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Promacta

Generic Name: Eltrombopag Tablets (el TROM boe pag)
Brand Name: Promacta

Warning

  • Very bad and sometimes deadly liver problems have happened with Promacta (eltrombopag tablets). Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • This medicine may raise the risk of liver failure when taken with interferon and ribavirin in patients with hepatitis C.

Uses of Promacta:

  • It is used to raise platelet counts.
  • It is used to treat immune thrombocytopenia (ITP).
  • It is used to treat aplastic anemia.

What do I need to tell my doctor BEFORE I take Promacta?

  • If you have an allergy to eltrombopag or any other part of this medicine.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Promacta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Promacta?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Do not stop taking Promacta without calling your doctor. You may have a greater risk of very low platelets and bleeding. If you need to stop this medicine, talk with your doctor.
  • This medicine may make cataracts worse or may raise the chance of new cataracts. Talk with the doctor.
  • Have an eye exam as you have been told by your doctor.
  • If you are of East Asian descent, talk with your doctor.
  • Blood clots have happened with Promacta. Sometimes, blood clots like heart attack and stroke have been deadly. Talk with the doctor.
  • Use care to prevent injury and avoid falls or crashes.
  • This medicine is not approved for use in people with a certain bone marrow problem called myelodysplastic syndrome (MDS). If you have MDS and you take this medicine, MDS may get worse and turn into a type of blood cancer called acute myelogenous leukemia (AML). If MDS turns into AML, you could die sooner from AML. If you have MDS, talk with your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Promacta while you are pregnant.

How is this medicine (Promacta) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Take on an empty stomach. Take 1 hour before or 2 hours after meals.
  • Take Promacta at least 2 hours before or 4 hours after any antacids; dairy products or other foods with calcium in them; or products that have calcium, iron, aluminum, magnesium, selenium, or zinc.
  • Swallow whole. Do not chew, break, or crush.

What do I do if I miss a dose?

  • Skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Dosage Information (comprehensive)

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
  • Feeling very tired or weak.
  • Very bad belly pain.
  • Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • A burning, numbness, or tingling feeling that is not normal.
  • Very upset stomach or throwing up.
  • Very loose stools (diarrhea).
  • Any bruising or bleeding while you take and after you stop taking this medicine.
  • Very bad mouth pain or irritation.
  • Feeling confused.
  • Swelling of belly.
  • Swelling in the arms or legs.
  • Fever or chills.
  • Call your doctor right away if you have signs of a blood clot like chest pain or pressure; coughing up blood; shortness of breath; swelling, warmth, numbness, change of color, or pain in a leg or arm; or trouble speaking or swallowing.

What are some other side effects of Promacta?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Not able to sleep.
  • Itching.
  • Not hungry.
  • Flu-like signs.
  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Feeling tired or weak.
  • Cough.
  • Muscle or joint pain.
  • Runny nose.
  • Stuffy nose.
  • Sneezing.
  • Back pain.
  • Hair loss.
  • Dizziness.
  • Muscle spasm.
  • Nose or throat irritation.
  • Belly pain.
  • Tooth pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Side Effects (complete list)

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Promacta?

  • Store at room temperature.
  • Store in the original container. Do not take out the antimoisture cube or packet.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time Promacta is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Promacta (eltrombopag tablets) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Promacta. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: December 6, 2017

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