Wednesday, 30 May 2012

Promacta


Pronunciation: el-TROM-boe-pag
Generic Name: Eltrombopag
Brand Name: Promacta

Promacta may cause serious and sometimes fatal liver problems. Your doctor will perform blood tests to check your liver before you start Promacta and for as along as you take it. Contact your doctor right away if you experience yellowing of the skin or eyes, dark urine, stomach pain, or unusual tiredness or weakness.





Promacta is used for:

Treating low blood platelets in certain patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).


Promacta is a thrombopoietin (TPO) receptor agonist. It works by causing the bone marrow to produce more clot-forming cells (platelets).


Do NOT use Promacta if:


  • you are allergic to any ingredient in Promacta

  • you have low blood platelets caused by chemotherapy or by a condition other than chronic ITP (eg, certain bone marrow problems, such as myelodysplastic syndrome or blood cancer; chronic liver disease)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Promacta:


Some medical conditions may interact with Promacta. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a history of liver or kidney problems, cataracts, other bleeding problems, or bone marrow problems, or if you have had surgery to remove your spleen

  • if you have a blood clot, a history of blood clots, a high number of clot-forming cells (platelets) in the blood, or a condition that may increase your risk of getting a blood clot (eg, antithrombin III deficiency, antiphospholipid syndrome)

  • if you use tobacco products

  • if you take a blood thinner (eg, warfarin) or an antiplatelet medicine (eg, clopidogrel)

Some MEDICINES MAY INTERACT with Promacta. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Ciprofloxacin, fluvoxamine, gemfibrozil, omeprazole, rifampin, or trimethoprim because they may increase the risk of Promacta's side effects

  • Acetaminophen, benzylpenicillin, doxorubicin, HMG-CoA reductase inhibitors (eg, atorvastatin, rosuvastatin), meglitinides (eg, nateglinide), methotrexate, narcotic pain medications (eg, codeine), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of their side effects may be increased by Promacta

This may not be a complete list of all interactions that may occur. Ask your health care provider if Promacta may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Promacta:


Use Promacta as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Promacta comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Promacta refilled.

  • Take Promacta by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.

  • Take Promacta at least 4 hours before or 4 hours after you take certain other medicines (eg, antacids), calcium-rich foods (eg, dairy products, calcium-fortified juices), or supplements that contain iron, calcium, aluminum, magnesium, selenium, or zinc.

  • Do not suddenly stop taking Promacta. You may have an increased risk of severe low platelets and bleeding. If you need to stop Promacta, your doctor will need to monitor your condition.

  • If you miss a dose of Promacta, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 1 day.

Ask your health care provider any questions you may have about how to use Promacta.



Important safety information:


  • If you stop taking Promacta, the number of clot-forming cells (platelets) in your blood may return to a similar low platelet count as before you started taking Promacta. Low blood platelets may increase your risk of bleeding, especially if you are also taking certain other medicines (eg, anticoagulants such as warfarin, antiplatelet medicines such as clopidogrel). These effects are most likely to occur within 4 weeks after you stop taking Promacta. Your doctor will check your blood platelet counts for at least 4 weeks after you stop taking Promacta. Tell your doctor if you have unusual bruising or bleeding after you stop taking Promacta. Avoid activities that may cause bruising or injury. Discuss any questions or concerns with your doctor.

  • Tell your doctor or dentist that you take Promacta before you receive any medical or dental care, emergency care, or surgery.

  • Serious blood clots have occurred in patients taking Promacta. Some serious blood clots may be fatal. The risk of developing a blood clot may be greater if you have a high number of clot-forming cells (platelets) in the blood. However, blood clots have occurred in patients with normal or low blood platelet levels. Tell your doctor immediately if you notice any signs of a blood clot (eg, pain, redness, tenderness, or swelling in the legs; chest pain; shortness of breath; coughing up blood).

  • Lab tests, including liver function, complete blood cell counts, peripheral blood smears, and eye exams, may be performed while you use Promacta and for at least 4 weeks after you stop Promacta. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Promacta with caution in East Asian patients (eg, Chinese, Japanese, Taiwanese, Korean) and in patients who have moderate to severe liver problems. They may be more sensitive to the medicine and may require a lower dose than other patients. Discuss any questions or concerns with your doctor.

  • Use Promacta with caution in the ELDERLY; they may be more sensitive to its effects.

  • Promacta should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: It is not known if Promacta can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Promacta while you are pregnant. It is not known if Promacta is found in breast milk. Do not breast-feed while taking Promacta.


Possible side effects of Promacta:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Back pain; diarrhea; indigestion; menstrual changes; mild flu-like symptoms (eg, fever, headache, tiredness, sore throat, body aches); minor muscle aches or pain; nausea; runny or stuff nose; sneezing; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye or eyelid; chest pain; coughing; coughing up blood; dark urine; frequent, painful, or urgent urination; new or worsening vision problems (eg, cloudy vision); pain, redness, tenderness, or swelling in the legs; severe or persistent nausea, vomiting, or stomach pain; symptoms of heart attack (eg, pain in the chest or jaw; numbness or an arm or leg; sudden, severe vomiting or headache; fainting); symptoms of stroke (eg, confusion, slurred speech, sudden vision changes, one-sided weakness); trouble breathing; unusual bruising or bleeding; unusual burning, itching, numbness, or tingling of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Promacta side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bleeding; chest pain; confusion; coughing; dark urine; one-sided weakness; pain, redness, tenderness, or warmth in the legs; slurred speech; trouble breathing; unusual tiredness or weakness; vision problems; yellowing of the skin or eyes.


Proper storage of Promacta:

Store Promacta at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Promacta out of the reach of children and away from pets.


General information:


  • If you have any questions about Promacta, please talk with your doctor, pharmacist, or other health care provider.

  • Promacta is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Promacta. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Promacta resources


  • Promacta Side Effects (in more detail)
  • Promacta Use in Pregnancy & Breastfeeding
  • Promacta Drug Interactions
  • Promacta Support Group
  • 1 Review for Promacta - Add your own review/rating


  • Promacta Prescribing Information (FDA)

  • Promacta Consumer Overview

  • Promacta Monograph (AHFS DI)

  • Promacta Advanced Consumer (Micromedex) - Includes Dosage Information

  • Eltrombopag Professional Patient Advice (Wolters Kluwer)



Compare Promacta with other medications


  • Idiopathic Thrombocytopenic Purpura
  • Thrombocytopenia Idiopathic

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