GlaxoSmithKline Votrient Pazopanib Tablet User Guide

GlaxoSmithKline Votrient Pazopanib Tablet

Specifications:

• Product: VOTRIENT (pazopanib) tablets
• Intended Use : Prescription medicine for treating advanced renal cell cancer in adults

Product Information

VOTRIENT is a prescription medicine used to treat advanced renal cell cancer in adults. It is essential to read the Medication Guide provided with VOTRIENT before starting and each time you get a refill as there may be new information. This guide does not replace discussions with your healthcare provider about your medical condition or treatment.

What You Should Know:

VOTRIENT can cause serious liver problems, including death. Your healthcare provider will conduct blood tests to check your liver before starting and during treatment with VOTRIENT. Contact your healthcare provider immediately if you experience any signs of liver problems while taking VOTRIENT, such as yellowing of skin or eyes, dark urine, tiredness, nausea, abdominal pain, easy bruising, or loss of appetite.

Your healthcare provider may adjust your VOTRIENT dosage or instruct you to stop taking it if you develop liver problems during treatment.

Before Taking VOTRIENT:

Prior to taking VOTRIENT, inform your healthcare provider if you have or had liver problems, high blood pressure, heart issues, irregular heartbeat, history of stroke, coughed up blood in the last 6 months, bleeding of stomach or intestines in the last 6 months, stomach or intestinal tears, thyroid problems, recent surgery within the last 7 days, other medical conditions, if you are pregnant or planning to become pregnant, or if you are breastfeeding or planning to breastfeed.

VOTRIENT should not be taken if you are pregnant as it can harm your unborn baby. It is not known if VOTRIENT passes into breast milk, so consult with your healthcare provider to decide whether to take VOTRIENT or breastfeed.

FAQ

• Q: Can VOTRIENT be used in children under 18 years of age?
  • A: It is not known if VOTRIENT is safe or effective in children under 18 years of age. Consult a healthcare provider for appropriate treatment options for children.
• Q: What should I do if I experience side effects while taking VOTRIENT?
  • A: If you experience any side effects or adverse reactions while taking VOTRIENT, promptly contact your healthcare provider for guidance and possible adjustments to your treatment plan.

MEDICATION GUIDE

VOTRIENT® (VO-tree-ent) (pazopanib)   tablets

Read the Medication Guide that comes with VOTRIENT before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is the most important information I should know about VOTRIENT?

• VOTRIENT can cause serious liver problems including death. Your healthcare provider will do blood tests to check your liver before you start and while you take VOTRIENT.

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

• yellowing of your skin or the whites of your eyes (jaundice)
• dark urine
• tiredness
• nausea or vomiting
• loss of appetite
• pain on the right side of your stomach area (abdomen)
• bruise easily

Your healthcare provider may need to prescribe a lower dose of VOTRIENT for you or tell you to stop taking VOTRIENT if you develop liver problems during treatment.
What is VOTRIENT?

VOTRIENT is a prescription medicine used to treat advanced renal cell cancer in adults.
It is not known if VOTRIENT is safe or effective in children under 18 years of age.

What should I tell my healthcare provider before taking VOTRIENT? Before you take VOTRIENT, tell your healthcare provider if you:

• have or had liver problems. You may need a lower dose of VOTRIENT or your healthcare provider may prescribe a different medicine to treat your advanced renal cell cancer.
• have high blood pressure
• have heart problems or an irregular heartbeat including QT prolongation
• have a history of a stroke
• have coughed up blood in the last 6 months
• had bleeding of your stomach or intestines in the last 6 months
• have a history of a tear (perforation) in your stomach or intestine or an abnormal connection between two parts of your gastrointestinal tract (fistula)
• have thyroid problems
• had recent surgery (within the last 7 days) or are going to have surgery
• have any other medical conditions
• are pregnant or plan to become pregnant? VOTRIENT can harm your unborn baby. You should not become pregnant while you are taking VOTRIENT.
• are breastfeeding or plan to breastfeed. It is not known if VOTRIENT passes into your breast milk. You and your healthcare provider should decide if you will take VOTRIENT or breastfeed. You should not do both.
  Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.
  VOTRIENT may affect the way other medicines work and other medicines may affect how VOTRIENT works.

Especially, tell your healthcare provider if you:

• take medicines that can affect how your liver enzymes work such as:
• certain antibiotics (used to treat infections)
• certain medicines used to treat HIV
• certain medicines used to treat depression
• medicines used to treat irregular heartbeats
• take a medicine that contains simvastatin to treat high cholesterol levels
• drink grapefruit juice

Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take VOTRIENT?

• Take VOTRIENT exactly as your healthcare provider tells you. Your healthcare provider will tell you how much VOTRIENT to take.
• Your healthcare provider may change your dose.
• Take VOTRIENT on an empty stomach, at least 1 hour before or 2 hours after food.
• Do not crush tablets of VOTRIENT.
• Do not eat grapefruit or drink grapefruit juice during treatment with VOTRIENT. Grapefruit products may increase the amount of VOTRIENT in your body.
• If you miss a dose, take it as soon as you remember. Do not take it if it is close (within 12 hours) to your next dose. Just take the next dose at your regular time. Do not take more than 1 dose of VOTRIENT at a time.
• Your healthcare provider will test your blood and heart before you start and while you take VOTRIENT. What are the possible side effects of VOTRIENT? VOTRIENT may cause serious side effects including:
• See “What is the most important information I should know about

VOTRIENT?”

• irregular or fast heartbeat or fainting

• bleeding problems. Symptoms may include unusual bleeding, bruising, and wounds that do not heal.

• heart attack or stroke. 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.

• tear in your stomach or intestinal wall (perforation) or bleeding. Symptoms may include pain, swelling in your stomach area, vomiting blood, and black sticky stools.

• high blood pressure including a sudden and severe rise in blood pressure which may be life-threatening

• 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, nausea and vomiting, severe anxiety, shortness of breath, seizures, or passing out (becoming unconscious).

• thyroid problems. Your healthcare provider may check you for this during treatment with VOTRIENT. Call your healthcare provider right away, if you have any of the symptoms listed above.

The most common side effects of VOTRIENT include:

• diarrhea
• change in hair color
• nausea or vomiting
• loss of appetite
• feeling tired

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of VOTRIENT. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How should I store VOTRIENT tablets?

Store VOTRIENT at room temperature between 68°F and 77ºF (20°C to 25°C).
Keep VOTRIENT and all medicines out of the reach of children.

General information about the safe and effective use of VOTRIENT:

Medicines are sometimes prescribed for purposes other than those listed in a medication Guide. Do not use VOTRIENT for a condition for which it was not prescribed. Do not give VOTRIENT to other people even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about VOTRIENT. If you would like more information, talk with your healthcare provider.
You can ask your pharmacist or healthcare provider for information about VOTRIENT that is written for healthcare professionals. For more information, go to  www.VOTRIENT.com or call 1-888-825-5249.

What are the ingredients in VOTRIENT?

Active Ingredient : pazopanib.

Inactive Ingredients:

Tablet Core: Magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate.

Coating : Gray film-coat: Hypromellose, iron oxide black, macrogol/polyethylene glycol 400 (PEG 400), polysorbate 80, titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

GlaxoSmithKline
Research Triangle Park, NC 27709
Revised: March 2012
VOTRIENT is a registered trademark of GlaxoSmithKline.
©2012, GlaxoSmithKline. All rights reserved.
VTR: XMG

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda

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