PROMACTA is a platelet booster, also known as a TPO-RA (thrombopoietin receptor agonist). This means that it boosts the number of platelets your child’s body makes.
PROMACTA is the only once-daily oral platelet booster that is available as a tablet and an oral suspension. It is also the only oral platelet booster approved to treat persistent or chronic immune thrombocytopenia (ITP) in children 1 year and older.
A hormone called thrombopoietin (TPO) naturally creates platelets in the body and, unlike some other drugs used to treat persistent or chronic ITP, PROMACTA acts the same as TPO—working alongside your body to create more platelets.
PROMACTA is the only once-daily oral platelet booster that comes in both a tablet and an oral suspension, so even if your child can’t swallow a pill, they can still receive a once-daily oral therapy. Some other treatments for persistent or chronic ITP require doctor visits for an injection, while PROMACTA can be taken at home, at school, or on the go!
PROMACTA is the #1 prescribed platelet booster, taken by more than 500,000 people worldwide across all approved uses.*,†
For pediatric patients, it's the only once-daily oral TPO-RA treatment for persistent or chronic ITP, and it has the following features:
PROMACTA has been proven to help pediatric patients with persistent or chronic immune thrombocytopenia (ITP) reach target platelet levels and maintain them for a long time.
Primary End Point
PETIT (Study 1): The primary end point was the proportion of patients achieving platelet counts ≥50,000/mcL at least once between Days 8 and 43 (Weeks 1 to 6) of the randomized period.
PETIT 2 (Study 2): The primary end point was the proportion of patients achieving platelet counts ≥50,000/mcL at least 6 of the 8 weeks between Weeks 5 to 12 of the randomized period.
Study Design
PETIT (Study 1): Open-label, double blind, randomized, placebo-controlled study to investigate the efficacy, safety, tolerability, and pharmacokinetics of eltrombopag in previously treated pediatric patients (n=67) with persistent or chronic ITP.
PETIT 2 (Study 2): Open-label, double-blind, randomized, placebo-controlled study to investigate the efficacy, safety, and tolerability of eltrombopag in previously treated pediatric patients (n=92) with chronic ITP.
13% of patients (6 of 45) on PROMACTA needed to take rescue medication to raise their platelet levels compared with 50% of patients (11 of 22) on placebo
53% of patients (8 of 15) taking other ITP medications were able to reduce or stop using them after starting PROMACTA
What is the most important information I should know about PROMACTA?
PROMACTA can cause serious side effects, including:
Liver problems.
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 (HCV) 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:
What are the possible side effects of PROMACTA?
PROMACTA may cause serious side effects, including:
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:
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 may keep PROMACTA from working correctly. Take PROMACTA at least 2 hours before or 4 hours after taking these products:
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 persistent or chronic immune thrombocytopenia (ITP) are:
The most common side effects of PROMACTA in children 1 year and older when used to treat persistent or chronic ITP are:
The most common side effects when PROMACTA is used in combination with other medicines to treat chronic HCV are:
The most common side effects associated with PROMACTA when used in combination with standard immunosuppressive therapy to treat severe aplastic anemia (SAA) reported more frequently than in patients with SAA when other medicines to treat SAA have not worked well enough are:
The most common side effects when PROMACTA is used to treat SAA when other medicines to treat SAA have not worked well enough are:
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.
PROMACTA is a prescription medicine used to treat adults and children 1 year and older with low blood platelet counts due to persistent or chronic immune thrombocytopenia (ITP)
PROMACTA is a prescription medicine used to treat adults and children 1 year and older with low blood platelet counts due to persistent or 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) in combination with standard immunosuppressive therapy as the first treatment for adults and children 2 years of age and older. PROMACTA is also used to treat your SAA when other medicines 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 persistent or 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 when used with other antiviral medicines that are approved to treat chronic HCV.
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.