Most Common Adverse Reactions

Clinical Trial Experience1,3

Adverse Reaction Profile

There is limited experience with DYANAVEL XR (amphetamine) in controlled trials. Based on limited experience, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common adverse reactions observed with amphetamine products include dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.

5-Week Open-Label Dose Optimization Period:
DYANAVEL XR (N=107)

The most frequently occurring adverse events (>5%) included decreased appetite (26%); insomnia (13%); affect lability (9%); upper abdominal pain (8%); mood swings (6%); and headache (6%).

Double-Blind Phase 3 Controlled Study

Most common adverse reactions ≥2% in the DYANAVEL XR group and greater than placebo

DYANAVEL XR (N=52)

Placebo (N=48)

Epistaxis

4%

0%

Allergic rhinitis

4%

0%

Upper abdominal pain

4%

2%

1-week randomized, double-blind, placebo-controlled laboratory classroom assessment conducted in 108 children with ADHD (aged 6-12 years). Classroom assessment followed a 5-week, open-label dose-optimization period with DYANAVEL XR (amphetamine).

In the clinical trial, no patients discontinued from the study due to adverse events. No serious adverse events were reported. Most adverse events were classified as mild in intensity.

 
 
 
 

IMPORTANT SAFETY INFORMATION & INDICATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including DYANAVEL XR, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

DYANAVEL XR (amphetamine) is contraindicated
in patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported with other amphetamines
in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs, because of increased risk of hypertensive crisis
Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. They may induce a mixed/manic episode in patients with bipolar disorder. Assess for presence of bipolar disorder prior to initiating treatment. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing DYANAVEL XR.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR. Treatment may need to be interrupted in children not growing as expected.
CNS stimulants, including DYANAVEL XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.
Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
DYANAVEL XR use during pregnancy may cause fetal harm.
Breastfeeding is not recommended during treatment with DYANAVEL XR.
INDICATION

DYANAVEL XR (amphetamine) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Please see Full Prescribing Information, including Boxed Warning regarding Abuse and Dependence.

REFERENCES
1.
DYANAVEL XR [Prescribing Information]. Monmouth Junction, NJ: Tris Pharma Inc.; 2015.
2.
Data on File, FP102-0024, Tris Pharma Inc.
3.
Data on File, FP102-0001, Tris Pharma Inc.

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IMPORTANT SAFETY INFORMATION & INDICATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including DYANAVEL XR, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.

DYANAVEL XR (amphetamine) is contraindicated
in patients known to be hypersensitive to amphetamine, or other components of DYANAVEL XR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported with other amphetamines
in patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs, because of increased risk of hypertensive crisis
Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in pediatric patients with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
CNS stimulants cause increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for tachycardia and hypertension.
CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. They may induce a mixed/manic episode in patients with bipolar disorder. Assess for presence of bipolar disorder prior to initiating treatment. At recommended doses, stimulants may cause psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania, in patients without prior history of psychotic illness or mania. If such symptoms occur, consider discontinuing DYANAVEL XR.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD; monitor weight and height during treatment with DYANAVEL XR. Treatment may need to be interrupted in children not growing as expected.
CNS stimulants, including DYANAVEL XR, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with ADHD stimulants.
Serotonin syndrome risk is increased when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue DYANAVEL XR and any concomitant serotonergic agents immediately, and initiate supportive treatment.
Most common adverse reactions observed with amphetamine products: dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia. Based on limited experience with DYANAVEL XR in controlled trials, the adverse reaction profile of DYANAVEL XR appears similar to other amphetamine extended-release products. The most common (≥2% in the DYANAVEL XR group and greater than placebo) adverse reactions reported in the Phase 3 controlled study conducted in 108 patients with ADHD (aged 6 to 12 years) were: epistaxis (DYANAVEL XR 4%, placebo 0%), allergic rhinitis (4%, 0%) and upper abdominal pain (4%, 2%).
DYANAVEL XR use during pregnancy may cause fetal harm.
Breastfeeding is not recommended during treatment with DYANAVEL XR.
INDICATION

DYANAVEL XR (amphetamine) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Please see Full Prescribing Information, including Boxed Warning regarding Abuse and Dependence.

REFERENCES
1.
DYANAVEL XR [Prescribing Information]. Monmouth Junction, NJ: Tris Pharma Inc.; 2015.
2.
Data on File, FP102-0024, Tris Pharma Inc.
3.
Data on File, FP102-0001, Tris Pharma Inc.