Release Profile

Specifically designed to release an immediate and extended methylphenidate dose throughout your patients' day1

Featuring multi-layer release beads and a biphasic pharmacokinetic profile, Adhansia XR combines attributes of an IR and ER in a single once-daily capsule.1

Pharmacokinetic data do not correlate to clinical efficacy. IR=immediate-release; ER=extended-release

Biphasic methylphenidate release in a single once-daily dose1

Adhansia XR produces an initial peak concentration, and a subsequent prolonged peak that tapers off thereafter.1

MEAN CONCENTRATION-TIME PROFILES FOR d,l-METHYLPHENIDATE ON DAY 5 (DAILY DOSING)1*

PK Profile PK Profile

Pharmacokinetic data do not correlate to clinical efficacy.

*Evaluated in 21 healthy adults under fasted conditions for 5 consecutive days. Steady state achieved from Day 3.1

Median (range) times to 1st Cmax=1.5 (1-2.5) hours and 2nd Cmax=12 (8.5-16) hours.1

Adhansia XR contains a racemic mixture of d- and l‑methylphenidate.1

Cmax=maximum plasma concentration; Cmin=minimum plasma concentration

Multi-layer release (MLR™) technology contains an immediate and extended dose in one capsule1-3

Each capsule of Adhansia XR contains multi-layer beads that include:1-3

Multi-layer release bead Multi-layer release bead Multi-layer release bead Multi-layer release bead
Image is a simplified representation for illustrative purposes only.
Not shown in actual size or color.

Outermost Layer

Innermost Layer

  1. Methylphenidate HCl layer
    • Contains ~20% of the methylphenidate dose
    • Water-soluble (dissolves upon contact with GI fluid); designed for immediate release
  2. Delayed-release coating
    • pH dependent; dissolves when the GI environment pH is ≥7
  3. Controlled-release coating
    • Controlled-release polymer that becomes permeable in the GI tract
  4. Methylphenidate HCl layer
    • Contains ~80% of the methylphenidate dose, which gradually diffuses through the controlled-release polymer
  5. Sugar sphere
    • Core of the bead upon which ~80% of the methylphenidate dose is layered
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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.

References: 1. Adhansia XR™ (methylphenidate HCl) prescribing information. Stamford, CT: Purdue Pharma L.P. 2. Wigal SB, Wigal T, Childress A, et al. The time course of effect of multilayer-release methylphenidate hydrochloride capsules: A randomized, double-blind study of adults with ADHD in a simulated adult workplace environment [published online ahead of print October 1, 2016]. J Atten Disord. 10.1177/1087054716672335. 3. Data on file. Purdue Pharma L.P. Stamford, CT.

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