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- What is Promacta (eltrombopag) and how is it used?
- What are the most important side effects and other facts about Promacta (eltrombopag)?
- Other side effects of Promacta (eltrombopag)
- What is the dosage for Promacta (eltrombopag)?
- Promacta (eltrombopag) contraindications, pregnancy safety and drug interactions
What is Promacta (eltrombopag) and how is it used?
Promacta is a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough.
Promacta is also used to treat people with:
- low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon.
- severe aplastic anemia (SAA) in combination with other medicines to treat SAA, as the first treatment for adults and children 2 years of age and older.
- severe aplastic anemia (SAA) when other medicines to treat SAA have not worked well enough.
Promacta is used to try to raise platelet counts in order to lower your risk for bleeding.
Promacta is not used to make platelet counts normal.
What are the most important side effects and other facts about Promacta (eltrombopag)?
RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C
RISK OF HEPATOTOXICITY
Promacta may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended
Promacta can cause serious side effects, including:
- If you have chronic hepatitis C virus and take Promacta with interferon and ribavirin treatment, Promacta may increase your risk of liver problems. If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking Promacta.
- Promacta may increase your risk of liver problems that may be severe and possibly life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking Promacta and during your treatment. Your healthcare provider may stop your treatment with Promacta if you have changes in your liver function blood tests.
Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:
Other side effects of Promacta (eltrombopag)
Promacta may cause serious side effects, including:
- Increased risk of worsening of a precancerous blood condition called myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML). Promacta is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive Promacta, you have an increased risk that your MDS condition may worsen and become a blood cancer called AML. If your MDS worsens to become AML, you may have an increased risk of death from AML.
- High platelet counts and higher risk for blood clots. Your risk of getting a blood clot is increased if your platelet count is too high during treatment with Promacta. Your risk of getting a blood clot may also be increased during treatment with Promacta if you have normal or low platelet counts.
- You may have severe problems or die from some forms of blood clots, such as clots that travel to the lungs or that cause heart attacks or strokes. Your healthcare provider will check your blood platelet counts, and change your dose or stop Promacta if your platelet counts get too high.
- Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg. People with chronic liver disease may be at risk for a type of blood clot in the stomach area (abdomen).
- Tell your healthcare provider right away if you have stomach-area (abdomen) pain, nausea, vomiting, or diarrhea as these may be symptoms of this type of blood clot.
- New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts can happen in people taking Promacta. Your healthcare provider will check your eyes before and during your treatment with Promacta. Tell your healthcare provider about any changes in your eyesight while taking Promacta.
The most common side effects of Promacta in adults and children include:
- low red blood cell count (anemia)
- abnormal liver function tests
Laboratory tests may show abnormal changes to the cells in your bone marrow.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Promacta. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Promacta (eltrombopag)?
- Take Promacta exactly as your healthcare provider tells you to take it. Your healthcare provider will prescribe the dose of Promacta tablets or Promacta for oral suspension that is right for you.
- If your healthcare provider prescribes Promacta tablets, take Promacta tablets whole. Do not split, chew, or crush Promacta tablets and do not mix with food or liquids.
- If your healthcare provider prescribes Promacta for oral suspension, see the “Instructions for Use” that comes with your medicine for instructions on how to correctly mix and take a dose of Promacta.
- Use a new single-use oral dosing syringe to prepare each dose of Promacta for oral suspension. Do not re-use the oral dosing syringe.
- Do not stop taking Promacta without talking with your healthcare provider first. Do not change your dose or schedule for taking Promacta unless your healthcare provider tells you to change it.
- Take Promacta on an empty stomach, either 1 hour before or 2 hours after eating food.
- Take Promacta at least 2 hours before or 4 hours after eating dairy products and calcium-fortified juices.
- If you miss a dose of Promacta, wait and take your next scheduled dose. Do not take more than 1 dose of Promacta in 1 day.
- If you take too much Promacta, you may have a higher risk of serious side effects. Call your healthcare provider right away.
- Your healthcare provider will check your platelet count during your treatment with Promacta and change your dose of Promacta as needed.
- Tell your healthcare provider about any bruising or bleeding that happens while you take and after you stop taking Promacta.
- If you have SAA, your healthcare provider may do tests to monitor your bone marrow during treatment with Promacta.
What should I avoid while taking Promacta?
Avoid situations and medicines that may increase your risk of bleeding.
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Promacta (eltrombopag) contraindications, pregnancy safety and drug interactions
Promacta is not for use in people with a pre-cancerous condition called myelodysplastic syndrome (MDS), or in people with low platelet counts caused by certain other medical conditions or diseases.
It is not known if Promacta is safe and effective when used with other antiviral medicines to treat chronic hepatitis C.
It is not known if Promacta is safe and effective in children:
- younger than 1 year with ITP
- with low blood platelet counts due to chronic hepatitis C
- whose severe aplastic anemia (SAA) has not improved after previous treatments.
- younger than 2 years when used in combination with other medicines to treat SAA as the first treatment for SAA.
Before you take Promacta, tell your healthcare provider about all of your medical conditions, including if you:
- have liver problems
- have a precancerous condition called MDS or a blood cancer
- have or had a blood clot
- have a history of cataracts
- have had surgery to remove your spleen (splenectomy)
- have bleeding problems
- are of Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean). You may need a lower dose of Promacta.
- are pregnant or plan to become pregnant. It is not known if Promacta will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with Promacta.
- are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with Promacta. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Promacta may affect the way certain medicines work. Certain other medicines may affect the way Promacta works.
Especially tell your healthcare provider if you take:
Certain medicines may keep Promacta from working correctly. Take Promacta at least 2 hours before or 4 hours after taking these products:
- antacid medicine used to treat stomach ulcers or heartburn
- multivitamins or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc which may be found in mineral supplements
Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
Promacta (eltrombopag) is a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough. Promacta is also used to treat people with low blood platelet counts due to chronic hepatitis C virus (HCV) infection, and severe aplastic anemia (SAA). The most common side effects of Promacta in adults and children include low red blood cell count (anemia), nausea, fever, abnormal liver function tests, cough, tiredness, headache, and diarrhea. Serious side effects of Promacta include increased risk of liver problems in patients with chronic hepatitis C.
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Related Disease Conditions
Thrombocytopenia (Low Platelet Count)
Thrombocytopenia (low platelet count) refers to a decreased number of platelets in the blood. Symptoms of thrombocytopenia include: Increased bruising Spontaneous bleeding Small, purple spots under the skin called purpura There are many causes of thrombocytopenia such as decreased platelet production (viral infections for example rubella, mumps, chickenpox, hepatitis C, and HIV); increased platelet destruction or consumption (for example sulfonamide antibiotics, heparin, blood transfusions, and lupus); or increased splenic sequestration (enlarged spleen due to conditions for example liver disease, blood cancers, and more). Treatment of thrombocytopenia depends on the cause.
Hepatitis C (HCV, Hep C)
Hepatitis C is an inflammation of the liver due to the hepatitis C virus (HCV), which is usually spread by blood transfusion, hemodialysis, and needle sticks, especially with intravenous drug abuse. Symptoms of chronic hepatitis include fatigue, fever, muscle aches, loss of appetite, and fever. Chronic hepatitis C may be cured in most individuals with drugs that target specific genomes of hepatitis C.
Is Hepatitis C Contagious?
Hepatitis C or hep C causes acute and chronic liver disease. Hep C is a form of liver disease with symptoms like fatigue, jaundice, nausea and vomiting, anorexia, and abdominal discomfort. Hepatitis C is a contagious viral infection caused by persons sharing drug needles, surgical instruments that have not been properly sanitized, and organ transplantation.
Hepatitis C Cure (Symptoms, Transmission, Treatments, and Cost)
Hepatitis is inflammation of the liver. There are a variety of toxins, diseases, illicit drugs, medications, bacterial and viral infections, and heavy alcohol use can case inflammation of the liver. Hepatitis C viral infection (HCV) is one type of hepatitis. According to the CDC, in 2014 there were an estimated 30,500 cases of acute hepatitis C infections in the US. An estimated 2.7-3.9 million people in the US have chronic hepatitis C. The virus is spread from person-to-person via blood-to-blood contact. Symptoms of HCV infection include joint pain, jaundice, dark urine, nausea, fatigue, fever, loss of appetites, clay colored stool. Hepatitis C can be cured with medications in most people. There is no vaccine against the hepatitis C virus.
Idiopathic Thrombocytopenic Purpura (ITP)
Idiopathic means that the cause of the condition isn't known. Thrombocytopenic means there's a lower than normal number of platelets in the blood. Purpura refers to purple bruises caused by bleeding under the skin. Idiopathic thrombocytopenic purpura (ITP) is a bleeding condition in which the blood doesn't clot as it should. This is due to a low number of blood cell fragments called platelets.
Is Hepatitis Contagious?
Hepatitis means "inflammation of the liver," and there are several different types of such as A, B, C, D, and E. Some types of hepatitis are contagious and some types are not. Hepatitis symptoms vary upon the type of disease; however, the following symptoms may develop in someone with hepatitis: fatigue, nausea and vomiting, abdominal pain and discomfort, jaundice (yellowing of the skin and whites of the eyes), and loss of appetite. Treatment for hepatitis depends upon the cause. Some types of hepatitis have a vaccine to prevent spread of disease such as hepatitis A and B.
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