On Oct 15, 2019 FDA has approved the first-and-only transdermal patch for the treatment of adults with schizophrenia:
SECUADO® (asenapine) Transdermal Patch
This post will summarize SECUADO® in the following sections:
- Dosing & Administration
- Application Sites
- Dose Conversion from Oral Asenapine
- Laboratory workup.Investigations
- Drug Interactions
DOSING & ADMINISTRATION:
- 3.8 mg/24 hours
- 5.7 mg/24 hours
- 7.6 mg/24 hours
- 3.8 mg/24 hours.
DOSE TITRATION TO:
- 5.7 mg/24 hours or 7.6 mg/24 hours after one week.
- once-daily transdermal drug delivery system.
- Upper arm, or
- Upper back
- Apply to a different application site each time a new SECUADO transdermal system is applied.
- Do not cut the patch.
- Showering is permitted, but the use during swimming or taking a bath has not been evaluated.
- Do not apply external heat sources (e.g., heating pad) over the patch.
DOSE CONVERSION FROM ORAL ASENAPINE:
- SECUADO 3.8 mg/24 hours = 5 mg twice daily of sublingual asenapine
- SECUADO 7.6 mg/24 hours = 10 mg twice daily of sublingual asenapine.
(1) Severe hepatic impairment (Child-Pugh C):
- 7-fold increase in asenapine level with severe hepatic impairment.
- No dosage adjustment for mild to moderate hepatic impairment (Child-Pugh A and B)
(2) Known hypersensitivity to SECUADO or to any components in the transdermal system.
(1) CBC (Complete Blood Count):
- Risk of Leukopenia, Neutropenia, and Agranulocytosis.
- Discontinue medications for severe neutropenia (absolute neutrophil count <1000/mm3).
(2) Hepatic Function Test:
Contraindicated in severe hepatic impairment.
(3) Metabolic Syndrome Monitoring:
Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain.
- Risk of QTc prolongation.
- Avoid use with QTc prolonging medications.
(5) Orthostatic Vitals:
- patients who are vulnerable to hypotension (elderly patients, patients with dehydration, hypovolemia, concomitant treatment with antihypertensive medications),
- patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure, or conduction abnormalities), and
- patients with cerebrovascular disease.
(1) Antihypertensive Medications:
- SECUADO may enhance the effects of certain antihypertensive agents.
- Mechanism: α1-adrenergic antagonism.
(2) Strong CYP1A2 Inhibitors:
- Asenapine is metabolized by CYP1A2.
- CYP1A2 inhibitors can increase asenapine levels.
- Ex: Fluvoxamine, ciprofloxacin.
- Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism by CYP2D6= increases paroxetine concentration.
- Reduce paroxetine dose by half.