Indicated for ADHD in patients ≥13 years. Patients ≤12 years had higher plasma exposure at the same dose and higher rates of adverse reactions, mainly insomnia and decreased appetite.

Indicated for the treatment of ADHD in patients ≥13 years. Patients ≤12 years experienced higher plasma exposure at the same dose and higher rates of adverse reactions, mainly insomnia and decreased appetite. IMPORTANT SAFETY INFORMATION WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Mydayis, other amphetamine-containing products, and methylphenidate, 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.MORE SAFETY INFO

IMPORTANT SAFETY INFORMATION WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Mydayis, other amphetamine-containing products, and methylphenidate, 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.MORE SAFETY INFO

once-daily dosing

Triple-bead delivery for extended release¹

Titration

For adult patients, the recommended starting dose of Mydayis is 12.5 mg once daily in the morning upon awakening. Initial doses of 25 mg once daily may be considered for some adult patients. Dosage may be adjusted in increments of 12.5 mg, no sooner than weekly, up to a max 50 mg/day, based on therapeutic needs and response of the patient. Doses above 50 mg/day have shown no additional clinically meaningful benefit.

For pediatric patients (ages 13-17 years), the recommended starting dose is 12.5 mg once daily in the morning upon awakening. Dosage may be adjusted in increments of 12.5 mg, no sooner than weekly, up to recommended max dose 25 mg/day. Dose should be individualized according to the needs and response of the patient. Doses higher than 25 mg have not been evaluated in clinical trials in pediatric patients.

Pharmacological treatment of ADHD may be needed for an extended period. Periodically re-evaluate the long-term use of Mydayis and adjust dosage as needed.

Dosing

Take Mydayis by mouth once daily in the morning upon awakening due to potential for insomnia and because effects may last up to 16 hours post-dose. In the event of a missed dose, do not administer later in the day. Do not administer additional medication to make up for the missed dose.

Administration (with or without food)

Capsule may be taken with or without food but should be taken the same way each time. Capsule may be swallowed whole or opened and sprinkled entirely on a spoonful of applesauce. Patients must swallow entire mixture right away without chewing or storing. The dose of a single capsule should not be divided.

CAPSULE

APPLESAUCE

Capsules shown are not actual size.
Beads shown are not actual color.

Dosing Safety Information

Prior to treatment, assess for cardiac disease and risk of abuse; after prescribing, keep careful prescription records, educate patients about abuse, monitor for signs of abuse, dependence and overdose, and periodically re-evaluate the need for Mydayis use.
Patients with severe renal impairment: Adult starting dose 12.5 mg/day; adult maximum dose 25 mg/day; pediatric (ages 13-17) maximum dose 12.5 mg/day, if tolerated. Patients with end-stage renal disease (ESRD): Not recommended for use.
To avoid substitution errors and overdosage, do not substitute for other amphetamines on mg-per-mg basis because of different amphetamine base compositions and differing PK profiles.

See Mechanism of Delivery

See Mixed Amphetamine Salts

Reference

Mydayis [package insert]. Lexington, MA; Takeda US Inc.

Adverse Reactions + More

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INDICATION AND LIMITATIONS OF USE

MYDAYIS^® is indicated for the treatment of ADHD in patients ≥13 years. Patients ≤12 years experienced higher plasma exposure at the same dose and higher rates of adverse reactions, mainly insomnia and decreased appetite.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Mydayis, other amphetamine-containing products, and methylphenidate, 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.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Mydayis. Angioedema and anaphylactic reactions have been reported with other amphetamines.
- Use with monoamine oxidase inhibitors (MAOIs) or within 14 days of last MAOI dose, due to increased risk of hypertensive crisis.
Warnings and Precautions
- Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Mydayis treatment.
- CNS stimulants cause increased blood pressure (mean increase ~2-4 mm Hg) and heart rate (mean increase ~3-6 bpm). Monitor for tachycardia and hypertension.
- Exacerbation of Pre-existing Psychosis : 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 : May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms : At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants are associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). Treatment may need to be interrupted in patients not growing or gaining weight as expected. Mydayis is not approved in pediatric patients ≤12 years.
- CNS stimulants are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants; further evaluation and referral may be required.
- Mydayis may lower the convulsive threshold in patients with prior history of seizure, prior EEG abnormalities in the absence of seizures, and in patients without a history of seizures and no prior EEG evidence of seizures. Discontinue if a seizure occurs.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also during overdosage situations. Discontinue Mydayis if it occurs and initiate supportive treatment.
- To avoid substitution errors and overdosage, do not substitute for other amphetamines on a mg-per-mg basis because of different amphetamine base compositions and differing PK profiles.
Adverse Reactions
Most common adverse reactions in patients with ADHD (incidence ≥5% and at a rate at least twice placebo) are:
- Pediatrics (13 years and older) : insomnia, decreased appetite, decreased weight, irritability, and nausea.
- Adults : insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety.
Pregnancy and Lactation
Mydayis may cause fetal harm. Breastfeeding is not recommended during Mydayis treatment.

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Takeda is committed to helping ensure the proper use of stimulant medication. Please see the Proper Use of Prescription Stimulant Medication for additional information.