INDICATION

Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

For US Healthcare Professionals

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Aptensio 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.

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EFFICACY AT 1 WEEK

Study 2: Once-daily Aptensio XR led to significant improvements at 1 week of treatment1

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Aptensio XR was superior to placebo at both the 20 mg/day and 40 mg/day doses1

Mean decrease in ADHD-RS-IV score per dose after 1 week of treatment1,2

Aptensio XR Dose Aptensio XR Dose
  • The primary efficacy end point was the mean decrease from baseline to the end of week 1 in the ADHD‐RS‐IV total score for Aptensio XR® (methylphenidate HCl extended-release) doses (10, 15, 20, and 40 mg/day) compared with placebo1
  • The recommended starting dose of Aptensio XR is 10 mg1
  • 86.5% of patients elected to continue receiving Aptensio XR in the open-label extension phase1
About ADHD-RS-IV

The Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) is an 18-item questionnaire completed by parents and/or teachers that measures inattention and hyperactivity-impulsivity symptoms on the basis of DSM-IV-TR criteria.1,3 Lower ADHD-RS-IV scores represent an improvement in ADHD symptoms.

Aptensio XR has proven efficacy, with safety data for up to 2 years1

The efficacy and safety of Aptensio XR were established in a phase III, multicenter, randomized, parallel, double-blind, placebo-controlled study using a standardized symptom rating scale.1

Study 2: Conducted with children and adolescents aged 6 to 17 years who met DSM-IV-TR criteria for ADHD (N=221)1

Clinical Study 2 Clinical Study 2

With an optional 21-month extension phase, some patients continued therapy for up to 2 years.1

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IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Aptensio 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.