Eltrombopag

What is eltrombopag?

Eltrombopag is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body.

Eltrombopag is used to prevent bleeding episodes in people with chronic immune thrombocytopenic purpura (ITP), a bleeding condition caused by a lack of platelets in the blood.

Eltrombopag is usually given after other medications or surgery have been tried without successful treatment of symptoms.

Eltrombopag may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about eltrombopag?

Eltrombopag is available only under a special program called PROMACTA Cares You must be enrolled in this program and sign all required agreements in order to take the medication. Read all program brochures and agreements carefully.

Before you take eltrombopag, tell your doctor if you have liver or kidney disease, cataract, a history of stroke or blood clot, or if you are of Eastern Asian descent. Also tell your doctor about all other medications you use.

Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take eltrombopag.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. For best results, keep taking the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

What should I discuss with my health care provider before taking eltrombopag?

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before you take eltrombopag, tell your doctor if you have:

• liver disease;

• kidney disease;

• cataract;

• a history of stroke or blood clot; or

• if you are of Eastern Asian descent.

Your name may need to be listed on a pregnancy registry if you become pregnant while taking eltrombopag. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether eltrombopag had any effect on the baby

Taking eltrombopag 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.

How should I take eltrombopag?

Eltrombopag is available only under a special program called PROMACTA Cares You must be enrolled in this program and sign all required agreements in order to take the medication. Read all program brochures and agreements carefully.

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

To be sure this medication is not causing harmful effects, your blood cells and liver function will need to be tested often. Your eyes may also need to be checked for signs of cataract formation. Do not miss any scheduled appointments.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. For best results, keep taking the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your eltrombopag injection.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose can cause slow heart rate, skin rash, or signs of a blood clot such as sudden numbness or weakness, sudden headache or confusion, problems with vision or speech, loss of balance, chest pain, sudden cough, and pain or swelling in one or both legs.

What should I avoid while taking eltrombopag?

Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take eltrombopag.

Eltrombopag side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking this medication and call your doctor at once if you have a serious side effect such as:

• nausea, pain in your upper stomach, low fever, loss of appetite;

• dark urine, clay-colored stools;

• jaundice (yellowing of the skin or eyes); or

• blurred vision, eye pain, or seeing halos around lights.

Less serious side effects may include:

• mild nausea, vomiting;

• muscle pain;

• numbness or tingly feeling;

• redness of the eyes;

• heavy vaginal bleeding; or

• upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect eltrombopag?

The following drugs can interact with eltrombopag. Tell your doctor if you are using any of these:

• acyclovir (Zovirax);

• antacids;

• atazanavir (Reyataz);

• birth control pills;

• cimetidine (Tagamet);

• famotidine (Pepcid);

• fluvoxamine (Luvox);

• gemfibrozil (Lopid);

• methotrexate (Rheumatrex, Trexall);

• rifampin (Rifadin, Rifater, Rifamate);

• ticlopidine (Ticlid);

• trimethoprim (Proloprim, Bactrim, Septra);

• zileuton (Zyflo);

• an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others;

• cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), or rosuvastatin (Crestor);

• diabetes medication you take by mouth, such as nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia); or

• heart rhythm medication such as amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), propafenone (Rythmol), verapamil (Calan, Covera, Isoptin).

This list is not complete and there may be other drugs that can interact with eltrombopag. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about eltrombopag.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.