For the treatment of ADHD in patients 6 years and older

Dosing AND TITRATION WITH
Quillivant XR®

Dosing Bottle Sizes Of Quillivant XR® (methylphenidate HCl) Extended Release

Fine-tune the dose for each patient's individual ADHD treatment needs

  • Uses innovative LiquiXR ® technology
  • Ability to start with a low dose
  • Titration in as little as 10 mg (2 mL) increments to help balance efficacy and side effects
  • Liquid formulation available in 4 volume sizes
  • The recommended starting dose of Quillivant XR (methylphenidate HCl) 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
  • With the calibrated oral dosing dispenser, dose may be adjusted* to meet the individual treatment needs of the patient
  • Because Quillivant XR can be titrated in small increments, you can work with your patients to determine the right dose

Prior to treating children and adults with CNS stimulants, including Quillivant XR, assess for the presence of cardiac disease (ie, perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) and risk for abuse. Starting dose is 20 mg (4 mL), which can be titrated up or down, weekly, in increments of 10 mg (2 mL) to 20 mg (4 mL) up to a maximum daily dose of 60 mg (12 mL). Reduce dosage if a paradoxical aggravation of symptoms or other adverse events occur. Discontinue if intolerable side effects develop or after 1 month if improvement is not seen after appropriate dose adjustments.

Quillivant XR® (methylphenidate HCl) Extended Release Dosing Titration Table

Formulation and administration

  • Quillivant XR MUST be reconstituted with water by a pharmacist
  • After reconstitution, the pharmacist must fully insert bottle adapter into neck of bottle
  • Before administering each dose, instruct the patient/caregiver to VIGOROUSLY SHAKE the bottle of Quillivant XR for at least 10 seconds, to ensure that the proper dose is administered

Patient assessment

  • Patients taking Quillivant XR for maintenance therapy should be re-evaluated periodically to assess the long-term usefulness of the drug
  • Reduce dosage or discontinue therapy if patients exhibit paradoxical aggravation of symptoms or other adverse reactions, or if improvement is not observed after an appropriate dose adjustment over a 1-month period
Important reminders for pharmacists
  • Quillivant XR is supplied as a powder for oral suspension which must be reconstituted with water prior to dispensing
  • After adding the specified amount of water to the bottle, be sure to fully insert bottle adapter into neck of bottle
  • Replace bottle cap. Shake with vigorous back and forth motion for at least 10 seconds to prepare suspension before dispensing prescription
  • See section 2.6 in Full Prescribing Information for additional details on reconstitution

How to calculate dosing and titration for Quillivant XR

Use the dosing calculator below to determine the bottle size to write for your patient’s prescription.*

Dosing and titration calculators

Use the following calculators to determine the bottle size to write for a patient prescription.

Prior to treating children and adults with CNS stimulants, including Quillivant XR, assess for the presence of cardiac disease (ie, 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 1 month if improvement is not seen after appropriate dose adjustments.

 

How to switch your patient from another methylphenidate to Quillivant XR

  • Discontinue other methylphenidate treatment, then follow the titration schedule for Quillivant XR
  • Do not substitute Quillivant XR for other methylphenidate products on a milligram-per-milligram basis due to different methylphenidate base compositions and differing pharmacokinetic profiles

 

Writing a prescription for
Quillivant XR

Quillivant XR® (methylphenidate HCl) Extended Release Example Prescription

When prescribing multiple bottle volumes of Quillivant XR with different NDCs when 1 bottle 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 bottle volumes within one 30-day time frame; however, this may require prior authorization or a call to your patient's insurance company

CNS, central nervous system; NDC, National Drug Code.

Important Safety Information

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including DYANAVEL XR, Quillivant XR, QuilliChew ER, and other amphetamine-containing or methylphenidate-containing products, 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.

  • DYANAVEL XR (amphetamine), Quillivant XR (methylphenidate HCI), and QuilliChew ER (methylphenidate HCI) are contraindicated:

    • in patients known to be hypersensitive to amphetamine, methylphenidate, or other components of DYANAVEL XR, Quillivant XR, and QuilliChew ER. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported.

    • in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs, because of risk of hypertensive crisis.

  • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, and other serious cardiac problems. Sudden death, stroke, and myocardial infarction have been reported in adults treated with CNS stimulants at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious cardiac problems when taking CNS stimulants at recommended doses for ADHD. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER.

  • CNS stimulants cause increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.

  • CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. They may induce a mixed/manic episode in patients with bipolar disorder. Assess for presence of bipolar disorder prior to initiating treatment. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing DYANAVEL XR, Quillivant XR, or QuilliChew ER.

  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER. Treatment may need to be interrupted in children not growing or gaining weight as expected.

  • CNS stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

  • 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.

  • Serotonin syndrome risk is increased when DYANAVEL XR is co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.

  • QuilliChew ER contains phenylalanine, a component of aspartame, and can be harmful to patients with phenylketonuria (PKU).

  • Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.

  • Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).

  • 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 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 to 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 to 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%).

  • DYANAVEL XR, Quillivant XR, and QuilliChew ER use during pregnancy may cause fetal harm.

  • Breastfeeding is not recommended during treatment with DYANAVEL XR, Quillivant XR, or QuilliChew ER.

INDICATION

DYANAVEL XR, Quillivant XR, and QuilliChew ER are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

See Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse and Dependence.