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Understanding Side Effects

PROMACTA

Understanding Side Effects Understanding Side Effects

What are the possible side effects of PROMACTA?

PROMACTA® (eltrombopag) may cause serious side effects, including:

 

  • Worsening of a precancerous blood condition to a blood cancer called acute myelogenous leukemia (AML). PROMACTA is not for treatment of people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive PROMACTA, your MDS condition may worsen and become AML. If MDS worsens to become AML, you may die sooner 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 PROMACTA. Your risk of getting a blood clot may also be increased during treatment with PROMACTA 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 health care provider will check your blood platelet counts and change your dose or stop PROMACTA if your platelet counts get too high. Tell your health care provider right away if you have signs and symptoms of a blood clot in the leg such as swelling, pain, or tenderness.

People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your health care provider right away if you have stomach area pain that may be a symptom of this type of blood clot 

 

  • New or worsened cataracts (a clouding of the lens in the eye). New or worsened cataracts have happened in people taking PROMACTA. Your health care provider will check your eyes before and during your treatment with PROMACTA. Tell your health care provider about any changes in your eyesight while taking PROMACTA

 

The most common side effects associated with PROMACTA when used in combination with standard immunosuppressive therapy to treat severe aplastic anemia (SAA) reported more frequently than in patients with SAA when other medicines to treat SAA have not worked well enough are:

 

  • abnormal liver function tests
  • rash
  • skin discoloration including darkening of skin patches (hyperpigmentation)

 

The most common side effects when PROMACTA is used to treat SAA when other medicines to treat SAA have not worked well enough:

 

  • nausea
  • feeling tired
  • cough
  • diarrhea
  • headache

Laboratory tests may show abnormal changes to the cells in your bone marrow.

 

Tell your health care provider about any bruising or bleeding that happens while you take or after you stop taking PROMACTA.

 

Tell your health care provider if you have any side effect that bothers you or does not go away.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.