Promacta (eltrombopag) is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body. Eltrombopag can lower the risk of bleeding by increasing platelets in your blood.
Promacta is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.
Promacta is also used to prevent bleeding in people with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).
Promacta is also used to treat severe aplastic anemia after other medicines have been tried without success.
Eltrombopag is not a cure for ITP and it will not make your platelet counts normal if you have this condition.
Important information
Before you take Promacta tell your doctor if you have kidney disease, blood cancer, a bone marrow disorder, high platelet levels, liver problems (if you are not being treated for hepatitis C), a history of cataracts or blood clot, if your spleen has been removed, or if you are of East Asian descent. Also tell your doctor about all other medications you use.
Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take Promacta.
If you have chronic hepatitis C, taking Promacta with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
After you stop taking this medicine, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking this medicine. Your blood will need to be tested weekly during this time.
Before taking Promacta
You should not use Promacta if you are allergic to eltrombopag.
To make sure Promacta is safe for you, tell your doctor if you have:
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liver disease (unless you are being treated for hepatitis C);
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kidney disease;
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high levels of platelets in your blood;
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a blood cancer or bone marrow disorder;
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if you have ever had cataracts or a blood clot;
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if your spleen has been removed; or
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if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).
Taking Promacta may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.
FDA pregnancy category C. It is not known whether Promacta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Promacta on the baby.
It is not known whether eltrombopag passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take Promacta?
Take Promacta exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take Promacta on an empty stomach, at least 1 hour before or 2 hours after a meal.
Do not take this medication with milk.
You will need frequent blood tests to check your liver function. Your eyes may also need to be checked for signs of cataract formation.
Taking Promacta long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.
It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.
If you take Promacta with other medicines to treat chronic hepatitis C, tell your doctor if you stop using any of your other hepatitis medicines.
Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.
After you stop taking Promacta, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking this medicine. Your blood will need to be tested weekly during this time.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Promacta?
Avoid taking other medicines within 4 hours before or 4 hours after you take Promacta. This includes antacids, vitamins, mineral supplements, or any other product that contains aluminum, calcium, iron, magnesium, selenium, or zinc.
Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or 4 hours after you take Promacta.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
Promacta side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Promacta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
You could develop a blood clot if your platelet count gets too high while you are using Promacta. Call your doctor or get emergency medical help if you have:
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signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
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signs of a blood clot in the stomach - severe stomach pain, vomiting, diarrhea;
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signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
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signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.
If you have chronic hepatitis C, taking Promacta with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems:
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nausea, upper stomach pain, loss of appetite;
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confusion, tired feeling; or
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dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Also call your doctor at once if you have:
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vision changes, eye pain, or seeing halos around lights;
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flu symptoms such as fever, cough, sore throat, headache, body aches, tired feeling;
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increased or frequent need to urinate;
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pain or burning when you urinate; or
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pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.
Common Promacta side effects may include:
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nausea, vomiting, diarrhea;
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cold symptoms such as stuffy nose, sneezing;
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flu symptoms;
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mouth pain;
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muscle pain, back pain;
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itching, tingling, or burning under your skin;
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skin rash; or
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abnormal 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.
See also: Side effects (in more detail)
What other drugs will affect Promacta?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Promacta, especially:
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a blood thinner (warfarin, Coumadin, Jantoven); or
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cholesterol medication - atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.
This list is not complete. Other drugs may interact with eltrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
