Alecensa

Negara: Selandia Baru

Bahasa: Inggris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg

Tersedia dari:

Roche Products (NZ) Ltd

INN (Nama Internasional):

Alectinib hydrochloride 161.33 mg (equivalent to alectinib 150mg)

Dosis:

150 mg

Bentuk farmasi:

Capsule

Komposisi:

Active: Alectinib hydrochloride 161.33mg equivalent to alectinib 150mg Excipient: Black ink (Alecensa) Carmellose calcium Carnauba wax Carrageenan Hyprolose Hypromellose Lactose monohydrate Magnesium stearate Maize starch Potassium chloride Sodium laurilsulfate Titanium dioxide

Jenis Resep:

Prescription

Diproduksi oleh:

Evonik Corporation

Indikasi Terapi:

Alecensa is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

Ringkasan produk:

Package - Contents - Shelf Life: Blister pack, PA/Al - PVC/Al - component only not to be sold separately - 56 capsules - 60 months from date of manufacture stored at or below 30°C. inner carton of 56 capsules, 8 capsules per blister strip - Combination pack, four separate PA/Al - PVC/Al blister packs of 56 capsules each - 224 capsules - 60 months from date of manufacture stored at or below 30°C. tertiary pack of 224 capsules containing four inner cartons of 56 capsules, 8 capsules/blister

Tanggal Otorisasi:

2017-04-26

Selebaran informasi

ALECENSA
®
180816
1
ALECENSA
®
_ALECTINIB HYDROCHLORIDE _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Alecensa. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Alecensa
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ALECENSA IS
USED FOR
Alecensa is used to treat adults with a
type of lung cancer called non-small
cell lung cancer. It is used if your
cancer:
•
is ALK-positive – this means
your cancer cells have a fault in a
gene called anaplastic lymphoma
kinase (ALK)
•
is advanced or has spread to
another part of your body
(metastatic)
Alecensa contains the active
ingredient alectinib.
Alecensa belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) agents which are used to
treat cancer.
Alecensa prevents the activity of the
ALK protein. This protein is known
to be involved in the growth and
spread of cancer cells.
Alecensa may slow down or stop the
growth of your cancer. It may also
help to shrink your cancer.
Some people may experience side
effects not yet known or mentioned
in this leaflet. If you notice any side
effects not listed in this leaflet, please
inform your doctor or pharmacist.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY ALECENSA HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
Alecensa is not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ALECENSA
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ALECENSA IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing alectinib
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or

Karakteristik produk

NEW ZEALAND DATA SHEET
Alecensa
®
20220831
Page 1 of 25
1
PRODUCT NAME
Alecensa
®
(alectinib) 150 mg hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 161.3 mg alectinib hydrochloride equivalent to
150 mg alectinib.
Excipients with known effect
Each capsule contains 33.7 mg lactose monohydrate and 6 mg sodium (as
sodium lauryl
sulfate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsule
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.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alecensa is indicated for the treatment of adult patients with
anaplastic lymphoma kinase
(ALK)-positive, locally advanced or metastatic non-small cell lung
cancer (NSCLC).
4.2
DOSE AND METHOD OF ADMINISTRATION
A validated ALK assay is required for the selection of ALK-positive
NSCLC patients. ALK
positive NSCLC status should be established prior to initiation of
Alecensa therapy in
first-line.
DOSE
The recommended dose of Alecensa is 600 mg (four 150 mg capsules)
given orally twice
daily with food (total daily dose of 1200 mg).
Patients with underlying severe hepatic impairment should receive a
dose of 450 mg (three
150 mg capsules) given orally twice daily with food (total daily dose
of 900 mg).
Alecensa
®
20220831
Page 2 of 25
Duration of treatment
It is recommended that patients are treated with Alecensa until
disease progression or
unacceptable toxicity.
Delayed or missed doses
Advise patients that if a dose of Alecensa is missed, or if the
patient vomits after taking a
dose of Alecensa, patients should be advised not to take an extra
dose, but to take the next
dose at the regular time.
Dose modifications
Management of adverse events may require temporary interruption, dose
reduction or
discontinuation of treatment with Alecensa. The dose of Alecensa
should be reduced in steps
of 150 mg twice daily based on tolerability (see Table 1). Dose
modification guidelines for
specific ad