See How PROMACTA Works in SAA
What is severe aplastic anemia (SAA)?
Aplastic anemia is a rare condition that stops the body from making enough blood cells.
Three types of blood cells are affected by this disease:
Aplastic anemia is a rare condition that stops the body from making enough blood cells.
Three types of blood cells are affected by this disease:
Adding PROMACTA to immunosuppressive therapy has been shown to be an effective first option for patients diagnosed with SAA.
PROMACTA is the first and only treatment for SAA proven to boost the production of blood cells in your bone marrow.
PROMACTA is the only therapy for SAA thought to work inside the bone marrow. PROMACTA is believed to work in the stem cell together with the body’s natural process for creating new blood cells.
When your bone marrow is not producing the amount of blood cells your body needs, PROMACTA helps your body increase the production of:
Adding PROMACTA to immunosuppressive therapy has been shown to be an effective first option for patients diagnosed with SAA.
Your doctor is looking to get a “response” from treatment with PROMACTA. A response is when your blood tests show that your white blood cell, red blood cell, or platelet counts have increased.
If your white blood cells, red blood cells, and platelets all increase above a certain level, that is called “complete response”
If some, but not all, of your blood cell counts increase above a specific level, that is called a “partial response”
When complete and partial response rates are added together, that is called an "overall response"
Once you start responding to therapy, your doctor will monitor how long your response lasts—that is called “duration of response”
Be sure to talk with your doctor about your specific treatment goals.
PROMACTA and immunosuppressive therapy was proven in a clinical trial to show high response rates.
Based on 87 patients
If you are being prescribed PROMACTA, you should tell your doctor 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 surgery to remove your spleen (splenectomy)
have bleeding problems
are of Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean)
are pregnant or plan to become pregnant
are breastfeeding or plan to breastfeed
Be sure to tell your doctor about any other medications you may be taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
During treatment with PROMACTA, your doctor will have you go for routine bloodwork and vision monitoring.
If your initial therapy does not work, your doctor may choose to put you on PROMACTA alone.
A clinical study showed that PROMACTA was effective after other treatments failed.
In the study:
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.