eltrombopag 12.5 mg powder packet for oral suspension

Generic name:
Eltrombopag - oral

Pronunciation
(el-TROM-boe-pag)

Brand name(s)
Alvaiz , Promacta

Eltrombopag may rarely cause severe (possibly fatal) liver problems. People with a certain liver problem (chronic hepatitis C) who are taking this medication with ribavirin and interferon may sometimes experience worsening of their liver problem. To help decrease the risk of liver problems, your doctor will order lab tests (liver function tests) before you start eltrombopag and while you are taking it. Keep all medical and lab appointments. Get medical help right away if you develop new or worsening symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, stomach/abdominal swelling, dark urine, yellowing eyes/skin, mental/mood changes). Talk with your doctor about the risks and benefits of this medication.

This medication is used to treat low platelet levels in people who have a certain blood disorder called chronic immune (idiopathic) thrombocytopenia purpura (ITP) or who have chronic hepatitis C. It may also be used to treat people with a certain blood disorder (aplastic anemia). Platelets are a type of blood cell needed to form blood clots and prevent bleeding. Eltrombopag decreases your risk of bleeding by increasing the number of platelets. Eltrombopag acts like a certain natural substance (thrombopoietin) that causes the body to produce platelets.

Read the Medication Guide provided by your pharmacist before you start using eltrombopag and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

There are different brands and forms of eltrombopag available, and the doses may be different. Do not change brands or forms without first consulting your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Take it without a meal or with a meal low in calcium (50 milligrams or less). Ask your doctor or pharmacist for details.

Take this medication at least 2 hours before or 4 hours after taking any products that contain magnesium, aluminum, or calcium-rich foods (containing more than 50 milligrams calcium). Some examples include antacids, dairy products (such as milk, yogurt), calcium-enriched juice, vitamins/minerals, quinapril, and sucralfate. Follow the same instructions with bismuth subsalicylate, iron, selenium, and zinc. These products may keep eltrombopag from working well.

The manufacturer directs not to split, chew, or crush the tablet before taking it, and not to mix it with food or liquid. However, many similar drugs (immediate-release tablets) can be split, chewed, or crushed. Follow your doctor's directions on how to take this medication. The manufacturer also states that the powder from the tablet may stain surfaces.

If you are using the suspension powder, read the manufacturer's Instructions for Use before you start using this medication. Ask your health care provider if you have any questions. Carefully follow the directions to mix and use each dose. Use the provided mixing bottle to mix each dose with cool or cold water. Gently and slowly shake the mixing bottle for at least 20 seconds to mix the water with the powder. After mixing, give this medication right away. Use the provided special measuring device (oral syringe) to prepare and give each dose. Do not use a household spoon because you may not get the correct dose. Do not re-use the oral syringe. Use a new oral syringe for each dose. If not used right away, the mixed medication may be stored at room temperature for up to 30 minutes. After 30 minutes, throw away any unused mixture, or any mixture left in the bottle. Clean the mixing supplies as directed.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. The dosage is based on your medical condition, response to treatment, age, and lab tests. Your doctor will order blood tests (platelet counts) to find the right dose for you. Keep all medical/lab appointments. Follow your doctor's directions carefully. If you are of East-Asian/Southeast-Asian descent or if you have liver problems, your doctor may direct you to start with a lower dose because you may be more sensitive to its effects.

Your risk of bleeding may increase when you stop using eltrombopag. After your last dose, your doctor should order a blood test once a week for at least 4 weeks to check your platelet count. Tell your doctor right away if you develop any bleeding/bruising.

Ask your doctor if you should keep taking your other medications for ITP (such as corticosteroids, azathioprine, danazol) while you are using eltrombopag.

Tell your doctor if your condition (bleeding/bruising) does not get better or if it gets worse.

See also Warning section.

Nausea, diarrhea, headache, muscle pain, and tingling/numbness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• vision changes

This medication may rarely cause serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs) especially if your platelet counts are too high. Keep all medical/lab test appointments. Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• trouble speaking
• weakness on one side of the body
• unusual sweating
• confusion
• sudden/severe headaches
• sudden vision changes

Eltrombopag can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using eltrombopag, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clots/clotting problems (such as Factor V Leiden)
• other blood disorders (such as blood cancer, myelodysplastic syndrome)
• certain eye problem (cataracts)
• liver disease

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Although this medication increases platelets and decreases the risk of bleeding, continue to avoid activities that can increase your risk of bleeding (such as contact sports, using sharp objects like razors and nail cutters).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using eltrombopag. Eltrombopag may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 7 days after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

See also How to Use.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests (creatinine and bilirubin), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as complete blood count, eye exams) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. See also Warnings section. Consult your doctor for more details.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up. Do not take more than 1 dose in 24 hours.

Different brands and forms of this medication have different storage needs. Check the product package for storage instructions or ask your pharmacist. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.