Promacta (Eltrombopag)

If you have chronic hepatitis C, taking PROMACTA with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

You should not use PROMACTA if you are allergic to it.

To make sure PROMACTA is safe for you, tell your doctor if you have:

• liver disease (unless you are being treated for hepatitis C);
• kidney disease;
• high levels of platelets in your blood;
• a blood cancer or bone marrow disorder;
• if you have ever had cataracts or a blood clot;
• if your spleen has been removed; or
• if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).

Taking PROMACTA may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of PROMACTA on the baby.

It is not known whether PROMACTA passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You could develop a blood clot if your platelet count gets too high while you are using PROMACTA. Call your doctor or get emergency medical help if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the stomach--severe stomach pain, vomiting, diarrhea;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

If you have chronic hepatitis C, taking PROMACTA with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems:

• nausea, upper stomach pain, loss of appetite;
• confusion, tired feeling; or
• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

• vision changes, eye pain, or seeing halos around lights;
• flu symptoms such as fever, cough, sore throat, headache, body aches, tired feeling;
• increased or frequent need to urinate;
• pain or burning when you urinate; or
• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Common side effects may include:

• nausea, vomiting, diarrhea, stomach pain;
• cold symptoms such as stuffy nose, sneezing;
• flu symptoms;
• mouth pain;
• muscle pain, back pain;
• itching, tingling, or burning under your skin;
• skin rash; or
• abnormal liver function tests.

Avoid taking other medicines within 4 hours before or 2 hours after you take PROMACTA. This includes antacids, vitamins, mineral supplements, or any other product that contains aluminum, calcium, iron, magnesium, selenium, or zinc.

Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or 2 hours after you take PROMACTA.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• a blood thinner (warfarin, Coumadin, Jantoven); or
• cholesterol medication--atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

This list is not complete. Other drugs may interact with PROMACTA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take PROMACTA on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush an PROMACTA tablet. Swallow the tablet whole with a full glass of water.

Do not take this medication with milk.

Follow all instructions for mixing PROMACTA oral suspension. Mix the oral suspension powder only with water. Use the dosing syringe to measure the water and to give the correct dose.

You will need frequent blood tests to check your liver function. Your eyes may also need to be checked for signs of cataract formation.

Taking PROMACTA long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

If you take PROMACTA with other medicines to treat chronic hepatitis C, tell your doctor if you stop using any of your other hepatitis medicines.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. After mixing PROMACTA oral suspension, store the liquid at room temperature and use it within 30 minutes.

After you stop taking PROMACTA, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking PROMACTA. Your blood will need to be tested weekly during this time.

Seek emergency medical attention or call the Poison Help line.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.