IMPORTANT SAFETY INFORMATION AND INDICATION
WARNING: ABUSE AND DEPENDENCE
CNS stimulants, including
Quillivant XRand QuilliChew ERare contraindicated:
- In patients known to be hypersensitive to methylphenidate or other components of
Quillivant XRand QuilliChew ER. 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.
- Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in pediatric patients 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 XRor 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 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 XRor QuilliChew ERuse.
- Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed.
- Stimulants 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.
- 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 XRand QuilliChew ER. Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. QuilliChew ERcontains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).
- Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are
Quillivant XR: The most common (≥2% in the Quillivant XRgroup and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 45 ADHD patients (ages 6-12years) in Quillivant XRcompared 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%). QuilliChew ER: The most common (≥2% in the QuilliChew ERgroup and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 90 pediatric subjects (ages 6-12years) in QuilliChew ERcompared 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%).
- CNS stimulant medications, such as
Quillivant XRand QuilliChew ER, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
- The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for
Quillivant XRand QuilliChew ERand any potential adverse effects on the breastfed infant from Quillivant XRand QuilliChew ERor from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.