Promacta

DRUG DESCRIPTION

PROMACTA (eltrombopag) Tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production. Each tablet contains eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid.

Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4 ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4•2(C2H7NO). The molecular weight is 564.65 for eltrombopag olamine and 442.5 for eltrombopag free acid. Eltrombopag olamine has the following structural formula:

PROMACTA® (eltrombopag) Structural Formula Illustration

Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water.

The inactive ingredients of PROMACTA are: Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate. Coating: hypromellose, polyethylene glycol 400, titanium dioxide, polysorbate 80 (12.5 mg tablet), FD&C Yellow No. 6 aluminum lake (25 mg tablet), FD&C Blue No. 2 aluminum lake (50 mg tablet), or Iron Oxide Red and Iron Oxide Black (75 mg tablet).

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); or
  • blurred vision, eye pain, or seeing halos around lights.

Less serious side...

Read All Potential Side Effects and See Pictures of Promacta »


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 other 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); or
  • blurred vision, eye pain, or seeing halos around lights.

Less serious side effects may include:

  • mild nausea, vomiting;
  • muscle pain;
  • numbness or tingly feeling;
  • redness of the eyes;
  • heavy vaginal bleeding; or
  • upset stomach.

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.

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 cells and liver function will need to be tested often. Do not miss any scheduled appointments.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. For best results, keep taking the medication as directed. Talk with your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

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.

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