ALECENSA alectinib hydrochloride 150 mg hard capsule blister pack

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

alectinib hydrochloride, Quantity: 161.33 mg (Equivalent: alectinib, Qty 150 mg)

Inapatikana kutoka:

Roche Products Pty Ltd

INN (Jina la Kimataifa):

alectinib hydrochloride

Dawa fomu:

Capsule, hard

Tungo:

Excipient Ingredients: magnesium stearate; potassium chloride; carmellose calcium; maize starch; Carnauba Wax; hypromellose; hyprolose; titanium dioxide; lactose monohydrate; sodium lauryl sulfate; carrageenan; iron oxide red; iron oxide yellow; indigo carmine aluminium lake; Shellac; glyceryl monooleate

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

224 hard capsules

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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

Bidhaa muhtasari:

Visual Identification: hard white capsules with ALE printed in black ink on the cap and 150 mg printed in black ink on the body; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 5 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Licence status A

Idhini ya tarehe:

2017-03-14

Taarifa za kipeperushi

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 difficulty breathing
�

Tabia za bidhaa

Alecensa 20210507
1
AUSTRALIAN PRODUCT INFORMATION – ALECENSA (ALECTINIB)
1.
NAME OF THE MEDICINE
Alecensa (alectinib) 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 161.3 mg alectinib hydrochloride equivalent to
150 mg alectinib.
Alectinib hydrochloride is a tyrosine kinase inhibitor for oral
administration. The molecular
formula is C
30
H
35
ClN
4
O
2
HCl. The molecular weight is 482.62 g/mol (free base form) and
519.08 g/mol (hydrochloride salt). Alectinib hydrochloride is
described chemically as: 9-
ethyl-6, 6-dimethyl-8-[4-(morpholin-4-yl) piperidin-1-yl]-11-oxo-6,
11-dihydro-5
_H_
-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). It has low solubility in
aqueous buffers across
the pH range, and low to high solubility in organic solvents.
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
_List of excipients_
.
3.
PHARMACEUTICAL FORM
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 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.
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).
Alecensa 20210507
2
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,