The most common side effects of PROMACTA in children 1 year and older when used to treat second-line persistent or chronic immune thrombocytopenia (ITP) are:
Upper respiratory tract infection (symptoms may include runny nose, stuffy nose, and sneezing), 17%
Pain or swelling (inflammation) in their nose or throat (nasopharyngitis), 12%
Liver problems
Worsening of a precancerous blood condition to a blood cancer called acute myelogenous leukemia (AML)
High platelet counts and higher risk for blood clots
New or worsened cataracts (a clouding of the lens in the eye)
.
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.