Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer loss of Otezla efficacy may occur.

Behçet’s Disease: Body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo.

Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo.

Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo

Plaque Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients with moderate to severe plaque psoriasis treated with Otezla and in 5% (19/382) of patients treated with.

Weight Decrease: Monitor body weight regularly evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla.

No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo During the clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103)

Behçet’s Disease: Treatment with Otezla is associated with an increase in depression.

Two patients who received placebo committed suicide compared to none on Otezla Patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Depression was reported as serious in 0.2% (3/1441) of Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8%

Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression.

One patient treated with Otezla attempted suicide one patient on placebo committed suicide

Observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Reported depression compared to 0.4% (2/506) on placebo. During clinical trials in patients with moderate to severe plaque psoriasis, 1.3% (12/920) of patients Plaque Psoriasis: Treatment with Otezla is associated with an increase in depression.Patients, 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 they should contact their healthcare provider if such changes occur Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla.Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting Monitor patients who are more susceptible to complications of diarrhea or vomiting advise patients to contact their healthcare provider.

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. In some cases, patients were hospitalized. Most events occurred within the first few weeks of treatment. Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla.If signs or symptoms of serious hypersensitivity reactions occur, discontinue Otezla and institute appropriate therapy Hypersensitivity: Hypersensitivity reactions, including angioedema and anaphylaxis, have been reported during postmarketing surveillance.Otezla is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation.

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