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Proven safety and tolerability1

Safety was proven across multiple phase III clinical trials

Once-daily Qelbree shows no evidence of abuse potential in all pediatric and adult studies—minimizing risk of treatment abuse, misuse, or diversion1-3

Safety_Small

Adverse reactions in clinical studies1

The most common AEs* (≥ 5% and twice the rate of placebo) reported by children and adolescents ages 6-17 (n=1289)1

Placebo
(n=463)

Qelbree
(n=826)

 

Somnolence†

4%

16%

Decreased appetite

0.4%

7%

Fatigue

2%

6%

*The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

The most common AEs (≥ 5% and twice the rate of placebo) reported by adults ages 18 to 60 (N=372)2

Placebo
(n=183)

Qelbree
(n=189)

 

Insomnia†

7%

23%

Headache†

7%

17%

Fatigue

3%

12%

Nausea

3%

12%

Decreased appetite

3%

10%

Dry mouth

2%

10%

Somnolence†

2%

6%

Constipation

1%

6%

†The following items were combined:

  • Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia.
  • Headache: headache, migraine, migraine with aura, tension headache.
  • Somnolence: somnolence, lethargy, sedation.

Abbreviations: AEs, adverse events; TEAEs, treatment-emergent adverse events.

Because clinical trials are conducted under widely varying conditions, AE rates observed in 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.

Qelbree discontinuation rates1

 

Children and adolescents ages 6 to 17

Qelbree (viloxazine extended-release capsules) discontinuaiton rate for children and adolescents ages 6-17: 3% vs 1% placebo

Adults ages 18 to 60

Qelbree (viloxazine extended-release capsules) discontinuaiton rate for adults ages 18-65: 9% vs 5% placebo

Qelbree Safety Profile

  •   Viloxazine is unlikely to have a DDI with amphetamine or methylphenidate1
  •   No clinically relevant liver enzyme elevation2
  •   Treatment with Qelbree did not appear to have any influence on ECG2

Abbreviations: DDI, Drug-Drug Interaction; ECG, Electrocardiogram.

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IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult and pediatric patients 6 years and older.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in [read more] patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all [read more] Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

 

CONTRAINDICATIONS

  • Concomitant administration of a monoamine oxidase inhibitor (MAOI), or dosing within 14 days after discontinuing an MAOI, because of an increased risk of hypertensive crisis
  • Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

WARNINGS & PRECAUTIONS

  • Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes
  • Heart rate, blood pressure increases: Qelbree can cause an increase in diastolic blood pressure and heart rate. Assess these measures prior to starting therapy, following increases in dosage, and periodically during therapy
  • Activation of mania, or hypomania: Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression 
  • Somnolence and fatigue: Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, due to potential somnolence (including sedation or lethargy) and fatigue, until they know how they will be affected by Qelbree 

ADVERSE REACTIONS

The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) in patients 6 to 17 years were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, and in adults, insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. 

PREGNANCY

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting www.womensmentalhealth.org/preg. 

Please see full Prescribing Information, including Boxed Warning.

References:

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
2. Data on file, Supernus Pharmaceuticals.
3. Yaganita T, Wakasa Y, Kiyohara H. Drug dependence potential of viloxazine hydrochloride tested in rhesus monkeys. Pharmacol Biochem Behav. 1979; 12(1):155-161.

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult and pediatric patients 6 years and older.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in [read more] patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all [read more] Qelbree-treated patients for clinical worsening and for emergence of suicidal thoughts and behaviors.

 

CONTRAINDICATIONS

  • Concomitant administration of a monoamine oxidase inhibitor (MAOI), or dosing within 14 days after discontinuing an MAOI, because of an increased risk of hypertensive crisis
  • Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

WARNINGS & PRECAUTIONS

  • Suicidal thoughts and behaviors: Closely monitor all Qelbree-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes
  • Heart rate, blood pressure increases: Qelbree can cause an increase in diastolic blood pressure and heart rate. Assess these measures prior to starting therapy, following increases in dosage, and periodically during therapy
  • Activation of mania, or hypomania: Noradrenergic drugs may induce a manic or mixed episode in patients with bipolar disorder. Prior to initiating treatment with Qelbree, screen patients to determine if they are at risk for bipolar disorder. Screening should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression 
  • Somnolence and fatigue: Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, due to potential somnolence (including sedation or lethargy) and fatigue, until they know how they will be affected by Qelbree 

ADVERSE REACTIONS

The most common adverse reactions (≥ 5% and at least twice the rate of placebo for any dose) in patients 6 to 17 years were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability, and in adults, insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation. 

PREGNANCY

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Qelbree during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting www.womensmentalhealth.org/preg. 

Please see full Prescribing Information, including Boxed Warning.