Eltrombopag

This medication guide only provides information about certain brand forms of eltrombopag.

Eltrombopag is used to treat low platelet levels in adults and children who are at least 1 year old with chronic immune thrombocytopenia. Eltrombopag is given after other treatments did not work or stopped working.

Eltrombopag is used to treat low platelet levels in the blood of adults with chronic hepatitis C before and during treatment with interferon.

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

Eltrombopag is also used in adults to treat severe aplastic anemia after other treatments did not work or stopped working.

Eltrombopag is not to be used in people:

• who have a pre-cancerous condition called myelodysplastic syndrome (MDS);
• who have low platelet levels in blood (caused by certain other medical conditions or diseases); or
• who need platelet levels to normalize.

Your doctor will determine if you are able to take eltrombopag.

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

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.

Your dose may change if you switch to a different brand form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Eltrombopag is usually taken once per day. Follow your doctor's instructions.

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

Read and carefully follow the Instructions for Use provided with your medicine. A healthcare provider will teach you how to properly use this medicine. Talk to your pharmacist if you do not understand these instructions or have any questions.

Be sure you understand how to prepare the oral suspension. Mix the oral suspension powder only with cool or cold water. Use a new dosing syringe each time you take the oral suspension.

You may take eltrombopag with a meal (containing fewer than 50 milligrams of calcium) or without a meal. Learn about the foods you should eat or avoid.

Take eltrombopag at least 2 hours before or 4 hours after eating foods high in calcium (dairy products, calcium-fortified juices, certain fruits and vegetables). Follow all instructions from your doctor or dietitian.

You will need frequent vision exams and blood tests to check your liver function before and during treatment with eltrombopag. Your dose may be changed based on the results.

Your platelet levels will also need to be checked regularly. Your bone marrow may be tested if you have severe aplastic anemia.

Do not change your dose or stop using eltrombopag suddenly. Ask your doctor before stopping the medicine.

Call your doctor if you have bleeding or bruising while using this medicine or after you stop taking eltrombopag.

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

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 the suspension away in the trash only.

Call your doctor right away if you notice any signs of liver problems, including nausea, pain in the upper stomach, confusion, feeling very tired, loss of appetite, dark urine, clay-colored stools, or yellowing of your skin or eyes.

Tell your doctor if you have or have ever had:

• a blood clot;
• a pre-cancerous condition called myelodysplastic syndrome (MDS) or blood cancer;
• a bleeding or blood clotting disorder;
• cataracts;
• surgery to remove your spleen;
• if you are of East or Southeast Asian descent;
• if you are using any medicine to treat hepatitis C; or
• liver disease.

It is not known if eltrombopag will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. You should still use effective birth control while using eltrombopag and for at least 7 days after your last dose.

Do not breastfeed while using eltrombopag.

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

You may develop a blood clot while 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.

Call your doctor at once if you have any of these other side effects, even if they occur after your treatment ends.

• easy bruising, unusual bleeding, pinpoint purple or red spots under your skin;
• blurred or cloudy vision, seeing halos around lights, vision changes;
• 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).

Your treatment may be permanently stopped if you have certain side effects.

Common side effects of eltrombopag may include:

• nausea, diarrhea;
• fever;
• cough;
• headache, tiredness;
• low red blood cells (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.

Skip the missed dose and take your next dose at the usual 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.

Ask your doctor before taking an antacid, and take only the type your doctor recommends.

Avoid activities that may increase your risk of bleeding or injury. Use extra care while shaving or brushing your teeth.

Take your eltrombopag dose 2 hours before or 4 hours after taking an antacid, vitamins, or supplements that contain calcium, magnesium, aluminum, iron, selenium, or zinc.

Tell your doctor about all your other medicines, especially:

• medicine used to prevent blood clots--alteplase, clopidogrel, dipyridamole, ticlopidine, and others;
• a blood thinner--warfarin, Coumadin, Jantoven, enoxaparin, apixaban, rivaroxaban, 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.