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Strattera® (atomoxetine) capsules

10, 18, 25, 40, 60, 80, and 100 mg capsules

Frequently asked questions

 

How does Strattera work?

Mechanism of Action

Based on preclinical data, Strattera is a selective norepinephrine reuptake inhibitor that selectively blocks the presynaptic norepinephrine reuptake transporter. Strattera increases norepinephrine concentration in the synaptic cleft and enhances the forward neurotransmission of norepinephrine. The precise mechanism by which Strattera produces its therapeutic effects in ADHD is unknown.

In vivo preclinical studies in the rat brain investigated the mechanism of action of Strattera and its interaction with monoamine transporters, the effects of extraneuronal norepinephrine levels, and the localization of the effects of Strattera in the rat brain. Based on radioligand binding studies, Strattera provided selective inhibition of norepinephrine reuptake and did not demonstrate selectivity for the serotonin or dopamine reuptake transporters.

In the prefrontal cortex, norepinephrine transporters are numerous compared with dopamine transporters, and dopamine is nonselectively taken up by norepinephrine transporters. The norepinephrine transporter has similar affinities for norepinephrine and dopamine, which may allow dopamine to diffuse transsynaptically through norepinephrine transporters. Strattera significantly increased norepinephrine and dopamine concentrations in the prefrontal cortex. Strattera did not increase dopamine in the nucleus accumbens and striatum, which are dopamine- and dopamine transporter-rich areas.

Please click here for a visual representation.

Nonstimulant

Strattera is a non-stimulant ADHD medication. Strattera is a non-controlled substance and lacks significant potential for abuse. There was no evidence of symptom rebound or adverse reactions suggesting a drug discontinuation or withdrawal syndrome. In a randomized, double-blind, placebo-controlled, abuse-potential study in adults comparing the effects of Strattera and placebo, Strattera was not associated with a pattern of response that suggested stimulant or euphoriant properties.

References

Bymaster FP, et al. Neuropsychopharmacol. 2002;27(5):699-711. 
Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company. 

 

Who are the right patients for Strattera and what are the response rates?

Indication

Strattera is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 and older, adolescents, and adults. The efficacy of Strattera was established in seven clinical trials in outpatients with ADHD: four 6- to 9-week trials in pediatric patients (ages 6-18), two 10-week trials in adults, and one maintenance trial in pediatrics (ages 6-15). Strattera is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome.

Response Rate

Strattera is a non-stimulant, non-scheduled medication that lacks potential for abuse.  Strattera meets many individuals’ needs for treatment of ADHD. Approximately 50% (adults) to 60% (children/adoelscents) of patients with ADHD demonstrate a response to treatment with Strattera.

In adult and child/adolescent patients with ADHD and comorbid anxiety, there is no worsening of anxiety with Strattera.  In children and adolescents with ADHD and comorbid Tourette’s Disorder, there is no worsening of tics with Strattera.

For adults, response rates are based on 2 separate registration studies that were large, parallel, randomized, double-blind, placebo-controlled trials to assess efficacy in adult outpatients with ADHD over 10 weeks. The primary outcome measure in both studies was a repeated measures analysis of the Conners’ Adult ADHD Rating Scale (CAARS)( Study 1, p=.004; Study 2, p<.001. Response was defined as a 25% or more reduction in CAARS-Inv:SV Total ADHD Symptom Score.

For children/adolescents (ages 6-18 years), response rates are based on results from 6 double-blind and placebo-controlled studies that ranged from 6-9 weeks. The primary endpoint was change from baseline on ADHD-RS Total Score in each study. Response was defined as a 25% or more reduction in ADHD-RS-IV-Parent:Inv Total Score in 6 pooled studies. Each study individually also showed approximately 60% of patients responded, based on 25% or more reduction.

References

Data on file, Lilly Research Laboratories, STR20081007a.
Data on file, Lilly Research Laboratories, STR20081007e.
Data on file, Lilly Research Laboratories, STR20110526d.
Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company.
Michelson D, et al. Pediatrics. 2001;108(5):E83.
Spencer T, et al. J Clin Psychiatry. 2002;63(12):1140-1147.
Michelson D, et al. Am J Psychiatry. 2002;159(11):1896-1901.
Kelsey D, et al. Pediatrics. 2004;114(1):e1-e8.
Block SL, et al. Clin Pediatr (Phila). 2009;48(7):723-733.
Geller D, et al. J Am Acad Child Adolesc Psychiatry. 2007;46(9):1119-1127.
Michelson D, et al. Biol Psychiatry. 2003;53(2):112-120.
Adler L, et al. Journal of ADHD & Related Disorders. 2010;1(3):5-15.
Adler LA, et al. J Clin Psychopharmacol. 2009;29(1):44-50.

 

How does Strattera work for patients with ADHD and comorbid anxiety disorder?

Adult

Approximately 29% of adults with ADHD have comorbid social anxiety disorder. Strattera improved ADHD symptoms in adults with ADHD and comorbid social anxiety disorder as measured by CAARS-Inv:SV Total ADHD Symptoms Score. Strattera did not worsen anxiety in patients with ADHD and comorbid social anxiety disorder.

This was a Phase 4, multicenter, randomized, double-blind, parallel-design, placebo-controlled study in adults with ADHD and comorbid social anxiety. Following an initial 2‐week medication washout and evaluation period, patients entered a 2‐week placebo lead‐in phase. Patients who maintained the initial severity criteria required for study entry were randomized to receive Strattera or placebo for a 14‐week period. Patients began treatment with 40 mg/day for a minimum of 7 days, followed by 80 mg/day, the target dose, for a minimum of 7 days. At week 10 or after, patients with significant residual symptoms could have their dose increased to a maximum of 100 mg/day. Active medication was given twice a day. The primary outcome measure was a last observation carried forward analysis of mean change from baseline on the Conners’ Adult ADHD Rating Scale Total ADHD Symptoms Score (CAARS; P<.001). Mean daily  dose was 83 mg/day ± 19.5 mg/day.

Patients with a >25% reduction in anxiety symptoms as measured on the Liebowitz Social Anxiety Scale Total Score while on placebo (during the blinded placebo lead-in period) were excluded from primary analyses to mitigate placebo response. Only patients with a ≤25% reduction in LSAS Total Score were included in analysis of CAARS Total ADHD Symptoms Score.

There have been postmarketing reports of anxiety. Of the 413 patients who completed the double-blind placebo lead-in, 149 (36.1%) patients discontinued the study (Strattera, n=82; placebo, n=67). Discontinuation due to adverse events included 22 patients receiving Strattera and 13 patients receiving placebo.

The response rate was significantly higher for Strattera than for placebo (41.5% vs 26.0%, P<.01). Response was defined as ≥30% reduction from baseline on CAARS-Inv:SV Total ADHD Symptoms Score.

Children/Adolescents

Research suggests about 25% to 35% of children with ADHD have comorbid anxiety disorders.  Strattera improved ADHD symptoms in children and adolescents with ADHD and comorbid anxiety disorders as measured by ADHD-RS Total Score. Strattera did not worsen anxiety in patients with ADHD and comorbid anxiety disorders.

These findings are based upon a multicenter, randomized, double-blind, placebo-controlled study in children and adolescents (ages 8-17) with ADHD and at least one of the following anxiety disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia. Active medication was given twice daily. After an initial 2-week screening period, patients entered a 2‐week placebo lead-in phase followed by randomization to Strattera or placebo for 10 weeks. Patients began treatment at 0.8 mg/kg/day for 3 days and increased to a target dose of 1.2 mg/kg/day. At visit 6, the dose could be increased to 1.8 mg/kg/day for residual ADHD symptoms. The final dose range was 0.8-1.8 mg/kg/day (maximum total daily dose of 120 mg, regardless of weight). No additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day. The total daily dose in children and adolescents up to 154 lb (70 kg) should not exceed 1.4 mg/kg/day or 100 mg, whichever is less. The maximum recommended total daily dose in children and adolescents over 154 lb (70 kg) is 100 mg. Median dose was 1.3 mg/kg/day ± 0.29 mg/kg/day. Co-primary efficacy measure was a last observation carried forward analysis of change from baseline to endpoint on the ADHD-RS Total Score (P<.001) after approximately 12 weeks of treatment.

The response rate was significantly higher for Strattera than for placebo (61.8% vs. 12.1%; P<.001). Response was defined as ≥25% reduction from baseline on ADHD-RS-IV Total Score. Patients with a >25% reduction in Pediatric Anxiety Rating Scale Total Score on placebo (during the blinded placebo lead-in period) were excluded from primary analyses to mitigate placebo response. Only patients with a baseline and at least one post-baseline measure and a ≤25% reduction on the PARS Total Score during the blinded placebo lead-in were included in analysis of ADHD-RS-IV.

There have been post-marketing reports of anxiety. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Of the 158 patients who completed the double-blind placebo lead-in, 26 (16%) patients discontinued the study1,2 (Strattera, n=12; placebo, n=14). Discontinuation due to adverse events included 1 patient receiving Strattera and 1 patient receiving placebo.

References

Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company.
Adler LA, et al. Depress Anxiety. 2009;26(3):212-221.
Adler L, et al. Journal of ADHD & Related Disorders. 2010;1(3):5-15.
Kessler RC, et al. Am J Psychiatry. 2006;163(4):716-723.
Geller D, et al. J Am Acad Child Adolesc Psychiatry. 2007;46(9):1119-1127.
Biederman J, et al. Am J Psychiatry. 1991;148(5):564-577.
MTA Cooperative Group. Arch Gen Psychiatry. 1999;56(12):1073-1086.

 

How should Strattera be titrated, dosed, and tapered?

Recommended Titration and Dosing

Strattera can be dosed once (QD) or twice daily (BID). In adults, to minimize possible nausea, Strattera may be taken BID (morning and late afternoon/early evening). In children, to minimize possible nausea and/or fatigue, the time of day that Strattera is taken can be adjusted (eg., evening instead of morning).

For adults, start daily dose at 40 mg and increase after a minimum of 3 days to a target daily dose of approximately 80 mg, administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. The maximum daily dose in adults is 100 mg/day. There are no data that support increased effectiveness at higher doses.

Please click here to learn more about dosing Strattera for Adults from a thought leader.

For children and adolescents up to 154 lb (70 kg) body weight, start total daily dose at 0.5 mg/kg and increase after a minimum of 3 days to a target daily dose of 1.2 mg/kg, administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. The maximum dose in children and adolescents up to 154 lb (70 kg) is 1.4 mg/kg/day or 100 mg/day, whichever is less. No additional benefits have been demonstrated for doses higher than 1.2 mg/kg/day in children and adolescents up to 154 lb (70 kg).

For children and adolescents over 154 lb (70 kg) body weight, start daily dose at 40 mg and increase after a minimum of 3 days to a target daily dose of approximately 80 mg, administered either as a single daily dose in the morning or as evenly divided doses in the morning and late afternoon/early evening. The maximum recommended total daily dose in children and adolescents over 154 lb (70 kg) is 100 mg. No additional benefits have been demonstrated for doses higher than 100 mg/day in children and adolescents over 154 lb.

It is generally agreed that pharmacological treatment of ADHD may be needed for extended periods. The maintenance dose is generally a continuation of the therapeutic dose in the acute phase. The physician who elects to use Strattera for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

In special populations (eg, hepatically impaired patients, those receiving strong CYP2D6 inhibitors, or those who are known to be poor CYP2D6 metabolizers), adjustments (lower) to normal doses and/or dosing regimens for Strattera should be made.

Strattera can be taken with or without food. Strattera capsules are not intended to be opened, and Strattera is an ocular irritant.

Tapering

Strattera can be discontinued without being tapered in both adults and children.
For adults, this finding is based upon combined data from 2 registration trials in adults. Four weeks after discontinuation from Strattera, there was an increase in the mean CAARS Total Score in patients who had initially received Strattera, but the increase was not statistically significant (P=.123), and for no group did the scores exceed baseline scores. Patients retained approximately 50% of their original symptom reductions after 4 weeks. There was no evidence of a rebound effect or with increased adverse events.

The primary efficacy measure in both studies was a repeated measures analysis of mean change from baseline on the CAARS Total Score (Study 1, p=.004; Study 2, p<.001). Results are included for all adults who completed the discontinuation phase of the study. The 2 identical double-blind studies  involved a 1-week initial evaluation/washout period followed by a 2-week placebo lead-in phase. Patients were randomized into 10 weeks of double-blind treatment with either Strattera or placebo, followed by a 4-week discontinuation phase. This was a twice-daily dosing study. Dosing was initiated at 60 mg/day and increased based on clinical response to a maximum of 120 mg/day. Mean final dose for the acute treatment phase was approximately 95 mg/day. Note that the maximum recommended total daily dose in adults is 100 mg. There are no data that support increased effectiveness at higher doses.

Treatment differences in mean change scores were assessed using an analysis of variance. Change from the last observation during the acute treatment phase to the last observation during the discontinuation phase was computed using a last observation carried forward (LOCF) approach. A similar LOCF approach was used for computing changes form the pretreatment acute phase to the end of the acute treatment phase.

For children, this finding is based upon combined data from 2 registration trials in children ages 7 to 13 years. One week after an abrupt discontinuation, there was a modest but statistically significant increase in the mean ADHD-RS score in patients who had initially received Strattera (P<.001) that did not exceed pretreatment baseline values. Patients retained approximately 60% of their original symptom reductions after 1 week. There was no evidence of a rebound effect.

The primary efficacy measure in both studies was analysis of last observation carried forward change from baseline to endpoint on the ADHD-RS-IV-Parent:Inv Total Score3 (Study 1, P<.001; Study 2, P<.001). Results are included for all children who completed the discontinuation phase of the study. These were identical double-blind studies, which involved a 2-week evaluation/washout period followed by approximately 9 weeks of double-blind treatment followed by 1 week of discontinuation. The mean final dose of acute treatment phase was approximately 1.6 mg/kg/day. Note that no additional benefit has been demonstrated for doses higher than 1.2 mg/kg/day; the total daily dose in children and adolescents up to 154 lb (70 kg) should not exceed 1.4 mg/kg or 100 mg, whichever is less; and, the maximum recommended total daily dose in children and adolescents over 154 lb (70 kg) is 100 mg.

Treatment differences in mean change scores were assessed using an analysis of variance. Change from the last observation during the acute treatment phase to the last observation during the discontinuation phase was computed using a last observation carried forward (LOCF) approach. A similar LOCF approach was used for computing changes form the pretreatment acute phase to the end of the acute treatment phase.

References

Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company.
Adler L, et al. Annals of Clin Psych. 2006;18(2):107‐113.
Block SL, et al. Clin Pediatr (Phila). 2009;48(7):723-733.
Wernicke JF, et al. J Clin Psychopharmacol. 2004;24(1):30-35.
Spencer T, et al. J Clin Psychiatry. 2002;63(12):1140-1147.
Michelson D, et al. Biol Psychiatry. 2003;53(2):112-120.
Data on File STR20110526d

 

What expectations should I set for my patients in regard to Strattera treatment, including when efficacy should be assessed, and what common adverse events could occur?

Common Adverse Events

In adults, the most common adverse events vs. placebo reported in clinical trials were nausea (26% vs. 6%), dry mouth (20% vs. 5%), decreased appetite (16% vs. 3%), erectile dysfunction (8% vs. 1%), dizziness (8% vs. 3%), constipation (8% vs. 3%), and urinary hesitation (6% vs. 1%).

In children and adolescents, the most common adverse events vs. placebo reported in clinical trials were decreased appetite (16% vs. 4%), somnolence (11% vs. 4%), nausea (10% vs. 5%), fatigue (8% vs. 3%), irritability (6% vs. 3%), and dizziness (5% vs. 2%).

These data are based upon adverse events reported in at least 5% of patients and twice the rate of placebo in clinical trials.

Efficacy Assessment Timing

While small changes in ADHD symptoms may be noticeable within the first 2 weeks, marked efficacy may take up to 4-6 weeks at target dose:  1.2 mg/kg/day for children and adolescents up to 154 lb (70 kg) body weight; 80 mg/day for children and adolescents over 154 lb (70 kg) body weight and for adults.

Evaluate efficacy throughout 4-6 weeks at target dose, increasing the dose after 2-4 weeks if optimal response is not occurring. Wait to make a final assessment of effectiveness until after 4-6 weeks at target dose.

To optimize response, as tolerated, doses can be increased after 2-4 weeks up to the maximum dose:  children and adolescents up to 154 lb (70 kg) is 1.4 mg/kg/day or 100 mg/day, whichever is less; the maximum dose in in children and adolescents over 154 lb (70 kg) and adults is 100 mg/day.

Be certain that patients have been on an adequate dose for an appropriate length of time before evaluating response to therapy.

Efficacy Assessment

Because Strattera demonstrates gradual improvement, it is important to select a few impairments that seem to be most concerning to patients and evaluate them over time. Be sure that goals are something that can be measured and are age appropriate. Remember that improvement may take 4-6 weeks after reaching target dose. Your patient can utilize our Progress Tracker as a tool to keep track of their changes during treatment.

Rating scales and other tools can be helpful at baseline and over time because patients on Strattera experience a gradual effect and may not notice the improvement in the impairment severity and may not report improvement to the clinician.

At each step along the treatment path an important question is “Are we there yet?” This question has multiple aspects including: Has the optimal therapeutic dose and dosing regimen been achieved? Are patients actively sharing in the setting and understanding of treatment goals? Are you, as a physician, able to quantifiably document treatment status over time?

An ADHD diagnosis is based on symptoms, but for patients it is the impairments that characterize their disorder. Therefore, it is important that patients be active partners in their treatment, and an important aspect of that partnership is the setting of realistic goals and time frames for achieving those goals.

Length of Effect

Enduring efficacy with Strattera has been demonstrated in children, adolescents, and adults.  Daily dosing of Strattera has been shown to provide 24-hour efficacy in children, and efficacy into the evening hours in adults.  Strattera has been shown to provide maintenance treatment of ADHD in children and adolescents 6-15 years of age, and Strattera has been shown to provide ADHD symptom reduction over 6 months in adults.

References

Strattera [package insert]. Indianapolis, IN: Eli Lilly and Company.
Block SL, et al. Clin Pediatr (Phila). 2009;48(7):723-733.
Spencer T, et al. J Clin Psychiatry. 2002;63(12):1140-1147.
Michelson D, et al. Am J Psychiatry. 2002;159(11):1896-1901.
Michelson D, et al. Biol Psychiatry. 2003;53(2):112-120.
Adler LA, et al. J Clin Psychopharmacol. 2009;29(1):44-50.
Barkley RA. Attention-Deficit Hyperactivity Disorder: A Handbook for Diagnosis and Treatment. 3rd ed. New York, NY: The Guilford Press; 2006:697-698, 706, and 725.
Pliszka S, AACAP Work Group on Quality Issues. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
Post RE, Kurlansik SL. Am Fam Physician. 2012;85(9):890-896.
American Academy of Pediatrics. Pediatrics. 2011;Suppl:SI1-SI21.
Rader R, et al. Am Fam Physician. 2009;79(8):657-665.
Adler L, Florence M. Scattered Minds. New York, NY: Penguin Group (USA) Incorporated; 2006:123, 142.
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders - Text Revision. 4th ed. Washington, DC: American Psychiatric Association; 2000:85-93.

 

How do I access savings cards for my patients, what does the card provide, and how does it work?

You can access the Strattera Savings Card in two ways:
1. If you have a Lilly rep, they should be able to provide the Strattera Savings Card to you
OR
2. You can direct your patients to download the Strattera Savings Card on our website*

The Strattera Savings Card provides a 30-day Free  Offer, allowing patients to get their first month’s prescription for FREE; and, the offer allows patients to save as little as $25 per month, with a maximum savings of $75 per month, for 11 months.

Once downloaded, the patient will have instructions to activate and use the card.

The Strattera Savings Card offer is invalid for patients whose prescription claims are eligible to be reimbursed, in whole or in part, by any governmental program. Offer void where prohibited by law. This offer is invalid for patients without commercial insurance coverage or those whose prescription claims for STRATTERA are eligible to be reimbursed, in whole or in part, by any governmental program, including, without limitation, Medicaid, Medicare, Medicare Part D, Medigap, DOD, VA, TRICARE/CHAMPUS, or any State Patient or Pharmaceutical Assistance Program. If you live in Massachusetts, the Card expires on the earlier of: (i) the expiration date of this Card (5/26/2017) or (ii) the date an AB rated generic equivalent for STRATTERA becomes available. Available only in the US and Puerto Rico for residents of the US and Puerto Rico. By accepting this offer, you agree that if you are required to do so under the terms of your insurance coverage for this prescription or are otherwise required to do so by law, you should notify your insurance carrier of your redemption of this Card. This offer is not valid with any other program, discount, incentive, or similar offer involving STRATTERA. It is prohibited for any person to sell, purchase, or trade; or to offer to sell, purchase or trade, or to counterfeit this Card. This offer may be terminated, rescinded, revoked or amended by Lilly USA, LLC at any time without notice. This Card is not health insurance. This Card expires on May 26, 2017.

*Adults and children who have a prescription for Strattera may use the Savings Card, but they must be 18 or older to download and activate it

 

What formulary access does Strattera have, and how do I learn about access for my patients?

Strattera is available to more than 90% of commercially insured patients in the United States. Please contact your patient’s insurance company for information specific to their plan.

Indications and Important Safety Information for STRATTERA® (atomoxetine) capsules 

Indications

Strattera is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). The efficacy of Strattera was established in seven clinical trials in outpatients with ADHD: four 6- to 9-week trials in pediatric patients (ages 6-18), two 10-week trials in adults, and one maintenance trial in pediatrics (ages 6-15). Strattera is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. 

Important Safety Information & Boxed Warning
 

Suicidal Ideation in Children and Adolescents

Strattera (atomoxetine) increased the risk of suicidal ideation in short-term studies in children or adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Anyone considering the use of Strattera in a child or adolescent must balance this risk with the clinical need. Co-morbidities occurring with ADHD may be associated with an increase in the risk of suicidal ideation and/or behavior. Patients who are started on therapy should be monitored closely for suicidality (suicidal thinking and behavior), clinical worsening, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and timely communication with the prescriber if changes in thoughts or behaviors occur. Strattera is not approved for major depressive disorder.

Pooled analyses of short-term (6 to 18 weeks) placebo-controlled trials of Strattera in children and adolescents (a total of 12 trials involving over 2200 patients, including 11 trials in ADHD and 1 trial in enuresis) have revealed a greater risk of suicidal ideation early during treatment in those receiving Strattera compared to placebo. The average risk of suicidal ideation in patients receiving Strattera was 0.4% (5/1357 patients), compared to none in placebo-treated patients (851 patients). No suicides occurred in these trials.


Contraindications

Warnings and Precautions

Most Common Adverse Reactions*

* In clinical trials, adverse events reported in at least 5% of patients and twice the rate of placebo.

Use in Specific Populations

AT HCP ISI 27Sep2013

Please see Prescribing Information, including Boxed Warning regarding suicidal ideation in children and adolescents, and 
Medication Guide.

Indications and Important Safety Information for STRATTERA® (atomoxetine) capsules

WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS
See Important Safety Information for Full Boxed Warning.

  • Increased risk of suicidal ideation in children or adolescents
  • No suicides occurred in clinical trials
  • Patients started on therapy should be monitored closely