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

A Teen's ADHD
Doesn't End

when the school day does.

Consider a treatment that lasts up to 16 hours
post-dose
measured from 2 hours.¹

MYDAYIS^® is the first and only triple-bead mixed amphetamine salts (MAS) formulation that may help with improved attention, with once-daily dosing.¹

Primary Endpoint¹: In Study 5, patients aged 13-17 treated with Mydayis experienced significant improvement in attention vs placebo based on LS mean PERMP total scores up to 16 h post-dose, measured from 2 h post-dose.

WHY MYDAYIS

TRIPLE-BEAD DELIVERY

for prolonged release

For over 20 years, Takeda has been committed to ADHD research to help meet the needs of adolescent patients. Mydayis is the first ADHD treatment to use triple-bead delivery for extended release of MAS medication through the morning, afternoon, and evening.¹

First Bead:
Immediate-release
Immediate release in the stomach

Second Bead:
Delayed-release (DR-1)
Release at pH 5.5

Third Bead:
Delayed-release (DR-2)
Release at pH 7.0

Beads shown are not actual size or color.

Three types of beads in a single capsule release at different pH levels for prolonged amphetamine delivery.¹

See how it works

better attention

Up to 16 hours

post-dose, measured from 2 hours,
vs placebo in patients aged 13-17 as evaluated by PERMP¹

See efficacy

IMPORTANT SAFETY INFORMATION (continued)

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.

PRIMARY ENDPOINT: Adolescent patients receiving Mydayis 25 mg demonstrated significant improvement in attention compared with placebo on PERMP total score measured from 2 hours and continuing up to 16 hours post-dose.¹ The post-dose average score over all testing sessions was 256 for Mydayis and 215 for placebo (P<0.0001).²

PERMP Attention in ADHD was measured using the Permanent Product Measure of Performance (PERMP), which is a skill-adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. Higher scores indicate better attention.^1,2

Patients can

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Prescription savings offer card for ADHD treatment

References

Mydayis [package insert]. Lexington, MA; Takeda US Inc.
Data on file; SPD465-202; Shire US Inc.

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.

Please click for Full Prescribing Information.

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

A Teen's ADHDDoesn't End