Important safety information for Otezla, an inhibitor of PDE4 for the treatment of adults with active psoriatic arthritis
Apremilast ( Otezla ) is an oral small-molecule inhibitor of phosphodiesterase 4 ( PDE4 ) specific for cyclic adenosine monophosphate ( cAMP ). PDE4 inhibition results in increased intracellular cAMP levels.
Otezla was approved on March 21, 2014 by the U.S. Food and Drug Administration ( FDA ) for the treatment of adults with active psoriatic arthritis.
Important safety information
Otezla is contraindicated in patients with a known hypersensitivity to Apremilast or to any of the excipients in the formulation.
Warnings and Precautions
Depression: treatment with Otezla is associated with an increase in adverse reactions of depression. During clinical trials, 1.0% ( 10/998 ) of patients treated with Otezla reported depression or depressed mood compared to 0.8% ( 4/495 ) treated with placebo; 0.3% ( 4/1441 ) of patients treated with Otezla discontinued treatment due to depression or depressed mood compared with none in placebo treated patients ( 0/495 ). Depression was reported as serious in 0.2% ( 3/1441 ) of patients exposed to Otezla, compared to none in placebo treated patients ( 0/495 ). Suicidal ideation and behavior were observed in 0.2% ( 3/1441 ) of patients on Otezla, compared to none on placebo ( 0/495 ). Two patients who received placebo committed suicide compared to none on Otezla.
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. 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.
Weight Decrease: body weight loss of 5-10% was reported in 10% of patients taking Otezla and in 3.3% of patients taking placebo. Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla.
Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with Rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers ( eg, Rifampin, Phenobarbital, Carbamazepine, Phenytoin ) is not recommended.
Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks ( after the initial 5-day titration ), were ( Apremilast % vs placebo % ): diarrhea ( 7.7 vs 1.6 ); nausea ( 8.9 vs 3.1 ); headache ( 5.9 vs 2.2 ); upper respiratory tract infection ( 3.9 vs 1.8 ); vomiting ( 3.2 vs 0.4 ); nasopharyngitis ( 2.6 vs 1.6 ); upper abdominal pain ( 2.0 vs 0.2 ).
Use in specific populations
Pregnancy and Nursing mothers: Otezla is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Apremilast or its metabolites are present in human milk. Caution should be exercised when Otezla is administered to a nursing woman.
Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment ( creatinine clearance less than 30 mL/min ). ( Xagena )
Source: Celgene, 2014
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