Active ingredients: Alectinib
Alecensa 150 mg hard capsules.
White hard capsule of 19.2 mm length, with “ALE” printed in black ink on the cap and “150 mg” printed in black ink on the body.
Each hard capsule contains alectinib hydrochloride equivalent to 150 mg alectinib.
Excipients with known effect: Each hard capsule contains 33.7 mg lactose (as monohydrate) and 6 mg sodium (as sodium laurilsulfate).
For the full list of excipients, see section 6.1.
Alectinib is a highly selective and potent ALK and RET tyrosine kinase inhibitor. In preclinical studies, inhibition of ALK tyrosine kinase activity led to blockage of downstream signalling pathways including STAT 3 and PI3K/AKT and induction of tumour cell death (apoptosis).
Titanium dioxide (E171)
Red iron oxide (E172)
Yellow iron oxide (E172)
Indigo carmine aluminum lake (E132)
Aluminium/aluminium (PA/Alu/PVC/Alu) blisters containing 8 hard capsules.
Pack size: 224 (4 packs of 56) hard capsules.
HDPE bottle with a child-resistant closure and an integrated desiccant.
Pack size: 240 hard capsules.
Not all pack sizes may be marketed.
Roche Registration GmbH, Emil-Barell-Strasse 1, 79639, Grenzach-Wyhlen, Germany
Date of first authorisation: 16 February 2017
Date of latest renewal: 1 December 2017