Promacta contains the active ingredient eltrombopag olamine, a thrombopoietin receptor agonist. It is available in tablet form in strengths of 12.5 mg, 25 mg, 50 mg, and 75 mg, and as an oral suspension in strengths of 12.5 mg and 25 mg. Promacta is taken orally. Key inactive ingredients in the tablet form include magnesium stearate and mannitol, while the oral suspension contains mannitol and xanthan gum. It is intended to stimulate platelet production.

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. Keep taking it unless your care team tells you to stop.

Take this medication on an empty stomach, at least 30 minutes before or 2 hours after food, or with a meal low in calcium. Take products with aluminum, calcium, iron, magnesium, selenium, or zinc in them at a different time of day than this medication. Take this medication 2 hours before or 4 hours after these products.

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 care team about the use of this medication in children. While this medication 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.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain

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

• Cough
• Diarrhea
• Fatigue
• Fever
• Headache
• 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.

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

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

• Cancer
• Eye disease, vision problems
• Have had your spleen removed
• History of blood clots
• Kidney disease
• Liver disease
• Low blood counts, such as low white cell, platelet, or red cell counts
• An unusual or allergic reaction to eltrombopag, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Antacids
• Bosentan
• Calcium supplements
• Certain medications for cholesterol, such as atorvastatin, fluvastatin, pravastatin, rosuvastatin
• Certain medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Ezetimibe
• Glyburide
• Imatinib
• Irinotecan
• Iron supplements
• Lapatinib
• Magnesium supplements
• Methotrexate
• Mitoxantrone
• Multivitamins with minerals
• NSAIDS, medications for pain and inflammation, such as 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?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

You may need blood work done while you are taking this medication.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

This medication may cause liver injury. The risk is increased if you have hepatitis C and also take interferon and ribavirin.

Avoid sports and activities that may cause injury even after you stop taking this medication. Severe falls or injuries can cause unseen bleeding. Be careful when using sharp tools or knives. Consider using an electric razor. Take special care brushing or flossing your teeth. Report any injuries, bruising, or red spots on the skin to your care team.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 7 days after the last dose. Contraception is recommended while taking this medication and for 7 days after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication.

What are the most serious risks of this medication?

This medicine can cause liver damage. Your healthcare provider will monitor your liver during treatment.

This medicine can increase your risk of liver problems if you have chronic hepatitis C virus and take interferon and ribavirin.