ALECENSA Description

ALECENSA is supplied as hard capsules containing 150 mg of alectinib (equivalent to 161.33 mg alectinib HCl).
ALECENSA (alectinib) is a kinase inhibitor for oral administration. The molecular formula for alectinib is C₃₀H₃₄N₄O₂·HCl. The molecular weight is 482.62 g/mol (free base form) and 519.08 g/mol (hydrochloride salt). Alectinib is described chemically as 9-ethyl-6, 6-dimethyl-8-[4-(morpholin-4-yl)piperidin-1-yl]-11-oxo-6, 11-dihydro-5H-benzo[b]carbazole-3-carbonitrile hydrochloride.
Alectinib HCl is a white to yellow white powder or powder with lumps with a pKa of 7.05 (base).
Excipients/Inactive Ingredients: Capsule Content: Lactose monohydrate, Hydroxypropylcellulose, Sodium lauryl sulfate, Carboxymethylcellulose calcium, Magnesium stearate.
Capsule Shell: Carrageenan, Potassium chloride, Titanium dioxide, Carnauba wax, Corn starch, Hypromellose.
Printing Ink: Red iron oxide (E172), Yellow iron oxide (E172), FD&C Blue No. 2 aluminum lake (E132), Carnauba wax, White shellac, Glyceryl monooleate, l-butanol, Dehydrated ethyl alcohol.