NINLARO ixazomib (as citrate) 2.3mg capsule blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

ixazomib citrate, Quantity: 3.29 mg (Equivalent: ixazomib, Qty 2.3 mg)

Beszerezhető a:

Takeda Pharmaceuticals Australia Pty Ltd

INN (nemzetközi neve):

ixazomib citrate

Gyógyszerészeti forma:

Capsule

Összetétel:

Excipient Ingredients: microcrystalline cellulose; purified talc; magnesium stearate; Gelatin; titanium dioxide; iron oxide red; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Az alkalmazás módja:

Oral

db csomag:

3 capsules, 1 capsule

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

NINLARO is indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Termék összefoglaló:

Visual Identification: Light pink gelatin capsule imprinted with the Takeda logo on the cap and 2.3 mg on the body, in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2016-11-15

Betegtájékoztató

NINLARO
®
N
i
n
l
a
r
o
®
C
M
I
V
2
.
0
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 NINLARO?
Ninlaro contains the active ingredient ixazomib citrate. Ninlaro is
used to treat patients with a type of cancer of the bone marrow
called multiple myeloma. It is used in people who have received at
least one prior multiple myeloma treatment.
For more information, see Section 1. Why am I using Ninlaro? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NINLARO?
Do not use if you have ever had an allergic reaction to Ninlaro 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
Ninlaro? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ninlaro 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 NINLARO?
•
Ninlaro is used with two other medicines called lenalidomide (a
medicine which affects how your immune system works) and
dexamethasone (an anti-inflammatory medicine).
•
Ninlaro, lenalidomide and dexamethasone are taken in 4 week (28 days)
treatment cycles.
More instructions can be found in Section 4. How do I use Ninlaro? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NINLARO?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Ninlaro.
•
Read this leaflet carefully before you start using this medicine. It
contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
Be sure to keep all your doctor's appointments so your progress can be
checked.
THINGS YOU
SHOULD NOT DO
•
Do not change your dose or stop taking Ninlaro without talking to yo

Termékjellemzők

NINLARO PI V2.0 (CCDS V4.0)
_ _
1
AUSTRALIAN PRODUCT INFORMATION
NINLARO
® (IXAZOMIB CITRATE)
1
NAME OF THE MEDICINE
Ixazomib citrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NINLARO (ixazomib) is an antineoplastic agent for oral use. Ixazomib
citrate, a prodrug, is the drug
substance that rapidly hydrolyses under physiological conditions to
its biologically active form,
ixazomib.
NINLARO oral hard capsules contain 5.7 mg, 4.3 mg or 3.3 mg of
ixazomib citrate equivalent to 4
mg, 3 mg or 2.3 mg of ixazomib, respectively.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Hard capsule. NINLARO is available in the following strengths:
4 mg: Light orange gelatin capsule imprinted with the Takeda logo on
the cap and 4 mg on the body,
in black ink
3 mg: Light grey gelatin capsule imprinted with the Takeda logo on the
cap and 3 mg on the body,
in black ink
2.3 mg: Light pink gelatin capsule imprinted with the Takeda logo on
the cap and 2.3 mg on the
body, in black ink
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NINLARO is indicated in combination with lenalidomide and
dexamethasone for the treatment of
patients with multiple myeloma who have received at least one prior
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment must be initiated and monitored under the supervision of a
physician experienced in the
management of multiple myeloma.
NINLARO IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE
The recommended starting dose of NINLARO is 4 mg (one capsule)
administered orally once a week
on Days 1, 8, and 15 of a 28 day treatment cycle.
The recommended starting dose of lenalidomide is 25 mg administered
daily on Days 1 to 21 of a
28 day treatment cycle.
The recommended starting dose of dexamethasone is 40 mg administered
on Days 1, 8, 15, and 22
of a 28 day treatment cycle.
NINLARO PI V2.0 (CCDS V4.0)
_ _
2
TABLE 1
DOSING SCHEDULE: NINLARO TAKEN WITH LENALIDOMIDE AND DEXAMETHASONE
For additional information regarding lenalidomide and dexamethasone,
refer to the res