SUNITINIB MSN sunitinib (as malate) 37.5 mg hard capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sunitinib malate, Quantity: 50.118 mg (Equivalent: sunitinib, Qty 37.5 mg)

Available from:

Accelagen Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: croscarmellose sodium; mannitol; Gelatin; pregelatinised maize starch; titanium dioxide; magnesium stearate; iron oxide yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

30 hard capsules, 28 hard capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sunitinib MSN 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 capsules with yellow opaque body imprinted with "8" and yellow opaque cap imprinted with "MS" in black ink, free from physical defects.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-07-22

Patient Information leaflet

Sunitinib MSN*
1
SUNITINIB MSN
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.
1.
WHY AM I USING SUNITINIB MSN?
Sunitinib MSN contains the active ingredient sunitinib. Sunitinib MSN
is used in treatment of renal cell carcinoma, treatment of
gastrointestinal stromal tumour (GIST) and treatment of pancreatic
neuroendocrine tumours.
For more information, see Section 1. Why am I using Sunitinib MSN? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SUNITINIB MSN?
Do not use if you have ever had an allergic reaction to 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
Sunitinb MSN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Sunitinib MSN 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 SUNITINIB MSN?
•
Follow all directions given to you by your doctor carefully.
More instructions can be found in Section 4. How do I use Sunitinib
MSN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SUNITINIB MSN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Sunitinib MSN.
•
Make sure you follow your doctor’s instructions and keep all
appointments.
•
Use a proven method of birth control to prevent pregnancy while being
treated with Sunitinib MSN
and for at least 4 weeks after finishing treatment with Sunitinib MSN.
•
Tell your doctor immediately if you become pregnant while taking
Sunitinib MSN.
•
Tell your doctor if you are going to have surgery, an operation or
dental treatment while taking
Sunitinib MSN.
•
If you are about to be started on any new medicine, remind your docto

Summary of Product characteristics

Sunitinib MSN hard capsule PI Ver 1.0
1
AUSTRALIAN PRODUCT INFORMATION – SUNITINIB MSN (SUNITINIB) HARD
CAPSULES
1.
NAME OF THE MEDICINE
Sunitinib.
2.
QUALITIATIVE AND QUANTITATIVE COMPOSITION
Each Sunitinib MSN 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.
Sunitinib MSN 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
orange opaque cap and body (12.5 mg),
orange opaque body and caramel opaque cap (25 mg), yellow opaque cap
and body (37.5 mg) and caramel
opaque 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: Size "4" hard gelatin capsules with orange opaque
body imprinted with "6" and orange
opaque cap imprinted with "MS" in white ink, free from physical
defects.
25 mg strength: Size "3" hard gelatin capsules with orange opaque body
imprinted with "7" and caramel
opaque cap imprinted with "MS" in white ink, free from physical
defects.
37.5 mg strength: Size "3" hard gelatin capsules with yellow opaque
body imprinted with "8" and yellow
opaque cap imprinted with "MS" in black ink, free from physical
defects.
50 mg strength: Size "2" hard gelatin capsules with caramel opaque
body imprinted with "9" and caramel
opaque cap imprinted with "MS" in white ink, free from physical
defects.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sunitinib MSN 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).
4.2 DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
administration of anti