Generic Name: eltrombopag (el-TROM-boe-pag)
Brand Name: Promacta
Eltrombopag may cause serious and sometimes fatal liver problems. Your doctor will perform blood tests to check your liver before you start eltrombopag and for as long as you take it. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, pale stools, stomach pain, or unusual tiredness.
Eltrombopag is used for:
Treating low blood platelets in certain patients.
Eltrombopag is a thrombopoietin receptor agonist. It works by causing the bone marrow to produce more clot-forming cells (platelets).
Do NOT use eltrombopag if:
- you are allergic to any ingredient in eltrombopag
Contact your doctor or health care provider right away if any of these apply to you.
Before using eltrombopag:
Some medical conditions may interact with eltrombopag. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of liver or kidney problems, cataracts, bleeding problems, or bone marrow problems (eg, blood cancer, myelodysplastic syndrome), or if you have had surgery to remove your spleen
- if you have a blood clot or a history of blood clots, a high number of clot-forming cells (platelets) in the blood, or a condition that may increase your risk of getting a blood clot (eg, antithrombin III deficiency, antiphospholipid syndrome, Factor V Leiden)
- if you use tobacco products
- if you take a blood thinner (eg, warfarin) or an antiplatelet medicine (eg, clopidogrel)
- if you are of East Asian ancestry (eg, Chinese, Japanese, Taiwanese, Korean)
Some MEDICINES MAY INTERACT with eltrombopag. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Ciprofloxacin, fluvoxamine, gemfibrozil, or trimethoprim because they may increase the risk of eltrombopag's side effects
- Omeprazole or rifampin because they may decrease eltrombopag's effectiveness
- Acetaminophen, benzylpenicillin, bosentan, doxorubicin, ezetimibe, glyburide, statins (eg, atorvastatin, rosuvastatin), imatinib, irinotecan, lapatinib, meglitinides (eg, nateglinide, repaglinide), methotrexate, mitoxantrone, narcotic pain medications (eg, codeine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), olmesartan, sulfasalazine, topotecan, or valsartan because the risk of their side effects may be increased by eltrombopag
This may not be a complete list of all interactions that may occur. Ask your health care provider if eltrombopag may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use eltrombopag:
Use eltrombopag as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Eltrombopag comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get eltrombopag refilled.
- Take eltrombopag by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.
- Take eltrombopag at least 4 hours before or 4 hours after you take certain other medicines (eg, antacids), calcium-rich foods (eg, dairy products, calcium-fortified juices), or supplements that contain iron, calcium, aluminum, magnesium, selenium, or zinc.
- Do not suddenly stop taking eltrombopag. You may have an increased risk of severe low platelets and bleeding. If you need to stop eltrombopag, your doctor will need to monitor your condition.
- If you miss a dose of eltrombopag, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 1 day.
Ask your health care provider any questions you may have about how to use eltrombopag.
Important safety information:
- If you stop taking eltrombopag, the number of clot-forming cells (platelets) in your blood may return to a similar low platelet count as before you started taking eltrombopag. Low blood platelets may increase your risk of bleeding, especially if you are also taking certain other medicines (eg, anticoagulants such as warfarin, antiplatelet medicines such as clopidogrel). These effects are most likely to occur within 4 weeks after you stop taking eltrombopag. Your doctor will check your blood platelet counts for at least 4 weeks after you stop taking eltrombopag. Tell your doctor if you have unusual bruising or bleeding after you stop taking eltrombopag. Avoid activities that may cause bruising or injury. Discuss any questions or concerns with your doctor.
- Do not change your dose of eltrombopag without checking with your doctor.
- Tell your doctor or dentist that you take eltrombopag before you receive any medical or dental care, emergency care, or surgery.
- Serious blood clots have occurred in patients taking eltrombopag. Some serious blood clots may be fatal. The risk of developing a blood clot may be greater if you have a high number of clot-forming cells (platelets) in the blood. However, blood clots have occurred in patients with normal or low blood platelet levels. Tell your doctor immediately if you notice any signs of a blood clot (eg, pain, redness, tenderness, or swelling in the legs; chest pain; shortness of breath; coughing up blood).
- Lab tests, including liver function, complete blood cell counts, peripheral blood smears, and eye exams, may be performed while you use eltrombopag and for at least 4 weeks after you stop eltrombopag. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use eltrombopag with caution in patients of East Asian ancestry (eg, Chinese, Japanese, Taiwanese, Korean) and in patients who have moderate to severe liver problems. They may be more sensitive to the medicine and may require a lower dose than other patients. Discuss any questions or concerns with your doctor.
- Eltrombopag should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: It is not known if eltrombopag can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using eltrombopag while you are pregnant. It is not known if eltrombopag is found in breast milk. Do not breast-feed while taking eltrombopag.
Possible side effects of eltrombopag:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; diarrhea; hair loss; mild flu-like symptoms (eg, fever, headache, tiredness, sore throat, body aches); mild loss of appetite; minor muscle aches or pain; nausea; symptoms of upper respiratory tract infection (eg, runny or stuffy nose, sneezing); trouble sleeping; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning with urination; chest pain; coughing up blood; frequent, painful, or urgent urination; new or worsening vision problems (eg, cloudy vision); pain or swelling in your throat or mouth; pain, redness, tenderness, or swelling in the legs; severe or persistent nausea, vomiting, or diarrhea; severe or persistent tiredness or weakness; shortness of breath; stomach pain; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or arm pain; sudden, severe nausea or vomiting; unusual sweating; fainting); symptoms of new or worsening liver problems (eg, confusion, dark urine, persistent loss of appetite, pale stools, stomach pain or swelling, yellowing of the skin or eyes); symptoms of stroke (eg, confusion, slurred speech, sudden vision changes, one-sided weakness); unusual bruising or bleeding; unusual burning, itching, numbness, or tingling of the skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest, jaw, or arm pain; confusion; coughing up blood; fainting; one-sided weakness; pain, redness, tenderness, or swelling in the legs; shortness of breath; slow heartbeat; slurred speech; sudden, severe nausea or vomiting; symptoms of new or worsening liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, unusual tiredness, yellowing of the skin or eyes); unusual sweating; vision problems.Proper storage of eltrombopag:
Store eltrombopag at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original bottle, away from heat, moisture, and light. Do not store in the bathroom. Keep eltrombopag out of the reach of children and away from pets.
- If you have any questions about eltrombopag, please talk with your doctor, pharmacist, or other health care provider.
- Eltrombopag is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take eltrombopag or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about eltrombopag. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to eltrombopag. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using eltrombopag.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.