Journal of Clinical and Aesthetic Dermatology

MAY 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

Issue link: https://jcadonline.epubxp.com/i/979610

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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% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) 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 (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended Adverse Reactions • Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4) 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); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information Also approved for the treatment of adults with active psoriatic arthritis Learn more at OTEZLAPRO.COM Convenient oral dosing 1 * No required lab monitoring 1 Samples available in office Bridge program offers 3 years for free † $0 co-pay ‡ START your patients on Otezla today Otezla ® is a registered trademark of Celgene Corporation. © 2018 Celgene Corporation 02/18 USII-APR180046 * Following a 5-day titration, the recommended maintenance dosage is 30 mg twice daily. † To receive a free bridge supply of Otezla, patients must have an on-label diagnosis and be denied or waiting for coverage. Patients in Massachusetts are not eligible to receive bridge. ‡ Certain restrictions apply; eligibility not based on income, must be 18 years or older. This offer is not valid for persons eligible for reimbursement of this product, in whole or in part under Medicaid, Medicare, or similar state or federal programs. Offer not valid for cash-paying patients. People who are not eligible can call 1-844-4OTEZLA to discuss other financial assistance opportunities. BSA, body surface area; ESTEEM, Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis; PASI, Psoriasis Area and Severity Index; sPGA, static Physician Global Assessment. References: 1. Otezla [package insert]. Summit, NJ: Celgene Corporation. 2. Papp K, Reich K, Leonardi CL, et al. J Am Acad Dermatol. 2015;73(1):37-49. Please turn the page for Brief Summary of Full Prescribing Information.

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