What is Xelstrym?
Xelstrym is a transdermal patch formulation of dextroamphetamine, a central nervous system (CNS) stimulant approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years and older. 1
Key Characteristics
Xelstrym is not filgrastim or any granulocyte colony-stimulating factor (G-CSF). The evidence provided about filgrastim 2, 3 is unrelated to Xelstrym and appears to be a database error in the question context.
Formulation and Dosing
- Available strengths: 4.5 mg/9 hours, 9 mg/9 hours, 13.5 mg/9 hours, and 18 mg/9 hours 1
- Pediatric dosing (6-17 years): Start at 4.5 mg/9 hours, titrate weekly by 4.5 mg increments up to maximum 18 mg/9 hours 1
- Adult dosing: Start at 9 mg/9 hours, maximum 18 mg/9 hours 1
- Application timing: Apply 2 hours before effect is needed, remove within 9 hours 1
- Application sites: Hip, upper arm, chest, upper back, or flank—rotate sites with each new patch 1
Critical Safety Warnings
Boxed Warning: Abuse, Misuse, and Addiction
Xelstrym carries a high potential for abuse and misuse that can lead to substance use disorder, including addiction. Misuse and abuse can result in overdose and death. 1 This is a federally controlled substance (Schedule CII). 1
Major Contraindications
- Known hypersensitivity to amphetamine products 1
- Current use or use within 14 days of monoamine oxidase inhibitors (MAOIs) 1
Serious Cardiovascular Risks
- Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease 1
- Sudden death has occurred in patients with heart defects or serious heart disease 1
- Monitor blood pressure and heart rate regularly during treatment 1
Psychiatric Risks
- Screen patients for risk factors for manic episodes before initiating treatment 1
- Monitor for new psychotic or manic symptoms; consider discontinuation if these occur 1
- Assess family history of suicide, bipolar illness, or depression 1
Pediatric Considerations
Xelstrym is not recommended in children under 6 years of age because they experience higher plasma exposure and higher incidence of adverse reactions (particularly weight loss) compared to older children at the same dosage. 1
Growth Suppression
Closely monitor height and weight in pediatric patients. Those not growing or gaining weight as expected may need treatment interruption. 1
Other Important Warnings
- Peripheral vasculopathy including Raynaud's phenomenon—monitor for digital changes 1
- Contact sensitization—discontinue if suspected 1
- Application site reactions—rotate sites daily to minimize 1
- External heat exposure—avoid during wear as it increases absorption rate and extent 1
- Serotonin syndrome—increased risk with serotonergic agents (SSRIs, SNRIs, triptans) 1
Renal Impairment Adjustments
- Severe renal impairment: Maximum dose 13.5 mg/9 hours 1
- End-stage renal disease (ESRD): Maximum dose 9 mg/9 hours 1
Pregnancy and Breastfeeding
- Pregnancy registry available at 1-866-961-2388 or https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ 1
- Do not breastfeed during treatment—dextroamphetamine passes into breast milk 1
Storage and Disposal
Keep in a safe place to prevent theft. Never share with others—selling or giving away is illegal and may cause harm or death. 1