CABOMETYX cabozantinib (as (S)-malate) 40 mg film-coated tablet bottle

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

cabozantinib (S)-malate, Quantity: 50.69 mg (Equivalent: cabozantinib, Qty 40 mg)

Dostupno od:

Ipsen Pty Ltd

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: lactose; microcrystalline cellulose; hypromellose; croscarmellose sodium; iron oxide yellow; hyprolose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; triacetin

Administracija rute:

Oral

Jedinice u paketu:

30

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Renal Cell Carcinoma (RCC),CABOMETYX is indicated as monotherapy for the treatment of advanced renal cell carcinoma (RCC):,- in treatment-na?ve adults with intermediate or poor risk,- in adults following prior treatment with vascular endothelial growth factor targeted therapy.,CABOMETYX in combination with nivolumab is indicated for the first-line treatment of advanced renal cell carcinoma.,Hepatocellular Carcinoma (HCC),CABOMETYX is indicated as monotherapy for the treatment of hepatocellular carcinoma (HCC) in adults who have previously been treated with sorafenib.,Differentiated Thyroid Carcinoma (DTC),CABOMETYX is indicated as monotherapy for the treatment of adult and paediatric patients aged 12 years and older with locally advanced or metastatic differentiated thyroid carcinoma (DTC) that has progressed during or after prior VEGFR-targeted therapy and who are radioactive iodine (RAI) refractory or ineligible.

Proizvod sažetak:

Visual Identification: Yellow, film-coated, triangle-shaped tablets, debossed with "XL" on one side and "40" on the other side of the tablet.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autorizacije:

Registered

Datum autorizacije:

2018-01-19

Uputa o lijeku

This medicine is subject to additional monitoring in Australia. This
will allow quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or
directly at www.tga.gov.au/reporting-problems
CABOMETYX
®
_20MG, 40MG AND 60 MG TABLETS_
_cabozantinib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about CABOMETYX.
This leaflet 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
CABOMETYX 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 CABOMETYX
IS USED FOR
CABOMETYX is used to treat:
•
advanced stages of a type of
kidney cancer called renal cell
carcinoma (RCC)
•
Liver cancer in adults who have
been previously treated with a
specific anticancer medicine
(sorafenib)
It contains the active ingredient
cabozantinib (S)-malate.
It is a multi-kinase inhibitor.
It works by blocking the action of
proteins called receptor tyrosine
kinases (RTKs), which are involved
in the growth of cells and the
development of new blood vessels
that supply them. These proteins can
be present in high amounts in cancer
cells, and by blocking their action
CABOMETYX can slow down the
rate at which the tumour grows and
help to cut off the blood supply that
the cancer needs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
CABOMETYX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CABOMETYX IF YOU
HAVE AN ALLERGY TO:
•
cabozantinib, the active
ingredient in CABOMETYX
•
any of the other ingredients listed
at the end of this leafle

Svojstava lijeka

CABOMETYX Product Information V6
1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
CABOMETYX
® CABOZANTINIB (AS (S)-MALATE) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
cabozantinib (S)-malate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CABOMETYX tablets contain cabozantinib
_(S)_
-malate equivalent to either 20 mg, 40 mg or
60 mg of cabozantinib as the active ingredient.
Each film-coated tablet contains either: 15.54 mg lactose (20 mg
tablet), 31.07 mg lactose (40
mg tablet) or 46.61 mg lactose (60 mg tablet)
For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
CABOMETYX 20 mg film-coated tablets are yellow, round with no score,
and debossed
with “XL” on one side and “20” on the other side of the
tablet.
CABOMETYX 40 mg film-coated tablets are yellow triangle shaped with no
score, and
debossed with “XL” on one side and “40” on the other side of
the tablet.
CABOMETYX 60 mg film-coated tablets are yellow oval shaped with no
score, and
debossed with “XL” on one side and “60” on the other side of
the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RENAL CELL CARCINOMA (RCC)
CABOMETYX is indicated for the treatment of advanced renal cell
carcinoma (RCC):
-
in treatment-naïve adults with intermediate or poor risk
-
in adults following prior treatment with vascular endothelial growth
factor targeted
therapy.
HEPATOCELLULAR CARCINOMA (HCC)
CABOMETYX is indicated as monotherapy for the treatment of
hepatocellular carcinoma
(HCC) in adults who have previously been treated with sorafenib.
4.2
DOSE AND METHOD OF ADMINISTRATION
▼

CABOMETYX Product Information V6
2
Therapy with CABOMETYX should be initiated by a physician experienced
in the
administration of anticancer medicinal products.
For RCC and HCC, the recommended