Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
APREMILAST
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
APREMILAST
A two-week starter pack (4 x 10mg, 4 x 20mg and 5 x 30mg for the first week. For dose titration 14 x 30mg tablets for the second week) Tablets; A two-week starter pack (4 x 10mg, 4 x 20mg and 5 x 30mg for the first week. For dose titration 14 x 30mg tablets for the second week) Tablets; 55 tablets in total. 4 tablets of 10mg, 4 tablets of 20mg, 47 tablets of 30mg Tablets Tablets; 55 tablets in total. 4 tablets of 10mg, 4 tablets of 20mg, 47 tablets of 30mg Tablets
GLENMARK PHARMACEUTICALS LTD
_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 Přečtěte si celý dokument
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) Přečtěte si celý dokument