eltrombopag

Pronunciation: el TROM boe pag

Brand: Promacta

Promacta

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50 mg, round, blue, imprinted with GS UFU 50

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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 used to prevent bleeding episodes in adults and children age 1 year and older, who have chronic immune thrombocytopenic purpura (ITP). ITP is a bleeding condition caused by a lack of platelets in the blood.

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 together with other medications to treat severe aplastic anemia in adults and children who are at least 2 years old.

Eltrombopag is sometimes given after other treatments have failed.

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?

Tell your doctor if you have ever had:

  • a blood clot;
  • blood cancer;
  • bleeding problems;
  • cataracts;
  • surgery to remove your spleen;
  • if you are of East or Southeast Asian descent; or
  • liver disease (unless you are being treated for hepatitis C).

May harm an unborn baby. Do not use if you are pregnant. Use effective birth control while using eltrombopag and for at least 7 days after your last dose. Tell your doctor if you become pregnant.

You should not breastfeed while using this medicine.

How should I take eltrombopag?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take eltrombopag in any of the following ways:

  • on an empty stomach, at least 1 hour before or 2 hours after eating;
  • with a meal containing fewer than 50 milligrams of calcium; or
  • at least 2 hours before or 4 hours after eating foods high in calcium (dairy products, calcium-fortified juices, certain fruits and vegetables).

Swallow the tablet whole and do not crush, chew, break it or mix with food or liquid.

Mix the oral suspension powder only with cool or cold water. Use a new dosing syringe each time you mix the medicine to measure the water and to give the correct dose.

You may need frequent medical tests to check your bone marrow cells or liver function. Your eyes may also need to be checked for signs of cataracts.

Eltrombopag is usually taken for 6 months. It may take up to 4 weeks before the medicine prevents major bleeding episodes.

Keep taking eltrombopag as directed. Tell your doctor if you have any bruising or bleeding that happens while you take and after you stop taking eltrombopag.

If you take eltrombopag with medication to treat chronic hepatitis C, tell your doctor if you stop using any of your hepatitis medications.

Store at room temperature away from moisture and heat. Keep the tablets in their original container. After mixing eltrombopag oral suspension, use it right away, if it is not used within 30 minutes throw it away in the trash only.

After you stop taking eltrombopag, your risk of bleeding or bruising may be even higher than it was before you started treatment. Your blood will need to be tested weekly during this time.

Eltrombopag doses are based on weight in children younger than 6 years old. Your child's dose needs may change if the child gains or loses weight.

What happens if I miss a dose?

Skip the missed dose and take your next dose at the regular time. Do not take two doses in one day.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Taking too much eltrombopag may cause a life-threatening blood clot.

What should I avoid while taking eltrombopag?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb eltrombopag and should not be taken at the same time.

Avoid activities that may increase your risk of bleeding or injury for at least 4 weeks after you stop taking eltrombopag. Use extra care 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, severe headache, slurred speech, problems with vision or balance;
  • signs of a blood clot in the lung --chest pain, sudden cough or shortness of breath, dizziness, coughing up blood;
  • signs of a blood clot deep in the body --pain, swelling, or warmth in one leg; or
  • signs of a blood clot in the stomach --severe stomach pain, vomiting, diarrhea.

Call your doctor at once if you have:

  • any bruising or bleeding episodes during or after treatment with eltrombopag;
  • vision changes, tunnel vision, eye pain, or seeing halos around lights;
  • pain or burning when you urinate;
  • low red blood cells (anemia) --pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet; or
  • liver problems --confusion, tiredness, right-sided upper stomach pain, swelling around your midsection, dark urine, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, diarrhea;
  • fever;
  • cough;
  • headache, tiredness;
  • anemia; or
  • abnormal bone marrow or 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?

Some medicines can make eltrombopag much less effective when taken at the same time. If you take any of the following medicines, take your eltrombopag dose 2 hours before or 4 hours after you take the other medicine:

  • antacids that contain calcium, magnesium, or aluminum; or
  • vitamin or mineral supplements that contain aluminum, calcium, iron, magnesium, selenium, or zinc.

Tell your doctor about all your other medicines, especially:

  • medicine used to prevent blood clots --alteplase, clopidogrel, dipyridamole, warfarin, enoxaparin, apixaban, ticlopidine, and others; or
  • cholesterol lowering medicine --atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

This list is not complete. Other drugs may affect eltrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about eltrombopag.

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