"The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration.
An FDA-initiated review of the current in"...
Promacta Patient Information Including Side Effects
Brand Names: Promacta
Generic Name: eltrombopag (Pronunciation: el TROM boe pag)
- What is eltrombopag (Promacta)?
- What are the possible side effects of eltrombopag (Promacta)?
- What is the most important information I should know about eltrombopag (Promacta)?
- What should I discuss with my health care provider before taking eltrombopag (Promacta)?
- How should I take eltrombopag (Promacta)?
- What happens if I miss a dose (Promacta)?
- What happens if I overdose (Promacta)?
- What should I avoid while taking eltrombopag (Promacta)?
- What other drugs will affect eltrombopag (Promacta)?
- Where can I get more information?
What is eltrombopag (Promacta)?
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 is not a cure for ITP and it will not make your platelet counts normal if you have this condition.
Eltrombopag may also be used for purposes not listed in this medication guide.
What are the possible side effects of eltrombopag (Promacta)?
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);
- sudden numbness or weakness, especially on one side of the body;
- sudden severe headache, confusion, problems with vision, speech, or balance;
- chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
- pain, swelling, warmth, or redness in one or both legs;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin; or
- blurred vision, eye pain, or seeing halos around lights.
Less serious side effects may include:
- mild nausea, vomiting, upset stomach;
- muscle pain;
- numbness or tingly feeling;
- redness of the eyes; or
- heavy vaginal bleeding.
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.
Read the Promacta (eltrombopag tablets) Side Effects Center for a complete guide to possible side effects »
What is the most important information I should know about eltrombopag (Promacta)?
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.
Take eltrombopag on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take this medication with milk. Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take eltrombopag.
Avoid taking other medications, including antacids or vitamin and mineral supplements, within 4 hours before or after you take eltrombopag.
Eltrombopag can cause harmful effects on your liver or bone marrow that may result in serious medical problems. To be sure this medication is not causing harmful effects, your blood and liver function will need to be tested often. Visit your doctor regularly.
After you stop taking eltrombopag, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking eltrombopag. Your blood will need to be tested weekly during this time.
Additional Promacta Information
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