SECUADO (asenapine) transdermal system is a translucent rounded square product with a printed backing on one side and a release liner on the other supplied as: �3.8 mg/24 hours transdermal system (system size: 20 cm2) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0172-3 �5.7 mg/24 hours transdermal system (system size: 30 cm2)
Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0173-3 �7.6 mg/24 hours transdermal system (system size: 40 cm2) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0174-3 16.2 StorageStore at room temperature 20�C to 25�C (68�F to 77�F) with excursions permitted between 15�C and 30�C (between 59�F and 86�F) [see USP Controlled Room Temperature]. HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use SECUADO� (asenapine) transdermal systemsafely and effectively. See full prescribing information for SECUADO�.SECUADO� (asenapine) transdermal systemInitial U.S. Approval:2009WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISSee full prescribing information for complete boxed warning.Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. SECUADO is not approved for the treatment of patients with dementia-related psychosis. (5.1) __________________INDICATIONS AND USAGE _________________SECUADO is an atypical antipsychotic indicated for the treatment of adults with schizophrenia. (1) _______________DOSAGE AND ADMINISTRATION ______________�For transdermal use only. (2.2) �Apply one SECUADO transdermal system every 24 hours. (2.2) �Apply SECUADO to one of the following sites: the hip, abdomen, upper arm, or upper back area. (2.2) �The recommended starting dose of SECUADO is 3.8 mg/24 hours. May increase dosage to 5.7 mg/24 hours or 7.6 mg/24 hours after one week. (2.1) ______________DOSAGE FORMS AND STRENGTHS _____________�Transdermal System: 3.8 mg/24 hours, 5.7 mg/24 hours and 7.6 mg/24 hours (3) ___________________CONTRAINDICATIONS ___________________�Severe hepatic impairment (Child-Pugh C). (8.7, 12.3) �Known hypersensitivity to SECUADO or to any components in the transdermal system. (4, 5.6, 17 ) _______________WARNINGS AND PRECAUTIONS _______________�Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). (5.2) �Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. (5. 3) �Tardive Dyskinesia: Discontinue if clinically appropriate. (5.4) �Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. (5.5) �Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. (5.7) �Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing SECUADO if a clinically significant decline in WBC occurs in absence of other causative factors. (5.9) �QT Prolongation: Increases in QT interval; avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval. (5.10) �Seizures: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold. (5.12) �Potential for Cognitive and Motor Impairment: Use caution when operating machinery. (5.13) �External Heat: Avoid exposing SECUADO to external heat sources during wear because both the rate and extent of absorption are increased. (5.16) �Application Site Reactions: During wear time or immediately after removal of SECUADO, local skin reactions may occur. Instruct patients to select a different transdermal system application site each day to limit the occurrence of skin reactions (5.17) ___________________ADVERSE REACTIONS ___________________Commonly observed adverse reactions (incidence ?5% and at least twice that for placebo): Extrapyramidal disorder, application site reaction, and weight gain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Noven Therapeutics, LLC at 1-800-455-8070 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ___________________DRUG INTERACTIONS____________________�Antihypertensive drugs: SECUADO may enhance antihypertensive effects. Monitor blood pressure and adjust dosage of antihypertensive drug accordingly. (7.1) �Strong CYP1A2 Inhibitors: Consider dose reduction for SECUADO based on clinical response. (7.1) �Paroxetine (CYP2D6 substrate and inhibitor): Reduce paroxetine dose by half. (7.1) ______________USE IN SPECIFIC POPULATIONS _______________Pregnancy: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. (8.1) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 10/2019
