Eltrombopag is used to prevent bleeding episodes in adults and children age 1 year and older, who have chronic immune thrombocytopenic purpura (ITP). ITP is a bleeding condition caused by a lack of platelets in the blood.

Eltrombopag is also used to prevent bleeding in adults with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).

Eltrombopag is also used together with other medications to treat severe aplastic anemia in adults and children who are at least 2 years old.

Eltrombopag is sometimes given after other treatments have failed.

Eltrombopag may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Eltrombopag comes as a tablet and as a powder for oral suspension (liquid) to take by mouth. It is usually taken once a day on an empty stomach, at least 1 hour before or 2 hours after eating. 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 2 hours before or 4 hours after you eat or drink foods that contain a lot of calcium, such as dairy products, calcium-fortified juices, cereals, oatmeal, and breads; trout; clams; leafy green vegetables such as spinach and collard greens; and tofu and other soy products. Ask your doctor if you are not sure if a food contains a lot of calcium. You may find it helpful to take eltrombopag close to the beginning or end of your day so that you will be able to eat these foods during most of your waking hours.

Swallow the tablets whole. Do not split, chew, or crush them and mix them into food or liquids.

If you are taking the powder for oral suspension, carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to prepare and measure your dose. Mix the powder with cool or cold water before use. Do not mix the powder with hot water. Immediately after preparation, swallow the dose. If it is not taken within 30 minutes or if there is remaining liquid, dispose of the mixture in the trash (do not pour it down the sink).

Do not allow the powder to touch your skin. If you spill the powder on your skin, wash it off immediately with soap and water. Call your doctor if you have a skin reaction or if you have any questions.

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.

If you have chronic ITP, you may receive other medications to treat your condition 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 may help to control your condition but will not cure it. Continue to take eltrombopag even if you feel well. Do not stop taking eltrombopag without talking to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take eltrombopag in any of the following ways:

• on an empty stomach, at least 1 hour before or 2 hours after eating;

• with a meal containing fewer than 50 milligrams of calcium; or

• at least 2 hours before or 4 hours after eating foods high in calcium (dairy products, calcium-fortified juices, certain fruits and vegetables).

Swallow the tablet whole and do not crush, chew, break it or mix with food or liquid.

Mix the oral suspension powder only with cool or cold water. Use a new dosing syringe each time you mix the medicine to measure the water and to give the correct dose.

You may need frequent medical tests to check your bone marrow cells or liver function. Your eyes may also need to be checked for signs of cataracts.

Eltrombopag is usually taken for 6 months. It may take up to 4 weeks before the medicine prevents major bleeding episodes.

Keep taking eltrombopag as directed. Tell your doctor if you have any bruising or bleeding that happens while you take and after you stop taking eltrombopag.

If you take eltrombopag with medication to treat chronic hepatitis C, tell your doctor if you stop using any of your hepatitis medications.

Store at room temperature away from moisture and heat. Keep the tablets in their original container. After mixing eltrombopag oral suspension, use it right away, if it is not used within 30 minutes throw it away in the trash only.

After you stop taking eltrombopag, your risk of bleeding or bruising may be even higher than it was before you started treatment. Your blood will need to be tested weekly during this time.

Eltrombopag doses are based on weight in children younger than 6 years old. Your child's dose needs may change if the child gains or loses weight.

Tell your doctor if you have ever had:

• a blood clot;

• blood cancer;

• bleeding problems;

• cataracts;

• surgery to remove your spleen;

• if you are of East or Southeast Asian descent; or

• liver disease (unless you are being treated for hepatitis C).

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using eltrombopag and for at least 7 days after your last dose. Tell your doctor if you become pregnant.

You should not breastfeed while using eltrombopag.

Skip the missed dose and take your next dose at the regular time. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking too much eltrombopag may cause a life-threatening blood clot.

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). If your medication came with a desiccant packet (small packet that contains a substance that absorbs moisture to keep the medication dry), leave the packet in the bottle but be careful not to swallow it.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb eltrombopag and should not be taken at the same time.

Avoid activities that may increase your risk of bleeding or injury for at least 4 weeks after you stop taking eltrombopag. Use extra care while shaving or brushing your teeth.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You could develop a blood clot if your platelet count gets too high while you are using eltrombopag. Call your doctor or get emergency medical help if you have:

• signs of a stroke--sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;

• signs of a blood clot deep in the body--pain, swelling, or warmth in one leg; or

• signs of a blood clot in the stomach--severe stomach pain, vomiting, diarrhea.

Eltrombopag may cause serious side effects. Call your doctor at once if you have:

• any bruising or bleeding episodes during or after treatment with eltrombopag;

• vision changes, tunnel vision, eye pain, or seeing halos around lights;

• pain or burning when you urinate;

• low red blood cells (anemia)--pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet; or

• liver problems--confusion, tiredness, right-sided upper stomach pain, swelling around your midsection, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of eltrombopag may include:

• nausea, diarrhea;

• fever;

• cough;

• headache, tiredness;

• anemia; or

• abnormal bone marrow or liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make eltrombopag much less effective when taken at the same time. If you take any of the following medicines, take your eltrombopag dose 2 hours before or 4 hours after you take the other medicine:

• antacids that contain calcium, magnesium, or aluminum; or

• vitamin or mineral supplements that contain aluminum, calcium, iron, magnesium, selenium, or zinc.

Tell your doctor about all your other medicines, especially:

• medicine used to prevent blood clots--alteplase, clopidogrel, dipyridamole, warfarin, enoxaparin, apixaban, ticlopidine, and others; or

• cholesterol lowering medicine --atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

This list is not complete. Other drugs may affect eltrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your doctor will order an eye exam before and during your treatment with eltrombopag.

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.