What should I discuss with my health care provider before taking eltrombopag?

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1 1 of 6 6/10/2016 3:57 PM Generic Name: eltrombopag (el TROM boe pag) Brand Name: Promacta 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 is the most important information I should know about eltrombopag? If you have chronic hepatitis C, taking eltrombopag 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). 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: 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; if you have ever had cataracts or a blood clot; if your spleen has been removed; or

2 2 of 6 6/10/2016 3:57 PM 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. Tell your doctor if you are breast-feeding a baby. How should I take eltrombopag? 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. 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 crush an eltrombopag tablet. Swallow the tablet whole with a full glass of water. Do not take this medication with milk. 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. 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 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. 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. 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?

3 3 of 6 6/10/2016 3:57 PM 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 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. Eltrombopag side effects 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. If you have chronic hepatitis C, taking eltrombopag 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, loss of appetite; confusion, tired feeling; or dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Also call your doctor at once if you have: vision changes, 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; or pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin. Common side effects may include: nausea, vomiting, diarrhea, stomach pain;

4 4 of 6 6/10/2016 3:57 PM cold symptoms such as stuffy nose, sneezing; flu symptoms; mouth pain; muscle pain, back pain; 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 FDA See also: Side effects (in more detail) Eltrombopag dosing information Usual Adult Dose for Aplastic Anemia: Initial dose: 50 mg orally once a day; increase daily dose if necessary in increments of 50 mg every two weeks Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean): ; increase to 50 mg once a day after 2 weeks if necessary, then increase daily dose in increments of 50 mg every 2 weeks Maintenance dose: The lowest dose to achieve and maintain a platelet count between 50 to 200 x 10(9)/L as necessary Maximum dose: 150 mg orally once a day Duration: -Patients who achieve trilineage response, including transfusion independence lasting at least 8 weeks: Eltrombopag dose may be reduced by 50% and discontinued if counts remain stable after 8 weeks at the reduced dose. -Treatment should be discontinued if no hematologic response is observed after 16 weeks of therapy. -Consider treatment discontinuation if new cytogenetic abnormalities are observed. -Treatment should be restarted at the previous effective dose if platelet counts fall to below 30 x 10(9)/L, hemoglobin falls to less than 9 g/dl, or ANC falls to less than 0.5 x 10(9)/L. Use: Treatment of severe aplastic anemia in patients who have had an insufficient response to immunosuppressive therapy. Usual Adult Dose for Idiopathic (Immune) Thrombocytopenic Purpura: Initial dose: 50 mg orally once a day Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean): Maintenance dose: The lowest dose to achieve and maintain a platelet count between 50 to 200 x 10(9)/L as necessary to reduce the risk of bleeding.

5 5 of 6 6/10/2016 3:57 PM Maximum dose: 75 mg orally once a day Duration: Treatment should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at the maximum daily dose. -Monitor CBC with differentials, including platelet counts, every week until the platelet count is stable, followed by monthly thereafter. They should also be monitored every week for at least 4 weeks following treatment discontinuation. -Platelet counts generally increase within 1 to 2 weeks after starting therapy and decrease within 1 to 2 weeks after treatment discontinuation. Use: Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Usual Adult Dose for Thrombocytopenia: Maintenance dose: The lowest dose to achieve and maintain a platelet count necessary to initiate and maintain antiviral therapy with pegylated interferon and ribavirin. Maximum dose: 100 mg orally once a day Duration: Treatment should be discontinued when concomitant antiviral therapy is discontinued -Adjust the daily dose by increments of 25 mg every two weeks as necessary according to platelet count response. -Monitor platelet counts every week prior to starting antiviral therapy. -During antiviral therapy, monitor CBC with differentials, including platelet counts, every week until the platelet count is stable. Monitor platelet counts monthly thereafter. -Platelet counts generally began to rise within the first week of treatment with eltrombopag. Use: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Usual Pediatric Dose for Idiopathic (Immune) Thrombocytopenic Purpura: 1 TO 5 YEARS: 6 YEARS OR OLDER: Initial dose: 50 mg orally once a day Patients of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean): Maintenance dose: The lowest dose to achieve and maintain a platelet count between 50 to 200 x 10(9)/L as necessary to reduce the risk of bleeding. Maximum dose: 75 mg orally once a day Duration: Treatment should be discontinued if the platelet count does not increase to a level sufficient to avoid clinically important bleeding after 4 weeks of therapy at the maximum daily dose.

6 6 of 6 6/10/2016 3:57 PM -Monitor CBC with differentials, including platelet counts, every week until the platelet count is stable, followed by monthly thereafter. They should also be monitored every week for at least 4 weeks following treatment discontinuation. -Platelet counts generally increase within 1 to 2 weeks after starting therapy and decrease within 1 to 2 weeks after treatment discontinuation. Use: Treatment of thrombocytopenia in patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 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. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright Cerner Multum, Inc. Version: Revision Date: , 8:43:41 AM.