Otezla Drug Facts
HIGHLIGHTS OF PRESCRIBING INFORMATION: These highlights do not include all the information needed to use OTEZLA safely and effectively. See full prescribing information for OTEZLA https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=f6b1f516-4972-4d82-bced-113e47b41cc5&type=display.
OTEZLA®(apremilast) tablets, for oral use Initial U.S. Approval: 2014
INDICATIONS AND USAGE OTEZLA, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: ∙ Adult patients with active psoriatic arthritis (1.1) ∙ Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy (1.2) ∙ Adult patients with oral ulcers associated with Behçet’s Disease (1.3)
DOSAGE AND ADMINISTRATION
To reduce risk of gastrointestinal symptoms, titrate to recommended dosage of 30 mg twice daily according to the following schedule (2.1)
∙ Day 1: 10 mg in morning ∙ Day 2: 10 mg in morning and 10 mg in evening ∙ Day 3: 10 mg in morning and 20 mg in evening ∙ Day 4: 20 mg in morning and 20 mg in evening ∙ Day 5: 20 mg in morning and 30 mg in evening ∙ Day 6 and thereafter: 30 mg twice daily Dosage in Severe Renal Impairment:
∙ Recommended dosage is 30 mg once daily (2.2) ∙ For initial dosage titration, titrate using only morning schedule listed in Table 1 and skip afternoon doses (2.2)
DOSAGE FORMS AND STRENGTHS Tablets: 10 mg, 20 mg, 30 mg (3)
CONTRAINDICATIONS Known hypersensitivity to apremilast or to any of the excipients in the formulation (4)
WARNINGS AND PRECAUTIONS ∙ Hypersensitivity: Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of OTEZLA in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue OTEZLA and institute appropriate therapy (5.1). ∙ Diarrhea, Nausea, and Vomiting: Consider OTEZLA dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting (5.2) ∙ Depression: Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior (5.3) ∙ Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of OTEZLA (5.4) ∙ Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur (5.5, 7.1)
ADVERSE REACTIONS ∙ Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache (6.1) ∙ Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache (6.1) ∙ Behçet’s Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS Severe Renal Impairment: Increased systemic exposure of OTEZLA has been observed, reduction in dosage to 30 mg once daily is recommended (2.2, 8.6)