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

Understanding the differences between

Mixed Amphetamine Salts
(MAS) Formulations

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.¹

The first amphetamine product (mixed amphetamine salts, or MAS, immediate-release) was approved for the treatment of ADHD in 1996. MAS have been used for the treatment of ADHD for over 20 years.²

3 TYPES OF MAS FORMULATIONS

MAS formulations differ in dosage, mechanism of release, pharmacokinetics, and duration of effect.
Three common formulations are presented below.^1-4

MAS formulations differ in dosages, mechanism of release, pharmacokinetics, and duration of effect.

Tablet and capsules shown are not actual size.

*Definitive clinical trials comparing MAS IR, MAS ER (other), and Mydayis have not been performed. Duration of effect is not described in MAS IR and MAS ER (other) labels; estimates are from Jain and Katic, 2016.⁴
No estimates of onset for MAS IR and MAS ER (other) were provided in this publication.

Dosing

To avoid substitution errors and overdosage, do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles.

Tablet and capsules shown are not actual size.

See Mechanism of Delivery

References

Mydayis [package insert]. Lexington, MA; Takeda US Inc.
Adderall XR [package insert]. Wayne, PA: Takeda US Inc.
Spencer TJ, Adler LA, Weisler RH, Youcha SH. Triple-bead mixed amphetamine salts (SPD465), 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.
Jain R, Katic A. Current and investigational medication delivery systems for treating attention-deficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2016;18(4):doi:10.4088/PCC.16r01979.

Clinical Data

Dosing + Administration

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.

Understanding the differences between

Mixed Amphetamine Salts (MAS) Formulations

3 TYPES OF MAS FORMULATIONS

Dosing

References

Mixed Amphetamine Salts
(MAS) Formulations