"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
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 also used to prevent bleeding in people with chronic hepatitis C who are treated with an interferon (such as Intron A, Infergen, Pegasys, PegIntron, Rebetron, Redipen, or Sylatron).
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; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using eltrombopag and call your doctor at once if you have:
- pain or burning when you urinate;
- fever, chills, body aches, flu symptoms, unusual weakness or tired feeling;
- nausea, upper stomach pain, itching, loss of appetite;
- dark urine, clay-colored stools;
- jaundice (yellowing of the skin or eyes);
- 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.
Common side effects may include:
- diarrhea, vomiting, upset stomach;
- cold symptoms such as stuffy nose, sneezing, cough, sore throat;
- headache, muscle pain, back pain, swelling in your hands or feet;
- tingly feeling;
- mild itching or rash;
- sleep problems (insomnia); or
- temporary hair loss.
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)?
Before you take eltrombopag tell your doctor if you have kidney disease, blood cancer, a bone marrow disorder, high platelet levels, liver problems (if you are not being treated for hepatitis C), a history of cataracts or blood clot, if your spleen has been removed, or if you are of East 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.
While using eltrombopag, you may need frequent blood tests at your doctor's office.
Eltrombopag may cause liver damage. Stop using eltrombopag and call your doctor at once if you have nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
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
- Promacta Drug Interactions Center: eltrombopag oral
- Promacta Side Effects Center
- Promacta FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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