Promacta (eltrombopag)

Promacta is a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to chronic immune thrombocytopenia (ITP), when other medicines or spleen removal have not worked well enough.

Promacta is also used to treat people with:

• low blood platelet counts due to chronic hepatitis C virus (HCV) infection before and during treatment with interferon.
• severe aplastic anemia (SAA) in combination with other medicines as the first treatment for adults and children 2 years of age and older.
• severe aplastic anemia (SAA) when other medicines have not worked well enough.

Promacta is used to raise platelet counts to lower your risk for bleeding. It does not make platelet counts normal.

Important Side Effects and Other Facts about Promacta (eltrombopag)

WARNING

RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C

RISK OF HEPATOTOXICITY

In patients with chronic hepatitis C, Promacta in combination with interferon and ribavirin may increase the risk of hepatic decompensation. Monitor hepatic function and discontinue dosing as recommended

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 healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking Promacta.
• Promacta may increase your risk of severe and possibly life threatening liver problems. Your healthcare provider will do blood tests to check your liver function before you start taking Promacta and during your treatment. Your healthcare provider may stop your treatment with Promacta if you have changes in your liver function blood tests.

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

Other Side Effects of Promacta (eltrombopag)

Promacta may cause serious side effects, including:

• Increased risk of worsening of a precancerous blood condition called myelodysplastic syndrome (MDS) to acute myelogenous leukemia (AML). Promacta is not for use in people with a precancerous condition called myelodysplastic syndromes (MDS). If you have MDS and receive Promacta, you have an increased risk that your MDS condition may worsen and become a blood cancer called AML. If your MDS worsens to become AML, you may have an increased risk of death 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 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 (abdomen).
• Tell your healthcare provider right away if you have stomach-area (abdomen) pain, nausea, vomiting, or diarrhea as these may be symptoms of this type of blood clot.

The most common side effects of Promacta in adults and children include:

• low red blood cell count (anemia)
• nausea
• fever
• abnormal liver function tests
• cough
• tiredness
• headache
• diarrhea

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

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of Promacta. For more information, ask your healthcare provider or pharmacist.

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

QUESTION

What is the dosage for Promacta (eltrombopag)?

• Take Promacta exactly as your healthcare provider tells you. Your healthcare provider will prescribe the dose of Promacta tablets or Promacta for oral suspension that is right for you.
• If your healthcare provider prescribes Promacta tablets, take them whole. Do not split, chew, or crush Promacta tablets and do not mix with food or liquids.
• If your healthcare provider prescribes Promacta for oral suspension, see the “Instructions for Use” that comes with your medicine for instructions on how to correctly mix and take a dose of Promacta.
• Use a new single-use oral dosing syringe to prepare each dose of Promacta for oral suspension. Do not re-use the oral dosing syringe.
• Do not stop taking Promacta without talking with your healthcare provider first. Do not change your dose or schedule for taking Promacta unless your healthcare provider tells you to.
• Take Promacta on an empty stomach, either 1 hour before or 2 hours after eating food.
• Take Promacta at least 2 hours before or 4 hours after eating dairy products and calcium-fortified juices.
• If you miss a dose of Promacta, wait and take your next scheduled dose. Do not take more than 1 dose of Promacta in 1 day.
• If you take too much Promacta, you may have a higher risk of serious side effects. Call your healthcare provider right away.
• Your healthcare provider will check your platelet count during your treatment with Promacta and adjust your dose as needed.
• Tell your healthcare provider about any bruising or bleeding that happens while you take and after you stop taking Promacta.
• If you have SAA, your healthcare provider may do tests to monitor your bone marrow during treatment with Promacta.

What should I avoid while taking Promacta?

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

Promacta (eltrombopag) Contraindications, Pregnancy Safety, and Drug Interactions

Promacta is not for use in people with a pre-cancerous condition called myelodysplastic syndrome (MDS), or in people with low platelet counts caused by certain other medical conditions or diseases.

It is not known if Promacta is safe and effective when used with other antiviral medicines to treat chronic hepatitis C.

It is not known if Promacta is safe and effective in children:

• younger than 1 year with ITP
• with low blood platelet counts due to chronic hepatitis C
• whose severe aplastic anemia (SAA) has not improved after previous treatments
• younger than 2 years when used in combination with other medicines as the first treatment for SAA

Before you take Promacta, tell your healthcare 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 had a blood clot
• have a history of cataracts
• have had spleen removal surgery (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 healthcare provider if you become pregnant or think you may be pregnant while taking Promacta.

• Females who are able to become pregnant should use effective birth control during treatment with Promacta and for at least 7 days after stopping treatment. Talk to your healthcare provider about birth control methods that may be right for you during this time.

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 other medicines may affect the way Promacta works.

Especially tell your healthcare provider if you take:

• certain medicines used to treat high cholesterol, called "statins"
• a blood thinner medicine

Certain medicines may interfere with Promacta. Take Promacta at least 2 hours before or 4 hours after taking these products:

• antacid medicine 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 unsure if your medicine is one that is listed above.

Keep a list of all the medicines you take and show it to your healthcare provider and pharmacist when you start a new medicine.

Summary

Promacta (eltrombopag) is a prescription medicine used to treat adults and children 1 year of age and older with low blood platelet counts due to chronic immune thrombocytopenia (ITP), when other medicines or spleen removal have not worked well enough. Promacta is also used to treat people with low blood platelet counts due to chronic hepatitis C virus (HCV) infection, and severe aplastic anemia (SAA). The most common side effects of Promacta in adults and children include low red blood cell count (anemia), nausea, fever, abnormal liver function tests, cough, tiredness, headache, and diarrhea. Serious side effects of Promacta include increased risk of liver problems in patients with chronic hepatitis C.