Serdexmethylphenidate and dexmethylphenidate

Serdexmethylphenidate and dexmethylphenidate
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Parth Vikram Singh, MBBS[2]

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Black Box Warning

ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete Boxed Warning. Condition Name: (AZSTARYS 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, including AZSTARYS, can result in overdose and death , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction)

Overview

Serdexmethylphenidate and dexmethylphenidate is a central nervous system (CNS) stimulant that is FDA approved for the treatment of Attention Deficit Hyperactivity Disorde (ADHD) in patients 6 years of age and older.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include appetite decreased, insomnia, nausea vomiting, dyspepsia,abdominal pain, weight decreased, anxiety,dizziness, irritability, affect lability, tachycardia, and blood pressure increased..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Adults and Pediatric Patients 13 to 17 years:

• Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Increase the dosage after one week to 52.3 mg/10.4 mg once daily depending on response and tolerability.
• Administer with or without food.
• Swallow capsules whole or open and sprinkle onto applesauce or add to water.
• To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis.

DOSAGE FORMS AND STRENGTHS

• Capsules (serdexmethylphenidate/dexmethylphenidate): 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Pediatric Patients 6 to 12 years:

• Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week. Maximum recommended dosage is 52.3 mg/10.4 mg once daily.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Serdexmethylphenidate and dexmethylphenidate in pediatric patients.

Contraindications

AZSTARYS is contraindicated in patients:

• with known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components of AZSTARYS. Bronchospasm, rash, and pruritus have been reported in patients who received AZSTARYS. 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), or within 14 days following discontinuation of treatment with an MAOI, because of the risk of hypertensive crisis.

Warnings

ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete Boxed Warning. Condition Name: (AZSTARYS 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, including AZSTARYS, can result in overdose and death , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction)

Abuse, Misuse, and Addiction

• AZSTARYS has a high potential for abuse and misuse. The use of AZSTARYS exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. AZSTARYS can be diverted for non-medical use into illicit channels or distribution.
• Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
• Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. *Educate patients and their families about these risks and proper disposal of any unused drug. *Advise patients to store AZSTARYS in a safe place, preferably locked, and instruct patients to not give AZSTARYS to anyone else. Throughout AZSTARYS treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

Risks to Patients with Serious Cardiac Disease

• Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.
• Avoid AZSTARYS use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.

Increased Blood Pressure and Heart Rate

• CNS stimulants cause an increase in blood pressure (mean increase approximately 2 to 4 mmHg) and heart rate (mean increase approximately 3 to 6 beats per minute). Some patients may have larger increases.
• Monitor all AZSTARYS-treated patients for hypertension and tachycardia.

Psychiatric Adverse Reactions

Exacerbation of Pre-Existing Psychosis

• CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.

Induction of a Manic Episode in Patients with Bipolar Disorder

• CNS stimulants may induce a manic or mixed mood episode in patients. Prior to initiating AZSTARYS 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).

New Psychotic or Manic Symptoms

• CNS stimulants, at the recommended dosage, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. 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% of placebo-treated patients. If such symptoms occur, consider discontinuing AZSTARYS.

Priapism

• Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate use, in both adult and pediatric male patients.
• Although priapism was not reported with methylphenidate initiation, it developed after some time on methylphenidate , often subsequent to an increase in dosage.
• Priapism also occurred during methylphenidate withdrawal (drug holidays or during discontinuation).
• AZSTARYS-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, including Raynaud's Phenomenon

• CNS stimulants used to treat ADHD, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post- marketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.
• Careful observation for digital changes is necessary during AZSTARYS treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for AZSTARYS-treated patients who develop signs or symptoms of peripheral vasculopathy.

Long-Term Suppression of Growth in Pediatric Patients

• CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients.
• In a long-term, open-label safety study with AZSTARYS conducted in pediatric patients 6 to 12 years of age with ADHD, there was a lower than expected increase in height and weight compared to pediatric patients of the same age and sex, on average.

• Closely monitor growth (weight and height) in AZSTARYS-treated pediatric patients. Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

Acute Angle Closure Glaucoma

• There have been reports of angle closure glaucoma associated with methylphenidate treatment.
• Although the mechanism is not clear, AZSTARYS-treated patients considered at risk for acute angle closure glaucoma (e.g., patients with significant hyperopia) should be evaluated by an ophthalmologist.

Increased Intraocular Pressure and Glaucoma

• There have been reports of an elevation of intraocular pressure (IOP) associated with methylphenidate treatment.

• Prescribe AZSTARYS to patients with open-angle glaucoma or abnormally increased IOP only if the benefit of treatment is considered to outweigh the risk. Closely monitor AZSTARYS-treated patients with a history of abnormally increased IOP or open angle glaucoma.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

• CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported .

• Before initiating AZSTARYS, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor AZSTARYS-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Adverse Reactions

Clinical Trials Experience

• Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adverse Reactions in Studies with Other Methylphenidate Products in Pediatric Patients and Adults with ADHD

• Commonly reported (≥ 5% 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, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia.

====Adverse Reactions in Studies with AZSTARYS in Pediatric Patients (6 to 12 years) with ADHD Short-Term Study====

• A short-term study conducted in pediatric patients 6 to 12 years of age with ADHD was comprised of a 3-week, open-label, dose optimization phase in which all patients received AZSTARYS (n=155), followed by a 1-week, double-blind, controlled phase in which patients were randomized to continue AZSTARYS (n=74) or switch to placebo (n=76). Because of the study design, the reported adverse reaction rates cannot be used to predict the rates that may be expected in clinical practice.

Long-Term Study

• A long-term, open-label safety study was conducted in pediatric patients 6 to 12 years of age with ADHD who either completed the short-term study or were de novo patients. This study was comprised of a 3-week dose optimization phase for patients not recently treated with AZSTARYS followed by a 12-month treatment phase for all patients during which 238 patients received open- label AZSTARYS and had evaluable safety data. A total of 154 patients were treated for 12 months. Because of the open-label, uncontrolled design of this study, the reported adverse reaction rates cannot be assessed in terms of a causal relationship to AZSTARYS treatment.
• To adjust for normal growth, z-scores were derived (measured in standard deviations [SD]); z- scores normalize for the natural growth of children and adolescents by comparisons to age- and sex-matched population standards. A z-score change less than 0.5 SD is considered not clinically significant.
• In this study, the mean increase in weight from baseline to Month 12 was 3.4 kg among study completers. The mean change in z-score from baseline to Month 12 was -0.20, indicating a lower than expected increase in body weight compared to children of the same age and sex, on average. Most of the weight z-score decline occurred in the first 4 months of treatment.
• The mean increase in height from baseline to Month 12 was 4.9 cm among completers. Using the same z-score analysis for height, the mean change in z-score from baseline to Month 12 was - 0.21, indicating a lower than expected increase in height compared to pediatric patients of the same age and sex, on average.

Postmarketing Experience

• The following adverse reactions have been identified during post approval use of methylphenidate products. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These adverse reactions are as follows:

Blood and Lymphatic System Disorders:

• pancytopenia, thrombocytopenia, thrombocytopenic purpura.

Cardiac Disorders:

• angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate.

Eye Disorders:

• diplopia, increased intraocular pressure, mydriasis, visual impairment, blurred vision.

General Disorders:

• chest pain, chest discomfort, hyperpyrexia.

Gastrointestinal Disorders:

• dry mouth.

Hepatobiliary disorders:

• hepatocellular injury, acute hepatic failure.

Immune System Disorders:

• hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticarias, pruritus NEC, rashes, eruptions, and exanthemas NEC.

Investigations:

• alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased, platelet count decreased, white blood cell count abnormal.

Musculoskeletal, Connective Tissue and Bone Disorders:

• arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps.

Nervous System:

• convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs, nervousness, headache, tremor, drowsiness, vertigo, motor and verbal tics’

Psychiatric Disorders:

• disorientation, libido changes, hallucination, hallucination auditory, hallucination visual, logorrhea, mania, restlessness, agitation.

Skin and Subcutaneous Tissue Disorders:

• alopecia, erythema, hyperhidrosis.

Urogenital System:

• priapism.

Vascular Disorders:

• Raynaud's phenomenon.

Drug Interactions

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Serdexmethylphenidate and dexmethylphenidate in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Serdexmethylphenidate and dexmethylphenidate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Serdexmethylphenidate and dexmethylphenidate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in geriatric settings.

Gender

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Serdexmethylphenidate and dexmethylphenidate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Serdexmethylphenidate and dexmethylphenidate in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Administration in the drug label.

Monitoring

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Serdexmethylphenidate and dexmethylphenidate and IV administrations.

Overdosage

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Mechanism of Action in the drug label.

Structure

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Structure in the drug label.

Pharmacodynamics

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Clinical Studies in the drug label.

How Supplied

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate How Supplied in the drug label.

Storage

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Serdexmethylphenidate and dexmethylphenidate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Serdexmethylphenidate and dexmethylphenidate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.