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Important Safety Information Full Prescribing Information
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Tablets Can Be Swallowed Whole or Chewed

Tablets Can Be Swallowed Whole or Chewed

The only FDA-approved scored ER methylphenidate tablet

  • 11 dosing options from 10 mg to 60 mg
  • LiquiXR® technology allows titration in increments of 10 mg, 15 mg, or 20 mg to help balance efficacy and side effects
  • Recommended starting dose of 20 mg given orally once daily in the morning2
  • Dosage may be increased or decreased weekly in increments of 10 mg, 15 mg, or 20 mg2
  • Daily dosage above 60 mg is not recommended2

QuilliChew ER Prescribing Guide

Quillichew ER Prescribing Guide
  • Prior to treating patients with QuilliChew ER (methlyphenidate HCl), assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical examination) and risk for abuse, misuse, and addiction. Assess the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating QuilliChew ER2
  • If paradoxical aggravation of symptoms or other adverse reactions occur, reduce dosage or discontinue the drug, if necessary. If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued2

If switching from other methylphenidate products to QuilliChew ER:

  • Discontinue that treatment and titrate with QuilliChew ER using the above titration schedule
  • Do not substitute for other methylphenidate products on a milligram-per-milligram basis because of different methylphenidate base compositions and differing pharmacokinetic profiles

Writing a prescription for QuilliChew ER

Example prescription

QuilliChew ER Example Prescription

When prescribing multiple dosage strengths of QuilliChew ER with different NDCs when 1 dosage strength could be used to fill the prescription, it is important to remember:

  • This may result in additional out-of-pocket or co-pay costs for your patients
  • Insurance may cover a prescription for multiple strengths within one 30-day time frame; however, this may require prior authorization or a call to your patient's insurance company
  • You may also want to consider other factors, such as tablet burden, when writing a prescription

CNS, central nervous system; ER, extended-release; FDA, US Food and Drug Administration; NDC, National Drug Code.

Reference: 1. Abbas R, Childress AC, Nagraj P, Rolke R, Berry SA, Palumbo DR. Relative bioavailability of methylphenidate extended-release chewable tablets chewed versus swallowed whole. Clin Ther. 2018;40(5):733-740. 2. QuilliChew ER [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ. 3. Wigal SB, Childress A, Berry SA, et al. Optimization of methylphenidate extended release chewable tablet dose in children with ADHD: open-label dose optimization in a laboratory classroom study. J Child Adolesc Psychopharmacol. 2018;28(5):314-321.

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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