PROMACTA (eltrombopag)

PROMACTA is a prescription medicine used to treat adults and children 1 year and older with low blood platelet counts due to chronic immune 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.

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 HCV 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 HCV.

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 platelet counts normal.

PROMACTA is for treatment of certain people with low platelet counts caused by chronic ITP, chronic HCV, or SAA, not for a precancerous condition called myelodysplastic syndromes (MDS) or low platelet counts caused by other conditions or diseases.

It is not known if PROMACTA is safe and effective in children in these disease states.

Important Safety Information for PROMACTA® (eltrombopag)

What is the most important information I should know about PROMACTA?

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. If your health care provider tells you to stop treatment with interferon and ribavirin, you will also need to stop taking PROMACTA.

PROMACTA may increase your risk of liver problems that may be severe and possibly life-threatening. Your health care provider will do blood tests to check your liver function before you start taking PROMACTA and during treatment. Your health care provider may stop your treatment with PROMACTA if you have changes in your liver function blood tests.

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 (abdomen) pain · confusion · swelling of the stomach area (abdomen)

What are the possible side effects of PROMACTA?

PROMACTA 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

· 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. See “What is the most important information I should know about 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 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

What should I tell my health care provider before taking PROMACTA?

Before you take PROMACTA, tell your health care provider about all of your medical conditions, including if you: · have liver problems · have a precancerous condition called MDS or a blood cancer · · · have or have had a blood clot · have a history of cataracts · have had surgery to remove your spleen (splenectomy) · have bleeding problems · are of Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean). You may need a lower dose of PROMACTA · are pregnant or plan to become pregnant. It is not known if PROMACTA will harm an unborn baby. Tell your health care provider if you become pregnant or think you may be pregnant during treatment with PROMACTA. If you are a woman who is able to become pregnant, you must use reliable birth control (contraception) while taking PROMACTA and for at least 7 days after you stop taking PROMACTA. Talk to your health care provider about options of effective birth control methods that may be right for you during this time · are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with PROMACTA. Talk to your health care provider about the best way to feed your baby during this time

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 other medicines may affect the way PROMACTA works.

Especially tell your health care provider if you take: · · . · certain medicines used to treat high cholesterol, called “statins” · a blood thinner medicine

Certain medicines may keep PROMACTA from working correctly. Take PROMACTA at least 2 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.

Know the medicines you take. Keep a list of them and show it to your health care provider and pharmacist when you get a new medicine.

What should I avoid while taking PROMACTA?

Avoid situations and medicines that may increase your risk of bleeding.

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

· nausea · diarrhea · upper respiratory tract infection (symptoms may include runny nose, stuffy nose, and sneezing) · vomiting · urinary tract infection · pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis) · abnormal liver function tests · muscle aches

The most common side effects of PROMACTA in children 1 year and older when used to treat chronic ITP are:

· upper respiratory tract infection (symptoms may include runny nose, stuffy nose, and sneezing) · pain or swelling (inflammation) in your nose or throat · nasopharyngitis

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 including fever, headache, tiredness, cough, sore throat, and body aches · trouble sleeping · feeling weak · cough · itching · chills · muscle aches · hair loss · swelling in your ankles, feet, and legs

The most common side effects when PROMACTA is used to treat severe aplastic anemia are:

· 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, and after you stop taking, PROMACTA.

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

If you take too much PROMACTA, you may have a higher risk of serious side effects. Call your health care provider right away.

These are not all the possible side effects of PROMACTA. For more information, ask your health care provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Keep PROMACTA and all medicines out of the reach of children.

General information about the safe and effective use of PROMACTA

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use PROMACTA for a condition for which it was not prescribed. Do not give PROMACTA to other people even if they have the same symptoms that you have. It may harm them.

This is a summary of the most important information about PROMACTA. If you would like more information, talk with your health care provider. You can ask your health care provider or pharmacist for information about PROMACTA that is written for health professionals.

For more information about PROMACTA, go to www.PROMACTA.com or call 1-888-669-6682.

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.

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