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.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.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.
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†If the patient’s health plan requires a prior authorization, or if patient experiences a delay in obtaining approval for Otezla, patients can qualify for the Bridge to Commercial Coverage Offer and receive Otezla free for up to 12 months while pursuing approval from their health plans. Patients who are not eligible can call 1-844-4OTEZLA (1-84) to discuss further financial support opportunities. This program is not open to patients receiving prescription reimbursement under any federal, state, or government-funded healthcare program. Terms, conditions, and program maximums apply. *The Otezla Co-Pay Card is for eligible commercially insured patients. While pursuing coverage, commercially insured patients can enroll in the combined Otezla Co-Pay Card * and Bridge Program † to start and stay on Otezla as prescribed for as little as $0.
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