Indicated for:

Psoriatic Arthritis:

• The treatment of adult patients with active psoriatic arthritis.

Plaque Psoriasis:

• The treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy.

Oral Ulcers Associated with Behçet’s Disease:

• For the treatment of adult patients with oral ulcers associated with Behçet’s Disease.

OTEZLA dosage should be reduced to 30 mg once daily in patients with severe renal impairment (creatinine clearance (CLcr) of less than 30 mL per minute estimated by the Cockcroft–Gault equation).

Hypersensitivity reactions, including 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.

Treatment with OTEZLA is associated with an increase in adverse reactions of depression. Before using OTEZLA in patients with a history of depression and/or suicidal thoughts or behavior prescribers should carefully weigh the risks and benefits of treatment with OTEZLA in such patients. Patients, their caregivers, and families should be advised of the need 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.

Patients treated with OTEZLA should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, weight loss should be evaluated, and discontinuation of OTEZLA should be considered.

There have been postmarketing reports of severe diarrhea, nausea, and vomiting associated with the use of OTEZLA. Most events occurred within the first few weeks of treatment. In some cases patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting.

Co-administration of strong cytochrome P450 enzyme inducer, rifampin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of OTEZLA. Therefore, the use of cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) with OTEZLA is not recommended.

Based on findings from animal reproduction studies, OTEZLA may increase the risk for fetal loss. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. 

It is not known whether OTEZLA or its metabolites are present in human milk; however apremilast was detected in milk of lactating mice.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Atopic dermatitis. GoToSource

• Hidradenitis suppurativa. GoToSource 

• Ankylosing spondylitis and rosacea. GoToSource

• Repigmentation in vitiligo and alopecia. GoToSource

Severe diarrhea and nausea, upper respiratory tract infection, nasopharyngitis and tension headache. GoToSource 

Depression and weight loss. GoToSource

Suicidal thoughts or behavior. GoToSource

Panic attacks. GoToSource

Chronic excessive tearing. GoToSource

Recurrence of melanoma. GoToSource

Gastrointestinal clostridial infection and pneumonia. GoToSource

Lawsuits filed for suicidal ideation and behaviors.