass out (become unconscious).
• thyroid problems. Your healthcare provider should check you for this during treatment with pazopanib tablets.
• Tumor lysis syndrome (TLS). TLS is a condition that can happen during treatment with pazopanib tablets that may cause death. TLS is caused by a fast breakdown of cancer cells. Your healthcare provider may do a blood test to check you for TLS. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with pazopanib tablets: irregular heartbeat, seizures, confusion, muscle cramps or spasms, or a decrease in urine output.
• protein in your urine. Your healthcare provider will check you for this problem. If there is too much protein in your urine, your healthcare provider may tell you to stop taking pazopanib tablets.
• serious infections. Serious infections can happen with pazopanib tablets and can cause death.

  Symptoms of an infection may include: fever, cold symptoms, such as runny nose or sore throat that do not go away, flu symptoms, such as cough, tiredness, and body aches, pain when urinating, cuts, scrapes or wounds that are red, warm, swollen or painful.

• collapsed lung (pneumothorax). A collapsed lung can happen with pazopanib tablets. Air may get trapped in the space between your lung and chest wall. This may cause you to have shortness of breath.

Call your healthcare provider right away if you have any of the symptoms listed above.

Other common side effects in people with advanced soft tissue sarcoma who take pazopanib tablets include: