Eltrombopag

If you have chronic hepatitis C (an ongoing viral infection that may damage the liver) and you take eltrombopag with certain medications for hepatitis C (interferon and ribavirin), there is an increased risk that you will develop serious liver problems.

Taking eltrombopag may increase the risk of liver damage. If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes, dark urine, excessive tiredness, pain in the upper right part of the stomach, swelling of the stomach area, or confusion.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain laboratory tests before and during your treatment to check your body's response to eltrombopag.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of taking eltrombopag.

Eltrombopag is used to treat thrombocytopenia (a low number of platelets [type of blood cell needed for blood clotting]) and aplastic anemia (condition in which the body does not make enough new blood cells). 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.

Eltrombopag comes as a tablet and as a powder for oral suspension (liquid) to take by mouth. Take 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. 

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. 

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. 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.

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.

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

Before taking eltrombopag,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had 
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking eltrombopag. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking antacids containing calcium, aluminum, or magnesium or vitamin or mineral supplements containing calcium, iron, zinc or selenium, take eltrombopag 2 hours before or 4 hours after you take them.
• tell your doctor if you are of East/Southeast Asian 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, myelodysplastic syndrome (MDS; a blood disorder that can lead to cancer), or liver disease. Also tell your doctor if you have had surgery to remove your spleen.
• tell your doctor if you are pregnant, or plan to become pregnant. You should not become pregnant during your treatment with eltrombopag. Use effective birth control while you are receiving treatment and for 7 days after your last dose. If you become pregnant while taking eltrombopag, call your doctor.
• tell your doctor if you are breastfeeding. You should not breastfeed while you are taking eltrombopag.
• 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.

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

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.

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

• headache
• cough
• fever
• tiredness

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 or get emergency medical treatment:

• 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, sudden weakness or numbness of the face, arm or leg, sudden headache, sudden vision problems, sudden difficulty walking
• stomach pain, nausea, vomiting, diarrhea
• cloudy, blurry vision, or other vision changes

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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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). 

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• rash
• slowed heartbeat
• excessive tiredness

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

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking eltrombopag.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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