Serdexmethylphenidate/dexmethylphenidate

What is Serdexmethylphenidate/dexmethylphenidate?

• Serdexmethylphenidate/dexmethylphenidate AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

What are the uses of this medicine?

• This medicine is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older.
• AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD.

How does this medicine work?

• Serdexmethylphenidate is a prodrug of dexmethylphenidate.
• Dexmethylphenidate HCl is a central nervous system (CNS) stimulant.
• The mode of therapeutic action in ADHD is not known.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• 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.
• Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.

What drug interactions can this medicine cause?

• Do not administer AZSTARYS concomitantly with MAOIs or within 14 days after discontinuing MAOI treatment.
• AZSTARYS may decrease the effectiveness of drugs used to treat hypertension. Monitor blood pressure and adjust the dosage of the antihypertensive drug, as needed.
• Avoid use of AZSTARYS in patients being treated with anesthetics on the day of surgery.
• Combined use of methylphenidate with risperidone may increase the risk of extrapyramidal symptoms (EPS).

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

Recommended dosage

Pediatric Patients 6 to 12 years of age

• The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning.
• The dosage may be increased after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, or decreased after one week to a dosage of 26.1 mg serdexmethylphenidate/5.2 mg dexmethylphenidate per day, depending on response and tolerability.
• Maximum recommended dosage is 52.3 mg serdexmethylphendiate/10.4 mg dexmethyphenidate once daily.

Adults and Pediatric Patients 13 to 17 years of age

• The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning.
• Increase the dosage after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day.
• Maximum recommended dosage is 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate once daily.

Administration

• Take AZSTARYS exactly as prescribed.
• Your healthcare provider may change the dose if needed.
• Take AZSTARYS 1 time each day in the morning with or without food.
• AZSTARYS capsules may be swallowed whole with water or other liquids.
• If AZSTARYS capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto 2 tablespoonfuls of applesauce or into 2oz (50mL) of water.
• Swallow all the applesauce or water mixture right away or within 10 minutes of mixing. Do not store applesauce or water and medicine mixture.
• Your healthcare provider may sometimes stop AZSTARYS treatment for a while to check ADHD symptoms.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

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

This medicine is available in fallowing brand namesː

• AZSTARYS

What side effects can this medication cause?

The most common side effects of this medicine include:

• decreased appetite
• nausea
• indigestion
• weight loss
• dizziness
• mood swings
• increased blood pressure
• trouble sleeping
• vomiting
• stomach pain
• anxiety
• irritability
• increased heart rate

AZSTARYS can cause serious side effects, including:

• Abuse and dependence

Heart-related problems, including:

• sudden death, stroke, and heart attack in adults
• sudden death in children who have heart problems or heart defects
• increased blood pressure and heart rate

Mental (psychiatric) problems, including:

• new or worse behavior and thought problems
• new or worse bipolar illness
• new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms

What special precautions should I follow?

• Sudden death has been reported in association with CNS stimulant treatment at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. In adults, sudden death, stroke, and myocardial infarction have been reported. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmias, or coronary artery disease.
• Monitor blood pressure and pulse. Consider the benefits and risks in patients for whom an increase in blood pressure or heart rate would be problematic.
• Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Evaluate for bipolar disorder prior to AZSTARYS use.
• 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.
• Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
• Monitor height and weight at appropriate intervals in pediatric patients.

What to do in case of emergency/overdose?

Signs and symptoms of acute methylphenidate overdose may include the following:

• nausea
• vomiting
• diarrhea
• restlessness
• anxiety
• agitation
• tremors
• hyperreflexia
• muscle twitching
• convulsions (may be followed by coma)
• euphoria
• confusion
• hallucinations
• delirium
• sweating
• flushing
• headache
• hyperpyrexia
• tachycardia
• palpitations
• cardiac arrhythmias
• hypertension
• hypotension
• tachypnea
• mydriasis
• dryness of mucous membranes
• rhabdomyolysis

Management of Overdose

• Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice on the management of overdosage with methylphenidate.
• Provide supportive care, including close medical supervision and monitoring.
• Treatment should consist of those general measures employed in the management of overdosage with any drug.
• Consider the possibility of multiple drug overdosages.
• Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs.
• Use supportive and symptomatic measures.

Can this medicine be used in pregnancy?

• There are no available data on AZSTARYS use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including AZSTARYS, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

Can this medicine be used in children?

• The safety and effectiveness of AZSTARYS have been established in pediatric patients ages 6 to 17 years of age for the treatment of ADHD.
• The safety and effectiveness of AZSTARYS in pediatric patients less than 6 years have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients: serdexmethylphenidate and dexmethylphenidate
• Inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, talc, black iron oxide, titanium dioxide, FD&C Blue No. 1 (26/5.2 mg and 39/7.8 mg), FD&C Red No. 40 (39/7.8 mg and 52/10.4 mg), FD&C Yellow No. 6 (52/10.4 mg).

Who manufactures and distributes this medicine?

• Distributed by Corium, Inc

What should I know about storage and disposal of this medication?

Storage

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
• Protect from moisture.
• Dispense in tight container (USP).

Disposal

• Comply with local laws and regulations on drug disposal of CNS stimulants.
• Dispose of remaining, unused, or expired AZSTARYS by a medicine take-back program or by an authorized collector registered with the Drug Enforcement Administration.
• If no take-back program or authorized collector is available, mix AZSTARYS with an undesirable, nontoxic substance to make it less appealing to children and pets.
• Place the mixture in a container such as a sealed plastic bag and discard AZSTARYS in the household trash.

• Dailymed label info on Serdexmethylphenidate/dexmethylphenidate
• FDA Serdexmethylphenidate/dexmethylphenidate

Serdexmethylphenidate/dexmethylphenidate Resources
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