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.Astellas reserves the right to rescind, revoke, or amend this offer without notice. This offer is void where prohibited by law. Annual re-enrollment in the Program is required and subject to eligibility. The Copay Card Program is valid for twelve (12) months from date of enrollment. Furthermore, this offer for PROGRAF is not valid in the state of California. PROGRAF patients who reside in the states of Massachusetts and California are not eligible to participate in the Program. However, this Program offer is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any federal or state-government funded prescription drug benefit program including but not limited to Medicaid, Medicare, Medigap, Veterans Affairs (VA), Department of Defense (DoD), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program.
Patients must have prescription drug coverage for PROGRAF or ASTAGRAF XL. *Eligible participants in the Copay Card Program ("Program") may receive annual savings up to $3000 for PROGRAF ® (tacrolimus) capsules or ASTAGRAF XL ® (tacrolimus extended-release capsules). Eligibility Restrictions, Terms and Conditions:
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