Mylan Pharmaceuticals Inc.

Lisdexamfetamine

Generic

Generic for Lisdexamfetamine dimesylate

ID: 00378685477

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LISDEXAMFETAMINE 10 MG CAPSULE 0378685477

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FORM

Capsule

STRENGTH

10 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

RECENT MAJOR CHANGES SECTION WARNING: ABUSE, MISUSE, AND ADDICTION 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Pretreatment Screening

🩺What it's for

Lisdexamfetamine dimesylate capsules are indicated for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see Clinical Studies (14.1)] Moderate to severe binge eating disorder (BED) in adults [see Clinical Studies (14.2)]. Limitations of Use: Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older [see Use in Specific Populations (8.4)].

💊How to take it

Indicated Population Initial Dose Titration Schedule Recommended Dose Maximum Dose ADHD (Adults and pediatric patients 6 years and older) (2.2) 30 mg every morning 10 mg or 20 mg weekly 30 mg to 70 mg per day 70 mg per day BED (Adults) (2.3) 30 mg every morning 20 mg weekly 50 mg to 70 mg per day 70 mg per day Prior to treatment, assess for presence of cardiac disease (2.4) Severe renal impairment: Maximum dose is 50 mg/day (2.5) End stage renal disease (ESRD): Maximum dose is 30 mg/day (2.5)

ℹ️Common side effects

The following adverse reactions are discussed in greater detail in other sections of the labeling: Known hypersensitivity to amphetamine products or other ingredients of lisdexamfetamine dimesylate capsules [see Contraindications (4)] Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see Contraindications (4) and Drug Interactions (7.1)] Abuse, Misuse, and Addiction [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9.2, 9.3)] Risks…

⚠️Serious risks

Lisdexamfetamine dimesylate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate, can result in overdose and death [see Overdosage (10)], and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

📋Interactions & cautions

Agents that alter 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 lisdexamfetamine dimesylate capsules dosage accordingly [see Drug Interactions (7.1)].

📦Storage & missed dose

Store at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

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A double-blind, placebo-controlled, randomized withdrawal design study (Study 9) was conducted in adults ages 18 to 55 (N = 123) who had a documented diagnosis of ADHD or met DSM-IV criteria for ADHD. At study entry, patients must have had documentation of treatment with lisdexamfetamine dimesylate for a minimum of 6 months and had to demonstrate treatment response as defined by Clinical Global Impression Severity (CGI-S) 3 and Total Score on the ADHD-RS < 22. ADHD-RS Total Score is a measure of core symptoms of ADHD. The CGI-S score assesses the clinician s impression of the patient s current illness state and ranges from 1 (not at all ill) to 7 (extremely ill). Patients that maintained treatment response at Week 3 of the open-label treatment phase (N = 116) were eligible to be randomized to ongoing treatment with the same dose of lisdexamfetamine dimesylate (N = 56) or switched to placebo (N = 60) during the double-blind phase. Patients were observed for relapse (treatment failure) during the 6-week double-blind phase. The efficacy endpoint was the proportion of patients with treatment failure during the double-blind phase. Treatment failure was defined as a 50% increase (worsening) in the ADHD-RS Total Score and 2-point increase in the CGI-S score compared to scores at entry into the double-blind phase. Maintenance of efficacy for patients treated with lisdexamfetamine dimesylate was demonstrated by the significantly lower proportion of patients with treatment failure (9%) compared to patients receiving placebo (75%) at endpoint during the double-blind phase (Study 9, Figure 7). Table 6: Summary of Primary Efficacy Results from Short-term Studies of Lisdexamfetamine Dimesylate in Pediatric Patients (Ages 6 to 17) and Adults with ADHD SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval. Study Number (Age range) Primary Endpoint Treatment Group Mean BaselineScore(SD) LS Mean Change from Baseline (SE) Placebo-subtracted Difference Difference (drug minus placebo) in least-squares mean change from baseline. (95% CI) Study 1 (6 - 12 years) ADHD-RS-IV Lisdexamfetamine dimesylate (30 mg/day) Doses statistically significantly superior to placebo. 43.2 (6.7) -21.8 (1.6) -15.6 (-19.9, -11.2) Lisdexamfetamine dimesylate (50 mg/day) 43.3 (6.7) -23.4 (1.6) -17.2 (-21.5, -12.9) Lisdexamfetamine dimesylate (70 mg/day) 45.1(6.8) -26.7 (1.5) -20.5 (-24.8, -16.2) Placebo 42.4 (7.1) -6.2 (1.6) -- Study 2 (6 - 12 years) Average SKAMP-DS Lisdexamfetamine dimesylate (30, 50 or 70 mg/day) --Pre-dose SKAMP-DS was not collected. 0.8 (0.1)LS Mean for SKAMP-DS (Study 2 and 3) or PERMP (Study 8) is post-dose average score over all sessions of the treatment day, rather than change from baseline. -0.9 (-1.1, -0.7) Placebo -- 1.7 (0.1) -- Study 3 (6 - 12 years) Average SKAMP-DS Lisdexamfetamine dimesylate (30, 50 or 70 mg/day) 0.9 (1.0)Pre-dose SKAMP-DS (Study 3) or PERMP (Study 8) total score, averaged over both periods. 0.7 (0.1) -0.7 (-0.9, -0.6) Placebo 0.7 (0.9) 1.4 (0.1) -- Study 4 (13 - 17 years) ADHD-RS-IV Lisdexamfetamine dimesylate (30 mg/day) 38.3 (6.7) -18.3 (1.2) -5.5 (-9.0, -2.0) Lisdexamfetamine dimesylate (50 mg/day) 37.3 (6.3) -21.1 (1.3) -8.3 (-11.8, -4.8) Lisdexamfetamine dimesylate (70 mg/day) 37.0 (7.3) -20.7 (1.3) -7.9 (-11.4, -4.5) Placebo 38.5 (7.1) -12.8 (1.2) -- Study 5 (6 - 17 years) ADHD-RS-IV Lisdexamfetamine dimesylate (30, 50 or 70 mg/day) 40.7 (7.3) -24.3 (1.2) -18.6 (-21.5, -15.7) Placebo 41.0 (7.1) -5.7 (1.1) -- Study 7 (18 - 55 years) ADHD-RS-IV Lisdexamfetamine dimesylate (30 mg/day) 40.5 (6.2) -16.2 (1.1) -8.0 (-11.5, -4.6) Lisdexamfetamine dimesylate (50 mg/day) 40.8 (7.3) -17.4 (1.0) -9.2 (-12.6, -5.7) Lisdexamfetamine dimesylate (70 mg/day) 41.0 (6.0) -18.6 (1.0) -10.4 (-13.9, -6.9) Placebo 39.4 (6.4) -8.2 (1.4) -- Study 8 (18 - 55 years) Average PERMP Lisdexamfetamine dimesylate (30, 50 or 70 mg/day) 260.1 (86.2) 312.9 (8.6) 23.4 (15.6, 31.2) Placebo 261.4 (75.0) 289.5 (8.6) -- Figure 4: LS Mean SKAMP Deportment Subscale Score by Treatment and Time-point for Pediatric Patients Ages 6 to 12 with ADHD after 1 Week of Double-Blind Treatment (Study 3) Higher score on the SKAMP-Deportment scale indicates more severe symptoms. Figure 5: Kaplan-Meier Estimated Proportion of Patients with Treatment Failure for Pediatric Patients Ages 6 to 17 (Study 6) Figure 6: LS Mean (SE) PERMP Total Score by Treatment and Time-point for Adults Ages 18 to 55 with ADHD after 1 Week of Double-Blind Treatment (Study 8) Higher score on the PERMP scale indicates less severe symptoms. Figure 7: Kaplan-Meier Estimated Proportion of Subjects with Relapse in Adults with ADHD (Study 9)

Adverse reactions reported in the controlled trials in pediatric patients ages 6 to 12 years (Study 1), pediatric patients ages 13 to 17 years (Study 4), and adult patients (Study 7) treated with lisdexamfetamine dimesylate or placebo are presented in Tables 1, 2 and 3 below. Table 1: Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 6 to 12 Years with ADHD Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 1) Lisdexamfetamine Dimesylate(n = 218) Placebo(n = 72) Decreased Appetite 39% 4% Insomnia 22% 3% Abdominal Pain Upper 12% 6% Irritability 10% 0% Vomiting 9% 4% Weight Decreased 9% 1% Nausea 6% 3% Dry Mouth 5% 0% Dizziness 5% 0% Affect Lability 3% 0% Rash 3% 0% Pyrexia 2% 1% Somnolence 2% 1% Tic 2% 0% Anorexia 2% 0% Table 2: Adverse Reactions Reported by 2% or More of Pediatric Patients Ages 13 to 17 Years with ADHD Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 4) Lisdexamfetamine Dimesylate(n = 233) Placebo(n = 77) Decreased Appetite 34% 3% Insomnia 13% 4% Weight Decreased 9% 0% Dry Mouth 4% 1% Palpitations 2% 1% Anorexia 2% 0% Tremor 2% 0% Table 3: Adverse Reactions Reported by 2% or More of Adult Patients with ADHD Taking Lisdexamfetamine Dimesylate and Greater than or Equal to Twice the Incidence in Patients Taking Placebo in a 4-Week Clinical Trial (Study 7) Lisdexamfetamine Dimesylate (n = 358) Placebo(n = 62) Decreased Appetite 27% 2% Insomnia 27% 8% Dry Mouth 26% 3% Diarrhea 7% 0% Nausea 7% 0% Anxiety 6% 0% Anorexia 5% 0% Feeling Jittery 4% 0% Agitation 3% 0% Increased Blood Pressure 3% 0% Hyperhidrosis 3% 0% Restlessness 3% 0% Decreased Weight 3% 0% Dyspnea 2% 0% Increased Heart Rate 2% 0% Tremor 2% 0% Palpitations 2% 0% In addition, in the adult population erectile dysfunction was observed in 2.6% of males on lisdexamfetamine dimesylate and 0% on placebo; decreased libido was observed in 1.4% of subjects on lisdexamfetamine dimesylate and 0% on placebo.

In a controlled trial of lisdexamfetamine dimesylate in pediatric patients ages 6 to 12 years (Study 1), mean weight loss from baseline after 4 weeks of therapy was -0.9, -1.9, and -2.5 pounds, respectively, for patients receiving 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate, compared to a 1 pound weight gain for patients receiving placebo. Higher doses were associated with greater weight loss with 4 weeks of treatment. Careful follow-up for weight in pediatric patients ages 6 to 12 years who received lisdexamfetamine dimesylate over 12 months suggests that consistently medicated pediatric patients (i.e., treatment for 7 days per week throughout the year) have a slowing in growth rate, measured by body weight as demonstrated by an age- and sex-normalized mean change from baseline in percentile, of -13.4 over 1 year (average percentiles at baseline and 12 months were 60.9 and 47.2, respectively). In a 4-week controlled trial of lisdexamfetamine dimesylate in pediatric patients ages 13 to 17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 lbs., respectively, for patients receiving 30 mg, 50 mg, and 70 mg of lisdexamfetamine dimesylate, compared to a 2.0 pound weight gain for patients receiving placebo. Careful follow-up of weight and height in pediatric patients ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated pediatric patients over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated pediatric patients ages 7 to 13 years (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. In a controlled trial of amphetamine (d- to l-enantiomer ratio of 3:1) in pediatric patients ages 13 to 17 years, mean weight change from baseline within the initial 4 weeks of therapy was -1.1 pounds and -2.8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine. Higher doses were associated with greater weight loss within the initial 4 weeks of treatment [see Warnings and Precautions (5.5)].

Table 5: Drugs Having Clinically Important Interactions with Amphetamines MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results. Intervention Do not administer lisdexamfetamine dimesylate during or within 14 days following the administration of MAOI [see Contraindications (4)]. Serotonergic Drugs Clinical Impact The concomitant use of lisdexamfetamine dimesylate and serotonergic drugs increases the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during lisdexamfetamine dimesylate initiation or dosage increase. If serotonin syndrome occurs, discontinue lisdexamfetamine dimesylate and the concomitant serotonergic drug(s) [see Warnings and Precautions (5.7)]. CYP2D6 Inhibitors Clinical Impact The concomitant use of lisdexamfetamine dimesylate and CYP2D6 inhibitors may increase the exposure of dextroamphetamine, the active metabolite of lisdexamfetamine dimesylate compared to the use of the drug alone and increase the risk of serotonin syndrome. Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during lisdexamfetamine dimesylate initiation and after a dosage increase. If serotonin syndrome occurs, discontinue lisdexamfetamine dimesylate and the CYP2D6 inhibitor [see Warnings and Precautions (5.7) and Overdosage (10)]. Alkalinizing Agents Clinical Impact Urinary alkalinizing agents can increase blood levels and potentiate the action of amphetamine. Intervention Co-administration of lisdexamfetamine dimesylate and urinary alkalinizing agents should be avoided. Acidifying Agents Clinical Impact Urinary acidifying agents can lower blood levels and efficacy of amphetamines. Intervention Increase dose based on clinical response. Tricyclic Antidepressants Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response.

A phase 2 study evaluated the efficacy of lisdexamfetamine dimesylate 30, 50 and 70 mg/day compared to placebo in reducing the number of binge days/week in adults with at least moderate to severe BED. This randomized, double-blind, parallel-group, placebo-controlled, forced-dose titration study (Study 10) consisted of an 11-week double-blind treatment period (3 weeks of forced-dose titration followed by 8 weeks of dose maintenance). Lisdexamfetamine dimesylate 30 mg/day was not statistically different from placebo on the primary endpoint. The 50 and 70 mg/day doses were statistically superior to placebo on the primary endpoint. The efficacy of lisdexamfetamine dimesylate in the treatment of BED was demonstrated in two 12-week randomized, double-blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies (Study 11 and Study 12) in adults aged 18-55 years (Study 11: N = 374, Study 12: N = 350) with moderate to severe BED. A diagnosis of BED was confirmed using DSM-IV criteria for BED. Severity of BED was determined based on having at least 3 binge days per week for 2 weeks prior to the baseline visit and on having a Clinical Global Impression Severity (CGI-S) score of 4 at the baseline visit. For both studies, a binge day was defined as a day with at least 1 binge episode, as determined from the subject s daily binge diary. Both 12-week studies consisted of a 4-week dose-optimization period and an 8-week dose-maintenance period. During dose-optimization, subjects assigned to lisdexamfetamine dimesylate began treatment at the titration dose of 30 mg/day and, after 1 week of treatment, were subsequently titrated to 50 mg/day. Additional increases to 70 mg/day were made as tolerated and clinically indicated. Following the dose-optimization period, subjects continued on their optimized dose for the duration of the dose-maintenance period. The primary efficacy outcome for the two studies was defined as the change from baseline at Week 12 in the number of binge days per week. Baseline is defined as the weekly average of the number of binge days per week for the 14 days prior to the baseline visit. Subjects from both studies on lisdexamfetamine dimesylate had a statistically significantly greater reduction from baseline in mean number of binge days per week at Week 12. In addition, subjects on lisdexamfetamine dimesylate showed greater improvement as compared to placebo across key secondary outcomes with higher proportion of subjects rated improved on the CGI-I rating scale, higher proportion of subjects with 4-week binge cessation, and greater reduction in the Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) total score. Table 7: Summary of Primary Efficacy Results in BED SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval. Study Number Treatment Group Primary Efficacy Measure: Binge Days per Week at Week 12 Mean Baseline Score (SD) LS Mean Change from Baseline (SE) Placebo-subtracted Difference Difference (drug minus placebo) in least-squares mean change from baseline. (95% CI) Study 11 Lisdexamfetamine dimesylate (50 or 70 mg/day)Doses statistically significantly superior to placebo. 4.79 (1.27) -3.87 (0.12) -1.35 (-1.70, -1.01) Placebo 4.60 (1.21) -2.51 (0.13) -- Study 12 Lisdexamfetamine dimesylate (50 or 70 mg/day) 4.66 (1.27) -3.92 (0.14) -1.66 (-2.04, -1.28) Placebo 4.82 (1.42) -2.26 (0.14) -- A double-blind, placebo controlled, randomized withdrawal design study (Study 13) was conducted to evaluate maintenance of efficacy based on time to relapse between lisdexamfetamine dimesylate and placebo in adults aged 18 to 55 (N = 267) with moderate to severe BED. In this longer-term study patients who had responded to lisdexamfetamine dimesylate in the preceding 12-week open-label treatment phase were randomized to continuation of lisdexamfetamine dimesylate or placebo for up to 26 weeks of observation for relapse. Response in the open-label phase was defined as 1 or fewer binge days each week for four consecutive weeks prior to the last visit at the end of the 12-week open-label phase and a CGI-S score of 2 or less at the same visit. Relapse during the double-blind phase was defined as having 2 or more binge days each week for two consecutive weeks (14 days) prior to any visit and having an increase in CGI-S score of 2 or more points compared to the randomized-withdrawal baseline. Maintenance of efficacy for patients who had an initial response during the open-label period and then continued on lisdexamfetamine dimesylate during the 26-week double-blind randomized-withdrawal phase was demonstrated with lisdexamfetamine dimesylate being superior over placebo as measured by time to relapse. Figure 8: Kaplan-Meier Estimated Proportions of Subjects with Relapse in Adults with BED (Study 13) Examination of population subgroups based on age (there were no patients over 65), gender, and race did not reveal any clear evidence of differential responsiveness in the treatment of BED.

Lisdexamfetamine Dimesylate Capsules are available containing 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg or 70 mg of lisdexamfetamine dimesylate. The 10 mg capsules are hard-shell gelatin capsules with a purple opaque cap and purple opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 10 in black ink on cap and body. They are available as follows: NDC 0378-6854-77bottles of 90 capsules The 20 mg capsules are hard-shell gelatin capsules with an ivory opaque cap and ivory opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 20 in black ink on cap and body. They are available as follows: NDC 0378-6855-77bottles of 90 capsules The 30 mg capsules are hard-shell gelatin capsules with an orange opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 30 in black ink on cap and body. They are available as follows: NDC 0378-6856-77bottles of 90 capsules The 40 mg capsules are hard-shell gelatin capsules with a green opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 40 in black ink on cap and body. They are available as follows: NDC 0378-6857-77bottles of 90 capsules The 50 mg capsules are hard-shell gelatin capsules with a blue opaque cap and white opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 50 in black ink on cap and body. They are available as follows: NDC 0378-6858-77bottles of 90 capsules The 60 mg capsules are hard-shell gelatin capsules with a blue opaque cap and blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 60 in black ink on cap and body. They are available as follows: NDC 0378-6859-77bottles of 90 capsules The 70 mg capsules are hard-shell gelatin capsules with an orange opaque cap and blue opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over LE 70 in black ink on cap and body. They are available as follows: NDC 0378-6860-77bottles of 90 capsules

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of lisdexamfetamine dimesylate capsules, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2), Overdosage (10)]. Advise patients to store lisdexamfetamine dimesylate capsules in a safe place, preferably locked, and instruct patients to not give lisdexamfetamine dimesylate capsules to anyone else. Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with lisdexamfetamine dimesylate capsules 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)]. Increased Blood Pressure and Heart Rate Instruct patients that lisdexamfetamine dimesylate capsules can cause elevations of their blood pressure and pulse rate and they should be monitored for such effects. Psychiatric Adverse Reactions Advise patients that lisdexamfetamine dimesylate capsules 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 in Pediatric Patients Advise patients that lisdexamfetamine dimesylate capsules 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 lisdexamfetamine dimesylate capsules 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 lisdexamfetamine dimesylate capsules. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings and Precautions (5.6)]. Serotonin Syndrome Caution patients about the risk of serotonin syndrome with concomitant use of lisdexamfetamine dimesylate capsules 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 (5.7) 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)]. Motor and Verbal Tics, and Worsening of Tourette s Syndrome Advise patients that motor and verbal tics and worsening of Tourette s Syndrome may occur during treatment with lisdexamfetamine dimesylate capsules. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette s syndrome occurs [see Warnings and Precautions (5.8)]. Pregnancy Registry Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to lisdexamfetamine dimesylate during pregnancy [see Use in Specific Populations (8.1)]. Pregnancy Advise patients of the potential fetal effects from the use of lisdexamfetamine dimesylate capsules during pregnancy. Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with lisdexamfetamine dimesylate capsules [see Use in Specific Populations (8.1)]. Lactation Advise women not to breastfeed if they are taking lisdexamfetamine dimesylate capsules [see Use in Specific Populations (8.2)]. Administration Instructions Capsules: Advise patients to take the capsules whole or empty and mix the entire contents with yogurt, water, or orange juice. Advise patients to consume the mixture immediately and not to store for future use [see Dosage and Administration (2.2)]. The brands listed are trademarks of their respective owners.

Lisdexamfetamine Dimesylate Capsules(lis dex am fet a meen dye mes i late) What is the most important information I should know about lisdexamfetamine dimesylate capsules? Lisdexamfetamine dimesylate capsules may cause serious side effects, including: Abuse, misuse, and addiction. Lisdexamfetamine dimesylate capsules have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of lisdexamfetamine dimesylate capsules, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of lisdexamfetamine dimesylate capsules or when they are used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child s risk for abuse, misuse, and addiction before starting treatment with lisdexamfetamine dimesylate capsules and will monitor you or your child during treatment. Lisdexamfetamine dimesylate capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give lisdexamfetamine dimesylate capsules to anyone else. See What are lisdexamfetamine dimesylate capsules? for more information. Keep lisdexamfetamine dimesylate capsules in a safe place and properly dispose of any unused medicine. See How should I store lisdexamfetamine dimesylate capsules? for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting treatment with lisdexamfetamine dimesylate capsules. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with lisdexamfetamine dimesylate capsules. Increased blood pressure and heart rate. Your healthcare provider should check you or your child s blood pressure and heart rate regularly during treatment with lisdexamfetamine dimesylate capsules. Mental (psychiatric) problems, including: new or worse behavior and thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with lisdexamfetamine dimesylate capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What are lisdexamfetamine dimesylate capsules? Lisdexamfetamine dimesylate capsules are a central nervous system (CNS) stimulant prescription medicine used for the treatment of: Attention Deficit Hyperactivity Disorder (ADHD) in adults and children 6 years of age and older. Lisdexamfetamine dimesylate capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. Moderate to severe binge eating disorder (BED) in adults. Lisdexamfetamine dimesylate capsules may help reduce the number of binge eating days in people with BED. Lisdexamfetamine dimesylate capsules are not for use in children under 6 years of age with ADHD. Lisdexamfetamine dimesylate capsules are not for weight loss. It is not known if lisdexamfetamine dimesylate capsules are safe and effective for the treatment of obesity. It is not known if lisdexamfetamine dimesylate capsules are safe and effective for use in children with BED. Lisdexamfetamine dimesylate capsules are a federally controlled substance (CII) because they contain lisdexamfetamine dimesylate that can be a target for people who abuse prescription medicines or street drugs. Keep lisdexamfetamine dimesylate capsules in a safe place to protect them from theft. Never give your lisdexamfetamine dimesylate capsules to anyone else because they may cause death or harm them. Selling or giving away lisdexamfetamine dimesylate capsules may harm others and is against the law. Do not take lisdexamfetamine dimesylate capsules if you or your child are: allergic to amphetamine products or any of the ingredients in lisdexamfetamine dimesylate capsules. See the end of this Medication Guide for a complete list of ingredients in lisdexamfetamine dimesylate capsules. taking, or have stopped taking in the last 14 days, a medicine called a Monoamine Oxidase Inhibitor (MAOI). being treated with the antibiotic linezolid or intravenous methylene blue. Before taking lisdexamfetamine dimesylate capsules, tell your healthcare provider about all medical conditions, including if you or your child: have heart problems, heart disease, heart defects, or high blood pressure have mental problems including psychosis, mania, bipolar illness, or depression or have a family history of suicide, bipolar illness, or depression have circulation problems in fingers and toes have kidney problems have or had repeated movements or sounds (tics) or Tourette s syndrome, or have a family history of tics or Tourette s syndrome are pregnant or plan to become pregnant. Lisdexamfetamine dimesylate capsules may harm the unborn baby. oThere is a pregnancy registry for females who are exposed to lisdexamfetamine dimesylate during pregnancy. The purpose of the registry is to collect information about the health of females exposed to lisdexamfetamine dimesylate and their baby. If you or your child becomes pregnant during treatment with lisdexamfetamine dimesylate capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/. are breastfeeding or plan to breastfeed. Lisdexamfetamine dimesylate passes into breast milk. You should not breastfeed during treatment with lisdexamfetamine dimesylate capsules. Talk to your healthcare provider about the best way to feed the baby during treatment with lisdexamfetamine dimesylate capsules. Tell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Lisdexamfetamine dimesylate capsules can affect the way other medicines work and other medicines may affect how lisdexamfetamine dimesylate capsules work. Taking lisdexamfetamine dimesylate capsules with other medicines can cause serious side effects. Sometimes the doses of other medicines will need to be changed while taking lisdexamfetamine dimesylate capsules. Especially tell your healthcare provider if you or your child take: selective serotonin reuptake inhibitors (SSRIs) medicines used to treat migraine headaches called triptans lithium tramadol buspirone serotonin norepinephrine reuptake inhibitors (SNRIs) tricyclic antidepressants fentanyl tryptophan St. John s Wort Keep a list of all medicines to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if lisdexamfetamine dimesylate capsules can be taken with other medicines. Do not start any new medicine during treatment with lisdexamfetamine dimesylate capsules without talking to your healthcare provider first. How should lisdexamfetamine dimesylate capsules be taken? Take lisdexamfetamine dimesylate capsules exactly as prescribed by your healthcare provider. Your healthcare provider may change the dose if needed. Take lisdexamfetamine dimesylate capsules 1 time each day in the morning with or without food. Taking Lisdexamfetamine Dimesylate Capsules: Lisdexamfetamine dimesylate capsules may be swallowed whole. If lisdexamfetamine dimesylate capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto yogurt, or poured into water or orange juice. oUsing a spoon, break apart any powder that is stuck together. Stir the lisdexamfetamine dimesylate powder and yogurt, water, or orange juice until they are completely mixed together. oSwallow all the yogurt, water, or orange juice mixture right away. Do not store the yogurt, water, or orange juice mixture. oIt is normal to see a filmy coating on the inside of your glass or container after you eat or drink all the lisdexamfetamine dimesylate mixture. If you or your child take too many lisdexamfetamine dimesylate capsules, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. What are the possible side effects of lisdexamfetamine dimesylate capsules? Lisdexamfetamine dimesylate capsules may cause serious side effects, including: See What is the most important information I should know about lisdexamfetamine dimesylate capsules? Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with lisdexamfetamine dimesylate capsules. Lisdexamfetamine dimesylate capsules treatment may be stopped if your child is not growing or gaining weight. Circulation problems in fingers and toes (Peripheral vasculopathy, including Raynaud s phenomenon). Signs and symptoms may include: oFingers or toes may feel numb, cool, painful oFingers or toes may change color from pale, to blue, to red Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with lisdexamfetamine dimesylate capsules. New or worsening tics or worsening Tourette s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette s syndrome during treatment with lisdexamfetamine dimesylate capsules. Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome may happen when lisdexamfetamine dimesylate capsules are taken with certain other medicines. Stop taking lisdexamfetamine dimesylate capsules and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome: oagitation oflushing ocoma oloss of coordination odizziness oseeing or hearing things that are not real (hallucination) ohigh body temperature (hyperthermia) ofast heartbeat oseizures osweating oconfusion otremors, stiff muscles, or muscle twitching ochanges in blood pressure onausea, vomiting, diarrhea The most common side effects of lisdexamfetamine dimesylate capsules in children 6 to 17 years old and adults with ADHD include: loss of appetite (anorexia) decreased appetite diarrhea dry mouth trouble sleeping stomach pain anxiety weight loss dizziness irritability nausea vomiting The most common side effects of lisdexamfetamine dimesylate capsules in adults with BED include: dry mouth decreased appetite constipation anxiety trouble sleeping increased heart rate feeling jittery These are not all the possible side effects of lisdexamfetamine dimesylate capsules. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store lisdexamfetamine dimesylate capsules? Store lisdexamfetamine dimesylate capsules in a safe place (like a locked cabinet) and in a tightly closed container at room temperature between 20 to 25 C (68 to 77 F). Protect lisdexamfetamine dimesylate capsules from light. Dispose of remaining, unused, or expired lisdexamfetamine dimesylate capsules by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix lisdexamfetamine dimesylate capsules with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away lisdexamfetamine dimesylate capsules in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines. Keep lisdexamfetamine dimesylate capsules and all medicines out of the reach of children. General information about the safe and effective use of lisdexamfetamine dimesylate capsules Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lisdexamfetamine dimesylate capsules for a condition for which they were not prescribed. Do not give lisdexamfetamine dimesylate capsules to other people, even if they have the same symptoms that you have. They may harm them and it is against the law. You can ask your pharmacist or healthcare provider for information about lisdexamfetamine dimesylate capsules that is written for healthcare professionals. What are the ingredients in lisdexamfetamine dimesylate capsules? Active ingredient: lisdexamfetamine dimesylate Capsule inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 10 mg capsules also contain D&C Red No. 33, FD&C Blue No. 1 and FD&C Red No. 40. The 20 mg, 30 mg, 40 mg and 70 mg capsules also contain yellow iron oxide. The 30 mg and 70 mg capsules also contain red iron oxide. The 40 mg, 50 mg, 60 mg and 70 mg capsules also contain FD&C Blue No. 2. In addition, the black imprinting ink for the 10 mg capsules contains black iron oxide, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Blue No. 2, FD&C Red No. 40, propylene glycol and shellac glaze. The black imprinting ink for the 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg capsules contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX). This Medication Guide has been approved by the U.S. Food and Drug Administration. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Halo Pharmaceutical Inc. Whippany, NJ 07981 U.S.A. Revised: 1/2024 HL:LISD:R2m/HL:MG:LISD:R2m