Eltrombopag 

(el trom' boe pag)

IMPORTANT WARNING:

Eltrombopag may cause liver damage. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes, dark urine, excessive tiredness, or pain in the upper right part of the stomach.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain blood tests to see how well your liver is working before and during your treatment with eltrombopag. Your doctor may tell you to stop taking eltrombopag if the tests show that your liver may not be working normally.

A program called Promacta CARES has been set up to be sure that eltrombopag is used safely. You and your doctor will need to enroll in this program before you can receive eltrombopag. You will need to get eltrombopag from a pharmacy that is enrolled in the program. As part of the program, you will receive written information about the risks of taking eltrombopag, and you will need to sign a form before you receive the medication. Your doctor will tell representatives of the program about how you are doing during your treatment, and you will only be able to receive eltrombopag at the pharmacy if your doctor has said that you are being monitored and having laboratory tests as required.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with eltrombopag and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of taking eltrombopag.

WHY is this medicine prescribed?

Eltrombopag is used to increase the number of platelets (cells that help the blood clot) in order to decrease the risk of bleeding in people who have chronic idiopathic thrombocytopenic purpura (ITP; an ongoing condition that may cause unusual bruising or bleeding due to an abnormally low number of platelets in the blood). Eltrombopag should only be used by people who have not been helped or cannot be treated with other treatments, including medications or surgery to remove the spleen. Eltrombopag is used to increase the number of platelets enough to lower the risk of bleeding, but it is not used to increase the number of platelets to a normal level. Eltrombopag is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.

HOW should this medicine be used?

Eltrombopag comes as a tablet to take by mouth. It is usually taken once a day on an empty stomach, at least 1 hour before or 2 hours after a meal. Take eltrombopag at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take eltrombopag exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Take eltrombopag at least 4 hours before or 4 hours after you eat or drink foods that contain calcium, such as dairy products and calcium-fortified juices and foods.

Your doctor will probably start you on a low dose of eltrombopag and adjust your dose depending on your response to the medication. At the beginning of your treatment, your doctor will order a blood test to check your platelet level once every week. Your doctor may increase your dose if your platelet level is too low. If your platelet level is too high, your doctor may decrease your dose or may not give you eltrombopag for a time. After your treatment has continued for some time and your doctor has found the dose of eltrombopag that works for you, your platelet level will be checked less often. Your platelet level will also be checked weekly for at least 4 weeks after you stop taking eltrombopag.

You may receive other medications for chronic ITP along with eltrombopag. Your doctor may decrease your dose of these medications if eltrombopag works well for you.

Eltrombopag does not work for everyone. If your platelet level does not increase enough after you have taken eltrombopag for some time, your doctor may tell you to stop taking eltrombopag.

Eltrombopag controls chronic ITP but does not cure it. Continue to take eltrombopag even if you feel well. Do not stop taking eltrombopag without talking to your doctor.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking eltrombopag,

  • tell your doctor and pharmacist if you are allergic to eltrombopag, any other medications, or any of the ingredients in eltrombopag tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen (Tylenol); anticoagulants (blood thinners) such as warfarin (Coumadin); aspirin and other nonsteroidal anti-inflammatory medications such as ibuprofen (Advil, Motrin) and naproxen (Aleve); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), fluvastatin (Lescol), pravastatin (Pravachol), and rosuvastatin (Crestor); ciprofloxacin (Cipro); fluvoxamine (Luvox); gemfibrozil (Lopid); methotrexate (Rheumatrex, Trexall); narcotic medications for pain; nateglinide (Starlix); omeprazole (Prilosec); penicillin G (Bicillin); repaglinide (Prandin, in Prandimet): rifampin (Rimactane, Rifadin, in Rifamate, Rifater); and trimethoprim (Primsol, in Bactrim, in Septra). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with eltrombopag, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • if you are taking antacids containing calcium, aluminum, or magnesium (Maalox, Mylanta, Tums) or vitamin or mineral supplements containing calcium, iron, zinc or selenium, take them 4 hours before or 4 hours after you take eltrombopag.
  • tell your doctor if you are of East Asian (Chinese, Japanese, Taiwanese, or Korean) descent and if you have or have ever had a cataract (clouding of the lens of the eye that may cause vision problems), blood clots, any condition that increases the risk that you will develop a blood clot, bleeding problems, any problem with your bone marrow, including cancer that affects your blood cells or myelodysplastic syndrome (condition in which the bone marrow produces abnormal blood cells and there is a risk that cancer of the blood cells may develop),or kidney disease. Also tell your doctor if you have had surgery to remove your spleen.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking eltrombopag, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking eltrombopag.
  • tell your doctor if you use tobacco products. Tobacco products may decrease the effectiveness of this medication.
  • continue to avoid activities that may cause injury and bleeding during your treatment with eltrombopag. Eltrombopag is given to decrease the risk that you will experience severe bleeding, but there is still a risk that bleeding may occur.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of eltrombopag in one day.

What SIDE EFFECTS can this medicine cause?

Eltrombopag may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea

  • vomiting
  • heartburn
  • muscle pain
  • numbness, burning, or tingling in the hands or feet
  • unusually long or heavy menstrual periods
  • red patches on the whites of the eyes or inside of the eyelids

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

  • swelling, pain, tenderness, warmth or redness in one leg
  • shortness of breath
  • coughing up blood
  • fast heartbeat
  • fast breathing
  • pain when breathing deeply
  • pain in the chest, arms, back, neck, jaw, or stomach
  • breaking out in cold sweat
  • lightheadedness
  • slow or difficult speech
  • dizziness or faintness
  • weakness or numbness of an arm or leg
  • vision changes

Eltrombopag may cause changes in your bone marrow. These changes may cause your bone marrow to make fewer than normal blood cells or to make abnormal blood cells. These blood cell problems may be life-threatening.

Eltrombopag may cause your platelet level to increase too much. This may increase the risk that you will develop a blood clot, which may spread to the lungs or cause a heart attack or stroke.Your doctor will monitor your platelet level carefully during your treatment with eltrombopag.

After your treatment with eltrombopag ends, your platelet level may drop lower than it was before you began your treatment with eltrombopag. This increases the risk that you will experience bleeding problems. Your doctor will monitor you carefully for 4 weeks after your treatment ends. If you have any unusual bruising or bleeding, tell your doctor immediately.

Eltrombopag may cause you to develop new cataracts or may cause cataracts that you already have to worsen. Your doctor will check your eyes before and during your treatment with eltrombopag.

Talk to your doctor about the risks of taking eltrombopag.

Eltrombopag may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• rash

  • slowed heartbeat
  • excessive tiredness

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand Names
  • Promacta®

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