Dosing You Can Adjust in Small Amounts

Low starting dose options and the ability to titrate within one prescription1

Concentration is 2.5 mg/mL amphetamine base

Before administering the dose, shake the bottle of DYANAVEL XR

Prior to treatment, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) and risk for abuse

After prescribing, keep prescription records, educate about and monitor for abuse and overdose, and re-evaluate the need for DYANAVEL XR use

Periodically re-evaluate the long-term use of DYANAVEL XR, and adjust dose as needed

 
 
 
 

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 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
During treatment with monoamine oxidase inhibitors (MAOIs) and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis
Prior to and during treatment assess for the presence of cardiac disease. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Prior to treatment, assess for the presence of bipolar disorder.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children 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 amphetamines are co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue all serotonergic agents 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. There is limited experience with DYANAVEL XR in controlled trials. Based on this limited experience, 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 6–12 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) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Please click here for Full Prescribing Information, including Boxed Warning regarding potential for Abuse and Dependence, and Medication Guide.

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 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
During treatment with monoamine oxidase inhibitors (MAOIs) and within 14 days following discontinuation of treatment with an MAOI because of the risk of hypertensive crisis
Prior to and during treatment assess for the presence of cardiac disease. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during DYANAVEL XR treatment.
CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychiatric illness. Prior to treatment, assess for the presence of bipolar disorder.
CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children 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 amphetamines are co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), MAOIs, and during overdosage situations. If it occurs, discontinue all serotonergic agents 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. There is limited experience with DYANAVEL XR in controlled trials. Based on this limited experience, 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 6–12 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) extended-release oral suspension is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Please click here for Full Prescribing Information, including Boxed Warning regarding potential for Abuse and Dependence, and Medication Guide.

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.