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Promacta

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Promacta

Promacta

Promacta Patient Information including How Should I Take

What should I discuss with my health care provider before taking eltrombopag (Promacta)?

To make sure you can safely take eltrombopag, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease;
  • a bleeding or blood clotting disorder;
  • high levels of platelets in your blood;
  • a blood cancer or bone marrow disorder;
  • if you have ever had cataracts or a blood clot;
  • if your spleen has been removed; or
  • if you are of Eastern Asian descent.

FDA pregnancy category C. It is not known whether eltrombopag will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of eltrombopag on the baby.

It is not known whether eltrombopag passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

Taking eltrombopag may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.

How should I take eltrombopag (Promacta)?

Eltrombopag is available only under a special program called PROMACTA Cares. You must be enrolled in this program and sign all required agreements in order to take the medication. Read all program brochures and agreements carefully.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take eltrombopag on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take eltrombopag.

Taking eltrombopag long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.

To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested often. Your eyes may also need to be checked for signs of cataract formation. Visit your doctor regularly.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

Store at room temperature away from moisture and heat.

After you stop taking eltrombopag, your risk of bleeding 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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Additional Promacta Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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