PROMACTA® (eltrombopag) FAQs

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING AND APPROVED USES

Important Safety Information for PROMACTA^® (eltrombopag) Tablets

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

PROMACTA can cause serious side effects, including:

Liver problems.

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

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, mineral supplements, or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc

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 immune thrombocytopenia (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)

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 or after you stop taking PROMACTA.

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

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.

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

Approved Uses for PROMACTA^® (eltrombopag) Tablets
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 not used to make platelet counts normal.

PROMACTA is for the treatment of certain people with low platelet counts caused by chronic ITP, chronic hepatitis C virus (HCV), or severe aplastic anemia (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 with chronic HCV or previously treated SAA, in children younger than 1 year with ITP, or children younger than 2 years when used in combination with standard immunosuppressive therapy as the first treatment for SAA.

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Important Safety Information, including Boxed WARNING:

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

PROMACTA can cause serious side effects, including:

Liver problems.

PROMACTA may increase your risk of liver problems that may be...

See More

Approved Uses for PROMACTA^® (eltrombopag) Tablets: 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 t...

See More

Important Safety Information, including Boxed WARNING:

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

PROMACTA can cause serious side effects, including:

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 (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

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

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, mineral supplements, or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc

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 immune thrombocytopenia (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)

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 or after you stop taking PROMACTA.

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

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.

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

Approved Uses for PROMACTA^® (eltrombopag) Tablets:
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 not used to make platelet counts normal.

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

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Find help for common questions

Whether you are curious about PROMACTA^® (eltrombopag) as a chronic ITP treatment or about chronic ITP in general, here is a quick guide with answers to common questions.

You can also watch the video below, featuring practicing hematologist Dr Morey A. Blinder, Professor of Medicine, Division of Hematology, at Washington University in St. Louis, Missouri. Here, Dr Blinder discusses topics such as: what chronic ITP is, what PROMACTA is, how PROMACTA works, what dietary considerations are associated with PROMACTA, and how you should take PROMACTA.

Dr. Blinder

24:10

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What is PROMACTA?

PROMACTA^® (eltrombopag) is the only oral prescription platelet booster used to treat adults and children 1 year and older with chronic immune thrombocytopenia (ITP)
PROMACTA is used after other ITP treatments (such as steroids or IVIg) have failed to keep your platelets up or have caused too many side effects
PROMACTA is the only platelet booster that comes in a once-daily tablet and as an oral suspension

To learn more about PROMACTA, go here.

What is chronic ITP?

Chronic immune thrombocytopenia (ITP) is a rare blood disorder. People with chronic ITP have not had enough platelets in their blood for 6 months or more.

Without platelets, it is harder for blood to clot. This can lead to bruising and bleeding. Fortunately, chronic ITP can be managed with treatment, such as PROMACTA^® (eltrombopag).

To learn more about chronic ITP, go here.

How is PROMACTA different from other chronic ITP treatments?

PROMACTA^® (eltrombopag) is the only platelet booster that comes in a tablet you can take once a day
Platelet boosters work differently from other chronic ITP treatments: Instead of suppressing the immune system, they boost platelet production
The safety and efficacy of PROMACTA have been studied in adults for up to 7 years

Click here to learn more about how PROMACTA may help.

Who can take PROMACTA?

PROMACTA^® (eltrombopag) is meant to be taken by people who:

are 1 year and older, AND
have chronic immune thrombocytopenia (ITP that has lasted for 6 months or more), AND
for whom other ITP treatments (such as steroids or IVIg) have failed to keep platelets up or have caused too many side effects

Curious if PROMACTA is right for you? Learn tips on how to discuss your chronic ITP treatment options with your doctor.

What are the possible side effects of PROMACTA?

The side effects of PROMACTA^® (eltrombopag) and other platelet boosters are generally mild. The most common side effects of PROMACTA when treating adults with 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

To learn more about side effects, go here.

How can I get PROMACTA for chronic ITP?

PROMACTA^® (eltrombopag) is a prescription medication, so you will have to work with your doctor to see if it is the right treatment for your chronic ITP.

Click here for tips on how to talk to your doctor about your chronic ITP treatment options.

Questions about cost? Click here to learn about the PROMACTA Co-pay Card and other financial assistance.

How should I take PROMACTA?

You should:

Take PROMACTA^® (eltrombopag) every day.
Take PROMACTA on an empty stomach, either 1 hour before or 2 hours after eating.
Avoid eating more than 50 mg of calcium 4 hours before and 2 hours after taking PROMACTA.

Click here to get more tips about taking PROMACTA.

Where else can I go for support?

First, check out our PROMACTA Patient Support Program by clicking here.

Other useful resources include:

American Society of Hematology www.hematology.org

Furthering the understanding, diagnosis, treatment, and prevention of certain blood and bone disorders

Guide2ITP www.guide2itp.com

Health Monitor’s PDSA-reviewed guide for anyone living with ITP

HealthyChildren.org www.healthychildren.org

A site run by the American Society of Pediatrics. The chronic condition section might be especially useful for parents who have children with chronic ITP

National Heart, Lung, and Blood Institute (NHLBI) www.nhlbi.nih.gov

NHLBI promotes the prevention and treatment of heart, lung, and blood diseases

Platelet Disorder Support Association (PDSA) www.pdsa.org

A helpful resource for ITP education, advocacy, research, and support, the PDSA website can help you find ITP experts or hematology centers of excellence near you

National Organization for Rare Disorders www.rarediseases.org

Providing a unified voice for those with rare diseases and their caregivers, seeking to help them so they won’t have to fight that battle alone

ITP and Me www.itpandme.com

Providing medical support and also emotional, lifestyle, and daily ITP guidance to people with ITP

Access resources that may help you stay on track with your chronic ITP treatment

Questions about PROMACTA?

Hear from a practicing hematologist and read our FAQs here

Have you read our patient guide?

View the Patient Brochure for PROMACTA (PDF)

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