• Concerned about chronic immune (idiopathic) thrombocytopenia because a previous treatment
    has not worked well enough?
  • PROMACTA helps increase your platelet count and keep it there while on treatment

    PROMACTA is a prescription medicine used to treat low blood platelet counts in people with chronic immune (idiopathic) thrombocytopenia (ITP), when either corticosteroids, immunoglobulins or surgery to remove the spleen have not worked well enough.

    PROMACTA should be used only in people with chronic ITP whose low blood platelet counts and clinical condition increase their risk for bleeding. PROMACTA is not used to make your platelet count normal. It is not known if PROMACTA is safe and effective in children.

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Indication


PROMACTA is a prescription medicine used to treat low blood platelet counts in people with chronic immune (idiopathic) thrombocytopenia (ITP), when either corticosteroids, immunoglobulins or surgery to remove the spleen have not worked well enough.


PROMACTA should be used only in people with chronic ITP whose low blood platelet counts and clinical condition increase their risk for bleeding. PROMACTA is not used to make your platelet count normal. It is not known if PROMACTA is safe and effective in children.

Important Safety Information


PROMACTA can cause serious side effects, including:

  • Liver problems

    If you have chronic hepatitis C virus and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems.

    Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems:

    • yellowing of the skin or the whites of the eyes (jaundice)
    • unusual darkening of the urine
    • unusual tiredness
    • right upper stomach area pain
    • confusion
    • swelling of the stomach area (abdomen)

PROMACTA may cause serious side effects, including:

  • Abnormal liver function tests. Your healthcare provider will order blood tests to check your liver before you start taking PROMACTA and during your treatment. In some cases treatment with PROMACTA may need to be stopped due to changes in your liver function tests.
  • 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 healthcare provider will check your blood platelet counts, and change your dose or stop PROMACTA if your platelet counts get too high. Tell your healthcare provider right away if you have signs and symptoms of a blood clot in the leg, such as swelling, pain, or tenderness in your leg.

    People with chronic liver disease may be at risk for a type of blood clot in the stomach area. Tell your healthcare 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 healthcare provider will check your eyes before and during your treatment with PROMACTA. Tell your healthcare provider about any changes in your eyesight while taking PROMACTA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PROMACTA may affect the way certain medicines work.

Certain medicines may keep PROMACTA from working correctly. Take PROMACTA at least 4 hours before or 4 hours after taking these products:

  • antacids used to treat stomach ulcers or heartburn
  • multivitamins or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc, which may be found in mineral supplements

Ask your healthcare provider if you are not sure if your medicine is one that is listed above.

The most common side effects with PROMACTA

The most common side effects of PROMACTA when used to treat chronic ITP are: nausea; diarrhea; upper respiratory tract infection (symptoms may include runny nose, stuffy nose, and sneezing); vomiting; muscle aches; urinary tract infection (symptoms may include frequent or urgent need to urinate, low fever in some people, pain or burning with urination); pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis); abnormal liver function tests; back pain; “flu” like symptoms (influenza), including fever, headache, tiredness, cough, sore throat, and body aches; skin tingling, itching, or burning; and rash.

Please see full Prescribing Information, including BOXED WARNING and Medication Guide, for PROMACTA.