Xelstrym Patch Dosage

Pretreatment Screening

​Prior to treating patients with XELSTRYM, assess:

• ​for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS AND PRECAUTIONS (5.2)].
• ​the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating XELSTRYM [see WARNINGS AND PRECAUTIONS (5.11)].

Recommended Dosage

​Pediatric Patients 6 to 17 years

• ​Recommended starting dose of XELSTRYM in pediatric patients 6 to 17 years is 4.5 mg/9 hours. Dosage may be adjusted in weekly increments of 4.5 mg up to a maximum recommended dose of 18 mg/9 hours.

Adults

• ​Recommended starting dose of XELSTRYM in adults is 9 mg/9 hours. Dosage may be adjusted up to a maximum recommended dose of 18 mg/9 hours.

​Apply XELSTRYM to the application site 2 hours before an effect is needed and remove within 9 hours after application. Dose titration and final dosage should be individualized depending on clinical response and tolerability.

Important Administration Instructions

• Apply one XELSTRYM transdermal system at a time for not more than 9 hours. Use only one XELSTRYM per 24 hours.
• Apply XELSTRYM to clean (void of lotions, oils, or gels), dry (not wet), and intact skin at the selected application site. Application sites include: hip, upper arm, chest, upper back, or flank. Select a different application site each time a new XELSTRYM transdermal system is applied [see WARNINGS AND PRECAUTIONS (5.9)].
• Avoid touching the adhesive side of XELSTRYM in order to avoid absorption of amphetamine. If the adhesive side is touched, immediately wash hands with soap and water.
• If the XELSTRYM transdermal system lifts at the edges, reattach XELSTRYM by pressing firmly and smoothing down the edges of the system. If XELSTRYM comes off completely, apply a new XELSTRYM transdermal system. XELSTRYM should not be applied or re-applied with dressings, tape or other common adhesives.
• Avoid exposing the application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing XELSTRYM [see WARNINGS AND PRECAUTIONS (5.10)]. When heat is applied to XELSTRYM after application, both the rate and the extent of absorption are increased [see CLINICAL PHARMACOLOGY (12.3)].

2.4 Switching from Other Amphetamine Products

For patients switching from another medication or any other amphetamine product, discontinue that treatment, and titrate with XELSTRYM using the titration schedule [see DOSAGE AND ADMINISTRATION (2.2)]​.

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see CLINICAL PHARMACOLOGY (12.3)]​.

Dosage in Patients with Renal Impairment

In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m2), the maximum dose should not exceed 13.5 mg/9 hours. The maximum recommended dose in end stage renal disease (GFR < 15 mL/min/1.73 m2) patients is 9 mg/9 hours [see USE IN SPECIFIC POPULATIONS (8.6)].

Dosage Modification due to Drug Interactions

Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines. Acidifying agents (e.g., ascorbic acid) decrease blood levels; adjust XELSTRYM dosage based on clinical response [see DRUG INTERACTIONS (7.1)].