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Important Safety Information Full Prescribing Information
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Below you will find tools to help you calculate dosing for your patients, as well as reconstitution and dispensing information that pharmacists may find useful. There are also several resources and links for you to share with patients, parents, and caregivers to help them access information about ADHD, ADHD support programs, and Tris Pharma products.

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Dosing Calculators

Quillivant XR methylphenidate HCl for extended-release oral suspension 25mg/5mL Logo
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Information for Pharmacists

Reconstituting and dispensing

Quillivant XR (methylphenidate HCl) is supplied as a powder for oral suspension and MUST be reconstituted with water prior to dispensing. Quillivant XR is already flavored; DO NOT add any flavoring. For full pharmacist instructions for reconstitution, preparation, dispensing, and storage, see Full Prescribing Information for Quillivant XR.

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ADHD Resources to Download

Pediatric patients and caregivers

Tris ADHD Quillivant/QuilliChew Patient Brochure
Quillivant/QuilliChew Patient Brochure

Download this guide for your patients so that they can learn more about ADHD, Quillivant XR, QuilliChew ER, support, and resources.

ADHD Community Resources

AAP/Healthy Children

Healthy Children is the official American Academy of Pediatrics (AAP) website for parents, hosting a variety of articles that address common questions and issues in diagnosing and treating ADHD in children. Search for ADHD at healthychildren.org for information about topics like:

  • ADHD Myths and Misconceptions
  • ADHD Medications Daily Routines
  • Causes of ADHD: What We Know Today

ADDA

The Attention Deficit Disorder Association (ADDA) is the world’s leading adult ADHD association, dedicated to helping adults with ADHD lead better lives. Visit add.org to learn more about:

  • Adult ADHD Self-Screening Questionnaire
  • Virtual Peer Support Groups
  • Educational Resources

ADDitude Magazine

Online magazine for caregivers of children with attention deficit disorders. Visit additudemag.com to learn more.

CHADD

Children and Adults with Attention-Deficit/Hyperactivity Disorder (CHADD) is a nationally recognized nonprofit organization providing education, advocacy, and support for individuals with ADHD. Visit chadd.org

CDC

The Centers for Disease Control and Prevention (CDC) has published facts, research, statistics, and a wide array of other tools for parents to educate themselves about ADHD. Visit cdc.gov/ncbddd/adhd to learn more.

NIMH

The National Institute of Mental Health (NIMH), a component of the US Department of Health and Human Services, provides in-depth information and resources on ADHD diagnosis and treatment at nimh.nih.gov.

Pharmacy Locator

To find a nearby pharmacy with Tris ADHD products in stock, search pharmacies by ZIP code below.

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ADHD, Attention Deficit Hyperactivity Disorder; CNS, central nervous system.

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IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE, MISUSE, AND ADDICTION

Quillivant XR has 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 Quillivant XR, can result in overdose and death. Before prescribing Quillivant XR 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

Quillivant XR® (methylphenidate HCI) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

WARNING: ABUSE, MISUSE, AND ADDICTION

Quillivant XR has 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 Quillivant XR, can result in overdose and death. Before prescribing Quillivant XR, 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.

  • Quillivant XR is contraindicated:
    • in patients known to be hypersensitive to methylphenidate or other components of Quillivant XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported.
    • during concomitant treatment with monoamine oxidase inhibitors (MAOIs), and within 14 days following discontinuation of treatment with an MAOI because of the 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 Quillivant XR, assess for the presence of cardiac disease. Avoid Quillivant XR 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 treatment with Quillivant XR.
  • CNS stimulants cause an increase in blood pressure (mean increase approximately 2 - 4 mm Hg) and heart rate (mean increase approximately 3 - 6 bpm). Some individuals may have larger increases. Monitor all patients for hypertension and tachycardia.
  • 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 Quillivant XR treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing Quillivant XR.
  • Cases of priapism have been reported with methylphenidate use and also during a period of withdrawal in both adult and pediatric male patients. Immediate medical attention should be sought in Quillivant XR treated patients who develop abnormally sustained or frequent and painful erections.
  • CNS stimulants including Quillivant XR used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, 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 Quillivant XR-treated patients who develop signs or symptoms of peripheral vasculopathy.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Growth should be monitored during treatment with stimulants, including Quillivant XR. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
  • Quillivant XR-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
  • Quillivant XR 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.
  • CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Before initiating Quillivant XR, 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.
  • 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 in controlled trials. 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 6-12 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%).
  • 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. 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/.
  • The developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for Quillivant XR and any potential adverse effects on the breastfed infant from Quillivant XR or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
  • 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 Quillivant XR, including Boxed Warning regarding Abuse, Misuse, and Addiction.

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