Alvaiz

• 9 mg, round, biconvex, blue film-coated tablets, debossed with “TV” on one side and “Z9” on the other side.
• 18 mg, round, biconvex, off-white film-coated tablets debossed with “TV” on one side and “Z18” on the other side.
• 36 mg, round, biconvex, red film-coated tablets, debossed with “TV” on one side and “Z36” on the other side.
• 54 mg, round, biconvex, orange film-coated tablets, debossed with “TV” on one side and “Z54” on the other side.

The following clinically significant adverse reactions associated with ALVAIZ are described in other sections.

• Hepatic Decompensation in Patients with Chronic Hepatitis C
  [see Warnings and Precautions ]
• Hepatotoxicity
  [see Warnings and Precautions ]
• Increased Risk of Death and Progression of Myelodysplastic Syndromes to Acute Myeloid Leukemia
  [see Warnings and Precautions ]
• Thrombotic/Thromboembolic Complications
  [see Warnings and Precautions ]
• Cataracts
  [see Warnings and Precautions ]

Eltrombopag chelates polyvalent cations (such as iron, calcium, aluminum, magnesium, selenium, and zinc) in foods, mineral supplements, and antacids.

Take ALVAIZ at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, dairy products, and mineral supplements to avoid significant reduction in absorption of ALVAIZ due to chelation

ALVAIZ (eltrombopag) tablets contain eltrombopag choline, a small molecule thrombopoietin (TPO) receptor agonist for oral administration.

Eltrombopag choline is a biphenyl hydrazone. The chemical name for eltrombopag choline is (Z)-3’-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-Pyrazol-4(5h)-ylidene)hydrazinyl)-2’-hydroxybiphenyl-3-carboxylic acid -choline (1:1). It has the molecular formula C₃₀H₃₅N₅O₅. The molecular weight is 545.63 g/mol for eltrombopag choline and 442.47 g/mol for eltrombopag free acid.

Eltrombopag choline has the following structural formula:

Eltrombopag choline is practically insoluble in aqueous buffer across a pH range of 1.2 to 6.8.

ALVAIZ (eltrombopag) tablets contain 9 mg, 18 mg, 36 mg, or 54 mg of eltrombopag, supplied as 11.1 mg, 22.2 mg, 44.4 mg, and 66.6 mg of eltrombopag choline, respectively. The inactive ingredients of ALVAIZ tablets are: