ARX-SUNITINIB sunitinib (as malate) 50 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sunitinib malate, Quantity: 66.825 mg (Equivalent: sunitinib, Qty mg)

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; mannitol; magnesium stearate; titanium dioxide; purified water; croscarmellose sodium; povidone; iron oxide black; iron oxide yellow; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; Shellac; ethanol absolute; ammonia; potassium hydroxide

Administration route:

Oral

Units in package:

28 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ARX-SUNITINIB is indicated for:,? treatment of advanced renal cell carcinoma (RCC),? treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance,? treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).

Product summary:

Visual Identification: Hard gelatin Size 1 capsule with opaque caramel cap and opaque caramel body, self-lock capsule, imprinted with white ink RM56 on the cap and body; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-02-22

Patient Information leaflet

ARX-SUNITINIB
1
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
1.
WHY AM I USING ARX-SUNITINIB?
2.
WHAT SHOULD I KNOW BEFORE I USE ARX-SUNITINIB?
3.
WHAT IF I AM TAKING OTHER MEDICINES?
4.
HOW DO I USE ARX-SUNITINIB?
5.
WHAT SHOULD I KNOW WHILE USING ARX-SUNITINIB?
6.
ARE THERE ANY SIDE EFFECTS?
ARX-SUNITINIB
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
ARX-SUNITINIB contains the active ingredient sunitinib. ARX-SUNITINIB
is used to treat advanced renal cell carcinoma (RCC) a
type of renal cancer; gastrointestinal stromal tumour and pancreatic
neuroendocrine tumours.
For more information, see Section 1. Why am I using ARX-SUNITINIB? in
the full CMI.
Do not use if you have ever had an allergic reaction to ARX-SUNITINIB
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
ARX-SUNITINIB?
in the full CMI.
Some medicines may interfere with ARX-SUNITINIB 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.
Your doctor will tell you the dose that you should take. The dose
depends on the type of cancer. For renal cell carcinoma and
GIST, the usual dose is 50 mg taken once a day for 4 weeks followed by
no medicine for 2 weeks, making a 6- week cycle. Your
doctor will let you know how many cycles of treatment you will need.
For pancreatic neuroendocrine tumours, the usual
recommended dose is 37.5 mg taken once daily. Your doctor may change
your dose or dosing schedule during treatment.
More instructions can be found in Section 4. How do I use
ARX-SUNITINIB? in the full CMI.
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ARX-SUNITINIB.
•
Make sure you follow your doctor’s instructions and keep all
appoin

Summary of Product characteristics

Page 1 of 36
AUSTRALIAN
PRODUCT
INFORMATION
–
ARX-SUNITINIB (SUNITINIB) CAPSULES
1.
NAME OF THE MEDICINE
Sunitinib.
2.
QUALITATIVE
AND
QUANTITATIVE
COMPOSITION
Each ARX-SUNITINIB capsule
contains
sunitinib
malate
equivalent
to
sunitinib
12.5 mg,
25 mg, 37.5 mg or 50 mg.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Capsule.
ARX-SUNITINIB is supplied as a hard gelatin capsule for oral
administration. The capsules
are differentiated by size, colour and printing. The hard gelatin
capsules consist of opaque
reddish brown cap and body (12.5 mg), opaque reddish brown body and
opaque caramel cap
(25 mg), opaque yellow cap and body (37.5 mg) and opaque caramel cap
and body (50 mg) and
are printed with white printing ink (12.5 mg, 25 mg and 50 mg) or
black printing ink (37.5 mg).
12.5 mg strength: Hard gelatin capsule with opaque reddish brown cap
and opaque reddish
brown body, self-lock capsule, imprinted with white ink “RM53” on
the cap, “RM53” on the
body.
25 mg strength: Hard gelatin capsule with opaque caramel cap and
opaque reddish brown body,
self-lock capsule imprinted with white ink “RM54” on the cap,
“RM54” on the body.
37.5 mg strength: Hard gelatin capsule with opaque yellow cap and
opaque yellow body, self-
lock imprinted with black ink “RM55” on the cap, “RM55” on the
body.
50 mg strength: Hard gelatin capsule with opaque caramel cap and
opaque caramel body, self-
lock imprinted with white ink “RM56” on the cap, “RM56” on the
body.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARX-SUNITINIB is indicated for:
•
treatment of advanced renal cell carcinoma (RCC)
•
treatment of gastrointestinal stromal tumour (GIST) after failure of
imatinib mesilate
treatment due to resistance or intolerance
Page 2 of 36
•
treatment
of
unresectable, well-differentiated
pancreatic
neuroendocrine
tumours
(pancreatic NET).
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
administration of an