LINADEX 10 (Lenalidomide Capsules 10 mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LENALIDOMIDE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

LENALIDOMIDE

Unit dalam pakej:

3x7s Capsules

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
LINADEX 5/10/15/25
Lenalidomide Capsules (5 mg, 10 mg, 15 mg & 25 mg)
Page. 1
What is in this leaflet
1. What LINADEX is used for
2. How LINADEX works
3. Before you use LINADEX
4. How to use LINADEX
5. While you are using it
6. Side effects
7. Storage and disposal of LINADEX
8. Product description
9. Manufacturer and product registration
holder
10. Date of revision
11. Serial Number
What LINADEX is used for
What is LINADEX
LINADEX contains the active substance
‘lenalidomide’. This medicine belongs to a
group of medicines which affect how your
immune system works.
What LINADEX is used for
LINADEX 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
LINADEX
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
LINADEX
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
LINADEX on its own.
Multiple myeloma – in patients who have
had treatment before
LINADEX is taken together with an anti-
inflammatory
medicine
called
‘dexamethasone’.
How LINADEX works
LINADEX 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 immune
system to atta

Ciri produk

LINADEX 5 (Lenalidomide Capsules 5 mg)
LINADEX 10 (Lenalidomide Capsules 10 mg)
LINADEX 15 (Lenalidomide Capsules 15 mg)
LINADEX 25 (Lenalidomide Capsules 25 mg)
Font size: 7
NAME AND STRENGTH OF ACTIVE INGREDIENT
Each capsule of LINADEX 5 contains 5 mg Lenalidomide.
Each capsule of LINADEX 10 contains 10 mg Lenalidomide.
Each capsule of LINADEX 15 contains 15 mg Lenalidomide.
Each capsule of LINADEX 25 contains 25 mg Lenalidomide.
DOSAGE FORM
Oral (Capsules)
PRODUCT DESCRIPTION
LINADEX 5 (Lenalidomide Capsules 5 mg):
White opaque cap and white opaque body, size '2' hard gelatin capsules
with 'H' on cap and 'L2' on body,
imprinted in black, filled with off white to pale yellow color powder.
LINADEX 10 (Lenalidomide Capsules 10 mg):
Orange opaque cap and white opaque body, size '0' hard gelatin
capsules with 'H' on cap and 'L4' on body,
imprinted in black, filled with off white to pale yellow color powder.
LINADEX 15 (Lenalidomide Capsules 15 mg):
Red opaque cap and white opaque body, size '0' hard gelatin capsules
with 'H' on cap and 'L5' on body,
imprinted in black, filled with off white to pale yellow color powder.
LINADEX 25 (Lenalidomide Capsules 25 mg):
White opaque cap and white opaque body, size '0' hard gelatin capsules
with 'H' on cap and 'L7' on body,
imprinted in black, filled with off white to pale yellow color powder.
PHARMACODYNAMICS
Pharmacotherapeutic group: Other immunosuppressants. ATC code:
L04AX04.
Mechanism of action
The lenalidomide mechanism of action includes anti-neoplastic,
anti-angiogenic, pro-erythropoietic, and
immunomodulatory properties. Specifically, lenalidomide inhibits
proliferation of certain haematopoietic
tumour cells (including MM plasma tumour cells and those with
deletions of chromosome 5), enhances T
cell- and Natural Killer (NK) cell-mediated immunity and increases the
number of NK T cells, inhibits
angiogenesis by blocking the migration and adhesion of endothelial
cells and the formation of micro vessels,
augments foetal haemoglobin production by CD34+ haematopoietic st