SAFETY AND SIDE EFFECTS

RELEXXII is contraindicated in patients:

• with a known hypersensitivity to methylphenidate or other components of RELEXXII. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other methylphenidate products.
• 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.

Healthcare providers should review the full Prescribing Information for complete safety information associated with RELEXXII (methylphenidate hydrochloride extended-release tablets).

Abuse, Misuse, and Addiction

RELEXXII has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants may result in overdose and death. Assess each patient's risk prior to prescribing and monitor for signs and symptoms of abuse, misuse, and addiction throughout treatment.¹

Risks to Patients with Serious Cardiac Disease

Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease treated with CNS stimulants at recommended ADHD doses. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious cardiac disease.¹

Increased Blood Pressure and Heart Rate

CNS stimulants may increase blood pressure and heart rate. Monitor all patients treated with RELEXXII for hypertension and tachycardia.¹

Psychiatric Adverse Reactions

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorders and may induce manic or mixed episodes in susceptible patients. Screen for risk factors prior to initiation and monitor for the emergence of psychotic or manic symptoms during treatment.¹

Priapism

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products. Patients who develop priapism should seek immediate medical attention.¹

Peripheral Vasculopathy, Including Raynaud’s Phenomenon

CNS stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Monitor patients for digital changes and consider further clinical evaluation when appropriate.¹

Long-Term Suppression of Growth in Pediatric Patients

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor height and weight during treatment. Treatment interruption may be necessary in patients who are not growing or gaining weight as expected.¹

Potential for Gastrointestinal Obstruction

Because the RELEXXII tablet is nondeformable and does not appreciably change shape in the gastrointestinal tract, RELEXXII should generally not be administered to patients with preexisting severe gastrointestinal narrowing. RELEXXII should be used only in patients who are able to swallow the tablet whole.¹

Acute Angle Closure Glaucoma and Increased Intraocular Pressure

Cases of angle closure glaucoma and increased intraocular pressure have been reported with methylphenidate treatment. Evaluate at-risk patients and monitor those with a history of open-angle glaucoma or elevated intraocular pressure. Prescribe RELEXXII to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk.¹

Motor and Verbal Tics and Worsening of Tourette’s Syndrome

Methylphenidate products have been associated with the onset or exacerbation of motor and verbal tics and worsening of Tourette’s syndrome. Assess family history and clinically evaluate patients prior to treatment initiation and monitor during therapy.¹

The safety profile of RELEXXII is based on adequate and well-controlled studies of another formulation of methylphenidate hydrochloride extended-release tablets. The most common adverse reactions varied by patient population.

Pediatric Patients (6–17 Years)

The most common adverse reaction reported in pediatric patients was:

• Upper abdominal pain¹

Additional adverse reactions reported in clinical studies included insomnia, vomiting, dizziness, pyrexia, nasopharyngitis, cough, and oropharyngeal pain.¹

Adults

The most common adverse reactions reported in adults (>5%) were:

• Decreased appetite
• Headache
• Dry mouth
• Nausea
• Insomnia
• Anxiety
• Dizziness
• Weight decreased
• Irritability
• Hyperhidrosis (increased sweating)¹

Discontinuations Due to Adverse Reactions of >1%

The most common adverse reactions associated with treatment discontinuation in either pediatric or adult clinical studies were:

• Anxiety
• Irritability
• Insomnia
• Increased blood pressure¹

See full Prescribing Information for complete adverse reaction data, warnings, precautions, and monitoring recommendations.