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Promacta

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Promacta

PROMACTA
(eltrombopag) Tablets

WARNING

RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C

In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see WARNINGS AND PRECAUTIONS].

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, 75 mg, or 100 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 (12.5 mg, 25 mg, 50 mg, and 75 mg tablets) or polyvinyl alcohol and talc (100 mg tablet), 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), Iron Oxide Red and Iron Oxide Black (75 mg tablet), or Iron Oxide Yellow and Iron Oxide Black (100 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; 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...

Read All Potential Side Effects and See Pictures of Promacta »

Last reviewed on RxList: 7/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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