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Important Safety Information, including Boxed WARNING

PROMACTA can cause serious side effects, including liver problems. If you have chronic HCV and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems.

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Indication(s)

PROMACTA is a prescription medicine used to treat adults and children 6 years of age and older with low blood platelet counts due to chronic immune (idiopathic) thrombocytopenia (ITP), when other medicines to treat your ITP or surgery to remove the spleen have not worked well enough. PROMACTA is used to try to raise platelet counts in order to lower your risk for bleeding. It is not known if PROMACTA is safe and effective in children younger than 6 years with ITP.

PROMACTA is a prescription medicine used to treat low blood platelet counts in people with chronic hepatitis C virus (HCV) infection before and during treatment with interferon. PROMACTA should only be used in people with chronic hepatitis C whose low blood platelet counts keep them from starting or continuing interferon-based therapy. It is not known if PROMACTA is safe and effective when used with other antiviral medicines that are approved to treat chronic hepatitis C.

PROMACTA is a prescription medicine used to treat people with severe aplastic anemia (SAA) when other medicines to treat your SAA have not worked well enough.

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 for PROMACTA® (eltrombopag)

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

  • Liver problems

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

Tell your health care 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 health care 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 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 in your leg.

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.

Tell your health care 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 health care provider if you are not sure if your medicine is one that is listed above.

Avoid situations and medications that may increase your risk of bleeding while taking PROMACTA.

The most common side effects with PROMACTA

The most common side effects of PROMACTA when used to treat chronic ITP in adults 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.

The most common side effects of PROMACTA in children 6 years and older when used to treat chronic ITP are upper respiratory tract infections (symptoms may include runny nose, stuffy nose, and sneezing); pain or swelling (inflammation) in your nose and throat (nasopharyngitis); runny, stuffy nose (rhinitis); stomach (abdominal) pain; cough; pain or swelling (inflammation) in your throat or mouth; toothache; abnormal liver function tests; diarrhea; rash; vitamin D deficiency.

The most common side effects when PROMACTA is used in combination with other medicines to treat chronic HCV are low red blood cell count (anemia); fever; tiredness; headache; nausea; diarrhea; decreased appetite; flu-like symptoms (influenza), including fever, headache, tiredness, cough, sore throat, and body aches; feeling weak; trouble sleeping; cough; itching; chills; muscle aches; hair loss; and swelling in your ankles, feet, and legs.

The most common side effects of PROMACTA when used to treat severe aplastic anemia are nausea, feeling tired, cough, diarrhea, headache, pain in arms, legs, hands or feet, shortness of breath, fever, dizziness, pain in nose or throat, abdominal pain, bruising, muscle spasms, abnormal liver function tests, joint pain, and runny nose.

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

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

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.