Generic Name: eltrombopag (el-TROM-boe-pag)
Brand Name: Promacta
Promacta may cause serious and sometimes fatal liver problems. Your doctor will perform blood tests to check your liver before you start Promacta 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.
Promacta is used for:
Treating low blood platelets in certain patients. It is also used to treat aplastic anemia in certain patients.
Promacta is a thrombopoietin receptor agonist. It works by causing the bone marrow to produce more cells.
Do NOT use Promacta if:
- you are allergic to any ingredient in Promacta
Contact your doctor or health care provider right away if any of these apply to you.
Before using Promacta:
Some medical conditions may interact with Promacta. 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, 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 Promacta. 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 Promacta's side effects
- Omeprazole or rifampin because they may decrease Promacta'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 Promacta
This may not be a complete list of all interactions that may occur. Ask your health care provider if Promacta 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 Promacta:
Use Promacta as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Promacta comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Promacta refilled.
- Take Promacta by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.
- Take Promacta 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 Promacta. You may have an increased risk of severe low platelets and bleeding. If you need to stop Promacta, your doctor will need to monitor your condition.
- If you miss a dose of Promacta, 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 Promacta.
Important safety information:
- If you stop taking Promacta, the number of clot-forming cells (platelets) in your blood may return to a similar low platelet count as before you started taking Promacta. 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 Promacta. Your doctor will check your blood platelet counts for at least 4 weeks after you stop taking Promacta. Tell your doctor if you have unusual bruising or bleeding after you stop taking Promacta. Avoid activities that may cause bruising or injury. Discuss any questions or concerns with your doctor.
- Do not change your dose of Promacta without checking with your doctor.
- Tell your doctor or dentist that you take Promacta before you receive any medical or dental care, emergency care, or surgery.
- Blood clots have occurred in patients taking Promacta. Some blood clots (eg, those that cause heart attacks or strokes) have been 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, and eye exams, may be performed while you use Promacta and for at least 4 weeks after you stop Promacta. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Promacta 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.
- PREGNANCY and BREAST-FEEDING: It is not known if Promacta can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Promacta while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Promacta.
Possible side effects of Promacta:
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; cough; diarrhea; dizziness; hair loss; joint pain; mild flu-like symptoms (eg, fever, headache, tiredness, sore throat, body aches); mild loss of appetite; minor muscle aches or pain; muscle spasms; 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.Proper storage of Promacta:
Store Promacta 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 Promacta out of the reach of children and away from pets.
- If you have any questions about Promacta, please talk with your doctor, pharmacist, or other health care provider.
- Promacta 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 Promacta 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 Promacta. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Promacta. 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 Promacta.
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.