# Dyanavel XR ### (amphetamine) **[Dyanavel XR](https://wiki.joshnp.com/books/drug-library/page/dyanavel-xr)** (amphetamine); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9)
--- ### **Summary** Dyanavel XR is an extended-release amphetamine supplied as an oral suspension and as an extended-release tablet under one label, approved for ADHD from age 6. The moiety is amphetamine in a 3.2:1 d- to l- ratio, dosed in amphetamine base rather than salt, with immediate- and extended-release components for once-daily morning dosing. Its differentiator is being the only full-day amphetamine available as a true liquid. Schedule II; brand only. --- ### **Forms & Strengths** - **Extended-release oral suspension** (bubblegum; 60 mL and 464 mL bottles): 2.5 mg/mL - **Extended-release tablets** (5 mg scored; may be chewed): 5 mg, 10 mg, 15 mg, 20 mg --- ### **Dosing** - **Age:** ≥ 6 y/o - **Onset:** ~ 1 hour - **Duration:** up to 13 hours - **Release Profile:** combined immediate-release and extended-release components; this label publishes no percentage split - **Initial Dose:** 2.5 mg or 5 mg once daily in the morning, all patients ≥ 6 - **Titration:** 2.5 mg to 10 mg per day every 4 to 7 days - **Max Dose:** 20 mg once daily - **Considerations:** Suspension and tablet substitute milligram for milligram; no other amphetamine does, because these strengths are base rather than salt. Titrate from scratch when switching in. --- ### **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:** Ion-exchange resin supplies the extended fraction, amphetamine aspartate and dextroamphetamine sulfate the immediate. Median Tmax ~4 h (suspension), ~5 h (tablet) - **Formulation:** 3.2:1 d- to l-amphetamine, all strengths as amphetamine base; the critical fact when converting in - **Metabolism:** CYP2D6 forms active 4-hydroxyamphetamine; norephedrine also active. Half-life 12.4 h d- and 15.1 h l- in adults, 10.4 h and 12.1 h in children 6-12; urinary recovery is pH dependent - **Pharmacogenomics:** CYP2D6 is polymorphic; no genotype-based adjustment specified, so titrate slowly rather than genotype - **Class Positioning:** Against [Adderall XR](https://wiki.joshnp.com/link/9), a 3.2:1 rather than 3:1 ratio, base rather than salt dosing, 13 hour ceiling; against [Adzenys XR-ODT](https://wiki.joshnp.com/link/40), also base-dosed, it is the option when nothing solid is accepted - **Impairment:** renal and hepatic impairment unstudied for this product; both may prolong exposure --- ### **Indications** - **ADHD** (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients ≥ 6 y/o --- ### **Off-Label Uses** - **None established.** One indication, and no off-label use of this formulation is supported by graded pediatric evidence. - **Where the evidence does not support use:** - **Children under 6:** argued against by this label; the liquid makes small doses easy to give, which is why this needs saying. - **Non-ADHD indications in youth:** AHRQ CER 267 graded none; insufficient (AHRQ 2024). - **Cognitive enhancement without ADHD:** not supported. --- ### **Contraindications & Warnings** - **Boxed Warning:** Abuse, misuse, and addiction. High potential for abuse, leading to substance use disorder; overdose and death, more so at higher doses or by non-oral routes. Assess risk before prescribing; reassess throughout. - **Contraindicated:** - Known hypersensitivity to amphetamine or components; angioedema and anaphylaxis reported - MAOI use, current or within 14 days, including linezolid and IV methylene blue - **Use with caution** (Warnings in this label, not contraindications): - Structural cardiac abnormality, cardiomyopathy, serious arrhythmia or coronary disease; label says avoid, for sudden death - Pre-existing hypertension, because BP and HR rise - Pre-existing psychosis; bipolar disorder, for treatment-emergent mania - Motor or verbal tics, or Tourette syndrome - Peripheral vasculopathy including Raynaud phenomenon - Renal or hepatic impairment; unstudied for this product, and both may prolong exposure - Substance use disorder in the patient or the household - **Screen before starting:** - Cardiac history, family history of sudden death or arrhythmia, and exam - Personal and family history of tics or Tourette syndrome - Mania risk: personal or family depression, bipolar disorder, suicide - Abuse and diversion risk; baseline height, weight, BP and HR --- ### **Drug Interactions** - **MAOIs** (also linezolid, IV methylene blue): hypertensive crisis, malignant hyperpyrexia, sometimes fatal. Do not co-prescribe; confirm a 14 day washout. - **Serotonergic agents** (SSRIs, SNRIs, TCAs, triptans, lithium, fentanyl, tramadol, buspirone, St John's Wort): serotonin syndrome. Start lower; stop both drugs if symptoms appear. - **CYP2D6 inhibitors** (paroxetine, fluoxetine, quinidine, ritonavir): raise exposure and serotonin syndrome risk. Prefer an alternative; else start lower. - **Urinary pH agents:** acidifiers (ascorbic acid, fruit juice) lower amphetamine levels; alkalinizers (bicarbonate, acetazolamide, thiazides) raise them. The label directs an explicit dose adjustment either way. - **Sympathomimetics** (decongestants, beta-agonists): additive cardiovascular effect. Avoid OTC decongestants. - **Laboratory assays:** amphetamines elevate plasma corticosteroids and interfere with urinary steroid determinations; interpret rather than repeat. --- ### **Administration** - Once daily in the morning, with or without food; a high-fat meal changes exposure only a few percent. - **Suspension:** shake hard before every dose; keep the bottle adapter inserted and measure with the pharmacy dispenser. - **Tablet:** may be chewed or swallowed whole, with no significant change in exposure or Tmax; only the 5 mg is scored. - **Between the two Dyanavel XR forms:** substitute milligram for milligram, the only such substitution the label permits. - **From any other amphetamine:** stop the previous drug and titrate from the beginning. - Avoid late dosing; with a 13 hour ceiling an afternoon dose reaches bedtime. - Store securely, preferably locked. --- ### **Side Effects** - **Common** (extended-release amphetamine class list, per this label): decreased appetite and weight loss, insomnia, irritability, abdominal pain, dry mouth, headache, tremor, restlessness, bowel change, palpitations, tachycardia, elevated blood pressure. - **Serious:** - Sudden death, myocardial infarction and stroke with structural cardiac abnormality or serious cardiac disease; avoid rather than monitor through it. - Psychosis or mania at recommended doses, roughly 0.1% in pooled stimulant trials; consider discontinuing. - Serotonin syndrome; stop both drugs and treat supportively. - Angioedema, anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis; stop and do not rechallenge. - Peripheral vasculopathy including Raynaud phenomenon, with digital ulceration reported; reduce or stop, refer if persistent. - Growth suppression; interrupt in a child not growing or gaining as expected. - New or worsening tics and Tourette syndrome. - Rhabdomyolysis, intestinal ischemia; priapism, a surgical emergency. --- ### **Monitoring & Labs** - **Cardiovascular:** HR and BP at baseline, each dose change, and every 6 months; mean rise 2-4 mm Hg and 3-6 bpm. - **Growth:** height, weight and BMI charted at baseline and every 6 months; interrupt if crossing two major percentile lines. - **Appetite and sleep:** every visit; with a 13 hour ceiling, sleep is what most often forces a timing change here. - **Psychiatric:** psychosis, mania, aggression, dysphoria at each visit and 2 weeks after any increase. - **Tics and digits:** ask about tics and inspect fingers and toes for colour change, coolness or unexplained wounds at each visit. - **Dosing technique:** watch the caregiver shake and draw a dose at first follow-up and whenever response turns erratic; an unshaken bottle looks like tolerance. - **Abuse and diversion:** adherence, bottle or pill counts and PDMP check at each refill. - **Laboratory:** none routinely required. --- ### **Discontinuation & Taper** - Can be stopped abruptly at therapeutic doses; no taper required. - Physical dependence is labelled; withdrawal is dysphoria, depression, fatigue, vivid dreams, sleep change, increased appetite. - Late-evening rebound irritability and hunger is pharmacodynamic offset, not withdrawal. - Drug holidays suit appetite or growth as the limiting problem, less so a child who struggles outside school hours. --- ### **Pregnancy & Lactation** - **Pregnancy:** Published data are insufficient to determine a drug-associated risk of major malformations or miscarriage. Amphetamines vasoconstrict placental vessels, may increase growth restriction, and stimulate uterine contractions. - **Pregnancy, clinical:** premature delivery and low birth weight in dependent mothers; background risk is 2% to 4% for major defects and 15% to 20% for miscarriage. Weigh rather than abstain. - **Neonate:** monitor for feeding difficulty, irritability, agitation and drowsiness. - **Lactation:** present in milk at relative infant doses of 2% to 13.8%, milk to plasma 1.9 to 7.5. No reported adverse infant effects; long-term neurodevelopment unknown; the label does not recommend breastfeeding. - **Lactation, practical:** some experts accept therapeutic doses, monitoring the infant for irritability, insomnia and feeding difficulty; prolactin is suppressed 25% to 40%. (LactMed 2025) - **Exposure Registry:** National Pregnancy Registry for Psychostimulants, 1-866-961-2388, https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/ --- ### **Counseling Points** - **Counsel the family on:** - Shaking the suspension hard before every dose; an unshaken bottle is the commonest cause of a Dyanavel XR that works some days and not others. - That the tablet may be chewed, which often solves swallowing without moving to the liquid. - The roughly 13 hour window, so a dose after mid-morning still works at bedtime. - Appetite suppression peaking midday; largest meal at breakfast and in the evening. - Never converting from a previous amphetamine milligram for milligram. - Storing the bottle locked, not with the other syrups; the bubblegum flavour is a formulation property. - Bringing a teacher rating scale to the next visit rather than a verbal impression. - **Advise them to call for:** - Chest pain on exertion, fainting, or a racing heart that does not settle. - New hallucinations, or new suspicious or fearful thinking. - Swelling of the lips, tongue or face, or any spreading rash or blistering. - Numbness, coldness or colour change in the fingers or toes. - A new or markedly worse tic; weight loss or clothes fitting more loosely. - A painful erection lasting more than a few hours. --- ### **References** 1. DailyMed. Dyanavel XR (amphetamine) extended-release oral suspension and extended-release tablets prescribing information. NextWave Pharmaceuticals. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ae304b29-0b40-40ec-ad0d-76b742d4a9b9 2. FDA. openFDA National Drug Code Directory, generic\_name "amphetamine". 2026. https://api.fda.gov/drug/ndc.json?search=generic\_name:%22amphetamine%22&limit=1000 3. LactMed. Amphetamine. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501307/ 4. AHRQ. ADHD Diagnosis and Treatment in Children and Adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK603001/