XELSTRYM

1 INDICATIONS AND USAGE XELSTRYM ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older [see CLINICAL STUDIES (14) ] . Limitations of Use The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.5) , Use in Specific Populations (8.4) ]. XELSTRYM is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older ( 1 ) Limitations of Use: The use of XELSTRYM is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage ( 5.5 , 8.4 ).

2 DOSAGE AND ADMINISTRATION Pediatric patients (6 to 17 years): Recommended starting dose is 4.5 mg/9 hours. Titrate dosage in weekly increments of 4.5 mg up to a maximum recommended dose of 18 mg/9 hours ( 2.2 ) Adults: Recommended starting dose is 9 mg/9 hours. Maximum recommended dose is 18 mg/9 hours ( 2.2 ) Apply one XELSTRYM transdermal system 2 hours before an effect is needed and remove within 9 hours ( 2.3 ) Apply XELSTRYM to one of the following sites: hip, upper arm, chest, upper back or flank. Change the site of application when applying a new transdermal system ( 2.3 ) Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles ( 2.5 ) Severe renal impairment: Maximum recommended dose is 13.5 mg/9 hours ( 2.6 ) End stage renal disease (ESRD): Maximum recommended dose is 9 mg/9 hours ( 2.6 ) 2.1 Pretreatment Screening Prior to treating patients with XELSTRYM, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS AND PRECAUTIONS (5.2) ] . the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating XELSTRYM [see WARNINGS AND PRECAUTIONS (5.11) ] . 2.2 Recommended Dosage Pediatric Patients 6 to 17 years Recommended starting dose of XELSTRYM in pediatric patients 6 to 17 years is 4.5 mg/9 hours. Dosage may be adjusted in weekly increments of 4.5 mg up to a maximum recommended dose of 18 mg/9 hours. Adults Recommended starting dose of XELSTRYM in adults is 9 mg/9 hours. Dosage may be adjusted up to a maximum recommended dose of 18 mg/9 hours. Apply XELSTRYM to the application site 2 hours before an effect is needed and remove within 9 hours after application. Dose titration and final dosage should be individualized depending on clinical response and tolerability. 2.3 Important Administration Instructions Apply one XELSTRYM transdermal system at a time for not more than 9 hours. Use only one XELSTRYM per 24 hours. Apply XELSTRYM to clean (void of lotions, oils, or gels), dry (not wet), and intact skin at the selected application site. Application sites include: hip, upper arm, chest, upper back, or flank. Select a different application site each time a new XELSTRYM transdermal system is applied [see WARNINGS AND PRECAUTIONS (5.9) ] . Avoid touching the adhesive side of XELSTRYM in order to avoid absorption of amphetamine. If the adhesive side is touched, immediately wash hands with soap and water. If the XELSTRYM transdermal system lifts at the edges, reattach XELSTRYM by pressing firmly and smoothing down the edges of the system. If XELSTRYM comes off completely, apply a new XELSTRYM transdermal system. XELSTRYM should not be applied or re-applied with dressings, tape or other common adhesives. Avoid exposing the application site to direct external heat sources, such as hair dryers, heating pads, electric blankets, heated water beds, etc., while wearing XELSTRYM [see WARNINGS AND PRECAUTIONS (5.10) ] . When heat is applied to XELSTRYM after application, both the rate and the extent of absorption are increased [see CLINICAL PHARMACOLOGY (12.3) ] . 2.4 Switching from Other Amphetamine Products For patients switching from another medication or any other amphetamine product, discontinue that treatment, and titrate with XELSTRYM using the titration schedule [see DOSAGE AND ADMINISTRATION (2.2) ] . Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine base compositions and differing pharmacokinetic profiles [see CLINICAL PHARMACOLOGY (12.3) ] . 2.5 Dosage in Patients with Renal Impairment In patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73 m 2 ), the maximum dose should not exceed 13.5 mg/9 hours. The maximum recommended dose in end stage renal disease (GFR < 15 mL/min/1.73 m 2 ) patients is 9 mg/9 hours [see USE IN SPECIFIC POPULATIONS (8.6) ]. 2.6 Dosage Modification due to Drug Interactions Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines. Acidifying agents (e.g., ascorbic acid) decrease blood levels; adjust XELSTRYM dosage based on clinical response [see DRUG INTERACTIONS (7.1) ].

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling Known hypersensitivity to amphetamine products or other ingredients of XELSTRYM [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 to Patients with Serious Cardiac Disease [see WARNINGS AND PRECAUTIONS (5.2) ] Increased Blood Pressure and Heart Rate [see WARNINGS AND PRECAUTIONS (5.3) ] Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS (5.4) ] Long-Term Suppression of Growth in Pediatric Patients [see WARNINGS AND PRECAUTIONS (5.5) ] Peripheral Vasculopathy, including Raynaud's phenomenon [see WARNINGS AND PRECAUTIONS (5.6) ] Serotonin Syndrome [see WARNINGS AND PRECAUTIONS (5.7) ] Contact Sensitization [see WARNINGS AND PRECAUTIONS (5.8) ] Application Site Reactions [see WARNINGS AND PRECAUTIONS (5.9) ] Use of External Heat [see WARNINGS AND PRECAUTIONS (5.10) ] Motor and Verbal Tics, and Worsening of Tourette’s Syndrome [see WARNINGS AND PRECAUTIONS (5.11) ] Most common adverse reactions (incidence ≥2% and greater than the rate for placebo) in pediatric patients 6 to 17 years treated with XELSTRYM were decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, blood pressure increased, and heart rate increased ( 6.1 ) Most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) in adults treated with lisdexamfetamine were decreased appetite, insomnia, dry mouth, diarrhea, nausea, and anxiety ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Noven Therapeutics, LLC at 1-877-567-7857 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. The safety of XELSTRYM for the treatment of ADHD in adults and pediatric patients 6 to 17 years is based on a study with XELSTRYM in pediatric patients (presented below) and adequate and well-controlled studies of lisdexamfetamine in adult and pediatric patients with ADHD. XELSTRYM was studied in pediatric patients 6 to 17 years with ADHD. The safety data are from a 7-week study including a 5-week open-label dose optimization phase (n=110) followed by a 2-week randomized, parallel-group, crossover, placebo-controlled double-blind treatment phase (n=105) [see CLINICAL TRIALS (14) ] . Adverse Reactions Leading to Discontinuation of Treatment In the dose-optimization phase (no placebo comparator in this phase), 2.7% (3/110) of patients treated with XELSTRYM discontinued due to adverse reactions. These adverse reactions reported in one patient each were abdominal pain (0.9%), irritability (0.9%) and decreased appetite (0.9%). There were no discontinuations due to adverse reactions during the double-blind phase. Adverse Reactions Occurring at an Incidence of 5% or More in XELSTRYM Treated Pediatric Patients Ages 6 to 17 Years During Dose-optimized Treatment Adverse reactions (incidence of ≥ 5%) that occurred during the dose-optimization phase of the clinical study include: decreased appetite (54%), insomnia 1 (32%), headache (21%), irritability (16%), abdominal pain 2 (16%) affect lability 3 (16%), application site pain 4 (13%), nausea (9%), application site pruritus (7%), and fatigue (5%). 1 insomnia includes insomnia, delayed sleep phase, initial insomnia, middle insomnia, and terminal insomnia 2 abdominal pain includes abdominal pain and abdominal pain upper 3 affect lability includes affect lability, emotional disorder, mood swings, and mood altered 4 application site pain includes application site pain and application site burn Adverse Reactions Occurring at an Incidence of 2% or More of XELSTRYM-Treated Pediatric Patients Ages 6 to 17 Years During Double-blind Treatment Adverse reactions (incidence of ≥ 2% and incidence greater than placebo) that occurred during the double-blind, placebo-controlled phase of the clinical study are shown in Table 1 . Table 1: Adverse Reactions Reported by ≥ 2% of Pediatric Patients 6 to 17 Years with ADHD Receiving XELSTRYM and Greater Incidence Than Placebo in the Double-Blind Phase * The following terms were combined: Insomnia includes insomnia, delayed sleep phase, initial insomnia, middle insomnia, and terminal insomnia Abdominal pain includes abdominal pain and abdominal pain upper Blood pressure increased includes blood pressure increased and blood pressure systolic increased Heart rate increased includes heart rate increased and tachycardia System Organ Class Preferred Term XELSTRYM All Doses (n = 105) % Placebo (n = 105) % Metabolism and nutrition disorders Decreased appetite 12 2 Nervous system disorders Headache 6 4 Psychiatric disorders Insomnia* 8 6 Affect lability 3 0 Tic 2 0 Gastrointestinal Disorders Vomiting 4 0 Abdominal pain * 4 2 Nausea 3 1 General disorders and administration site conditions Irritability 2 1 Investigations/Cardiac Disorders Blood pressure increased * 2 1 Heart rate increased * 2 0 Application Site Reactions Based on daily patient diaries and dermal reaction scales at clinic assessments, local skin reactions were reported with XELSTRYM. During the wear time or immediately after removal of XELSTRYM, patients experienced pain, pruritus, burning sensation, erythema, discomfort, edema, and swelling. Patients who experienced discomfort and pain at the application site during the wear time reported resolution within 2 to 4 hours after XELSTRYM application. Most dermal irritation was limited to the site of application. All patients who reported application site reactions in the 7-week pediatric classroom study continued to use XELSTRYM, and there were no discontinuations from the study due to application site reactions. During the dose-optimization phase of the clinical study, 45% of patients reported application site discomfort associated with the use of XELSTRYM in daily patient diaries; 72% of patients reported discomfort at clinic visit assessments; and 13% of patients reported severe discomfort at clinic visit assessments. XELSTRYM 4.5 mg was the starting dose for all patients undergoing titration during the dose optimization phase and the majority of application site discomfort was reported at this starting dose. During the dose-optimization phase, 73% of patients reported application site irritation. Application site reactions that occurred during the double-blind phase of the clinical study are presented in Table 2 . Table 2: Summary Application Site Reactions During the Double-Blind Phase XELSTRYM n/N Placebo n/N Discomfort Reported in patient diaries 8/96 (8%) 8/98 (8%) Clinic assessments Any discomfort 72/104 (69%) 9/101 (9%) Severe discomfort 10/104 (10%) 4/101 (4%) Irritation Reported in patient diaries 64/103 (62%) 41/105 (39%) Reported at Clinic assessments 97/103 (94%) 55/101 (54%) Weight Loss and Slowing Growth Rate In a 7-week trial of XELSTRYM with a 5-week dose optimization phase and a 2-week crossover placebo-controlled phase in pediatric patients ages 6 to 17 years, patients had a mean weight loss from baseline of -3.1 pounds after 5 weeks of XELSTRYM. Leukopenia and Neutropenia In the 2-week crossover phase of the 7-week trial of XELSTRYM in pediatric patients ages 6 to 17 years, shifts in WBCs from normal to low occurred in 10% of patients treated with XELSTRYM and 2% of patients treated with placebo. Shifts in neutrophils from normal to low occurred in 14% of patients treated with XELSTRYM and 6% of patients treated with placebo. Weight Loss and Slowing Growth Rate in Pediatric Patients with ADHD with Lisdexamfetamine and Other Stimulants Lisdexamfetamine The long-term safety of XELSTRYM for the treatment of ADHD relies on information from adequate and well-controlled studies of lisdexamfetamine. In a controlled trial of lisdexamfetamine in pediatric patients 6 to 12 years, 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, compared to 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 6 to 12 years who received lisdexamfetamine 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 in pediatric patients 13 to 17 years, mean weight loss from baseline to endpoint was -2.7, -4.3, and -4.8 pounds, respectively, for patients receiving 30 mg, 50 mg, and 70 mg of lisdexamfetamine, compared to a 2 pound weight gain for patients receiving placebo. Other CNS stimulants Careful follow-up of weight and height in pediatric patients 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 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- and l-enantiomer ration of 3:1) in pediatric patients 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) ] . Clinical Trials Experience in Adult Patients with ADHD Treated with Lisdexamfetamine Adverse Reactions Associated with Discontinuation of Treatment in Adult ADHD Clinical Trials In a controlled trial of lisdexamfetamine in adults with ADHD, 6% (21/358) of lisdexamfetamine-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia and restlessness. Adverse Reactions Occurring at an Incidence of ≥5% or More Among Lisdexamfetamine-Treated Patients with ADHD in Clinical Trials The most common adverse reactions (incidence ≥5% and at a rate at least twice placebo) were: Decreased appetite, insomnia, dry mouth, diarrhea, nausea, and anxiety. In addition, in the adult population, erectile dysfunction was observed in 2.6% of males on lisdexamfetamine and 0% on placebo; decreased libido was observed in 1.4% of subjects on lisdexamfetamine and 0% on placebo. Weight Loss in Adults with ADHD In a controlled adult trial of lisdexamfetamine, mean weight loss after 4 weeks of therapy was 2.8 pounds, 3.1 pounds, and 4.3 pounds, for patients receiving final doses of 30 mg, 50 mg, and 70 mg of lisdexamfetamine, respectively, compared to a mean weight gain of 0.5 pounds for patients receiving placebo. Adverse Reactions with Other Amphetamine Products in Pediatric Patients and Adults with ADHD Cardiac Disorders: Palpitations, tachycardia, and chest pain. Gastrointestinal Disorders: Dry mouth, abdominal pain upper, dyspepsia, diarrhea, constipation, vomiting, nausea, and tooth disorder (e.g., teeth clenching, tooth infection). General Disorders and Administration Site Conditions: Asthenia, fatigue, pyrexia, and feeling jittery. Infections and Infestations: Infection, urinary tract infection. Injury, Poisoning, and Procedural Complications: Accidental injury. Investigations: Weight decreased, blood pressure increased, and ECG voltage criteria for ventricular hypertrophy. Metabolism and Nutrition Disorders: Loss of appetite. Musculoskeletal and Connective Tissue Disorders: Muscle twitching, growth retardation. Nervous System Disorders: Somnolence, insomnia, tremor, dizziness, headache, tics, speech disorder (e.g., stuttering, excessive speech), psychomotor hyperactivity, and agitation. Psychiatric Disorders: Depression, anxiety, dermatillomania, mood swings, anger, affect lability, logorrhea, irritability, nervousness, paranoia, and restlessness. Reproductive System and Breast Disorders: Impotence, libido decreased, erectile dysfunction, and dysmenorrhea. Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea, rhinitis allergic. Skin and Subcutaneous Tissue Disorders: Rash, photosensitivity reaction, and hyperhidrosis. Vascular Disorders: Hypertension, epistaxis. 6.2 Postmarketing Experience 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 always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders: Palpitations, chest pain, sudden death, and myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Eye Disorders: Vision blurred, diplopia, difficulties with visual accommodation, and mydriasis. Gastrointestinal Disorders: Dysgeusia, constipation, intestinal ischemia, and other gastrointestinal disturbances. Hepatobiliary Disorders: Eosinophilic hepatitis. Immune System Disorders: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylactic reaction. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, have been reported. Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis. Nervous System Disorders: Seizures, overstimulation, restlessness, dyskinesia, tremor, motor and verbal tics, and paresthesia (including formication). Psychiatric Disorders: Psychotic episodes at recommended doses, depression, logorrhea, aggression, anger, dermatillomania, bruxism, dysphoria, euphoria, and irritability. Reproductive System and Breast Disorders: Impotence, changes in libido, and frequent or prolonged erections. Skin and Subcutaneous Tissue Disorders: Alopecia. Vascular Disorders: Raynaud's phenomenon.

7 DRUG INTERACTIONS Acidifying and Alkalinizing Agents: Agents that alter GI and urinary pH can alter blood levels of amphetamine. Acidifying agents can decrease amphetamine blood levels, while alkalinizing agents increase amphetamine blood levels ( 2.7 , 7.1 ) 7.1 Drugs Having Clinically Important Interactions with Amphetamine Table 3: Drugs Having Clinically Important Interactions with Amphetamines MAO Inhibitors (MAOI) Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamine’s 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 XELSTRYM during or within 14 days following the administration of MAOI [see CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.7) ]. Serotonergic Drugs Clinical Impact The concomitant use of XELSTRYM 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 XELSTRYM initiation or dosage increase. If serotonin syndrome occurs, discontinue XELSTRYM and the concomitant serotonergic drug(s) [see WARNINGS AND PRECAUTIONS (5.7) ] . CYP2D6 Inhibitors Clinical Impact The concomitant use of XELSTRYM and CYP2D6 inhibitors may increase the exposure of XELSTRYM 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 XELSTRYM initiation and after a dosage increase. If serotonin syndrome occurs, discontinue XELSTRYM 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 XELSTRYM 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 dextroamphetamine in the brain; cardiovascular effects can be potentiated. Intervention Monitor frequently and adjust or use alternative therapy based on clinical response. 7.2 Drugs Having No Clinically Important Interactions with Amphetamine From a pharmacokinetic perspective, no dose adjustment of XELSTRYM is necessary when XELSTRYM is co-administered with guanfacine, venlafaxine, or omeprazole. In addition, no dose adjustment of guanfacine or venlafaxine is needed when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ]. From a pharmacokinetic perspective, no dose adjustment for drugs that are substrates of CYP1A2 (e.g. theophylline, duloxetine, melatonin), CYP2D6 (e.g. atomoxetine, desipramine, venlafaxine), CYP2C19 (e.g. omeprazole, lansoprazole, clobazam), and CYP3A4 (e.g. midazolam, pimozide, simvastatin) is necessary when XELSTRYM is co-administered [see CLINICAL PHARMACOLOGY (12.3) ].

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied XELSTRYM (dextroamphetamine) transdermal system is a translucent product with a printed backing on one side and a release liner on the other packaged in an individual pouch supplied as: 4.5 mg/9 hours transdermal system (system size: 4.76 cm 2 ) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0205-3 9 mg/9 hours transdermal system (system size: 9.52 cm 2 ) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0210-3 13.5 mg/9 hours transdermal system (system size: 14.29 cm 2 ) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0215-3 18 mg/9 hours transdermal system (system size: 19.05 cm 2 ) Carton of 30 transdermal systems, each transdermal system is packaged in an individual pouch NDC 68968-0220-3 Storage and Handling Store at 68°F to 77° F (20°C to 25° C); excursions permitted between 15°C to 30° C (59 to 86° F) [see USP Controlled Room Temperature]. Protect from light. Store XELSTRYM in the individual sealed pouch until use. Apply immediately upon removal from the protective pouch.