Flexible, once-daily dosing in the first extended-release oral suspension amphetamine for ADHD

  • Low starting dose
  • Ability to titrate within 1 prescription
  • Microtitration up or down in increments of 1 mL to 4 mL for treatment tailored to each patient’s needs
  • The recommended starting dose is 2.5 mg (1 mL) or 5 mg (2 mL) given orally once daily in the morning
  • Dosage may be increased or decreased in increments of 2.5 mg (1 mL) to 10 mg (4 mL) per day every 4 to 7 days
  • Daily dosage above 20 mg (8 mL) is not recommended
DYANAVEL® XR (amphetamine) Extended Release Dose Titration Information

Prior to treating children and adults with CNS stimulants, including DYANAVEL XR, assess for the presence of cardiac disease (ie, perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) and risk for abuse. After prescribing, keep prescription records, educate and monitor for abuse and overdose, and reevaluate the need for DYANAVEL XR use. Periodically reevaluate the long-term use of DYANAVEL XR, and adjust dose as needed.

How to calculate dosing and titration for DYANAVEL XR (amphetamine)

Use the calculator below to determine the dispensing volume to write for your patient’s prescription.*

Calculator Directions

  • Select a starting dose of 1 mL (2.5 mg) or 2 mL (5 mg).
  • Then add subsequent doses as needed, specifying the new dose amount to be taken and for how many days (dose adjustments can be made every 4 to 7 days). The dose can be increased by 1 mL (2.5 mg) to 4 mL (10 mg) per day from the previous dose specified. The maximum daily dose is 8 mL (20 mg).
  • The total number of days for all doses specified (including the # of days for the starting dose) must add up to 30 or 31 days.
Enter starting dose
Daily dose:
Take dose for:
 
DYANAVEL XR (2.5mg/mL)
Dispense mL
*Prior to treating children and adults with CNS stimulants, including DYANAVEL XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) and risk for abuse. The recommended starting dose is 2.5 mg (1 mL) or 5 mg (2 mL) given orally once daily in the morning. Dosage may be increased or decreased in increments of 2.5 mg (1 mL) to 10 mg (4 mL) per day every 4 to 7 days. Daily dosage above 20 mg (8 mL) is not recommended.1

Administration of DYANAVEL XR liquid

Provide your patient with the following instructions on administration:

  • Use with the oral dosing dispenser provided by the pharmacist
  • Ensure that the bottle adapter has been firmly inserted into the bottle by the pharmacist. Once the bottle adapter has been inserted into the bottle it should not be removed
  • Shake the bottle of DYANAVEL XR before each dose
  • Measure the appropriate dose as prescribed
  • Using the filled oral dosing dispenser, dispense DYANAVEL XR liquid directly into mouth
  • Replace bottle cap and store bottle as directed
  • Wash oral dosing dispenser after each use

See full Instructions for Use in full Prescribing Information.

How to switch your patient from another amphetamine to DYANAVEL XR*

*Prior to treating children and adults with CNS stimulants, including DYANAVEL XR, assess for the presence of cardiac disease (ie, perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) and risk for abuse. The recommended starting dose is 2.5 mg (1 mL) or 5 mg (2 mL) given orally once daily in the morning. Dosage may be increased or decreased in increments of 2.5 mg (1 mL) to 10 mg (4 mL) per day every 4 to 7 days. Daily dosage above 20 mg (8 mL) is not recommended.

Writing a prescription for
DYANAVEL XR liquid

DYANAVEL® XR (amphetamine) Extended Release Example Prescription
DYANAVEL® XR (amphetamine) Extended Release Example Prescription With Titration

Important Safety Information

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, and other amphetamine-containing or methylphenidate-containing products, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

  • DYANAVEL XR (amphetamine), Quillivant XR (methylphenidate HCI), and QuilliChew ER (methylphenidate HCI) are contraindicated:

    • in patients known to be hypersensitive to amphetamine, methylphenidate, or other components of DYANAVEL XR, Quillivant XR, and QuilliChew ER. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported.

    • in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs, because of risk of hypertensive crisis.

  • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, and other serious cardiac problems. Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious cardiac problems when taking CNS stimulants at recommended doses for ADHD. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER.

  • CNS stimulants cause increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.

  • CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. They may induce a mixed/manic episode in patients with bipolar disorder. Assess for presence of bipolar disorder prior to initiating treatment. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing DYANAVEL XR, Quillivant XR, or QuilliChew ER.

  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER. Treatment may need to be interrupted in children not growing or gaining weight as expected.

  • CNS stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

  • Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.

  • Serotonin syndrome risk is increased when DYANAVEL XR is co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.

  • QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).

  • Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.

  • Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).

  • Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are: appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased.

  • There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.

    • Quillivant XR: The most common (≥2% in the Quillivant XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6 to 12 years) in Quillivant XR compared to placebo were affect lability (9% Quillivant XR, 2% placebo), excoriation (4%, 0%), initial insomnia (2%, 0%), tic (2%, 0%), decreased appetite (2%, 0%), vomiting (2%, 0%), motion sickness (2%, 0%), eye pain (2%, 0%), and rash (2%, 0%).

    • QuilliChew ER: The most common (≥2% in the QuilliChew ER group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6 to 12 years) in QuilliChew ER compared to placebo were decreased appetite (2.4% QuilliChew ER, 0% placebo), aggression (2.4%, 0%), emotional poverty (2.4%, 0%), nausea (2.4%, 0%), headache (2.4%, 0%), and weight decreased (2.4%, 0%).

  • DYANAVEL XR, Quillivant XR, and QuilliChew ER use during pregnancy may cause fetal harm.

  • Breastfeeding is not recommended during treatment with DYANAVEL XR, Quillivant XR, or QuilliChew ER.

INDICATION

DYANAVEL XR, Quillivant XR, and QuilliChew ER are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

See Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse and Dependence.