|See warnings and precautions below.|
The active ingredient in OTEZLA tablets is apremilast. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its empirical formula is C22H24N2O7S and the molecular weight is 460.5.
OTEZLA tablets are supplied in 10, 20, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide red, iron oxide yellow (20 and 30 mg only) and iron oxide black (30 mg only).
| Mechanism of Action:
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action in psoriatic arthritis patients is not well defined.
| INDICATIONS AND USAGE:
OTEZLA, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of adult patients with active psoriatic arthritis.
Known hypersensitivity to apremilast or any excipients in formulation
| WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS:
The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION::
Dosage in Psoriatic Arthritis
OTEZLA can be administered without regard to meals. Do not crush, split, or chew the tablets.
Dosage Adjustment in Patients with Severe Renal Impairment
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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