Rozlytrek Description

ROZLYTREK (entrectinib) capsules for oral use are supplied as printed hard-shell capsules containing 100 mg (yellow opaque HPMC capsule) or 200 mg of entrectinib (orange opaque HPMC capsule).
100 mg: Size 2 yellow opaque body and cap, with "ENT 100" printed in blue ink on body.
200 mg: Size 0 orange opaque body and cap, with "ENT 200" printed in blue ink on body.
Entrectinib is white to pale pink powder.
Entrectinib is a kinase inhibitor. The molecular formula for entrectinib is C₃₁H₃₄F₂N₆O₂ and the molecular weight is 560.64 Daltons. The chemical name is N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methylpiperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide.
Excipients/Inactive Ingredients: Inactive ingredients are tartaric acid, lactose anhydrous, hypromellose, crospovidone, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate.
The yellow opaque capsule shell contains hypromellose, titanium dioxide, and yellow iron oxide. The orange opaque capsule shell contains hypromellose, titanium dioxide, and FD&C yellow #6. The printing ink contains shellac, propylene glycol, strong ammonia solution, and FD&C blue #2 aluminum lake.