Aptensio XR® (methylphenidate HCl extended-release) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Limitations of Use
Pediatric patients younger than 6 years of age experienced higher plasma exposure than patients 6 years and older at the same dose and high rates of adverse reactions, most notably weight loss.
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.
Aptensio XR is contraindicated:
- In patients known to be hypersensitive to methylphenidate or other components of Aptensio XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported
- During treatment with monoamine oxidase inhibitors (MAOIs) and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis
- The safety and effectiveness of Aptensio XR have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials. The safety and effectiveness were not established in pediatric patients under 6 years
- The long-term efficacy of methylphenidate in pediatric patients has not been established
- Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including Aptensio XR
- Prior to treating pediatric patients and adults with CNS stimulants including Aptensio XR, assess for the presence of cardiac disease (ie, perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam). Educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Aptensio XR use
- Sudden death, stroke, and myocardial infarction have occurred in adults treated with CNS stimulants at recommended doses. Sudden death has occurred in children and adolescents with structural cardiac abnormalities and other serious cardiac problems, as well as in adults taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Aptensio XR treatment
- CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mm Hg) and heart rate (mean increase approximately 3 to 6 bpm). Individuals may have larger increases. Monitor all patients for hypertension and tachycardia
- Exacerbation of preexisting psychosis: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder
- Induction of a manic episode in patients with bipolar disorder: Prior to initiating treatment, screen patients for risk factors for developing a manic episode (eg, comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression)
- New psychotic or manic symptoms: CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (eg, hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania
- Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate products. Immediate medical attention should be sought if signs or symptoms of prolonged penile erections or priapism are observed
- CNS stimulants 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. Careful observation for digital changes is necessary during treatment with ADHD stimulants
- Based on accumulated data from other methylphenidate products, the most common (≥2% and twice the rate of placebo) adverse reactions are decreased appetite, decreased weight, 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 pyrexia. There is limited experience with Aptensio XR in US double-blind, placebo-controlled trials. Because of very different study designs, adverse events following Aptensio XR treatment were not merged between studies. Adverse events following treatment with placebo were, however, merged. At least 5% of patients in any treatment group reported abdominal pain (combined preferred terms abdominal pain and abdominal pain upper), decreased appetite, headache, and insomnia
- Limited published studies report on the use of methylphenidate in pregnant women; however, the data are insufficient to inform any drug-associated risks. The background risk of major birth defects and miscarriage for the indicated population are unknown
- Patients should be advised to tell their physicians if they are pregnant or plan to become pregnant. It is not known if Aptensio XR will harm their unborn baby
- Nursing mothers should be advised to discontinue drug or discontinue nursing, taking into consideration the importance of the drug to the mother, because methylphenidate is present in human milk
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