Xelstrym

— THERAPEUTIC CATEGORIES —
  • ADHD

Xelstrym Generic Name & Formulations

General Description

Dextroamphetamine 4.5mg, 9mg, 13.5mg, 18mg; delivered over 9hrs; transdermal patches.

Pharmacological Class

CNS stimulant.

How Supplied

Patches—30

Manufacturer

Generic Availability

NO

Mechanism of Action

The exact mode of therapeutic action of amphetamines in ADHD is not known. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity.

Xelstrym Indications

Indications

Attention deficit hyperactivity disorder.

Limitations of Use

Pediatric patients <6years of age experienced more long-term weight loss than those ≥6years.

Xelstrym Dosage and Administration

Adult

Individualize. ≥18yrs: Initially apply one 9mg patch to clean, dry and intact skin at application site (eg, hip, upper arm, chest, upper back, or flank); remove 9hrs after application. May titrate to max 18mg/9hrs. Rotate application sites. Severe renal impairment (eGFR 15–<30mL/min/1.73m2): max 13.5mg/9hrs; ESRD (eGFR <15mL/min/1.73m2): max 9mg/9hrs.

Children

<6yrs: not established. Individualize. 6–17yrs: Initially apply one 4.5mg patch to clean, dry and intact skin at application site (eg, hip, upper arm, chest, upper back, or flank); remove 9hrs after application. May titrate dose at 4.5mg weekly increments up to max 18mg/9hrs. Rotate application sites. Severe renal impairment (eGFR 15–<30mL/min/1.73m2): max 13.5mg/9hrs; ESRD (eGFR <15mL/min/1.73m2): max 9mg/9hrs.

Xelstrym Contraindications

Contraindications

During or within 14 days of MAOIs.

Xelstrym Boxed Warnings

Boxed Warning

Abuse, misuse, and addiction.

Xelstrym Warnings/Precautions

Warnings/Precautions

Do not substitute for other amphetamine products on a mg-per-mg basis. High potential for abuse, misuse, and addiction; assess patient’s risk before prescribing. Assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, or other cardiac disease. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode prior to initiating. Consider discontinuing if new psychotic/manic symptoms occur. Monitor for serotonin syndrome; discontinue if occurs. Assess family history and evaluate for tics or Tourette’s syndrome before initiating; monitor for emergence or worsening, and discontinue if clinically appropriate. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Discontinue if contact sensitization is suspected; may require alternative oral amphetamine treatment. Avoid exposing patch to direct external heat sources. Reevaluate periodically. Renal impairment. Labor & delivery. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended.

Xelstrym Pharmacokinetics

Absorption

Peak plasma levels: reached at 6–9 hours (after a single application); 6 hours (after repeat applications).

On average, ~90% of dextroamphetamine is delivered over 9 hours. After repeat applications for 4 weeks in adults with ADHD, Cmax and AUC0–24 were increased by 46% and 54%, respectively.

Application of a heating pad on Xelstrym for 6 consecutive hours led to a faster absorption rate.

Metabolism

Enzymes involved are not clearly defined, but CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine.

Elimination

Renal. Half-life: ~6.4 hours (pediatrics); 11.5 hours (adults).

Xelstrym Interactions

Interactions

See Contraindications. Hypertensive crisis with MAOIs. Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort), CYP2D6 inhibitors; consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by alkalinizer; avoid. Antagonized by acidifiers; increase dose. May potentiate TCAs, sympathomimetics; adjust dose or use alternatives. 

Xelstrym Adverse Reactions

Adverse Reactions

Decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety; hypertension, tachycardia, psychiatric reactions, motor/verbal tics, contact sensitization, application site reactions. Also for children: headache, tic, abdominal pain, vomiting, irritability, increased BP/HR.

Xelstrym Clinical Trials

See Literature

Xelstrym Note

Not Applicable

Xelstrym Patient Counseling

See Literature