IMPORTANT SAFETY INFORMATION AND INDICATION
WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Quillivant XR, QuilliChew ER, 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 and QuilliChew ER are contraindicated:
    • In patients known to be hypersensitive to methylphenidate or other components of Quillivant XR and 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 XR or 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 XR or QuilliChew ER use.
  • 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 XR and 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).
  • Based on accumulated data from other methylphenidate products, the most common (≥5% and twice the rate of placebo) adverse reactions are
  • There is limited experience with Quillivant XR and QuilliChew ER in controlled trials.
    • Quillivant XR: 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%).
    • QuilliChew ER: 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%).
  • CNS stimulant medications, such as Quillivant XR and 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 XR and QuilliChew ER and any potential adverse effects on the breastfed infant from Quillivant XR and QuilliChew ER or from the underlying maternal condition. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.

INDICATION

Quillivant XR and QuilliChew ER are central nervous system (CNS) stimulants indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Please see full Prescribing Information including BOXED WARNING and Medication Guide for Quillivant XR.

Please see full Prescribing Information including BOXED WARNING and Medication Guide for QuilliChew ER.

Tailored Dosing

With the calibrated oral dosing dispenser, treatment may be precisely adjusted weekly in increments* to meet the unique needs of the patient

  • The recommended starting dose for Quillivant XR for patients with ADHD ages 6 years and above is 20 mg
  • Quillivant XR can be adjusted weekly in increments of 10 mg to 20 mg up to a maximum daily dose of 60 mg
  • Prior to treating pediatric patients and adults with CNS stimulants, including Quillivant XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). Starting dose is 20 mg which can be titrated up or down, weekly, in increments of 10 to 20 mg up to a maximum daily dose of 60 mg. Reduce dosage if a paradoxical aggravation of symptoms or other adverse events occur. Discontinue if intolerable side effects develop or after one month if improvement is not seen after appropriate dose adjustments.

Dosing Information

  • Prior to treating pediatric patients and adults with CNS stimulants, including Quillivant XR, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)
  • Quillivant XR MUST be reconstituted with water by a pharmacist
  • After reconstitution by a pharmacist with water, Quillivant XR is an extended-release oral suspension: 25 mg/5 mL (5 mg/mL). The pharmacist must insert bottle adapter into neck of bottle. The bottle MUST be shaken vigorously (up and down) for at least 10 seconds before each use
  • The recommended starting dose of Quillivant XR is 20 mg (4 mL) once daily in the morning with or without food for patients 6 years and above
  • The dose may be titrated weekly in increments of 10 mg (2 mL) to 20 mg (4 mL) up to a 60 mg (12 mL) maximum daily dose
  • The dose should be individualized according to the treatment needs and responses of the patient
  • Patients taking Quillivant XR for maintenance therapy should be reevaluated periodically to assess the long-term usefulness of the drug
  • Reduce dosage or discontinue therapy if patients exhibit paradoxical aggravation of symptoms or other side effects, or if improvement is not observed after an appropriate dose adjustment over a one-month period
CHECK contents

Step 1. Remove the Quillivant XR bottle and oral dosing dispenser from the box. If the oral dosing dispenser is missing or not provided, please contact your pharmacist for a replacement.

Step 2. Check and make sure that the Quillivant XR bottle contains liquid medicine. If Quillivant XR is still in powder form, do not use it. Return it to your pharmacist.

SHAKE vigorously

Step 3: Shake the bottle well (up and down) for at least 10 seconds before each use.

PREPARE dose

Step 4. Uncap the bottle and check that the bottle adapter has been inserted into the bottle. If bottle adapter has not been inserted into the bottle, insert adapter into the bottle. Once the bottle adapter has been inserted into the bottle, it should not be removed. If the bottle adapter has not been inserted and is missing from the box, contact your pharmacist.

Step 5. Check the Quillivant XR dose in milliliters (mL) as prescribed by your doctor. Locate this number on the oral dosing dispenser.

Step 6. Insert tip of the oral dosing dispenser into the upright bottle and push the plunger all the way down.

Step 7. With the oral dosing dispenser in place, turn the bottle upside down. Pull the plunger to the number of mL you need (the amount of liquid medicine in Step 5). Measure the number of mL of medicine from the white end of the plunger.

Step 8. Remove the oral dosing dispenser from the bottle adapter.

ADMINISTER Quillivant XR

Step 9. Slowly squirt Quillivant XR directly into your or your child's mouth.

PROPER STORAGE

Step 10. Cap the bottle tightly. Store the bottle upright at 59ºF to 86ºF (15ºC to 30ºC).

Step 11. Clean the oral dosing dispenser after each use by placing in the dishwasher, or by rinsing with tap water.

Remind patients that they must vigorously shake the bottle for at least 10 seconds before each dose, to ensure that the proper dose is administered.