Apremilast

DEA Class; Rx

Common Brand Names; Otezla

• DMARDs, PDE4 Inhibitors

Oral phosphodiesterase-4 inhibitor (PDE4) and a targeted synthetic DMARD
Used in adults for the treatment of active psoriatic arthritis, oral ulcers associated with Behcet’s Disease, and plaque psoriasis in candidates for systemic or phototherapy
Patients with severe diarrhea, nausea, and vomiting may need dose reduction or drug discontinuation

Hypersensitivity to apremilast or to any of the excipients in the formulation

• Diarrhea (7.7-17%)
• Nausea (7.4-17%)
• Diarrhea (41.3%)
• Nausea (19.2%)
• Headache (14.4%)
• Upper respiratory tract infection (11.5%)
• Upper abdominal pain (8.7%)
• Vomiting (8.7%)
• Back pain (7.7%)
• Viral upper respiratory tract infection (6.7%)
• Arthralgia (5.8%)

Hypersensitivity reactions, including angioedema and anaphylaxis, reported; with known hypersensitivity to apremilast; if signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue and institute appropriate therapy

Associated with an increase in adverse reactions of depression; before using, evaluate patient for history of depression and/or suicidal thoughts or behavior

Weight decrease of 5-10% of body weight reported in 10-12% of patients

Because patients 65 years of age or older may be at a higher risk of complications such as volume depletion or hypotension from severe diarrhea, nausea, or vomiting, monitor geriatric patients closely for such complications

Available pharmacovigilance data use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but data are extremely limited

There are no data on the presence of apremilast in human milk, the effects on the breastfed infant, or the effects on milk production

60 mg/day PO.

60 mg/day PO.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Apremilast 

tablet

• 10mg
• 20mg
• 30mg