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Important Safety Information Full Prescribing Information
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For your patients with ADHD who are 6 years and older

QuilliChew ER® delivers

Their days may not be consistent but their medication should be.

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Unique technology provides continuous release of methylphenidate1

• Lasting improvements in attention and behavior2

Watch a video about the advanced technology in QuilliChew ER
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Effective symptom control through the most important parts of the day2

Efficacy for QuilliChew ER caret
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Smooth PK profile3,4

PK data for QuilliChew ER caret
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Most dosing options in an
ER methylphenidate tablet

Dosing for QuilliChew ER caret

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ADHD, Attention Deficit Hyperactivity Disorder; ER, extended-release; IR, immediate-release; PK, pharmacokinetic.

References: 1. Kando JC, King TR, Pardo A. A novel, modified-release drug delivery technology containing amphetamine and methylphenidate ion-exchange complexes. Poster presented at: American Psychiatric Association Annual Meeting; May 1-3, 2021. 2. Wigal SB, Childress A, Berry SA, et al. Efficacy and safety of a chewable methylphenidate extended-release tablet in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2017;27(8):690-699. 3. QuilliChew ER [package insert]. Tris Pharma, Inc., Monmouth Junction 4. Abbas R, Palumbo D, Walters F, et al. Single-dose pharmacokinetic properties and relative bioavailability of a novel methylphenidate extended-release chewable tablet compared with immediate-release methylphenidate chewable tablet; 2016. Clin Ther. 2016;28(5): 1151-1157.

IMPORTANT SAFETY INFORMATION

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WARNING: ABUSE, MISUSE, AND ADDICTION

QuilliChew ER 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 QuilliChew ER, can result in overdose and death. Before prescribing 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

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

WARNING: ABUSE, MISUSE, AND ADDICTION

QuilliChew ER 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 QuilliChew ER, can result in overdose and death. Before prescribing 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.

  • QuilliChew ER is contraindicated:
    • in patients known to be hypersensitive to methylphenidate or other components of QuilliChew ER. 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 dosages. Serious cardiovascular effects with overdose may precipitate sudden cardiac death. Prior to treating patients with QuilliChew ER, assess for the presence of cardiac disease. Avoid 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 treatment with QuilliChew ER.
  • 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 QuilliChew ER treatment, screen patients for risk factors for developing a manic episode. If new psychotic or manic symptoms occur, consider discontinuing QuilliChew ER.
  • 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 QuilliChew ER treated patients who develop abnormally sustained or frequent and painful erections.
  • CNS stimulants including QuilliChew ER 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 QuilliChew ER-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 QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted.
  • 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.
  • QuilliChew ER-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.
  • 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.
  • 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 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.
  • 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 QuilliChew ER in controlled trials. 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 6-12 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%).
  • 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 QuilliChew ER and any potential adverse effects on the breastfed infant from QuilliChew ER 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 QuilliChew ER, including Boxed Warning regarding Abuse, Misuse, and Addiction.

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