LENANGIO 15 (LENALIDOMIDE HARD CAPSULES 15MG)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LENALIDOMIDE (POVIDONE)

Boleh didapati daripada:

Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

LENALIDOMIDE (POVIDONE)

Unit dalam pakej:

1 x 7 Capsules; 2 x 7 Capsules; 3 x 7 Capsules; 4 x 7 Capsules; 3 x 10 Capsules

Dikeluarkan oleh:

DR. REDDY'S LABORATORIES LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
LENANGIO
® 5/10/15/25
Lenalidomide Hard Capsules (5mg, 10mg, 15mg, 25mg)
1
WHAT IS IN THIS LEAFLET
1.
What Lenangio
is used for
2.
How Lenangio
works
3.
Before you use Lenangio
4.
How to use Lenangio
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Lenangio
8.
Product description
9.
Manufacturer and product registration
holder
10.
Date of revision
WHAT LENANGIO
IS USED FOR
_What is Lenangio _
Lenangio
contains the active substance
‘lenalidomide’. This medicine belongs to a
group of medicines which affect how your
immune system works
_. _
_ _
_What Lenangio_
_ _
_is used for _
Lenangio
is used in adults for multiple
myeloma.
_What is multiple myeloma _
Multiple myeloma is a type of cancer which
affects a certain kind of white blood cell,
called the plasma cell. These cells collect in
the bone marrow and divide, becoming out of
control. This can damage the bones and
kidneys.
Multiple myeloma generally cannot be cured.
However, the signs and symptoms can be
greatly reduced or disappear for a period of
time. This is called a ‘response’.
Newly diagnosed multiple myeloma – in
patients who have had a bone marrow
transplant
Lenangio
is used on its own as maintenance
therapy after patients have recovered enough
following a bone marrow transplant.
Newly
diagnosed
multiple
myeloma
–
in
patients
who
cannot
have
a
bone
marrow
transplant
Lenangio
is taken with an anti- inflammatory
medicine called ‘dexamethasone’.
You will take this other medicine at the start
of treatment and then continue to take
Lenangio
on its own.
Multiple myeloma – in patients who have had
treatment before
Lenangio
is taken together with an anti-
inflammatory medicine called
‘dexamethasone’.
HOW LENANGIO
WORKS
Lenangio
works by affecting the body’s
immune system and directly attacking the
cancer. It works in a number of different
ways:
•
by stopping the cancer cells developing
•
by stopping blood vessels growing in the
cancer
•
by stimulating part of the

Ciri produk

1
PRESCRIBING INFORMATION
LENANGIO
® 5 (LENALIDOMIDE HARD CAPSULES 5 MG)
LENANGIO
® 10 (LENALIDOMIDE HARD CAPSULES 10 MG)
LENANGIO
® 15 (LENALIDOMIDE HARD CAPSULES 15 MG)
LENANGIO
® 25 (LENALIDOMIDE HARD CAPSULES 25 MG)
COMPOSITION
LENANGIO
® 25 (LENALIDOMIDE HARD CAPSULES 25 MG)
Each hard capsule contains: Lenalidomide 25mg
LENANGIO
® 15 (LENALIDOMIDE HARD CAPSULES 15 MG)
Each hard capsule contains: Lenalidomide 15mg
LENANGIO
® 10 (LENALIDOMIDE HARD CAPSULES 10 MG)
Each hard capsule contains: Lenalidomide 10 mg
LENANGIO
® 5 (LENALIDOMIDE HARD
CAPSULES 5 MG)
Each hard capsule contains: Lenalidomide 5mg
For the full list of excipients, see section
LIST OF EXCIPIENTS
PHARMACEUTICAL FORM
Hard capsule.
_Lenangio_
®
_ 25 (Lenalidomide Hard Capsules 25 mg)_
: White to off white colored powder filled
in size ‘0’ hard gelatin capsules with opaque white colored cap
imprinted ‘RDY’ with black ink
and opaque white colored body imprinted ‘25mg’ with black ink
_Lenangio_
®
_ 15 (Lenalidomide Hard Capsules 15 mg)_
: White to off white colored powder filled
in size ‘1’ hard gelatin capsules with blue colored cap imprinted
‘RDY’ with black ink and
white colored body imprinted ‘15mg’ with black ink.
_Lenangio_
®
_ 10 (Lenalidomide Hard Capsules 10 mg)_
: White to off white colored powder filled
in size ‘2’ hard gelatin capsules with pale green colored cap
imprinted ‘RDY’ with black ink
and pale yellow colored body imprinted ‘10mg’ with black ink.
WARNING:
Lenalidomide should never be taken by pregnant women or women capable
of
becoming pregnant as even a single dose can cause severe birth defects
or death to an unborn
baby.
2
_Lenangio_
®
_ 5 (Lenalidomide Hard Capsules 5 mg)_
: White to off white colored powder filled in
size ‘4’ hard gelatin capsules with White opaque colored cap
imprinted ‘RDY’ with black ink
and White opaque colored body imprinted ‘5mg’ with black ink
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
Lenangio
®
as monotherapy is indicated for the mainten