Incivek

DRUG DESCRIPTION

INCIVEK (telaprevir) is an inhibitor of the HCV NS3/4A protease.

The IUPAC name for telaprevir is (1S,3aR,6aS)-2-[(25)-2-({(2S)-2-cyclohexyl-2-[(pyrazm-2-ylcarbonyl)amino]acetyl}ammo)-3,3-dimemylbutanoyl]-N-[(3S)-l-(cyclopropylamino)-l,2-dioxohexan-3-yl]-3,3a,4,5,6,6a-hexahydro-lH-cyclopenta[c]pyrrole-l-carboxamide. Its molecular formula is C36H53N7O6 and its molecular weight is 679.85. Telaprevir has the following structural formula:

INCIVEKô 
  (telaprevir) Structural Formula Illustration

Telaprevir drug substance is a white to off-white powder with a solubility in water of 0.0047 mg/mL.

Telaprevir interconverts to an ft-diastereomer, VRT-127394, which is the major metabolite in plasma and is approximately 30-fold less potent than telaprevir. INCIVEK is available as a purple, capsule-shaped, film-coated tablet for oral administration containing 375 mg of telaprevir. Each tablet contains the inactive ingredients colloidal silicon dioxide, croscarmellose sodium, D&C Red No. 40, dibasic calcium phosphate (anhydrous), FD&C Blue No. 2, hypromellose acetate succinate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, sodium stearyl fumarate, talc, and titanium dioxide.



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