What is the most important information I should know about eltrombopag?
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).
What is eltrombopag?
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.
Eltrombopag 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. This medicine is for use in adults and children who are at least 1 year old, after other medicines have been tried without success.
Eltrombopag is also used to prevent bleeding in adults with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).
Eltrombopag is also used to treat severe aplastic anemia in adults 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.
Eltrombopag may also be used for purposes not listed in this medication guide.
What should I discuss with my health care provider before taking eltrombopag?
You should not use eltrombopag if you are allergic to it.
To make sure eltrombopag is safe for you, tell your doctor if you have ever had:
- liver disease (unless you are being treated for hepatitis C);
- kidney disease;
- high levels of platelets in your blood;
- a blood cancer or bone marrow disorder;
- cataracts or a blood clot;
- if your spleen has been removed; or
- if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).
Taking eltrombopag 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.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
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 eltrombopag on the baby.
It is not known whether eltrombopag passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How should I take eltrombopag?
Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Take eltrombopag on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medicine with milk or calcium-fortified juice.
Follow all instructions for mixing eltrombopag oral suspension. Mix the oral suspension powder only with water. Use the dosing syringe to measure the water and to give the correct dose.
Do not crush an eltrombopag tablet. Swallow the tablet whole with a full glass of water.
You will need frequent blood tests to check your liver function. Your eyes may also need to be checked for signs of cataract formation.
If you take eltrombopag with other medicines to treat chronic hepatitis C, tell your doctor if you stop using any of your other hepatitis medicines.
Taking eltrombopag 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.
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 mixing eltrombopag oral suspension, store the liquid at room temperature and use it within 30 minutes.
After you stop taking eltrombopag, 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 eltrombopag. 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 eltrombopag?
Avoid taking other medicines within 4 hours before or 2 hours after you take eltrombopag. 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 2 hours after you take eltrombopag.
Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.
What are the possible side effects of eltrombopag?
Get emergency medical help if you have signs of an allergic reaction: 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 eltrombopag. Call your doctor or get emergency medical help if you have:
-
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;
-
signs of a blood clot in the stomach --severe stomach pain, vomiting, diarrhea;
-
signs of a blood clot in the lung --chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
-
signs of a blood clot in your leg --pain, swelling, warmth, or redness in one or both legs.
Call your doctor at once if you have:
- vision changes, tunnel vision, eye pain, or seeing halos around lights;
- flu symptoms such as fever, cough, sore throat, headache, body aches, tired feeling;
- increased or frequent need to urinate;
- pain or burning when you urinate;
- pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
-
liver problems --confusion, nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- nausea, vomiting, diarrhea, stomach pain;
- cold symptoms such as stuffy nose or sneezing;
- flu symptoms;
- mouth pain, tooth pain;
- muscle pain, back pain, headache;
- feeling weak or tired;
- itching, tingling, or burning under your skin;
- skin rash; or
- 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.
What other drugs will affect eltrombopag?
Tell your doctor about all your current medicines and any you start or stop using, especially:
- a blood thinner (warfarin, Coumadin, Jantoven); or
- 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.
Where can I get more information?
Your doctor or pharmacist can provide more information about eltrombopag.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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