Eltrombopag tablets

What is this medication?

ELTROMBOPAG (el TROM boe pag) helps your body make more platelets. It is used to treat low platelets caused by chronic immune (idiopathic) thrombocytopenic purpura (ITP) or chronic hepatitis C infection. It is also used in patients with severe aplastic anemia.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Promacta

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• history of blood clots
• eye disease, vision problems
• kidney disease
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• have had your spleen removed
• an unusual or allergic reaction to eltrombopag, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 30 minutes before or 2 hours after food, or with a meal low in calcium. Avoid calcium-rich foods and antacids, aluminum, calcium, iron, magnesium, selenium, and zinc products for 2 hours before and 4 hours after taking this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, wait and take your next scheduled dose. Do not take more than 1 dose in 1 day. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• antacids
• bosentan
• calcium supplements
• certain medicines for cholesterol like atorvastatin, fluvastatin, pravastatin, rosuvastatin
• certain medicines that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• ezetimibe
• glyburide
• imatinib
• irinotecan
• iron supplements
• lapatinib
• magnesium supplements
• methotrexate
• mitoxantrone
• multivitamins with minerals
• NSAIDS, medicines for pain and inflammation, like ibuprofen or naproxen
• olmesartan
• omeprazole
• repaglinide
• rifampin
• selenium
• sulfasalazine
• topotecan
• valsartan
• zinc

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine. To receive this medicine, you, your doctor and your pharmacy must be registered in the Promacta Cares program.

Visit your prescriber or health care professional for regular checks on your progress and for the needed blood tests. It is important to keep all appointments.

Tell your doctor or health care professional right away if you have any change in your eyesight.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• dark urine
• general ill feeling or flu-like symptoms
• light-colored stools
• loss of appetite
• right upper belly pain
• signs and symptoms of a blood clot such as breathing problems; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness or weakness of the face, arm or leg
• shortness of breath, chest pain, swelling in a leg
• unusual bleeding or bruising
• unusually weak or tired
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• cough
• diarrhea
• dry mouth
• headache
• muscle aches
• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.