Schizophrenia

Initiate SECUADO at a dosage of 3.8 mg/24 hours. In a short-term, placebo-controlled trial, there was no suggestion of added benefit at a dosage of 7.6 mg/24 hours, on average, but there was an increase in certain adverse reactions. The dosage may be increased to 5.7 mg/24 hours or 7.6 mg/24 hours, as needed, after one week. The safety of doses above 7.6 mg/24 hours has not been evaluated in clinical studies [see Clinical Studies (14)].

Based on the average exposure (AUC) of asenapine, SECUADO 3.8 mg/24 hours corresponds to 5 mg twice daily of sublingual asenapine and SECUADO 7.6 mg/24 hours corresponds to 10 mg twice daily of sublingual asenapine [see Clinical Pharmacology (12.3)].

Important Application Instructions

• See the FDA-approved patient labeling (Instructions for Use).
• SECUADO transdermal system is applied once daily. Each SECUADO transdermal system should be worn for 24 hours only. Instruct patients to wear only one SECUADO transdermal system at any time.
• Apply SECUADO to clean, dry, and intact skin at the selected application site. Application sites include: the upper arm, upper back, abdomen, or hip. Apply the transdermal system to a different application site each time a new SECUADO transdermal system is applied.
• Do not cut open the pouch until ready to apply SECUADO and do not use the transdermal system if the individual pouch seal is broken or if it appears to be damaged. Do not cut SECUADO, the whole transdermal system should be applied.
• If the SECUADO transdermal system lifts at the edges, reattach SECUADO by pressing firmly and smoothing down the edges of the system. If SECUADO comes off completely, apply a new SECUADO transdermal system.
• Discard SECUADO by folding the used transdermal system so that the adhesive side sticks to itself and safely discard.
• If irritation or a burning sensation occurs while wearing SECUADO, remove the system and apply a new transdermal system to a new application site [see Warnings and Precautions (5.17)].
• Showering is permitted, but the use of SECUADO during swimming or taking a bath has not been evaluated.
• Do not apply external heat sources (e.g., heating pad) over the SECUADO transdermal system [see Warnings and Precautions (5.16)]. Prolonged application of heat over a SECUADO transdermal system increases plasma concentrations of asenapine [see Clinical Pharmacology (12.3)].