# Xelstrym ### (dextroamphetamine) **[Xelstrym](https://wiki.joshnp.com/books/drug-library/page/xelstrym)** (dextroamphetamine); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=0862f02a-72a8-41cc-8845-57cf4974bb6f&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0862f02a-72a8-41cc-8845-57cf4974bb6f)
--- ### **Summary** Xelstrym is a dextroamphetamine transdermal system, the only amphetamine patch on the U.S. market, approved for ADHD from age 6 and worn up to 9 hours a day. It delivers single-entity d-amphetamine through the skin, bypassing swallowing and letting a caregiver end the exposure early by removing the patch. That reversibility is its differentiator; its cost is the skin, where irritation and discomfort were near-universal. Schedule II; brand only. --- ### **Forms & Strengths** - **Transdermal system** (9 hour wear; dose set by patch area): 4.5 mg/9 h, 9 mg/9 h, 13.5 mg/9 h, 18 mg/9 h --- ### **Dosing** - **Age:** ≥ 6 y/o - **Onset:** ~ 2 hours - **Duration:** up to 12 hours - **Release Profile:** continuous transdermal delivery, about 90% of content over 9 hours; peak plasma at 6 to 9 hours, ~6 hours on repeat - **Initial Dose:** - 6-17 y/o: 4.5 mg/9 h daily - ≥ 18 y/o: 9 mg/9 h daily - **Titration:** 4.5 mg/9 h every 7 days, patients 6-17 - **Max Dose:** - All ages: 18 mg/9 h, one system per 24 hours - Severe renal impairment, GFR 15 to under 30 mL/min/1.73 m²: 13.5 mg/9 h - End-stage renal disease, GFR under 15 mL/min/1.73 m²: 9 mg/9 h - **Considerations:** Apply 2 hours before effect is needed, remove within 9 hours, and use a shorter wear to shorten the day. Rotate sites daily, never cut a patch, and keep external heat off it. --- ### **Pharmacology** - **Mechanism:** Blocks reuptake at DAT and NET and promotes presynaptic catecholamine release via VMAT2 and TAAR1; the release component distinguishes amphetamines from methylphenidate - **Delivery / Release:** Dextroamphetamine in an acrylic adhesive matrix; absorption tracks wear time and area, not site, with 20% to 30% variability - **Formulation:** d-isomer only, unlike [Adderall](https://wiki.joshnp.com/link/8) or [Evekeo](https://wiki.joshnp.com/link/18) - **Metabolism:** CYP2D6, polymorphic, forms active 4-hydroxyamphetamine. Half-life after a 9 hour wear is 6.4 h in children, 11.5 h in adults; not dialyzable, hence the ESRD cap - **Class Positioning:** the only amphetamine whose exposure can be curtailed mid-day; the cost is daily adhesive on skin and a 1.5-fold rise under heat. [Daytrana](https://wiki.joshnp.com/link/13) is methylphenidate, not interchangeable --- ### **Indications** - **ADHD** (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o --- ### **Off-Label Uses** - **None established** for this formulation by graded pediatric evidence. - **Where the evidence does not support use:** - **Children under 6:** argued against by this label. - **Wear beyond 9 hours:** a dose increase without a dose change. - **Cutting a patch:** forbidden. - **Non-ADHD indications, and cognitive enhancement without ADHD:** AHRQ CER 267 graded none (AHRQ 2024). --- ### **Contraindications & Warnings** - **Boxed Warning:** Abuse, misuse, and addiction. High abuse potential leading to substance use disorder; overdose and death, more so at higher doses. Assess risk before prescribing; reassess throughout. - **Contraindicated:** - Known hypersensitivity to amphetamine or components - MAOI use, current or within 14 days, including linezolid and IV methylene blue - **Contact sensitization:** suspect it if erythema comes with edema, papules or vesicles that fail to improve within 48 hours or spread beyond the site. Discontinue. - **Its consequence is not local:** a sensitized patient may be unable to take amphetamine in ANY form. - **Use with caution** (Warnings, not contraindications): - Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid - Hypertension; psychosis; bipolar disorder; tics or Tourette syndrome; Raynaud phenomenon - Dermatitis, eczema or fragile skin at candidate sites - Regular external heat at the site (see Interactions) - Severe renal impairment and ESRD, capping the dose at 13.5 and 9 mg/9 h - Substance use disorder in the household; a worn patch is removable by anyone - **Screen before starting:** cardiac and family cardiac history with exam; tic history; skin at candidate sites and any prior adhesive reaction. - **Also screen:** renal function, which sets the ceiling; abuse and diversion risk; baseline height, weight, BP, HR. --- ### **Drug Interactions** - **MAOIs** (also linezolid, IV methylene blue): hypertensive crisis. Confirm a 14 day washout before the first patch. - **Serotonergic agents** (SSRIs, SNRIs, TCAs, triptans, lithium, tramadol): serotonin syndrome. Start lower; remove the patch and stop the other agent if symptoms appear. - **CYP2D6 inhibitors** (paroxetine, fluoxetine, quinidine): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower. - **Urinary pH agents:** acidifiers lower levels; alkaline urine raises exposure. Adjust strength by clinical response. - **External heat** is a pharmacokinetic interaction: a heating pad over the system for 6 hours raised Cmax to about 116% and AUC to about 150%. Instruct explicitly against it. - **Sympathomimetics:** additive cardiovascular effect; avoid OTC decongestants. --- ### **Administration** - One system per 24 hours, applied 2 hours before effect is needed and removed within 9 hours. - **Early removal is a legitimate dose adjustment:** absorption tracks wear time, so it answers an evening appetite or sleep problem. - Clean, dry, intact skin free of lotion or oil: hip, upper arm, chest, upper back or flank. Rotate daily; 28 days on one adult site raised Cmax 86% against 46% with rotation. - Avoid touching the adhesive side. Press a lifting edge down, replace one that falls off, and never tape, cut or trim. - A used system still contains drug; dispose of it as a Schedule II item. - **From any other amphetamine:** stop the previous drug and titrate from the starting strength. --- ### **Side Effects** - **Common,** 6-17, dose optimization: decreased appetite 54%, insomnia 32%, headache 21%, irritability, abdominal pain and affect lability 16% each, site pain 13%, nausea 9%, fatigue 5%. - **Application site reactions are near-universal and are the defining tolerability issue:** at double-blind clinic assessment, irritation 94% vs 54% placebo, any discomfort 69% vs 9%, severe 10% vs 4%. - **What to tell them:** pain, itch, burning, erythema and edema during or just after wear; discomfort resolves in 2 to 4 hours, and nobody in the pediatric study stopped for it. - **Serious:** - Contact sensitization, which may end the ability to take amphetamine in any form. - Sudden death with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor. - Psychosis or mania, roughly 0.1% in pooled stimulant trials, and serotonin syndrome; remove the patch, stop any serotonergic agent, consider discontinuing. - Anaphylaxis, angioedema, urticaria, Stevens-Johnson syndrome; stop and do not rechallenge. - Peripheral vasculopathy with digital ulceration; growth suppression, mean weight falling over the 7 week trial; new or worsening tics, 2% vs 0%. --- ### **Monitoring & Labs** - **Application sites:** inspect at every visit and at 2 weeks, when irritation peaks; ask whether a site is being reused. - **Contact sensitization:** apply the criteria above at any visit where erythema is reported. - **Cardiovascular:** HR and BP at baseline, each dose change, and every 6 months. - **Growth, appetite and sleep:** height, weight and BMI charted at baseline and every 6 months; appetite and sleep every visit. The first response to insomnia is earlier removal. - **Psychiatric and tics:** psychosis, mania, aggression, affect lability and tics at each visit and 2 weeks after any increase; inspect the digits. - **Renal function:** at baseline and whenever GFR could change, since the ceiling drops to 13.5 then 9 mg/9 h. - **Abuse and diversion:** adherence, patch counts and PDMP check at each refill; used patches retain drug. No routine labs. --- ### **Discontinuation & Taper** - Can be stopped abruptly; no taper required. - Offset is not immediate on removal; half-life after a 9 hour wear is 6.4 h in children, up to 11.5 h in adults. - Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite. - Drug holidays are easy: a holiday is a day without a patch. - **If stopped for contact sensitization, do not simply switch to an oral amphetamine.** Some sensitized patients cannot take amphetamine at all. --- ### **Pregnancy & Lactation** - **Pregnancy:** Published data have not identified a drug-associated risk of major birth defects or miscarriage; background risk is 2% to 4% and 15% to 20%. - **Pregnancy, clinical:** amphetamines vasoconstrict, may reduce placental perfusion and stimulate contractions; premature delivery and low birth weight are reported. - **Neonate:** monitor for withdrawal: feeding difficulty, irritability, agitation, drowsiness. - **Lactation:** in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5; the label does not recommend breastfeeding. - **Lactation, dextroamphetamine:** four mothers on a mean 18 mg daily gave a median milk level of 219 mcg/L, 5.7% of the maternal dose, with all four infants normal. (LactMed 2025) - **Exposure Registry:** National Pregnancy Registry for Psychiatric Medications, ADHD arm, 1-866-961-2388, https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/ --- ### **Counseling Points** - **Counsel the family on:** - That the skin under the patch will almost certainly be red, often itchy or stinging, and that this is expected rather than an allergy. - The numbers, out loud: most children had irritation, about one in ten severely, and none stopped for it. Warned in advance, families get through week one. - That discomfort settles within 2 to 4 hours; apply 2 hours before it is needed, so before breakfast on a school morning. - Daily site rotation, since reusing one spot hurts more and delivers more drug. - That early removal shortens the day, but effect fades over hours rather than at removal. - No heat over the patch, no touching the sticky side, and never cutting one. - That a used patch still contains medication and is disposed of as a controlled substance. - **Advise them to call for:** - Redness under the patch with swelling, bumps or blisters, or that does not settle within two days or spreads outside the outline; any rash elsewhere on the body. - Chest pain on exertion, fainting, or a racing heart that does not settle. - New hallucinations, or new suspicious or fearful thinking. - Numbness or colour change in the fingers or toes; a new tic; weight loss; a patch that fell off and cannot be found. --- ### **References** 1. DailyMed. Xelstrym (dextroamphetamine) transdermal system prescribing information. Noven Therapeutics. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0862f02a-72a8-41cc-8845-57cf4974bb6f 2. FDA. openFDA National Drug Code Directory, generic\_name "dextroamphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic\_name:%22dextroamphetamine%22&limit=1000 3. LactMed. Dextroamphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501740/ 4. AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/