Promacta

Generic Name: eltrombopag (el TROM boe pag)
Brand Names: Promacta

What is Promacta?

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

Promacta 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.

Promacta 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).

Promacta is not a cure for ITP and it will not make your platelet counts normal if you have this condition.

Important information

Before you take Promacta 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.

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Take Promacta 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 Promacta.

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

While using Promacta, you may need frequent blood tests at your doctor's office.

Promacta may cause liver damage. Stop using Promacta 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 Promacta, 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 this medicine. Your blood will need to be tested weekly during this time.

Before taking this medicine

You should not use Promacta if you are allergic to eltrombopag.

To make sure Promacta is safe for you, tell your doctor if you have:

  • liver disease (unless you are being treated for hepatitis C);

  • kidney disease;

  • high levels of platelets in your blood;

  • a blood cancer or bone marrow disorder;

  • if you have ever had cataracts or a blood clot;

  • if your spleen has been removed; or

  • if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).

FDA pregnancy category C. It is not known whether Promacta will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

See also: Pregnancy and breastfeeding warnings (in more detail)

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Promacta on the baby.

It is not known whether eltrombopag passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Taking Promacta 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 Promacta?

Take Promacta exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

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

Do not take this medication with milk.

Taking Promacta long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.

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

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

After you stop taking Promacta, 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 Promacta. Your blood will need to be tested weekly during this time.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

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

Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or after you take this medicine.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Promacta side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Promacta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Promacta 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 Promacta 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.

See also: Side effects (in more detail)

What other drugs will affect Promacta?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Promacta, especially:

  • bosentan;

  • rifampin;

  • glyburide or repaglinide;

  • methotrexate;

  • olmesartan or valsartan;

  • sulfasalazine;

  • cancer medicine--imatinib, irinotecan, lapatinib, mitoxantrone, or topotecan; or

  • cholesterol medication--atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

This list is not complete. Other drugs may interact with Promacta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about Promacta.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Promacta only for the indication prescribed.
  • Disclaimer: 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.

Copyright 1996-2014 Cerner Multum, Inc. Version: 5.01. Revision Date: 2013-01-15, 12:24:39 AM.

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