ALECENSA

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ALECTINIB AS HYDROCHLORIDE

Fáanlegur frá:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Lyfjaform:

CAPSULES

Samsetning:

ALECTINIB AS HYDROCHLORIDE 150 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Ábendingar:

Alectinib is indicated for the treatment of patients with ALK positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who progressed on or are intolerant to crizotinibAlecensa as monotherapy is indicated for the first-line treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Leyfisdagur:

2021-03-31

Upplýsingar fylgiseðill

PATIENT PACKAGE INSERT
IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with
a doctor‘s prescription only
ALECENSA
®
150 MG
Capsules
COMPOSITION:
Each capsule contains:
ALECTINIB 150 MG
For information on the inactive ingredients, see
section 6 - “Further information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE AS IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
∙ Keep this leaflet. You may need to read it
again.
∙ This leaflet contains concise information about
the medicine. If you have further questions,
refer to the doctor or pharmacist.
∙ This medicine has been prescribed for the
treatment of your ailment. Do not pass it on to
others. It may harm them, even if it seems to
you that their ailment is similar.
1) WHAT IS THE MEDICINE INTENDED FOR?
ALECENSA is intended for treatment:
a. in non-small cell lung cancer [NSCLC]) in
tumors that meet ALL of the following criteria:
∙ The tumor is ALK-positive - that is, the cancer
cells have a fault in the gene called ALK
('anaplastic lymphoma kinase').
∙ The tumor is locally advanced or has spread to
another area of your body (metastatic).
∙ The tumor progressed despite treatment
with a drug called crizotinib, or intolerance to
crizotinib.
b. as first line of treatment of advanced non-small
cell lung cancer [NSCLC], that is ALK-positive.
How ALECENSA works
ALECENSA blocks the action of an enzyme called
’ALK-type tyrosine kinase‘. An abnormal form of
this enzyme (due to a fault in the gene) encourages
cancer cell growth. ALECENSA can slow down or
stop the growth of your cancer. It can also help
to shrink your cancer.
Therapeutic group: Tyrosine kinase inhibitor
2) BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙ you are sensitive (allergic) to the active
ingredient (alectinib) or any of the additional
ingredients contained in the medicine (detailed
in section 6 – “Further information”).
∙ you are pregnant
∙ you are breast-feeding
SPECIAL WARNINGS REGARDING USE

Vara einkenni

1
Alecensa PI Ver 7
ALECENSA
Alectinib
Capsules 150 mg
1.
NAME OF THE MEDICINAL PRODUCT
Alecensa 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
3.
PHARMACEUTICAL FORM
Hard capsule.
White to yellowish white, size 1 hard capsules, 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
Alectinib is indicated for the treatment of patients with ALK
positive, locally advanced or metastatic
non-small cell lung cancer (NSCLC) who progressed on or are intolerant
to crizotinib.
Alecensa as monotherapy is indicated for the first-line treatment of
adult patients with anaplastic
lymphoma kinase (ALK)-positive advanced non-small cell lung cancer
(NSCLC).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Alecensa should be initiated and supervised by a
physician experienced in the use of
anticancer medicinal products.
A validated ALK assay is necessary for the selection of ALK-positive
NSCLC patients. ALK-positive
NSCLC status should be established prior to initiation of Alecensa
therapy.
Posology
The recommended dose of Alecensa is 600 mg (four 150 mg capsules)
taken twice daily with food
(total daily dose of 1200 mg).
Patients with underlying severe hepatic impairment (Child-Pugh C)
should receive a starting dose of
450 mg taken twice daily with food (total daily dose of 900 mg).
_Duration of treatment_
Treatment with Alecensa should be continued until disease progression
or unacceptable toxicity.
2
_Delayed or missed doses_
If a planned dose of Alecensa is missed, patients can make up that
dose unless the next dose is due
within 6 hours. Patients should not take two doses at the same time to
make up for a missed dose. If
vomiting occurs after taki