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Eltrombopag

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Warning

Eltrombopag may rarely cause severe (possibly fatal) liver problems. People with a certain liver problem (chronic hepatitis C) who are taking this medication with ribavirin and interferon may sometimes experience worsening of their liver problem. To help decrease the risk of liver problems, your doctor will order lab tests (liver function tests) before you start eltrombopag and while you are taking it. Keep all medical and lab appointments. Get medical help right away if you develop new or worsening symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, stomach/abdominal swelling, dark urine, yellowing eyes/skin, mental/mood changes). Talk with your doctor about the risks and benefits of this medication.

Precautions

Before using eltrombopag, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots/clotting problems (such as Factor V Leiden), other blood disorders (such as blood cancer, myelodysplastic syndrome), certain eye problem (cataracts), liver disease.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Although this medication increases platelets and decreases the risk of bleeding, continue to avoid activities that can increase your risk of bleeding (such as contact sports, using sharp objects like razors and nail cutters).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using eltrombopag. Eltrombopag may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 7 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Side Effects

See also Warning section.

Nausea, diarrhea, headache, muscle pain, and tingling/numbness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: vision changes.

This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs) especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you have: shortness of breath/rapid breathing, chest/jaw/left arm pain, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, trouble speaking, weakness on one side of the body, unusual sweating, confusion, sudden/severe headaches, sudden vision changes.

Eltrombopag can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.