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.

.

ADVERSE EVENTS

Once-daily Aptensio XR has proven safety1

.

No patients discontinued due to adverse events (AEs) during the double-blind phase of Study 1. Two patients, 4.4% of the patients taking 40 mg Aptensio XR in the double-blind phase of Study 2, discontinued due to insomnia, nausea, and/or rapid heart rate1

Treatment-related adverse events (≥2%) in Study 21

Treatment Related Adverse Events Treatment Related Adverse Events

Overall, among 183 patients administered Aptensio XR® (methylphenidate HCl extended-release) during the double-blind phase of Study 2 (10, 15, 20, and 40 mg strengths), 3 patients discontinued treatment (1.6%) due to adverse events.1

  • All patient-reported AEs considered related to Aptensio XR were commonly known effects of methylphenidate1
  • Commonly reported (≥2% of the methylphenidate group and at least twice the rate of the placebo group) adverse reactions from placebo-controlled trials of methylphenidate products include: decreased appetite, weight loss, nausea, abdominal pain, dyspepsia, dry mouth, vomiting, insomnia, anxiety, nervousness, restlessness, affect lability, agitation, irritability, dizziness, vertigo, tremor, blurred vision, increased blood pressure, increased heart rate, tachycardia, palpitations, hyperhidrosis, and pyrexia1
.

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.