First FDA Approved Transdermal Antipsychotic: Asenapine (SECUADO®)

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:

  1. Indication
  2. Dosing & Administration
  3. Application Sites
  4. Dose Conversion from Oral Asenapine
  5. Contraindications
  6. Laboratory workup.Investigations
  7. Drug Interactions
INDICATION:
  • Schizophrenia

DOSING & ADMINISTRATION:

 

AVAILABLE DOSES:

  • 3.8 mg/24 hours
  • 5.7 mg/24 hours
  • 7.6 mg/24 hours

STARTING DOSE:

  • 3.8 mg/24 hours.

DOSE TITRATION TO:

  • 5.7 mg/24 hours or 7.6 mg/24 hours after one week.

DOSING FREQUENCY:

  • once-daily transdermal drug delivery system.
APPLICATION SITES:
  • Hip
  • Abdomen
  • Upper arm, or
  • Upper back
CLINICAL FACTS:
  • 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.
CONTRAINDICATIONS:

(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.

LABORATORY WORKUP/INVESTIGATIONS:

(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.

(4) EKG:

  • 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.
DRUG INTERACTIONS:

(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.

(3)  Paroxetine:

  • Asenapine may enhance the inhibitory effects of paroxetine on its own metabolism by CYP2D6= increases paroxetine concentration.
  • Reduce paroxetine dose by half.
REFERENCES:
  1. Noven Pharmaceuticals, Inc. Media Press Release
  2. SECUADO® (asenapine) transdermal system package insert. (PDF)

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