Ninlaro Hard Capsule 3mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ixazomib citrate

Boleh didapati daripada:

Takeda Malaysia Sdn Bhd

INN (Nama Antarabangsa):

ixazomib citrate

Unit dalam pakej:

1 Capsules; 3 Capsules

Dikeluarkan oleh:

Haupt. Pharma. Amareg .GmbH...

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
NINLARO HARD CAPSULE
_ _ IXAZOMIB 2.3MG, 3MG AND 4MG
__________________________________________________________________________________________
pg. 1
WHAT IS IN THIS LEAFLET
1.
What Ninlaro is used for
2.
How Ninlaro works
3.
Before you use Ninlaro
4.
How to use Ninlaro
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Ninlaro
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT NINLARO IS USED FOR
Ninlaro is a prescription
medicine used to treat multiple
myeloma in combination with
the medicines lenalidomide and
dexamethasone, in people who
have received at least one prior
treatment for their multiple
myeloma. It is not known if
Ninlaro is safe and effective in
children.
HOW NINLARO WORKS
Ninlaro is a proteasome
inhibitor. Proteasomes are
enzymes found in cells that
help the cell break down old or
unwanted proteins. These
proteins are split into amino
acids which can then be
recycled to make new proteins.
Cancer cells depend on the
proteasome to provide this
protein metabolism (turnover)
function to regulate their
growth and survival. Ninlaro
disrupts a cancer cells’ ability
to survive by blocking the
proteasome and disrupting
protein metabolism. Myeloma
cells may be uniquely sensitive
to proteasome inhibitors
because they make large
amounts of protein (called M-
protein) and need this recycling
function to survive.
Laboratory and animal studies
show that Ninlaro inhibits the
growth of myeloma cells,
including those that are
resistant to Bortezomib and
other anti-myeloma therapies.
Ninlaro also induces myeloma
cell death (apoptosis).
BEFORE YOU USE NINLARO
-
When you must not use it
You should not take Ninlaro if
you are allergic to ixazomib or
any of the other ingredients of
this medicine.
-
Before you start to use it
Before you take Ninlaro, tell
your doctor if you
:
•
Have a history of
bleeding
•
Have persistent nausea,
vomiting or diarrhoea
•
Have a history of nerve
prob

Ciri produk

1
1.
NAME OF THE MEDICINAL PRODUCT
Ninlaro
®
Hard capsule 2.3mg
Ninlaro
®
Hard capsule 3mg
Ninlaro
®
Hard capsule 4mg
2.
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Ninlaro is available in the following capsule strengths:
•
4mg: Ninlaro 4 mg hard capsules contain 4 mg of ixazomib equivalent to
5.7 mg of ixazomib
citrate.
•
3 mg: Ninlaro 3 mg hard capsules contain 3 mg of ixazomib equivalent
to 4.3 mg of ixazomib
citrate.
•
2.3 mg: Ninlaro 2.3 mg hard capsules contain 2.3 mg of ixazomib
equivalent to 3.3 mg of ixazomib
citrate.
and the following excipients:
_Excipients: _microcrystalline cellulose, talc and magnesium stearate.
3.
PRODUCT DESCRIPTION
Ninlaro is supplied as immediate release hard gelatin capsule and are
distinguished both by color and
dose specific imprinted markings on the body.
•
4mg: Light orange gelatin capsule imprinted with “Takeda” on the
cap and “4.0mg” on the body in
black ink.
•
3 mg: Light grey gelatin capsule imprinted with “Takeda” on the
cap and “3.0 mg” on the body in
black ink.
•
2.3 mg: Light pink gelatin capsule imprinted with “Takeda” on the
cap and “2.3 mg” on the body in
black ink.
4.
INDICATION
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.
5.
DOSAGE AND ADMINISTRATION
5.1
DOSING AND ADMINISTRATION GUIDELINES
_Ninlaro in combination with lenalidomide and dexamethasone _
The recommended starting dose of Ninlaro is 4 mg 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 through 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.
TABLE 1: DOSING SCHEDULE FOR NINLARO TAKEN WITH LENALIDOMIDE AND
DEXAMETHASONE
28-DAY CYCLE (A 4-WEEK CYCLE)
WEEK 1
WEEK 2
WEEK 3
WEEK 4
Day 1
Days 2-7
Day 8
Days 9-
14
Day
15
Days 16-
21