Frequently Asked Questions

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) after an initial ITP treatment has not worked well enough.

 

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.

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.

Here are 3 important things to know:
1. PROMACTA can be taken without a meal or with a meal low in calcium (≤50 mg)
2. PROMACTA should be taken 2 hours before or 4 hours after taking medications like antacids, mineral supplements, or foods that are high in calcium
3. Weekly doctor visits aren’t required for administration of PROMACTA
Click here to get more tips about taking PROMACTA.

Avoid situations and medicines that may increase your risk of bleeding while taking 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

The most common side effects when PROMACTA is used in combination with other medicines to treat chronic HCV are:

• low red blood cell count (anemia)
• fever
• tiredness
• headache
• nausea
• diarrhea
• decreased appetite
• flu-like symptoms including fever, headache, tiredness, cough, sore throat, and body aches
• trouble sleeping
• feeling weak
• cough
• itching
• chills
• muscle aches
• hair loss
• swelling in your ankles, feet, and legs

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

 

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

Tablets:

• Store PROMACTA tablets at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep PROMACTA in the bottle given to you

For oral suspension:

• Store PROMACTA for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C)
• After mixing, PROMACTA should be taken right away but may be stored for no more than 30 minutes between 68°F to 77°F (20°C to 25°C). Throw away (discard) the mixture if not used within 30 minutes

Keep PROMACTA and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROMACTA for a condition for which it was not prescribed. Do not give PROMACTA to other people, even if they have the same symptoms that you have. It may harm them.

 

For more information about PROMACTA, go to www.PROMACTA.com or call 1-844-776-6228.

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.

PROMACTA can be taken without a meal or with a meal low in calcium (≤50 mg). PROMACTA should be taken 2 hours before or 4 hours after taking medications like antacids, mineral supplements, or foods that are high in calcium. Click here for a helpful meal-planning resource.

Your doctor will check your platelet count every week and change your dose of PROMACTA as needed until he/she decides that your dose of PROMACTA can stay the same. Once your doctor decides your dose can stay the same, you will need to have your platelet count checked once a month. 

 

After stopping PROMACTA, your platelet count needs to be monitored weekly for at least 4 weeks to check if your platelet count drops too low.

 

Before starting PROMACTA, your liver function will be checked through blood tests. During dose adjustments, it will be tested every 2 weeks, transitioning to monthly tests once your dose can stay the same. In some cases, treatment with PROMACTA may need to be stopped due to changes in your liver function tests.