OTEZLA FILM-COATED TABLETS 20 MG

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

APREMILAST

Tilgjengelig fra:

Amgen Biopharmaceuticals Malaysia Sdn Bhd

INN (International Name):

APREMILAST

Enheter i pakken:

Starter pack: 4 tablets of 10 mg apremilast, 4 tablets of 20 mg apremilast, 19 tablets of 30 mg apremilast Tablets

Produsert av:

Celgene International Sarl

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
OTEZLA
® TABLETS
Apremilast (10mg, 20mg, 30mg)
WHAT IS IN THIS LEAFLET
1.
What Otezla
®
is used for
2.
How Otezla
®
works
3.
Before you use Otezla
®
4.
How to use Otezla
®
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Otezla
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial number
WHAT OTEZLA
® IS USED FOR
Otezla is used to treat adults with the
following conditions:
•
Moderate to severe plaque
psoriasis (an inflammatory
disease of the skin, which
can cause red, scaly, thick,
itchy, painful patches on
your skin, and can also
affect your scalp and nails)
•
Psoriatic arthritis (an
inflammatory disease of
the joints, often
accompanied by psoriasis)
HOW OTEZLA
® WORKS
Otezla works by reducing the activity
of a natural substance in the body’s
cells called ‘phosphodiesterase 4’.
This helps regulate the immune
response associated with psoriasis
and psoriatic arthritis. By regulating
the immune response, Otezla can
help to control the signs and
symptoms of these conditions.
In psoriasis, treatment with Otezla
results in a reduction in psoriatic skin
plaques and other signs and
symptoms of the disease.
In psoriatic arthritis, treatment with
Otezla results in an improvement in
swollen and painful joints, and can
improve your general physical
function.
Otezla has also been shown to
improve the quality of life in patients
with psoriasis or psoriatic arthritis.
This means that the impact of your
condition on daily activities,
relationships and other factors should
be less than it was before.
_Ask your doctor if you have any _
_questions about how Otezla works, _
_or why this medicine has been _
_prescribed for you. _
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
BEFORE YOU USE OTEZLA
®
_A)_
_ _
_WHEN YOU MUST NOT USE IT _
_Do not take Otezla if you have an _
_allergy to apremilast, the active _
_ingredient of Otezla, or any of the _
_othe

Preparatomtale

1
OTEZLA
®
(APREMILAST) TABLETS
I)
NAME OF THE MEDICINE
Generic name:
apremilast
Molecular formula:
C
22
H
24
N
2
O
7
S
Molecular weight:
460.5
CAS number:
608141-41-9
ATC code:
L04AA32
Chemical name:
N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-
(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-
yl]acetamide
Chemical structure:
II)
DESCRIPTION
Apremilast is a white to pale yellow non-hygroscopic powder with a
melting point of approximately
156.1°C. It is practically insoluble in water, slightly soluble in
ethanol, and soluble in acetone.
Apremilast is the S-enantiomer with a specific rotation of +28.1° in
acetonitrile at a concentration of
20 mg/mL.
LIST OF EXCIPIENTS
Otezla tablets contain microcrystalline cellulose, lactose,
croscarmellose sodium, magnesium stearate,
polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide red,
iron oxide yellow (20 and 30 mg
only) and iron oxide black (30 mg only).
III)
PHARMACOLOGY
Pharmacotherapeutic group: Selective immunosuppressants.
PHARMACODYNAMIC PROPERTIES
Mechanism of action
Apremilast, an oral small-molecule inhibitor of phosphodiesterase 4
(PDE4), works intracellularly to
modulate a network of pro-inflammatory and anti-inflammatory
mediators. PDE4 is a cyclic adenosine
monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory
cells. PDE4 inhibition
elevates intracellular cAMP levels, which in turn down-regulates the
inflammatory response by
modulating the expression of TNF-α, IL-23, IL-17 and other
inflammatory cytokines. Cyclic AMP also
modulates levels of anti-inflammatory cytokines such as IL-10. These
pro- and anti-inflammatory
mediators have been implicated in psoriatic arthritis (PsA) and
psoriasis (PSOR).
Clinical Pharmacodynamics
In clinical studies in patients with psoriatic arthritis, apremilast
significantly modulated, but did not
fully inhibit, plasma protein levels of IL-1α, IL-6, IL-8, MCP-1,
MIP-1β, MMP-3, and TNF-α. After 40
weeks of treatment with apremilast, there was a decrease in plasma
protein levels of IL-17 a