Dosage &
Administration

A once-daily treatment designed
to help your patients meet the
demands of their day1

Learn about how to start patients on Adhansia XR, titrate the dose, and provide ongoing monitoring.

Pre-treatment Screening1

Assess for:

  • Presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam)
  • Risk of abuse prior to prescribing; monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, and periodically re-evaluate the need for Adhansia XR use

General Dosing Information1

Available in six dosage strengths1

Six capsule strengths including 25mg, 35mg, 45mg, 55mg, 70mg, and 85mg
Capsules shown are not actual size.

Once daily in the morning, with or without food.1

Adhansia XR capsule may be:

How to administer Adhansia XR capsule

Opened and the entire contents sprinkled onto a tablespoon of applesauce or yogurt. The entire mixture should be eaten, without chewing, immediately or within 10 minutes (if not eaten within 10 minutes after mixing, discard and do not store).1

The dose of a single capsule should not be divided. Patients should not take anything less than one capsule per day. In the event of a missed dose, do not administer later in the day or administer additional medication to make up for the missed dose.1

Initiation & Titration

Recommended starting dose for patients 6 years or older: 25 mg once daily1

  • If switching from other methylphenidate products, discontinue that treatment, and titrate with Adhansia XR using the recommended titration schedule
  • Do not substitute Adhansia XR for other methylphenidate products on a milligram-per-milligram basis because of different methylphenidate base compositions and differing pharmacokinetic profiles

Titrate the dose in increments of 10 to 15 mg at intervals of no less than 5 days1

  • Dosages >100 mg daily in adults and >85 mg daily in pediatric patients have not been evaluated in clinical trials and are not recommended
    • In short-term controlled trials:
      • In adults - Although efficacy was demonstrated at dosages of 100 mg daily, dosages >85 mg daily were associated with a disproportionate increase in the incidence of certain adverse reactions
      • In pediatric patients - Efficacy was demonstrated at dosages of 70 mg daily, but dosages ≥70 mg daily were associated with a disproportionate increase in the incidence of certain adverse reactions
  • Individualize dosage adjustments based upon assessment of clinical benefit and tolerability with careful consideration of the dose-related adverse reactions

Ongoing Monitoring1

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of Adhansia XR, and adjust dosage as needed.

Dose reduction and discontinuation:

  • If paradoxical aggravation of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue the drug
  • Adhansia XR should be periodically discontinued to assess the patient's condition. If improvement is not seen after appropriate dosage adjustment over 1 month, discontinue Adhansia XR
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Stimulant Use

Important Safety Information

Contraindications

Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products. Adhansia XR is also contraindicated in patients receiving concomitant treatment with monoamine oxidase inhibitors (MAOIs), and also within 14 days following discontinuation of treatment with a MAOI, because of the risk of hypertensive crisis.

Warnings and Precautions

Potential for Abuse and Dependence

CNS stimulants, including Adhansia 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.

Serious Cardiovascular Events

Sudden death, stroke and myocardial infarction have occurred in adults treated with CNS stimulant treatment at recommended doses. Sudden death has occurred in pediatric patients with structural cardiac abnormalities and other serious cardiac problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Adhansia XR treatment.

Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia.

Psychiatric Adverse Reactions

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).

CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing Adhansia XR. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared to 0% in placebo-treated patients.

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products, in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or during discontinuation). Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's Phenomenon

CNS stimulants, including Adhansia 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. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.

Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.

Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Adhansia XR. Patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Allergic-Type Reactions FD&C Yellow No. 5

Adhansia XR 45 mg capsules contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Adverse Reactions

The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in adults are insomnia, dry mouth, and decreased appetite.

The most common (≥5% and twice the rate of placebo) adverse reactions occurring with Adhansia XR in pediatric patients are decreased appetite, insomnia, and weight decreased.

Pregnancy Exposure Registry

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Adhansia XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-23881-866-961-2388.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-75351-888-726-7535 or FDA at 1-800-FDA-10881-800-FDA-1088 or www.fda.gov/medwatch.

Please read Full Prescribing Information, including Boxed Warning.

Reference: 1. Adhansia XR™ (methylphenidate HCl) prescribing information. Stamford, CT: Purdue Pharma L.P.

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