ODOMZO sonidegib diphosphate 200mg hard capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sonidegib phosphate, Quantity: 280.8 mg (Equivalent: sonidegib, Qty 200 mg)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

sonidegib phosphate

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; purified water; Gelatin; lactose monohydrate; titanium dioxide; iron oxide red; sodium lauryl sulfate; poloxamer; crospovidone; butylated hydroxytoluene; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; Shellac; sulfuric acid

Administration route:

Oral

Units in package:

30

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Odomzo is indicated for the treatment of adult patients with:,- Locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.,- Metastatic BCC

Product summary:

Visual Identification: Opaque pink capsule,cap imprinted in black ink with NVR, body imprinted in black ink with SONIDEGIB 200MG, containing white powder with granules; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-10-17

Patient Information leaflet

ODOMZO
®
™v3.0
1
ODOMZO
®
_sonidegib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ODOMZO. It 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 ODOMZO
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 ODOMZO IS
USED FOR
ODOMZO contains the active
ingredient sonidegib.
ODOMZO belongs to a group of
medicines called anti-neoplastic (or
anti-cancer) medicines. It works by
blocking cancer cells from growing
and making new cells.
ODOMZO is used to treat adults with
a type of skin cancer called advanced
basal cell carcinoma. It is used when
the cancer:

has spread to surrounding areas
(called "locally advanced" basal
cell carcinoma) and your doctor
has decided that treatment with
surgery or radiation is not
appropriate.

has spread to other parts of the
body (called "metastatic" basal
cell carcinoma).
Surgery and radiation treatment may
not be appropriate because:

surgery will change the shape of a
body part (cause deformity) e.g.
face, neck

surgery may cause you to lose the
use of a body part such as an eye
or ear

the cancer has returned after
previous surgery and further
surgery may not work or is not
possible

radiation was previously not
successful or it is not suitable for
you to have radiation.
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 not addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
ODOMZO
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ODOMZO IF YOU ARE
YOU ARE PREGNANT, THINK YOU MAY
BE PREGNANT, OR ARE PLANNING TO
BECOME PREGNANT DURING THE COURSE
OF TREATMENT

Summary of Product characteristics

1
ODOMZO v4.5
AUSTRALIAN PRODUCT INFORMATION
ODOMZO

Sonidegib 200 mg capsule
1.
NAME OF THE MEDICINE
Sonidegib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule of ODOMZO contains 200 mg - sonidegib (as
diphosphate).
Excipient with known effects: Each capsule contains lactose
monohydrate 38.60 mg.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Hard gelatin capsule.
Size #00, Coni-snap, opaque pink capsule, cap imprinted in black ink
with “NVR,” body imprinted in
black ink with “SONIDEGIB 200MG,” containing white to practically
white powder with granules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ODOMZO is indicated for the treatment of adult patients with:
•
Locally advanced basal cell carcinoma (BCC) who are not amenable to
curative surgery or
radiation therapy.
•
Metastatic BCC.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL TARGET POPULATION
The recommended dose of ODOMZO is 200 mg taken orally once daily on an
empty stomach, at the
same time each day. ODOMZO should be taken at least 1 hour before, or
two hours after a meal.
ODOMZO capsules must be swallowed whole. They must not be chewed or
crushed.
If a dose is missed, the recommended dose of ODOMZO should be taken
within 6 hours after the
missed dose. If more than 6 hours have passed, the patient should be
instructed not to take the
missed dose. The patient should continue treatment with the next
prescribed dose.
Continue treatment as long as clinical benefit is observed or until
unacceptable toxicity develops.
2
ODOMZO v4.5
DOSE MODIFICATIONS IN:
RENAL IMPAIRMENT
Sonidegib has not been studied in patients with renal impairment.
Based on the available data,
sonidegib elimination via the kidney is negligible. A population
pharmacokinetic analysis did not find
significant influence of renal function on the apparent clearance
(CL/F) of sonidegib suggesting that
dose adjustment is not necessary in patients with renal impairment
(see SECTION 5
PHARMACOLOGICAL PROPERTIES).
H