eltrombopag (Promacta)

Brand Names: Promacta

Generic Name: eltrombopag

• What is eltrombopag (Promacta)?
• What are the possible side effects of eltrombopag (Promacta)?
• What is the most important information I should know about eltrombopag (Promacta)?
• What should I discuss with my health care provider before taking eltrombopag (Promacta)?
• How should I take eltrombopag (Promacta)?
• What happens if I miss a dose (Promacta)?
• What happens if I overdose (Promacta)?
• What should I avoid while taking eltrombopag (Promacta)?
• What other drugs will affect eltrombopag (Promacta)?
• Where can I get more information (Promacta)?

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 not a cure for ITP and it will not make your platelet counts normal if you have this condition.

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 is not for use in treating myelodysplastic syndrome (also called "preleukemia").

Eltrombopag may also be used for purposes not listed in this medication guide.

Promacta 50 mg

round, blue, imprinted with GS UFU 50

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:

• 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, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or
• liver problems--confusion, tiredness, stomach pain (upper right side), stomach swelling, 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.

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).

Tell your doctor if you have ever had:

• a blood clot;
• liver disease (unless you are being treated for hepatitis C);
• cataracts;
• surgery to remove your spleen; or
• if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).

Eltrombopag may harm an unborn baby. Use effective birth control to prevent pregnancy while taking this medicine, 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.

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, or break it.

Mix the oral suspension powder only with 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 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.

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 and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of 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, store the liquid at room temperature and use it within 30 minutes.

After you stop taking eltrombopag, your risk of bleeding or bruising 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.

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

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.

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 foods high in calcium (including calcium-fortified fruit juice and certain fruits or vegetables) 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.

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:

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

Tell your doctor about all your other medicines, 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 affect eltrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Your doctor or pharmacist can provide more information about eltrombopag.

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