Eltrombopag

What it is used for

Eltrombopag is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding.

for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.

in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. Limitations of Use: Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndrome (MDS).

Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection. 1.1 Treatment of Thrombocytopenia in Patients With Persistent or Chronic Immune Thrombocytopenia Eltrombopag tablets are indicated for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.

Eltrombopag tablets should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. 1.2 Treatment of Thrombocytopenia in Patients With Hepatitis C Infection Eltrombopag tablets are indicated for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy.

Eltrombopag tablets should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. 1.3 Treatment of Severe Aplastic Anemia Eltrombopag tablets are indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.

Eltrombopag tablets are indicated for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. 1.4 Limitations of Use Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndromes (MDS). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for treatment of chronic hepatitis C infection.

The most important thing to know

Eltrombopag tablets can cause serious side effects, including: Liver problems: If you have chronic hepatitis C virus and take eltrombopag tablets with interferon and ribavirin treatment, eltrombopag tablets 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 eltrombopag tablets.

Eltrombopag tablets 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 eltrombopag tablets and during your treatment. Your healthcare provider may stop your treatment with eltrombopag tablets 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: yellowing of the skin or the whites of the eyes (jaundice) right upper stomach area (abdomen) pain unusual darkening of the urine confusion unusual tiredness swelling of the stomach area (abdomen) See “

How to take it

Take eltrombopag tablets exactly as your healthcare provider tells you to take it. Your healthcare provider will prescribe the dose of eltrombopag tablets that is right for you. If your healthcare provider prescribes eltrombopag tablets, take eltrombopag tablets whole. Do not split, chew, or crush eltrombopag tablets and do not mix with food or liquids.

Do not stop taking eltrombopag tablets without talking with your healthcare provider first. Do not change your dose or schedule for taking eltrombopag tablets unless your healthcare provider tells you to change it. Take eltrombopag tablets without a meal or with a meal low in calcium (50 mg or less) and at least 2 hours before or 4 hours after eating calcium-rich foods, such as dairy products, calcium-fortified juices, and certain fruits and vegetables.

If you miss a dose of eltrombopag tablets, wait and take your next scheduled dose.

Side effects, and when to stop

” for other side effects of eltrombopag tablets. What are eltrombopag tablets? Eltrombopag tablets are a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to persistent or chronic immune thrombocytopenia (ITP), when other medicines to treat ITP or surgery to remove the spleen have not worked well enough.

Eltrombopag tablets are 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. Eltrombopag tablets are used to try to raise platelet counts in order to lower your risk for bleeding. Eltrombopag tablets are not used to make platelet counts normal. Eltrombopag tablets are 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 eltrombopag tablets are safe and effective when used with other antiviral medicines to treat chronic hepatitis C. It is not known if eltrombopag tablets are 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 eltrombopag tablets, 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 East-/Southeast-Asian ancestry.

You may need a lower dose of eltrombopag tablets are pregnant or plan to become pregnant. It is not known if eltrombopag tablets will harm an unborn baby. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with eltrombopag tablets. Females who are able to become pregnant, should use effective birth control (contraception) during treatment with eltrombopag tablets and for at least 7 days after stopping treatment with eltrombopag tablets.

Talk to your healthcare provider about birth control methods that may be right for you during this time. are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment with eltrombopag tablets. 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.

Eltrombopag tablets may affect the way certain medicines work. Certain other medicines may affect the way eltrombopag tablets works. Especially tell your healthcare provider if you take: certain medicines used to treat high cholesterol, called “statins” a blood thinner medicine Certain medicines may keep eltrombopag tablets from working correctly.

Take eltrombopag tablets 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.

Who should not take it

Do not take more than 1 dose of eltrombopag tablet in 1 day. If you take too much eltrombopag tablets, 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 eltrombopag tablets and change your dose of eltrombopag tablets as needed.

Tell your healthcare provider about any bruising or bleeding that happens while you take and after you stop taking eltrombopag tablets. If you have SAA, your healthcare provider may do tests to monitor your bone marrow during treatment with eltrombopag tablets.

What to avoid

Avoid situations and medicines that may increase your risk of bleeding. What are the possible side effects of eltrombopag tablets? Eltrombopag tablets may cause serious side effects, including: Increased risk of worsening of a precancerous blood condition called myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML).

Eltrombopag tablets are not for use in people with a precancerous condition called myelodysplastic syndromes (MDS). See “ What are eltrombopag tablets?” If you have MDS and receive eltrombopag tablets, 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 eltrombopag tablets. Your risk of getting a blood clot may also be increased during treatment with eltrombopag tablets 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 eltrombopag tablets 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 eltrombopag tablets. Your healthcare provider will check your eyes before and during your treatment with eltrombopag tablets.

Tell your healthcare provider about any changes in your eyesight while taking eltrombopag tablets. The most common side effects of eltrombopag tablets in adults and children include: low red blood cell count (anemia) cough nausea tiredness fever headache abnormal liver function tests diarrhea 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 eltrombopag tablets. 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.

Storing it

Store eltrombopag tablets at room temperature between 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Keep eltrombopag tablets in the bottle given to you. Keep eltrombopag tablets and all medicines out of the reach of children.