FDA approved Xelstrym (amphetamine) Transdermal System for ADHD in Adults and Children 6+FDA approved new ADHD patch Xelstrym for adults and children 6 and older.

Amphetamine is a central nervous system (CNS) stimulant. The exact mechanism of action in ADHD is not fully known, but amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Xelstrym is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. Limitation of Use: Not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage.

Pediatric patients (6 to 17 years): Recommended starting dose is 4.5 mg/9 hours. Titrate in weekly increments of 4.5 mg up to a maximum of 18 mg/9 hours. Adults: Recommended starting dose is 9 mg/9 hours. Maximum recommended dose is 18 mg/9 hours. Apply one transdermal system 2 hours before an effect is needed and remove within 9 hours. Apply to clean, dry, intact skin on hip, upper arm, chest, upper back, or flank. Change application site with each new system. Do not substitute for other amphetamine products on a mg-per-mg basis due to different base compositions and pharmacokinetic profiles. Severe renal impairment (GFR 15 to <30 mL/min/1.73 m2): Maximum dose 13.5 mg/9 hours. End stage renal disease (GFR <15 mL/min/1.73 m2): Maximum dose 9 mg/9 hours.

The efficacy of Xelstrim for the treatment of ADHD in adults and pediatric patients 6 to 17 years was established in a study with Xelstrim in pediatric patients and also based on adequate and well-controlled studies of lisdexamfetamine in pediatric and adult patients. Efficacy of lisdexamfetamine in ADHD has been established in three short-term trials in pediatric patients 6 to 12 years, one short-term trial in pediatric patients 13 to 17 years, and one short-term trial in adult patients. Specific efficacy data for Xelstrim are not detailed in the label.

Prior to treatment, assess for cardiac disease (history, family history of sudden death or ventricular arrhythmia, physical exam). Evaluate for motor or verbal tics or Tourette's syndrome. Avoid exposing application site to direct external heat sources (hair dryers, heating pads, electric blankets, heated water beds) as heat increases rate and extent of absorption. Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines; acidifying agents (e.g., ascorbic acid) decrease blood levels, requiring dosage adjustment based on clinical response.

Xelstrim offers a transdermal delivery option for ADHD treatment in patients aged 6 years and older. It may be considered for patients who have difficulty swallowing tablets or prefer a non-oral route. Dosing is individualized based on clinical response and tolerability. The 9-hour wear time allows for daytime symptom control with removal in the evening. Not recommended for children under 6 years.