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Dyanavel XR

(amphetamine)

Dyanavel XR (amphetamine); CII

Full Prescribing Information DailyMed Drug Information

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, a 3.2:1 rather than 3:1 ratio, base rather than salt dosing, 13 hour ceiling; against Adzenys XR-ODT, 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/
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