CABOMETYX cabozantinib (as (S)-malate) 60 mg film-coated tablet bottle

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktívna zložka:

cabozantinib (S)-malate, Quantity: 76.03 mg (Equivalent: cabozantinib, Qty 60 mg)

Dostupné z:

Ipsen Pty Ltd

Forma lieku:

Tablet, film coated

Zloženie:

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

Spôsob podávania:

Oral

Počet v balení:

30

Typ predpisu:

(S4) Prescription Only Medicine

Terapeutické indikácie:

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.

Prehľad produktov:

Visual Identification: Yellow, film-coated, oval-shaped tablets, debossed with "XL" on one side and "60" 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

Stav Autorizácia:

Registered

Dátum Autorizácia:

2018-01-19

Príbalový leták

CABOMETYX
®
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A
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®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING CABOMETYX?
CABOMETYX contains the active ingredient cabozantinib. CABOMETYX is
used to treat patients with advanced kidney cancer
(advanced renal cell carcinoma), liver cancer, or a type of thyroid
cancer called differentiated thyroid cancer.
For more information, see Section 1. Why am I using CABOMETYX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CABOMETYX?
Do not use if you have ever had an allergic reaction to cabozantinib
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CABOMETYX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CABOMETYX and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CABOMETYX?
•
The usual dose is 60 mg taken once a day. Your doctor will decide on
the right dose for you.
•
CABOMETYX should not be taken with food. Grapefruit juice should be
avoided while using this medicine.
More instructions can be found in Section 4. How do I use CABOMETYX?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CABOMETYX?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CABOMETYX.
•
Tell your doctor immediately if you become pregnant.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not take CABOMETYX to treat any other complaints unless your doctor
tells you to.
•
Do not give your medicine to anyone else, even if they have the s

Súhrn charakteristických

CABOMETYX Product Information V10
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 as monotherapy 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.
CABOMETYX in combination with nivolumab is indicated for the
first-line treatment of
advanced renal cell carcinoma.
▼

CABOMETYX Product Information V10
2
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