VOTRIENT

VOTRIENT is the brand name for pazopanib and is available as an oral tablet.

VOTRIENT is available as a 200 mg oral tablet.

VOTRIENT is a tyrosine kinase inhibitor that is used to treat:

• Advanced kidney cancer (renal cell carcinoma)
• Advanced soft tissue sarcoma, after previously receiving chemotherapy

VOTRIENT is a targeted therapy for cancer known as a tyrosine kinase inhibitor (TKI). It targets and blocks specific proteins in cancer cells called tyrosine kinases, including those in the VEGFR family, among others. These proteins are involved in providing blood supply to the tumor. By blocking these tyrosine kinases, it prevents blood vessels from forming and supplying blood to the tumor. This helps slow and stop cancer growth.

The typical dose is 800 mg (four 200 mg tablets) by mouth once daily. Your dose might be lower if you have liver problems. During treatment, your dose can change based on how well you tolerate VOTRIENT. It might also change if you’re taking certain medications that interact with VOTRIENT.

VOTRIENT is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of VOTRIENT:

• Elevated liver enzymes
• Diarrhea
• Elevated blood sugar
• High blood pressure
• Changes in hair color (e.g., lighter hair color)
• Low white blood cell levels
• Elevated bilirubin levels
• Low platelet levels
• Nausea
• Loss of appetite or not feeling hungry
• Vomiting
• Fatigue
• Low blood sugar

Serious side effects are rare with VOTRIENT. Contact your healthcare provider immediately if you experience any of the following.

• Serious infections: body aches, chills, fever, headache, new cough, sore throat, tiredness
• Serious heart problems: chest pounding, chest pain, irregular heartbeat, shortness of breath, lightheadedness, swelling in the legs
• Gut problems: fever; chills; intense stomach pain or cramps; bloating; skin irritation, swelling, or redness around the anus; discharge from the anus; blood in stool
• Serious liver problems: right-sided stomach pain, tiredness, loss of appetite, yellowing of the skin or eyes
  Serious bleeding: unusual bleeding, bleeding that’s hard to stop, easy bruising, blood in urine or stool
• Blood clot in the lungs or serious lung problems: cough, chest pain, trouble breathing, shortness of breath, racing heart
• Blood clot near the heart: chest pain, stomach discomfort, sweating, nausea, dizziness
• Blood clot in the leg: leg cramp, swelling, pain, muscle tightness
• Dangerously high blood pressure: anxiety, blurry vision, confusion, chest pain, nausea, vomiting, headache
• Tumor lysis syndrome: fever, chills, nausea or vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, muscle or joint pain, unusual tiredness

The following medications may interact with VOTRIENT:

• Strong CYP3A4 Inhibitors: Avoid coadministration of VOTRIENT with strong CYP3A4 inhibitors. If coadministration cannot be avoided, reduce the dose of VOTRIENT
• Strong CYP3A4 Inducers: Consider an alternate concomitant medication with no or minimal enzyme induction potential. VOTRIENT is not recommended if chronic use of strong CYP3A4 inducers cannot be avoided
• CYP Substrates: Coadministration of VOTRIENT with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6 or CYP2C8 is not recommended
• Concomitant Use With Simvastatin: Concomitant use of VOTRIENT with simvastatin increases the risk of alanine aminotransferase (ALT) elevations. Increase to weekly monitoring of liver function as recommended Withhold VOTRIENT and resume at reduced dose, or permanently discontinue based on severity of hepatotoxicity
• Concomitant Use With Gastric Acid-Reducing Agents: Avoid concomitant use of VOTRIENT with gastric acid-reducing agents
• Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2-receptor antagonists. Separate antacid and pazopanib dosing by several hours

Novartis Pharmaceuticals

VOTRIENT can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start taking VOTRIENT. You should not become pregnant while you are taking VOTRIENT. You should use effective birth control during treatment with VOTRIENT and for at least 2 weeks after your final dose of VOTRIENT. Talk to your healthcare provider about types of birth control that may be
right for you during this time. If you are a male (including one who has had a vasectomy) with a sexual partner who is pregnant, think that they may be pregnant, or who could become pregnant (including those who use other forms of birth control), you should use condoms during sexual intercourse during treatment with VOTRIENT and for at least 2 weeks after the last dose of VOTRIENT.

• pazopanib