Manufacturer
Abbvie Ireland NL B.V(IRELAND)
Registraction Number
MAL24126009ARZ
Content:
Each extended-release tablet contains:
-Upadacitinib (as hemihydrate): 45 mg
Indications:
-Rheumatoid Arthritis: For the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs (DMARDs).
-Psoriatic Arthritis: For the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more DMARDs.
-Ankylosing Spondylitis: For the treatment of active ankylosing spondylitis in adult patients who have responded inadequately to conventional therapy.
-Atopic Dermatitis: For the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
-Ulcerative Colitis: For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
-Crohn’s Disease: For the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent2.
Instructions:
Dosage: The recommended dose is 45 mg taken orally once daily with food until disease progression or unacceptable toxicity.
Administration: Swallow the tablet whole with water. Do not chew, crush, or split the tablet. If a dose is missed, it can be taken as soon as remembered on the same day, unless the next dose is due within 8 hours2.
Malaysia
