Aprezo 10mg Film Coated Tablets

Country: Մալայզիա

language: անգլերեն

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

active_ingredient:

APREMILAST

MAH:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN:

APREMILAST

units_in_package:

A two-week starter pack (4 x 10 mg, 4 x 20 mg and 5 x 30 mg for the first week. For dose titration 14 x 30 mg tablets for the second week) Tablets; A two-week starter pack (4 x 10 mg, 4 x 20 mg and 5 x 30 mg for the first week. For dose titration 14 x 30 mg tablets for the second week) Tablets Tablets; 55 tablets in total. 4 tablets of 10mg, 4 tablets of 20mg, 47 tablets of 30mg Tablets; 55 tablets in total. 4 tablets of 10mg, 4 tablets of 20mg, 47 tablets of 30mg Tablets

manufactured_by:

GLENMARK PHARMACEUTICALS LTD

PIL

_Consumer Medication Information Leaflet (RiMUP) _
APREZO FILM COATED TABLET
Apremilast 10mg, 20mg, 30mg
Page 1 of 3
WHAT IS IN THIS LEAFLET
1.
What APREZO is used for
2.
How APREZO works
3.
Before you use APREZO
4.
How to use APREZO
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
APREZO
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT APREZO IS USED FOR
Apremilast is indicated for:
•
Apremilast, alone or in
combination with Disease Modifying
Antirheumatic Drugs (DMARDs), is
indicated for the treatment of active
psoriatic arthritis (PsA) in adult
patients who have had an inadequate
response or who have been intolerant
to a prior DMARD therapy.
•
The treatment of adult
patients with moderate to severe
plaque psoriasis who are candidates
for phototherapy or systemic therapy.
HOW APREZO WORKS
Psoriatic arthritis and psoriasis are
usually lifelong conditions and there
is currently no cure. Apremilast
works by reducing the activity of an
enzyme in the body called
‘phosphodiesterase 4’, which is
involved in the process of
inflammation. By reducing the
activity of this enzyme, Apremilast
can help to control the inflammation
associated with psoriatic arthritis and
psoriasis, and thereby reduce the
signs and symptoms of these
conditions.
In psoriatic arthritis, treatment with
Apremilast results in an
improvement in swollen and painful
joints, and can improve your general
physical function.
In psoriasis, treatment with
Apremilast results in a reduction in
psoriatic skin plaques and other signs
and symptoms of the disease.
Apremilast 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.
BEFORE YOU USE APREZO
_- When you must not use it _
If you are allergic to apremilast or
any of the other ingredients of this
medicine.
During pregnancy and in nursing
w

SPC

A
N
PASIB75, N (%)
SPGACOF CLEAR OR
ALMOST CLEAR, N (%)
PLACEBO
APREMILAST
30 MG BID
APREMILAST
30 MG BID
N=282
15 (5.3)
11(3.9)
N=562
186 (33.1)
122 (21.7)
N=137
8 (5.8)
6 (4.4)
N=274
79 (28.8)
56 (20.4)
STUDY PSOR-1
STUDY PSOR-2
PLACEBO
35 (7)
32 (6)
160 (17)
31 (6)
21 (4)
155 (17)
84 (9)
75 (8)
PLACEBO
(N=506) N (%)
APREMILAST 30 MG BID
(N=920) N (%)
8 (2)
9 (2)
6 (1)
5 (1)
4 (1)
4 (1)
5 (1)
1 (0)
2 (0)
2 (0)
0 (0)
0 (0)
0 (0)
10 (1)
9 (1)
9 (1)
17 (2)
12 (1)
12 (1)
26 (3)
21 (2)
20 (2)
19 (2)
29 (3)
29 (3)
35 (4)
11 (2)
39 (4)
19 (4)
55 (6)
Upper respiratory tract infection
Tension headache
Nausea
Abdominal pain*
Vomiting
Fatigue
Headache
Diarrhea
Insomnia
Back pain
Decreased appetite
Frequent bowel movements
Depression
Bronchitis
Tooth abscess
Folliculitis
Sinus headache
Migraine
Dyspepsia
PREFERRED TERM
ACR 20
WEEK 16
PLACEBO ±
DMARDS
N=168
19%
1%
6%
APREMILAST
30 MG
TWICE
DAILY ±
DMARDS
N=168
38% b
4%
16%
PLACEBO ±
DMARDS
N=159
19%
1%
5%
APREMILAST
30 MG
TWICE
DAILY ±
DMARDS
N=162
32% b
1%
11%
PLACEBO ±
DMARDS
N=169
18%
2%
8%
APREMILAST
30 MG
TWICE
DAILY ±
DMARDS
N=167
41% b
4%
15%
ACR 50
WEEK 16
ACR 70
WEEK 16
166
23
-2
164
23
-7
PLACEBO (N*=168)
APREMILAST 30 MG
TWICE DAILY (N*=168)
13
-2
165
61
-6
165
59
-3
158
55
-8
165
166
1.2
1.1
1.2
0.8
-0.09
0.1
-0.2
-0.1
159
167
159
56
-19
159
56
-10
159
58
-14
-5
13
166
164
Baseline
Mean Change at Week 16
Sample Size
Sample Size
Baseline
Mean Change at Week 16
b
Number of swollen joints
a
Number of tender joints
Baseline
Mean Change at Week 16
Sample Size
Sample Size
Baseline
Mean Change at Week 16
Physician's global assessment
c
of disease activity
Sample Size
Sample Size
Sample Size
Baseline
Baseline
Baseline
Mean Change at Week 16
Mean Change at Week 16
Mean Change at Week 16
CRPe
HAQ-DId score
Patient's global assessment
c
of disease activity
c
Patient's assessment of pain
6 (1.2)
8 (1.6)
7 (1.4)
15 (3.1)
11 (2.2)
9 (1.8)
46 (9.3)
37 (7.4)
24 (4.8)
38 (7.7)
44 (8.9)
29 (5.9)
PLACEBO
APREMILAST 30 MG BID
DAY 1 TO 5
(N=497)
N (%)
DAY 6 TO DAY
112 (N=490)