Quillivant XRTM (methylphenidate HCl) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Quillivant XR was established in a 2-week, placebo-controlled trial in children aged 6 to 12 years with a diagnosis of ADHD. Accumulated efficacy data from other methylphenidate products were also considered.
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IMPORTANT SAFETY INFORMATION AND INDICATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including Quillivant XR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy.
- 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 treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis.
- Stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in children and adolescents with structural cardiac abnormalities and other serious cardiac problems, and in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. 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 stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to Quillivant XR use.
- Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
- 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.
- 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, and blood pressure increased. There is limited experience with Quillivant XR in controlled trials. Based on this limited experience, the adverse reaction profile of Quillivant XR appears similar to other methylphenidate extended-release products. 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 (aged 6-12 years) were affect lability (9%), excoriation (4%), initial insomnia (2%), tic (2%), decreased appetite (2%), vomiting (2%), motion sickness (2%), eye pain (2%), and rash (2%).
- Based on animal data, use of Quillivant XR during pregnancy may cause fetal harm. Quillivant XR should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
- Nursing mothers should be advised to discontinue drug or discontinue nursing, taking into consideration the importance of the drug to the mother because methylphenidate is present in human milk.
Quillivant XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of Quillivant XR was established in a 2-week, placebo-controlled trial in children aged 6 to 12 years with a diagnosis of ADHD. Accumulated efficacy data from other methylphenidate products were also considered.