Frequently Asked Questions

PROMACTA is a prescription medicine used to treat low blood platelet counts in people with chronic immune (idiopathic) thrombocytopenia (ITP) when either corticosteroids, immunoglobulins, or surgery to remove the spleen have not worked well enough. PROMACTA should be used only in people with chronic ITP whose low blood platelet counts and clinical condition increase their risk for bleeding. PROMACTA is not used to make your platelet count normal. It is not known if PROMACTA is safe and effective in children.

Before you take PROMACTA, tell your doctor if you:

• Have liver or kidney 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 Asian and you are of Chinese, Japanese, Taiwanese, or Korean ancestry. You may need a lower dose of PROMACTA
• Have any other medical conditions
• Are pregnant or plan to become pregnant. It is not known if PROMACTA will harm an unborn baby
• Are breastfeeding or plan to breastfeed. It is not known if PROMACTA passes into your breast milk. You and your healthcare provider should decide whether you will take PROMACTA or breastfeed. You should not do both

Tell your doctor 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 doctor 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 or products that contain iron, calcium, aluminum, magnesium, selenium, and zinc, which may be found in mineral supplements

Ask your doctor 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 doctor and pharmacist when you get a new medicine.

Take PROMACTA exactly as your doctor tells you to take it. Do not stop taking PROMACTA without talking with your doctor first. Do not change your dose or schedule for taking PROMACTA unless your doctor tells you to change it. Take PROMACTA on an empty stomach, either 1 hour before or 2 hours after eating food. Take PROMACTA at least 2 hours before or 4 hours after eating dairy products and calcium fortified juices. If you miss a dose of PROMACTA, wait and take your next scheduled dose. Do not take more than one dose of PROMACTA in one day. If you take too much PROMACTA, you may have a higher risk of serious side effects. Call your doctor right away. Your doctor will check your platelet count during your treatment with PROMACTA and change your dose of PROMACTA as needed. Tell your doctor about any bruising or bleeding that happens while you take and after you stop 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
• Abnormal liver function tests. Your health care provider will order blood tests to check your liver before you start taking PROMACTA and during your treatment. In some cases treatment with PROMACTA may need to be stopped due to changes in your liver function tests

• High platelet counts and a 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 in your leg

  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 of PROMACTA when used to treat chronic ITP are:

• nausea
• diarrhea
• upper respiratory tract infection. Symptoms may include runny nose, stuffy nose, and sneezing
• vomiting
• muscle aches
• urinary tract infection. Symptoms may include frequent or urgent need to urinate, low fever in some people, pain or burning with urination
• pain or swelling (inflammation) in your throat or mouth (oropharyngeal pain and pharyngitis)
• abnormal liver function tests
• back pain
• flu-like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches
• skin tingling, itching, or burning
• rash

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. If you take too much PROMACTA, you may have a higher risk of serious side effects. Call your health care provider right away.

• Store PROMACTA at room temperature between 68°F to 77°F (20°C to 25°C)
• Keep PROMACTA tightly closed in the bottle given to you
• The PROMACTA bottle may contain a desiccant pack to help keep your medicine dry. Do not remove the desiccant pack from the bottle. 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 1-888-825-5249.

Thrombopoietin (TPO) is a protein produced primarily in the liver that controls how many platelets are made. In people with chronic ITP, there usually isn't enough TPO reaching the bone marrow when platelet levels get low. This means that there are not enough platelets being produced to make up for the ones that have been destroyed.

PROMACTA is a TPO-receptor agonist. TPO-receptor agonists are a type of chronic ITP treatment that works by increasing the number of platelets being made. TPO-receptor agonists bind to the same receptors as TPO in your body. This action sends a signal to your body to make more platelets.

If you miss a dose of PROMACTA, wait and take your next scheduled dose. Do not take more than one dose of PROMACTA in one day.

Take PROMACTA on an empty stomach, either 1 hour before or 2 hours after eating food. Avoid the following for at least 2 hours before or 4 hours after taking PROMACTA: dairy products, calcium-rich or magnesium-rich foods, antacids, multivitamins, supplements, or other products that contain iron, calcium, aluminum, magnesium, selenium, and zinc. These minerals may reduce your body's ability to absorb PROMACTA. Click here for meal-planning resources.

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.