Jakavi 15mg Tablets

Nchi: Malesia

Lugha: Kiingereza

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

Viambatanisho vya kazi:

RUXOLITINIB PHOSPHATE

Inapatikana kutoka:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Jina la Kimataifa):

RUXOLITINIB PHOSPHATE

Vitengo katika mfuko:

56tablet Tablets; 14tablet Tablets

Viwandani na:

NOVARTIS PHARMA STEIN AG

Taarifa za kipeperushi

_Customer Medication Indication Leaflet (RiMUP) _
JAKAVI
®
RUXOLITINIB (5MG, 10MG, 15MG, 20MG TABLETS)
1
WHAT IS IN THIS LEAFLET
1.
What Jakavi is used for
2.
How Jakavi works
3.
Before you use Jakavi
4.
How to use Jakavi
5.
While you are using Jakavi
6.
Side effects
7.
Storage and Disposal of
Jakavi
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT JAKAVI IS USED FOR
Jakavi contains the active
substance ruxolitinib.
Jakavi is used to treat adult
patients with an enlarged spleen
or with symptoms related to
myelofibrosis, a rare form of
blood cancer.
Jakavi is also used to treat adult
patients with polycythaemia vera
who are resistant to or intolerant
of hydroxyurea.
Jakavi is also used to treat
patients 12 years of age and older
and adults with graft-versus-host
disease (GvHD). There are two
forms of GvHD: an early form
called acute GvHD that usually
develops soon after the
transplantation and can affect
skin, liver and gastrointestinal
tract, and a form called chronic
GvHD, which develops later,
usually weeks to months after the
transplantation. Almost any organ
can be affected by chronic GvHD.
HOW JAKAVI WORKS
Enlargement of the spleen is one
of the characteristics of
myelofibrosis. Myelofibrosis is a
disorder of the bone marrow, in
which the marrow is replaced by
scar tissue. The abnormal marrow
can no longer produce enough
normal blood cells and as a result
the spleen becomes significantly
enlarged. By blocking the action
of certain enzymes (called Janus
Associated Kinases), Jakavi can
reduce the size of the spleen in
patients with myelofibrosis and
relieve symptoms such as fever,
night sweats, bone pain and
weight loss. Jakavi can help
reduce the risk of serious blood or
vascular complications.
Polycythaemia vera is a disorder
of the bone marrow, in which the
marrow produce too many red
blood cells. The blood becomes
thicker as a result of the increased
red blood cells. Jakavi can relieve
the symptoms, reduce spleen size
and the volume of red

Tabia za bidhaa

1
Regulatory Affairs
JAKAVI
®
(RUXOLITINIB)
5mg, 10mg, 15 mg and 20 mg tablets
MALAYSIA PACKAGE INSERT
(AUG 2021; EU SMPCJUL 2021APR 2022)
Effective date:
26-Oct-202012-Jan-2021
Safety Label Change
(SLC) Tracking Number:
2020-PSB/GLC-1155-sNA
Document status:
Final
Novartis
Page 2
Malaysia Package Insert
26-Oct-202012-Jan-2021
Jakavi
2
1.
NAME OF THE MEDICINAL PRODUCT
Jakavi 5 mg tablets
Jakavi 10 mg tablets
Jakavi 15 mg tablets
Jakavi 20 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jakavi 5 mg tablets
Each tablet contains 5 mg ruxolitinib (as phosphate).
_Excipient with known effect _
Each tablet contains 71.45 mg lactose monohydrate.
Jakavi 10 mg tablets
Each tablet contains 10 mg ruxolitinib (as phosphate).
_Excipient with known effect_
Each tablet contains 142.90 mg lactose monohydrate.
Jakavi 15 mg tablets
Each tablet contains 15 mg ruxolitinib (as phosphate).
_Excipient with known effect_
Each tablet contains 214.35 mg lactose monohydrate.
Jakavi 20 mg tablets
Each tablet contains 20 mg ruxolitinib (as phosphate).
_Excipient with known effect_
Each tablet contains 285.80 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Jakavi 5 mg tablets
Round curved white to almost white tablets of approximately 7.5 mm in
diameter with “NVR”
debossed on one side and “L5” debossed on the other side.
Jakavi 10 mg tablets
Round curved white to almost white tablets of approximately 9.3 mm in
diameter with “NVR”
debossed on one side and “L10” debossed on the other side.
Jakavi 15 mg tablets
Ovaloid curved white to almost white tablets of approximately 15.0 x
7.0 mm with “NVR” debossed
on one side and “L15” debossed on the other side.
Jakavi 20 mg tablets
Elongated curved white to almost white tablets of approximately 16.5 x
7.4 mm with “NVR” debossed
Novartis
Page 3
Malaysia Package Insert
26-Oct-202012-Jan-2021
Jakavi
3
on one side and “L20” debossed on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myelofib