Responsible
Stimulant Use

These are considerations for use of prescription stimulants and should not serve as medical guidance, but rather as a resource for healthcare professionals.

Potential for Abuse and Dependence

CNS stimulants, including Adhansia XR, other methylphenidate and amphetamine-containing products, have a high potential for abuse and dependence.1

It is important for prescribers and their patients to be aware of these risks-as well as their potential for diversion:10

  • Prescription stimulant misuse, as defined below, can lead to serious adverse effects, including cardiac problems in people with pre-existing cardiac abnormalities; the potential for habitual use; and the danger of overdose3
    • The misuse of prescription stimulants can lead to substance use disorder, addiction, physical dependence, or overdose1,4,5
    • Addiction can last a lifetime, lead to death, and requires treatment4
    • Stimulant misuse among young adults (18-25 years old) is more than double any other age group2
  • Prescription drug diversion often happens when people (regardless of age) receive stimulants for free from a friend or relative8
    • It is especially common among college students, and students with ADHD, who are frequently approached to divert their medication6,7
    • Diversion is also a problem in adults in general.17 For example, parents of children with ADHD may divert their child's medication to themselves9

Tips for Healthcare Providers

Before prescribing Adhansia XR:

  • Assess the risk of abuse1
    • Ask patients about other medications they currently take to identify potential misuse12
    • Ask patients if they or a family member have ever misused prescription medications, or abused alcohol, prescription medicines, or street drugs1
    • Use evidence-based screening tools to identify potential misuse or abuse13
  • Check electronic health records to assess patients' medical and prescription history14
  • Check your state's Prescription Drug Monitoring Program (PDMP) to identify individuals at risk for misuse and patients who are obtaining controlled substances from multiple providers12
  • Use electronic prescribing for controlled substances to help improve efficiency, promote patient safety, and reduce diversion15,16
  • Advise patients and their caregivers:1
    • That Adhansia XR is a federally controlled substance, and it can be abused and lead to dependence
    • Not to give Adhansia XR to anyone else
    • To store Adhansia XR in a safe place, preferably locked, to prevent abuse
    • To comply with laws and regulations on drug disposal
      • To dispose of remaining, unused, or expired Adhansia XR by a medicine take‑back program if available

After Prescribing Adhansia XR:

  • Monitor for signs of abuse and dependence1
  • Take note of rapid increases in the amount of medication requested, or unscheduled or early refill requests12
  • Keep careful prescription records1
  • Re-evaluate the need for Adhansia XR use1
  • Provide or refer patients to appropriate treatment if the patient has developed a substance use disorder12
Potential for Abuse and Dependence

Additional Resources:

Some additional information on considerations for use of prescription stimulants is available on the following government websites:


Important Definitions

Abuse
The intentional non-therapeutic use of a drug to achieve a desired psychological or physiological effect.1
Misuse
The act of taking a medication in a manner other than prescribed; taking another person's prescription; or taking a medication to feel euphoria.12
Addiction
A chronic, relapsing disease, characterized by compulsive drug seeking and use despite adverse consequences.4
Diversion
The unlawful channeling of regulated pharmaceuticals from legal sources to the illicit marketplace. This includes transferring drugs to people for whom they were not prescribed.10,11
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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. Substance Abuse and Mental Health Services Administration. (2018). Key substance use and mental health indicators in the United States: Results from the 2017 National Survey on Drug Use and Health (HHS Publication No. SMA 18-5068, NSDUH Series H-53). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Accessed on May 7, 2019. Retrieved from https://www.samhsa.gov/data/. 3. Benson K, Flory K, Humphreys KL, Lee SS. Misuse of stimulant medication among college students: a comprehensive review and meta-analysis. Clin Child Fam Psychol Rev 2015;18(1):50-76. 4. National Institute on Drug Abuse. Drug Misuse and Addiction: What is drug addiction? Accessed on Apr. 9, 2019. Retrieved from https://www.drugabuse.gov/publications/drugs-brains-behavior-science-addiction/drug-misuse-addiction#footnote. 5. National Institute on Drug Abuse. Drug Facts: Prescription Stimulants. Updated June 2018. Accessed May 7, 2019. Retrieved from https://www.drugabuse.gov/publications/drugfacts/prescription-stimulants. 6. McCabe SE, West BT, Teter CJ, Boyd CJ. Trends in medical use, diversion, and nonmedical use of prescription medications among college students from 2003 to 2013: Connecting the dots. Addict Behav 2014;39(7):1176-82. 7. Garnier LM, Arria AM, Caldeira KM, Vincent KB, O'Grady KE, Wish ED. Sharing and selling of prescription medications in a college student sample. J Clin Psychiatry 2010;71(3):262-269. 8. Center for Behavioral Health Statistics and Quality. (2018). 2017 National Survey on Drug Use and Health: Detailed Tables. Substance Abuse and Mental Health Services Administration, Rockville, MD. 9. Pham T, Milanaik R, Kaplan A, Papaioannou H, Adesman A. Household Diversion of Prescription Stimulants: Medication Misuse by Parents of Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2017;27(8):741-746. 10. Inciardi JA, Surratt H L, Lugo Y, Cicero T J. The Diversion of Prescription Opioid Analgesics. Law Enforc Exec Forum. 2007;7(7):127-141. 11. Wood D. Drug diversion. Aust Prescr. 2015;38(5):164-166. 12. National Institute on Drug Abuse: Misuse of Prescription Drugs 2018. Accessed on Apr 9, 2019. Retrieved from https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/2609-misuse-of-prescription-drugs.pdf. 13. National Institutes of Health, National Institute of Drug Abuse. Chart of Evidence-Based Screening Tools and Assessments. June 2018. Accessed Dec. 2018. Retrieved from https://www.drugabuse.gov/nidamed-medical-health-professionals/screening-tools-resources/chart-screening-tools. 14. Division of Human Development and Disability, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention. What States Need to Know about PDMPs. Page last updated Oct 3, 2017. Accessed on Apr 9, 2019. Retrieved from https://www.cdc.gov/drugoverdose/pdmp/states.html. 15. Porterfield A, Engelbert K. Electronic Prescribing: Improving the Efficiency and Accuracy of Prescribing in the Ambulatory Care Settings. Perspectives in Health Information Management, Spring 2014. 16. Drug Enforcement Administration. Economic Impact Analysis of the Interim Final Prescription Rule. March 2010. Accessed Apr 9, 2019. Retrieved from https://www.deadiversion.usdoj.gov/ecomm/e_rx/eia_dea_218.pdf. 17. Cassidy TA, Varughese S, Russo L, Budman SH, Eaton TA, Butler SF. Nonmedical Use and Diversion of ADHD Stimulants Among U.S. Adults Ages 18-49: A National Internet Survey. J Atten Disord. 2015;19(7):630-40.

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