Eltrombopag (By mouth)

Introduction

Eltrombopag (el-TROM-boe-pag)

Treats thrombocytopenia in patients with chronic idiopathic thrombocytopenic purpura (ITP).

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine on an empty stomach. Take this medicine at least 1 hour before or 2 hours after a meal.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you use penicillin G injections, doxorubicin (Adriamycin®), methotrexate (Rheumatrex®, Trexall®), nateglinide (Starlix®), repaglinide (Prandin®), or rifampin (Rifadin®, Rimactane®). Tell your doctor if you also use a blood thinner (such as warfarin, Coumadin®) or a medicine to lower cholesterol (such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, Crestor®, Lescol®, Lipitor®, or Pravachol®).
• Antacids, multivitamins, or other products (such as dairy products or juices) that contain aluminum, calcium, iron, magnesium, selenium, or zinc must be taken at least 4 hours before or 4 hours after you take eltrombopag.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding or if you have kidney disease, liver disease, bleeding problems, bone marrow problems, a blood cancer, myelodysplastic syndrome (MDS), or a history of blood clots or cataracts.
• Check with your doctor right away if you have nausea or vomiting, dark urine, light-colored stools, right upper stomach pain, tiredness, or yellow eyes or skin. These may be signs of a serious liver problem.
• Patients who are Asian or have Asian relatives may need lower doses of this medicine.
• This medicine may cause changes in your blood marrow. These changes may cause your body to make fewer blood cells. You will need blood tests to check for this.
• Blood clotting problems may occur while you use this medicine. Check with your doctor right away if you have pain, swelling, or tenderness in your leg, trouble breathing, or chest pain.
• This medicine may cause cataracts or make them worse. Check with your doctor right away if you have blurred vision, difficulty reading, or any other change in your vision.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. You will need blood tests while you use this medicine. Your doctor will also check your blood for a few weeks after you stop using this medicine.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Brand Name(s)

Promacta

When This Medicine Should Not Be Used

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision or changes in vision
• Burning, itching, numbness, prickling, or tingling feelings
• Change in how much or how often you urinate or burning or painful urination
• Chest pain, trouble breathing, or coughing up blood
• Dark-colored urine or light-colored stools
• Fever, chills, cough, runny or stuffy nose, sore throat, and body aches
• Nausea, vomiting, loss of appetite, or stomach pain
• Pain in your lower leg (calf)
• Sudden or severe headache or problems with vision, speech, or walking
• Unusual bleeding, bruising, tiredness, or weakness
• Yellowing of your skin or the whites of your eyes

If you notice these less serious side effects, talk with your doctor:

• Nausea, vomiting, diarrhea, or stomach upset

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088