Serdexmethylphenidate / dexmethylphenidate

Class
Psychostimulants
Subclass
Piperidines
Substance name
Serdexmethylphenidate / dexmethylphenidate
Brand names
Azstarys®
Contains
Dexmethylphenidate
Serdexmethylphenidate
Common formulations
Capsule
See also
Dexmethylphenidate ER (Focalin XR®)
Dosage and administration
Adults patients
Treatment of ADHD
•
Start at: 39.2/7.8 mg PO qAM
•
Maintenance: 39.2-52.3/7.8-10.4 mg PO qAM
•
Maximum: 52.3/10.4 mg per day
Taken with or without food. Increase the dose after one week based on response and tolerability.
Indications for use
Labeled indications
Adults
•
Treatment of ADHD
Safety risks
Boxed warnings
Drug abuse, drug misuse, stimulant use disorder
•
Use extreme caution in all patients. Assess the risk of abuse, misuse, and addiction before prescribing serdexmethylphenidate/dexmethylphenidate. Reassess the risk throughout treatment and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Contraindications
Hypersensitivity to serdexmethylphenidate/dexmethylphenidate or its components
Serious cardiac disease
•
Avoid using in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Assess for the presence of cardiac disease with a careful history, family history of sudden death or ventricular arrhythmia, and a physical examination before initiating serdexmethylphenidate/dexmethylphenidate.
Concomitant use of MAOIs
•
Do not use serdexmethylphenidate/dexmethylphenidate with or within 14 days of stopping MAOIs.
Warnings and precautions
Acute angle-closure glaucoma
•
Use caution in patients with untreated anatomically narrow angles.
Exacerbation of ADHD
•
Maintain a high level of suspicion, as paradoxical aggravation of symptoms can occur. Reduce the dose, or if necessary, discontinue serdexmethylphenidate/dexmethylphenidate if paradoxical aggravation of symptoms or other adverse reactions occur. Discontinue serdexmethylphenidate/dexmethylphenidate if improvement is not observed after appropriate dosage adjustment over a 1-month period.
Exacerbation of increased intraocular pressure
•
Use caution in patients with open-angle glaucoma or increased intraocular pressure.
Exacerbation of peripheral vascular disease, Raynaud's phenomenon
•
Maintain a high level of suspicion, as methylphenidate has been associated with an increased risk of peripheral vasculopathy, including Raynaud's phenomenon.
Exacerbation of psychosis
•
Use caution in patients with psychotic disorders.
Exacerbation of tics
•
Use caution in patients with Tourette's syndrome. Assess family history and clinically evaluate patients for motor or verbal tics or Tourette syndrome before initiating serdexmethylphenidate/dexmethylphenidate.
Growth delay
•
Maintain a high level of suspicion, as long-term use of CNS stimulants has been associated with growth delay in pediatric patients. Closely monitor growth.
Hypertension, tachycardia
•
Maintain a high level of suspicion, as CNS stimulants can cause an increase in BP and HR. Monitor for hypertension and tachycardia.
Manic or mixed episodes
•
Use caution in patients with bipolar disorder. Screen patients for risk factors for developing a manic episode, such as comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression, before prescribing serdexmethylphenidate/dexmethylphenidate.
Priapism
•
Maintain a high level of suspicion, as methylphenidate has been associated with an increased risk of prolonged and painful erections.
Psychosis, mania
•
Maintain a high level of suspicion, as CNS stimulants can cause psychotic or manic symptoms, such as hallucinations, delusional thinking, and mania.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals. Enroll patients in a dedicated pregnancy outcome monitoring registry.
Breastfeeding
Use only if benefits outweigh potential risks.
•
Monitor breastfed infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
Undetectable levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Common 1-10%
•
Weight loss, nausea, loss of appetite, abdominal pain, vomiting, dyspepsia, insomnia, emotional lability, anxiety, irritability, dizziness, hypertension, tachycardia
Unknown frequency
•
Pancytopenia, ↓ platelet count, purpura, angina pectoris, bradycardia, palpitations, ↑ intraocular pressure, diplopia, mydriasis, visual disturbances, blurred vision, fever, chest pain, dry mouth, chest discomfort, ↑ serum transaminases, angioedema, urticaria, pruritus, skin rash, ↑ serum ALP, ↑ serum TBIL, ↑ liver enzymes, ↑ WBC count, ↓ WBC count, arthralgia, myalgia, muscle twitching, muscle cramps, seizure, dyskinesia, nervousness, headache, tremor, somnolence, vertigo, motor tics, verbal tics, disorientation, ↓ libido, hallucinations, mania, restlessness, hair loss, agitation, skin erythema, hyperhidrosis, raynaud's phenomenon, priapism, supraventricular tachycardia, premature ventricular contractions, acute liver failure, anaphylaxis, exfoliative dermatitis, rhabdomyolysis
Interactions
Drug(s)
Check Interactions
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