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About ADHD

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About ADHD

ADHD is one of the most prevalent neurodevelopmental disorders, characterized by a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.1

Although most often diagnosed during childhood, patients with ADHD have waxing and waning symptoms, with 90% of patients with childhood ADHD continuing to experience symptoms into adulthood.2

Symptoms and Diagnosis

ADHD clinical guidelines are provided by the American Psychiatric Association in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).3

According to the DSM-5, ADHD presents in 1 of 3 ways:

Hyperactive and Impulsive ADHD Boy Yelling

Predominantly hyperactive-impulsive

Inattentive Only ADHD Girl Falls Asleep During School

Predominantly inattentive

Boy With Combined Inattentive, Hyperactive, Impulsive ADHD Balances Pencil

Combined

Symptoms are divided into two categories of inattention and hyperactivity-impulsivity that include behaviors like failure to pay close attention to details, difficulty organizing tasks and activities, excessive talking, fidgeting, or an inability to remain seated in appropriate situations. Children must have at least six symptoms from either (or both) the inattention group of criteria and the hyperactivity and impulsivity criteria, while older adolescents and adults (over age 17 years) must have at least five. Please click here for additional information on the DSM-5 criteria for diagnosing ADHD.

Treatment and Management3-7

Treatments for ADHD include medication, psychotherapy, education or training, or a combination of treatments that include close monitoring.

Treatment plans should be individualized to help the patient control symptoms, cope with the disorder, and manage relationships.7

Several different types of medications are FDA-approved to treat ADHD:

  • Stimulants are the most widely used ADHD medications. These include methylphenidate and amphetamine medications.
  • Nonstimulants include atomoxetine and viloxazine, guanfacine and clonidine.

Medications can affect patients differently and can have common side effects such as decreased appetite or sleep problems. Healthcare providers may need to switch treatment or adjust the dose to find the right balance between benefits and side effects.

Tris Pharma Medical

Please visit TrisMedical.com for in-depth clinical information and a wide variety of resources on ADHD and related conditions.

Is methylphenidate or amphetamine right for my patient?

Although both methylphenidate and amphetamine have similar efficacy for ADHD, some patients may respond to or tolerate one or the other better.4

Tris Pharma offers amphetamine and methylphenidate treatment options for patients 6 years and older with ADHD.

Amphetamine Treatments

DYANAVEL XR Tablet amphetamine extended-release tablets 5mg, 10mg, 15mg, 20mg Logo Once Daily DYANAVEL XR extended release
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Once-daily tablet amphetamine
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DYANAVEL XR tablet
DYANAVEL XR Liquid amphetamine extended-release oral suspension 2.5 mg/mL Logo/mL Logo #1 DYANAVEL XR extended release oral suspension
Tris Once-Daily ADHD Liquid Amphetamine Droplet Icon
Once-daily liquid amphetamine
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DYANAVEL XR liquid

Methylphenidate Treatments

QuilliChew ER methylphenidate HCl for extended-release chewable tablets 20mg, 30mg, 40mg Logo #1 QuilliChew ER, the only once-daily extended-release methylphenidate tablet
Tris Once-Daily ADHD Tablet Methylphenidate Tablet Icon
Once-daily tablet methylphenidate
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QuilliChew ER
Quillivant XR methylphenidate HCl for extended-release oral suspension 25mg/5mL Logo #1 Quillivant XR, the first once-daily, long-acting* liquid methylphenidate treatment
Tris Once-Daily ADHD Liquid Methylphenidate Droplet Icon
Once-daily liquid methylphenidate
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Quillivant XR

Deciding whether to prescribe a methylphenidate such as Quillivant XR or QuilliChew ER, or an amphetamine such as DYANAVEL XR tablet or DYANAVEL XR oral suspension, depends largely on the individual needs of the patient, prior patient response or lack of response to methylphenidate or amphetamine, and patient preference for liquid vs tablet formulation.

Prior to treatment with Quillivant XR, QuilliChew ER, or DYANAVEL XR, patients should be assessed for the risk of abuse, known hypersensitivity and presence of cardiac disease. During treatment, careful prescription records should be maintained, and patients should be informed about abuse and monitored for signs of abuse and overdose. The need for continued stimulant medication use should be periodically reevaluated and, if necessary, dosage reduced or treatment discontinued.

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References: 1. U.S. Department of Health and Human Services, National Institutes of Health website. Attention Deficit/Hyperactivity Disorder. Available at: https://www.nimh.nih.gov/health/topics/attention-deficit-hyperactivity-disorder-adhd Accessed September 19, 2023. 2. Sibley MH, Arnold LE, Swanson JM, Hechtman LT, Kennedy TM, Owens E, Molina BSG, Jensen PS, Hinshaw SP, Roy A, Chronis-Tuscano A, Newcorn JH, Rohde LA; MTA Cooperative Group. Variable Patterns of Remission From ADHD in the Multimodal Treatment Study of ADHD. Am J Psychiatry. 2022 Feb;179(2):142-151. doi: 10.1176/appi.ajp.2021.21010032. Epub 2021 Aug 13. PMID: 34384227; PMCID: PMC8810708. 3. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, 5th edition. Arlington, VA., American Psychiatric Association, 2013. 4. Faraone SV. The pharmacology of amphetamine and methylphenidate: Relevance to the neurobiology of attention-deficit/hyperactivity disorder and other psychiatric comorbidities. Neurosci Biobehav Rev. 2018 Apr;87:255-270. 5 Treatment of ADHD. Available at: https://www.cdc.gov/ncbddd/adhd/treatment.html 6. Miller C, Taskiran S. Child Mind Institute. What are Non-Stimulant Medications for ADHD? Available at: https://childmind.org/article/what-are-nonstimulant-medications-for-adhd/ 7. CHADD website. Treatment of ADHD. Available at: https://chadd.org/about-adhd/treatment-of-adhd/

IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL XR, Quillivant XR and QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing DYANAVEL XR, Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

IMPORTANT SAFETY INFORMATION

INDICATION

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

WARNING: ABUSE, MISUSE, AND ADDICTION

DYANAVEL XR, Quillivant XR and QuilliChew ER have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, can result in overdose and death. Before prescribing DYANAVEL XR, Quillivant XR, QuilliChew ER, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

  • DYANAVEL XR, Quillivant XR, and QuilliChew ER 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 (including MAOIs such as linezolid or intravenous methylene blue), because of risk of hypertensive crisis.
  • Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD doses. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with DYANAVEL XR, Quillivant XR, and QuilliChew ER, assess for the presence of cardiac disease. Avoid DYANAVEL XR, Quillivant XR, and QuilliChew ER use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR, Quillivant XR, and QuilliChew ER treatment.
  • 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.
  • Use of CNS stimulants may cause exacerbation of pre-existing psychosis and may induce a manic or mixed episode in patients with bipolar disorder. In patients without prior history of psychotic illness or mania, CNS stimulants may cause new psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) at the recommended dosage. Prior to initiating DYANAVEL XR, Quillivant XR, and QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing DYANAVEL XR, Quillivant XR, and 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 including DYANAVEL XR, Quillivant XR, and QuilliChew ER 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. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for DYANAVEL XR, Quillivant XR, and QuilliChew ER-treated patients who develop signs or symptoms of peripheral vasculopathy.
  • CNS stimulants, including amphetamine and methylphenidate products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating DYANAVEL XR, Quillivant XR, and QuilliChew ER, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. Discontinue treatment if clinically appropriate.
  • Cases of priapism have been reported with methylphenidate use and during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in QuilliChew ER and Quillivant XR treated patients who develop abnormally sustained or frequent and painful erections.
  • 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). Before prescribing QuilliChew ER in patients with PKU, consider the combined daily amount of phenylalanine from all sources, including QuilliChew ER.
  • Quillivant XR and QuilliChew ER treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
  • Quillivant XR and QuilliChew ER should be prescribed to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Close monitoring of patients with a history of increased IOP or open angle glaucoma is necessary.
  • 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 use during pregnancy may cause fetal harm and because of the potential for serious adverse reactions in a breastfed infant, breastfeeding is not recommended during treatment with DYANAVEL XR.
  • There are limited studies on the use of methylphenidate in pregnant women. However, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers. The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
  • To monitor pregnancy outcomes in women exposed to ADHD medications during pregnancy, healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

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