First mixed
amphetamine salts

to use triple-bead delivery for prolonged delivery through the morning, afternoon, and evening.^1,2

The three bead types within Mydayis release mixed amphetamine salts (MAS) at different pH levels, enabling prolonged amphetamine delivery over time as the pH in the digestive tract changes.^1,3,4

First Bead: Immediate-release Provides immediate MAS drug release in the stomach

First Bead:
Immediate-release
Provides immediate drug release in the stomach.

Second Bead:
Delayed-release (DR-1)
Provides a delayed release of mixed amphetamine salts at pH 5.5, predicted to occur in the proximal small intestine.

Third Bead:
Delayed-release (DR-2)
Has two coatings; the first coating is porous which allows for a slow release of amphetamine. The second coating delays release of the medication until pH 7.0, which is predicted to occur later in the GI tract (distal small intestine).

Beads are not to scale and colored for visualization only.

EXTENDED DRUG DELIVERY

MYDAYIS reduced peak-to-trough FLUCTUATIONS VS A DOSE-AUGMENTATION STRATEGY^1,4

With one capsule of Mydayis 37.5 mg, healthy adults achieved similar plasma concentrations as with a dose of MAS-ER (other) 25 mg followed by a dose of MAS-IR 12.5 mg 8 hours later.

Mean Plasma Concentration in Adults

Mean plasma concentration of MAS over time

Efficacy conclusions cannot be drawn from pharmacokinetic data.

Mydayis delivers d- and l-amphetamine salts at a 3:1 ratio; similar kinetics are seen for l-amphetamine.

MAS-ER=Mixed amphetamine salts extended release
MAS-IR=Mixed amphetamine salts immediate release

Adolescent patient data

Based on a study of adolescent patients aged 13-17 (n=14), a single dose of Mydayis is expected to produce about 21%-31% higher C_max and AUC for d- and l-amphetamine, compared to the same dose of Mydayis administered to adults (aged 19 to 51 years).¹
Comparison of the amphetamine pharmacokinetics in adolescent patients with ADHD and healthy adults indicates that body weight is the primary determinant of these apparent differences.¹

See Clinical Data

See Dosing + Administration

References

Mydayis [package insert]. Lexington, MA; Takeda US Inc.
Spencer TJ, Adler LA, Weisler RH, Youch SH. Triple-bead mixed amphetamine salts (Mydayis), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo-controlled study. J Clin Psychiatry. 2008;69(9):1437-1448.
Nugent SG, Kumar D, Rampton DS, Evans DF. Intestinal luminal pH in inflammatory bowel disease: possible determinants and implications for therapy with aminosalicylates and other drugs. Gut. 2001;48(4):571-577.
Ermer JC, Shojaei A, Pennick M, Anderson CS, Silverberg A, Youcha SH. Bioavailability of triple-bead mixed amphetamine salts compared with a dose-augmentation strategy of mixed amphetamine salts extended release plus mixed amphetamine salts immediate release. Curr Med Res Opin. 2007;23(5):1067-1075.

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.

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.

First mixedamphetamine salts

to use triple-bead delivery for prolonged delivery through the morning, afternoon, and evening.1,2