Loading…
XELSTRYM is a brand name for Dextroamphetamine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's FDA label. Tap a section to expand.
5 mg/9 hours. 2 ) Adults: Recommended starting dose is 9 mg/9 hours. 3 ) Apply XELSTRYM to one of the following sites: hip, upper arm, chest, upper back or flank. 2) ] . 11) ] . 5 mg/9 hours. 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. 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. 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. 10) ] . 3) ] . 2) ] . 3) ] . 5 mg/9 hours. 6) ]. 6 Dosage Modification due to Drug Interactions Agents that alter urinary pH can impact excretion and alter blood levels of amphetamines.
1) ].
gov/medwatch. 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) ] .
7% (3/110) of patients treated with XELSTRYM discontinued due to adverse reactions. 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 .
3 ) Psychiatric Adverse Reactions: Prior to initiating XELSTRYM, screen patients for risk factors for developing a manic episode. 4 ) Long-Term Suppression of Growth in Pediatric Patients: Closely monitor growth (height and weight) in pediatric patients.
5 ) Peripheral Vasculopathy, including Raynaud’s phenomenon: Careful observation for digital changes is necessary during XELSTRYM treatment. , SSRIs, SNRIs, triptans), but also during overdosage situations. 7 , 10 ) Contact Sensitization: Use of XELSTRYM may lead to contact sensitization.
8 ) Application Site Reactions: During wear time or immediately after removal of XELSTRYM, local skin reactions may occur. 10 ) Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Before initiating XELSTRYM, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome.
Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome. 1 Abuse, Misuse, and Addiction XELSTRYM has a high potential for abuse and misuse. The use of XELSTRYM exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction.
2) ] . Misuse and abuse of CNS stimulants, including XELSTRYM, 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.
Before prescribing XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store XELSTRYM in a safe place, preferably locked, and instruct patients to not give XELSTRYM to anyone else.
Throughout XELSTRYM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. 2 Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.
4 CONTRAINDICATIONS XELSTRYM is contraindicated in patients: with known hypersensitivity to amphetamine products or other components of XELSTRYM. 1 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in United States of America? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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.
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 . 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.
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.
2, respectively). 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. 7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
8 pounds, respectively, for patients receiving 10 mg and 20 mg of amphetamine. 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.
4% of subjects on lisdexamfetamine and 0% on placebo. 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.
, 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. , 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. 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.
Avoid XELSTRYM use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. 3 Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm).
Monitor all XELSTRYM-treated patients for potential tachycardia and hypertension. 4 Psychiatric Adverse Reactions Exacerbation of Pre-existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Induction of a Manic Episode in Patients with Bipolar Disorder CNS stimulants may induce a manic or mixed episode in patients. , comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression).
, hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. 1% of CNS stimulant-treated patients compared to 0% of placebo-treated patients. If such symptoms occur, consider discontinuing XELSTRYM.
4) ]. CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in XELSTRYM-treated pediatric patients treated with CNS stimulants, including XELSTRYM.
In a 7-week trial with a dose-optimization phase and a placebo-controlled phase of XELSTRYM in pediatric patients 6 to 17 years old with ADHD, there was a mean decrease in weight while taking XELSTRYM. 1) ] . Pediatric patients not growing or gaining height or weight as expected may need to have their treatment interrupted.
4) ] . 6 Peripheral Vasculopathy, including Raynaud’s Phenomenon CNS stimulants, including XELSTRYM, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown.
Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post-marketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant.
Careful observation for digital changes is necessary during XELSTRYM treatment. , rheumatology referral) may be appropriate for XELSTRYM-treated patients who develop signs or symptoms of peripheral vasculopathy. 7 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.
1) ] . The co-administration with cytochrome P450 2D6 (CYP2D6) inhibitors may also increase the risk with increased exposure to XELSTRYM. 1) ] . , nausea, vomiting, diarrhea). Concomitant use of XELSTRYM with MAOI drugs is contraindicated [see CONTRAINDICATIONS (4) ] .
Discontinue treatment with XELSTRYM and any concomitant serotonergic agents immediately if symptoms of serotonin syndrome occur, and initiate supportive symptomatic treatment. If concomitant use of XELSTRYM with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate XELSTRYM with lower doses, monitoring patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.
8 Contact Sensitization Use of XELSTRYM may lead to contact sensitization (allergic contact dermatitis). Erythema is commonly seen with use of XELSTRYM and is not by itself an indication of sensitization. However, contact sensitization should be suspected if erythema is accompanied by evidence of a more intense local reaction (edema, papules, vesicles) that does not significantly improve within 48 hours or spreads beyond the application site.
Confirmation of a diagnosis of contact sensitization may require further diagnostic testing [see CONTRAINDICATION (4) ] . Manifestations of systemic sensitization may include a flare-up of previous dermatitis or of prior positive patch-test sites, or generalized skin eruptions in previously unaffected skin.
Other systemic reactions may include headache, fever, malaise, arthralgia, diarrhea, or vomiting. No cases of systemic sensitization have been observed in clinical trials of XELSTRYM. Patients who develop contact sensitization to XELSTRYM and require oral treatment with amphetamine should be initiated on oral medication under close medical supervision.
Discontinue XELSTRYM if contact sensitization is suspected. It is possible that some patients sensitized to amphetamine by exposure to XELSTRYM may not be able to take amphetamine in any form. 1) ] . Patients who experienced discomfort and/or pain during the wear time reported resolution within 2 to 4 hours after application.
The potential for application site reactions and increased skin irritation, discomfort or pain may occur with XELSTRYM if the same application site is used repeatedly. Patients should select a different application site each day to minimize skin reactions.
10 Use of External Heat When heat is applied to XELSTRYM after application, both the rate and extent of absorption are increased. 3) ]. , while wearing XELSTRYM. 11 Motor and Verbal Tics, and Worsening of Tourette’s Syndrome CNS stimulants, including amphetamine, have been associated with the onset or exacerbation of motor and verbal tics.
2) ] . Before initiating XELSTRYM, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor XELSTRYM-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.