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IMPORTANT SAFETY INFORMATION

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 indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Limitations of Use

The use of Quillivant XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage

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. Quillivant XR is not approved for use and is not recommended in pediatric patients below 6 years of age. Closely monitor growth (height and weight) in Quillivant XR treated pediatric patients. Pediatric patients who are not growing or gaining height or 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. Closely monitor Quillivant XR-treated patients with a history of abnormally increased IOP or open angle glaucoma.
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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