Limitations of Use

Pediatric patients 12 years and younger experienced higher plasma exposure than patients 13 years and older at the same dose, and experienced higher rates of adverse reactions, mainly insomnia and decreased appetite [see Use in Specific Populations (8.4)].

2.1 Important Information Prior to Initiating Treatment

Prior to initiating treatment with MYDAYIS, assess for the presence of cardiac disease (e.g., a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

Assess the risk of abuse, prior to prescribing and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for MYDAYIS use [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

2.2 General Instructions for Use

Because the effects of MYDAYIS may last up to 16 hours and there is potential for insomnia, administer once daily in the morning upon awakening. 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 [see Adverse Reactions (6.1), Clinical Studies (14)].

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.

2.3 Administration Instructions

Administer MYDAYIS orally with or without food. Advise patients to take MYDAYIS consistently either with food or without food [see Clinical Pharmacology (12.3)].

MYDAYIS may be administered in one of the following ways:

• Swallow MYDAYIS capsules whole, or
• Open capsule and sprinkle the entire contents over a spoonful of applesauce. The sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the sprinkled applesauce in its entirety without chewing.
• The dose of a single capsule should not be divided.

2.4 Dosing Information

2.5 Dosage Modifications due to Drug Interactions

Agents that alter gastrointestinal and urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust MYDAYIS dosage accordingly [see Drug Interactions (7.1)].

2.6 Dosage in Patients with Renal Impairment

In adult patients with severe renal impairment (GFR between 15 to < 30 mL/min/1.73 m2), the recommended starting dose of MYDAYIS is 12.5 mg daily with a maximum recommended dose of 25 mg daily. MYDAYIS is not recommended for use in patients with end stage renal disease (ESRD < 15 ml/min/1.73 m2). In pediatric patients (13 to 17 years) with severe renal impairment, the maximum dose is 12.5 mg, if tolerated [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].

2.7 Switching from other Amphetamine Products

For patients switching from another medication or any other amphetamine products, discontinue that treatment, and titrate with MYDAYIS using the titration schedule [see Dosage and Administration (2.4)].

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see Warnings and Precautions (5.9), Description (11), Clinical Pharmacology (12.3)].

5.1 Potential for 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 [see Boxed Warning, Drug Abuse and Dependence (9.2, 9.3)].

5.2 Serious Cardiovascular Reactions

Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during MYDAYIS treatment.

5.3 Blood Pressure and Heart Rate Increases

CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for potential tachycardia and hypertension [see Adverse Reactions (6.1)].

5.4 Psychiatric Adverse Reactions

5.5 Long-Term Suppression of Growth

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in pediatric patients treated with CNS stimulants, including MYDAYIS. In a 4-week, placebo-controlled trial of MYDAYIS in patients ages 6 to 17 years old with ADHD, there was a decrease in weight in the MYDAYIS groups compared to weight gain in the placebo group [see Adverse Reactions (6.1)].

Patients who are not growing or gaining weight as expected may need to have their treatment interrupted. MYDAYIS is not approved for use in pediatric patients 12 years and younger [Use in Specific Populations (8.4)].

5.6 Peripheral Vasculopathy, including Raynaud's Phenomenon

Stimulants, including MYDAYIS, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

5.7 Seizures

MYDAYIS may lower the convulsive threshold in patients with prior history of seizure, in patients with prior EEG abnormalities in the absence of seizures, and in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, MYDAYIS should be discontinued.

5.8 Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort [see Drug Interactions (7.1)]. The co-administration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase the risk with increased exposure to MYDAYIS. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions (7.1)].

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of MYDAYIS with MAOI drugs is contraindicated [see Contraindications (4)].

Discontinue treatment with MYDAYIS and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of MYDAYIS with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate MYDAYIS with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

5.9 Potential for Overdose Due to Medication Errors

Medication errors, including substitution and dispensing errors, between MYDAYIS and other amphetamine products could occur, leading to possible overdosage. 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 [see Dosage and Administration (2.7) and Overdosage (10)].

6.1 Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

MYDAYIS was studied in adults (18 to 55 years) and pediatric patients (13 to 17 years) who met Diagnostic and Statistical Manual of Mental Disorders, 4th or 5th editions (DSM-IV-TR® or DSM-5) criteria for ADHD. The safety data for adults were pooled from three randomized, double-blind, placebo-controlled studies in doses of 12.5 mg to 75 mg per day (1.5 times the maximum recommended dosage). Doses higher than 50 mg per day did not demonstrate additional clinical benefit and are not recommended.

The safety data for pediatric patients (13 to 17 years) is from 1 randomized, double-blind, placebo-controlled study of doses of 12.5 mg to 25 mg. The total exposure in patients treated with MYDAYIS totalled 704; this included pediatric patients, 78 adolescent patients and 626 adult patients from multiple well-controlled trials. The duration of use ranged from 4 to 7 weeks [see Clinical Studies (14)].

6.2 Adverse Reactions Associated with the Use of Amphetamines

The following adverse reactions have been associated with the use of amphetamines. The following adverse reactions have been identified during post approval use of amphetamines. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Dyspnea, sudden death. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, restlessness, euphoria, dyskinesia, dysphoria, headache, tics, fatigue, aggression, anger, logorrhea, dermatillomania, and paresthesia (including formication).

Eye Disorders: Mydriasis.

Gastrointestinal: Unpleasant taste, constipation, intestinal ischemia.

Allergic: Urticaria, rash, hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido, frequent or prolonged erections.

Skin: Alopecia.

Vascular Disorders: Raynaud's phenomenon.

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.

7.1 Drugs Having Clinically Important Interactions with Amphetamines

7.2 Drug/Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

Safety and effectiveness of MYDAYIS in pediatric patients with ADHD ages 13 to 17 years have been established in two placebo-controlled clinical studies [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), Clinical Studies (14)].

Safety and effectiveness of MYDAYIS have not been established in pediatric patients ages 12 years and younger.

MYDAYIS has been studied for the treatment of ADHD in pediatric patients 6 to 12 years in two placebo controlled safety and efficacy trials. In the first trial, pediatric patients 6 to 12 years experienced higher rates of adverse reactions in some cases compared to patients 13 years and older, including higher rates of insomnia (30% versus 8%) and appetite decreased (43% versus 22%). In addition, amphetamine systemic exposures (both d- and l-) in pediatric patients 6 to 12 years following a single dose were higher than those observed in adults at the same dose (72-79% higher Cmax and approximately 83% higher AUC). A second trial evaluated a lower dose than those approved for pediatric patients 13 to 17 years; efficacy was not demonstrated for the lower dose. Therefore, a safe and effective dose cannot be established in pediatric patients 12 years and younger.

8.5 Geriatric Use

Clinical studies of MYDAYIS did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should start at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Renal Impairment

Due to reduced clearance of amphetamine in patients with severe renal insufficiency (GFR 15 to < 30 mL/min/1.73 m2), the maximum dose in adults should be reduced. Pediatric patients ages 13 to 17 years with severe renal insufficiency can be given the recommended starting dose if tolerated, but the dose should not be escalated. MYDAYIS is not recommended in patients with ESRD (GFR < 15 mL/min/1.73 m2) [see Dosage and Administration (2.6), Clinical Pharmacology (12.3)].

D-amphetamine is not dialyzable.

9.1 Controlled Substance

MYDAYIS contains mixed amphetamine salts, which are in Schedule II.

9.2 Abuse

MYDAYIS is a CNS stimulant that contains mixed amphetamine salts which have a high potential for abuse. Abuse is characterized by impaired control over drug use, compulsive use, continued use despite harm, and craving.

Signs and symptoms of amphetamine abuse may include increased heart rate, respiratory rate, blood pressure, and/or sweating, dilated pupils, hyperactivity, restlessness, insomnia, decreased appetite, loss of coordination, tremors, flushed skin, vomiting, and/or abdominal pain. Anxiety, psychosis, hostility, aggression, suicidal or homicidal ideation have also been seen. Abusers of amphetamine may use unapproved routes of administration which can result in overdose and death [see Overdosage (10)].

To reduce the abuse of CNS stimulants, including MYDAYIS, assess the risk of abuse prior to prescribing. After prescribing, keep careful prescription records, educate patients and their families about abuse and on proper storage and disposal of CNS stimulants. Monitor for signs of abuse while on therapy, and re-evaluate the need for MYDAYIS use.

9.3 Dependence

Inactive Ingredients and Colors: The inactive ingredients in MYDAYIS capsules include: hard gelatin capsules, ethylcellulose, hydroxypropyl methylcellulose, methacrylic acid copolymer, methyl acrylate, methyl methacrylate, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. The gelatin capsules for all four strengths contain gelatin, titanium dioxide, yellow iron oxide, and edible inks. The 12.5 mg and 25 mg strength gelatin capsules also contain FD&C Blue #2. The 37.5 mg strength also contains red iron oxide. The 50 mg strength capsule also contains D&C Red #28, D&C Red #33, and FD&C Blue #1.

12.1 Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The exact mode of therapeutic action in ADHD is not known.

12.2 Pharmacodynamics

Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

12.3 Pharmacokinetics

MYDAYIS contains d-amphetamine and l-amphetamine salts in the ratio of 3:1. Pharmacokinetic studies of d- and l-amphetamine after oral administration of MYDAYIS have been conducted in healthy adults (19 to 52 years) and pediatric patients (6 to 17 years) with ADHD. Following administration of MYDAYIS, the peak plasma concentrations occurred in about 7 – 10 hours in pediatric patients and about 8 hours in adults for both d-amphetamine and l-amphetamine. The mean plasma elimination half-life for d- amphetamine ranges from about 10 – 11 hours and l-amphetamine from 10 – 13 hours in both pediatric and adult patients.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

Acute administration of high doses of amphetamine (d- or d, l-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance of these findings to humans is unknown.

Adult patients (18 to 55 years) with ADHD

The approved adult doses, 12.5 mg, 25 mg, and 37.5 mg are based on Studies 1 and 3 and the 50 mg dose efficacy is based on Study 2. Doses up to 75 mg per day (1.5 times the maximum recommended adult dosage) were evaluated, but demonstrated no additional clinical benefit.

A 4-week, randomized, double-blind, multi-center, placebo-controlled, forced-dose titration, safety and efficacy study (Study 1) was conducted in adults aged 18 to 55 years (N=275) who met DSM-5 criteria for ADHD. Patients were randomized in a 1:1:1 ratio, to two MYDAYIS treatment groups and a placebo group. Group 1 received a dose of 12.5 mg/day throughout the study. Group 2 were titrated on a weekly basis from the initial dose 12.5 mg until target dose of 37.5 mg/day was reached by Week 3 and were maintained at 37.5 mg throughout the study. Group 3 received placebo.

The primary efficacy endpoint was defined as the change from baseline of the adult ADHD-Rating Scale (RS) with prompts total score at Week 4. Baseline adult ADHD-RS with prompts total score was defined as the last valid adult ADHD-RS with prompts total score assessment prior to taking the first dose of double-blind investigational product, usually at Visit 2. The primary comparison of interest was at Week 4 for each MYDAYIS dose compared with placebo. MYDAYIS demonstrated a statistically significant treatment effect compared with placebo on change of ADHD-RS total score from baseline at visit 6 (Week 4), for both 12.5 mg and 37.5 mg doses respectively (Study 1 in Table 4). Patients on MYDAYIS also showed statistically significantly greater improvement on the Clinical Global Impression of Improvement (CGI-I) score compared with placebo treatment.

Two multi-center, randomized, double-blind, placebo-controlled, crossover studies of MYDAYIS 25 mg/day (Study 3) and 50 mg/day (Study 2) were conducted in adult patients who met DSM-IV TR criteria for ADHD. The efficacy was determined using the Permanent Product Measure of Performance (PERMP), a skill-adjusted math test that measures attention in ADHD. PERMP total score results from the sum of the number of math problems attempted plus the number of math problems answered correctly. Efficacy assessments were conducted at 2, 4, 8, 12, 14, and 16 hours post-dose using the PERMP. MYDAYIS treatment, compared to placebo, reached statistical significance at either 2 hours (Study 2) or 4 hours (Study 3) post-dose to 16 hours post-dose in both studies. In a pre-specified supplementary analysis for Study 2, the maximum approved dose of MYDAYIS (50 mg) demonstrated a statistically significant treatment effect compared with placebo beginning at 2 to 16 hours post-dose (Study 2 and Study 3 in Table 4).

Pediatric patients (13 to 17 years) with ADHD

A 4-week, randomized, double-blind, multi-center, placebo-controlled, dose-optimization, safety and efficacy study (Study 4) was conducted. In Study 4, the 157 pediatric patients 13 to 17 years old who met DSM-IV TR criteria for ADHD, were randomized in a 1:1 ratio to MYDAYIS or placebo group. Subjects were titrated from a dose of 12.5 mg/day until an optimal dose was reached (up to a maximum dose of 25 mg); this dose was maintained during the dose-maintenance period (Study 4 in Table 4).

The primary efficacy endpoint was defined as the change from baseline of the ADHD-RS-IV Total Score at Week 4. The baseline ADHD-RS-IV Total Score was defined as the last valid ADHD-RS-IV Total Score assessment prior to taking the first dose of double-blind investigational product, usually at Visit 2. MYDAYIS demonstrated a statistically significant treatment effect compared with placebo on the change of ADHD RS-IV total scores from baseline at Visit 6 (Week 4). MYDAYIS also showed statistically significantly greater improvement on the Clinical Global Impression of Improvement (CGI-I) score at Visit 6 (Week 4).

A multi-center, randomized, double-blind, placebo-controlled, crossover study of MYDAYIS 25 mg/day (Study 5) was conducted in adolescent patients who met DSM-IV TR criteria for ADHD. The efficacy was determined using the Permanent Product Measure of Performance (PERMP), a skill-adjusted math test that measures attention in ADHD. PERMP total score results from the sum of the number of math problems attempted plus the number of math problems answered correctly. Efficacy assessments were conducted at 2, 4, 8, 12, 14, and 16 hours post-dose using the PERMP. MYDAYIS treatment, compared to placebo, reached statistical significance at 2 to 16 hours post-dose (Study 5 in Table 4, Figure 2).

Figure 2 LS Mean (SE) PERMP Total score by Treatment and Time-point for Adolescents Ages 13 to 17 with ADHD after 1 Week of Double Blind Treatment (Study 5)

LS Mean: least-squares mean; SE: standard error

In both adults and pediatric patients, examination of a population subset based on gender or race did not reveal any differences.

How Supplied

MYDAYIS extended-release capsules are available as:

• 12.5 mg: Green body/green cap (imprinted with black SHIRE 465 and 12.5 mg), bottles of 100, NDC 54092-468-01
• 25 mg: Ivory body/green cap (imprinted with black SHIRE 465 and 25 mg), bottles of 100, NDC 54092-471-01
• 37.5 mg: Ivory body/caramel cap (imprinted with black SHIRE 465 and 37.5 mg), bottles of 100, NDC 54092-474-01
• 50 mg: Ivory body/purple cap (imprinted with black SHIRE 465 and 50 mg), bottles of 100, NDC 54092-477-01

Storage and Handling

Dispense in a tight, light-resistant container as defined in the USP.

Store at room temperature, 20ºC to 25ºC (68ºF to 77ºF). Excursions permitted between 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature].

Controlled Substance Status/High Potential for Abuse and Dependence

Advise patients and their caregivers that MYDAYIS is a federally controlled substance because it can be abused or lead to dependence. Advise patients to store MYDAYIS in a safe place, preferably locked, to prevent abuse. Advise patients to comply with laws and regulations on drug disposal. Advise patients to dispose of remaining, unused, or expired MYDAYIS by a medicine take-back program if available [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9)].

Serious Cardiovascular Risks

Advise patients, caregivers, and family members that there is a potential serious cardiovascular risk including sudden death, myocardial infarction, stroke, and hypertension with MYDAYIS use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings and Precautions (5.2)].

Blood Pressure and Heart Rate Increases

Instruct patients that MYDAYIS can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects [see Warnings and Precautions (5.3)].

Psychiatric Risks

Advise patients that MYDAYIS, at recommended doses, may cause psychotic or manic symptoms even in patients without prior history of psychotic symptoms or mania [see Warnings and Precautions (5.4)].

Long-Term Suppression of Growth

Advise patients, family members, and caregivers that MYDAYIS may cause slowing of growth including weight loss [see Warnings and Precautions (5.5)].

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud's Phenomenon]

Instruct patients beginning treatment with MYDAYIS about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking MYDAYIS. Further clinical evaluation (e.g. rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)].

Seizures

Caution patient that MYDAYIS may lower the convulsive threshold. Advise patients to contact their healthcare provider immediately and to discontinue MYDAYIS if a seizure occurs [see Warnings and Precautions (5.7)].

Serotonin Syndrome

Caution patients about the risk of serotonin syndrome with concomitant use of MYDAYIS and other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort, and with drugs that impair metabolism of serotonin (in particular MAOIs, both those intended to treat psychiatric disorders and also others such as linezolid [see Contraindications (4), Warnings and Precautions (5.8) and Drug Interactions (7.1)]. Advise patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome.

Concomitant Medications

Advise patients to notify their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs because there is a potential for interactions [see Drug Interactions (7.1)].

Pregnancy Registry

Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MYDAYIS during pregnancy [see Use in Specific Populations (8.1)].

Pregnancy

Advise patients of the potential fetal effects from the use of MYDAYIS during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with MYDAYIS [see Use in Specific Populations (8.1)].

Lactation

Advise women not to breastfeed if they are taking MYDAYIS [see Use in Specific Populations (8.2)].

Alcohol

Advise patients to avoid alcohol while taking MYDAYIS. Consumption of alcohol while taking MYDAYIS may result in a more rapid release of the dose of mixed amphetamine salts [see Clinical Pharmacology (12.3)].