PROMACTA

for Thrombocytopenia
Associated with
Chronic Hepatitis C

Indication: PROMACTA is a prescription-only medicine used to treat low blood platelet counts in adults with chronic hepatitis C virus (HCV) infection before and during treatment with interferon.

PROMACTA should only be used in patients with chronic hepatitis C whose low blood platelet counts keep them from starting or continuing interferon-based therapy. PROMACTA is not used to make your platelet count normal. It is not known if PROMACTA is safe and effective when used with other antiviral medicines that are approved to treat chronic hepatitis C. It is not known if PROMACTA is safe and effective in children.

PROMACTA

for Chronic
Immune (Idiopathic)
Thrombocytopenia

Indication: PROMACTA is a prescription-only medicine used to treat low blood platelet counts in adults 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 patients 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 for PROMACTA® (eltrombopag) tablets

PROMACTA can cause serious side effects, including:

  • Liver problems

PROMACTA may damage your liver and cause serious illness and death. You must have blood tests to check your liver before you start taking PROMACTA and during treatment with PROMACTA. Your healthcare provider will order these blood tests. In some cases, treatment with PROMACTA may need to be stopped. 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)

Your risk of developing liver problems may be increased if you have chronic hepatitis C virus with cirrhosis, and take PROMACTA with interferon and ribavirin treatment.

PROMACTA may cause serious side effects, including:

  • Bone marrow changes (increased reticulin and possible bone marrow fibrosis)

Long-term use of PROMACTA may cause changes in your bone marrow. These changes may lead to abnormal blood cells or your body making less blood cells. The mild form of these bone marrow changes is called "increased reticulin," which may progress to a more severe form called "fibrosis." The mild form may cause no problems while the severe form may cause life-threatening blood problems. Signs of bone marrow changes may show up as abnormal results in your blood tests. Your healthcare provider will decide if abnormal blood test results mean that you should have bone marrow tests or if you should stop taking PROMACTA.

  • 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. Stomach area pain 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 non-prescription medicines, vitamins, and herbal supplements. PROMACTA may affect the way certain medicines work.

Certain medicines may keep PROMACTA from working correctly. Take PROMACTA either 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. When you are being treated with PROMACTA, your healthcare provider will closely monitor your dose of PROMACTA and blood tests, including platelet counts and liver tests.

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 infections (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 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.