Icon: Rx Information

Proven safety and tolerability1

Three side effects occurred in ≥ 5% of pediatric patients (ages 6-17) and twice the rate of placebo across phase III trials.1,2

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Nonscheduled Qelbree was proven safe and tolerable, with no evidence of abuse potential or dependence across several phase III clinical trials.1,2

97% of patients completed the studies.1

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Adverse reactions in clinical studies1,2

 

The most common AEs* (≥ 5% and twice the rate of placebo) reported by children and adolescents ages 6-17 (n=826)1,2

Placebo
(n=463)

Qelbree
(n=826)

 

Somnolence

4%

16%


Decreased appetite

0.4%

7%


Fatigue

2%

6%

*TEAEs.

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 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.

Qelbree had low discontinuation rates2

 

Discontinuation rates due to AEs across all phase III trials (n=826) and safety profile2

Placebo showing 1% and Qelbree™ (viloxazine extended-release capsules) showing 3%

Qelbree Safety Profile

  •   Viloxazine is unlikely to have a DDI with amphetamine1
  •   Viloxazine is unlikely to have a DDI on methylphenidate1
  •   No clinically relevant liver enzyme elevation1,2

Abbreviations: DDI, Drug-Drug Interaction.

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients ages 6 to 17.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in pediatric [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 pediatric 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.

IMPORTANT SAFETY INFORMATION (CONT’D)

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

  • 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) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

DOSING SAFETY INFORMATION

  • Swallow Qelbree capsules whole or sprinkle entire contents on a teaspoonful of applesauce and consume all within 2 hours, without regard to meals. Do not cut, crush, or chew the capsules
  • Severe renal impairment: Initiate Qelbree at 100 mg once daily and increase by 50 mg to 100 mg at weekly intervals to a maximum recommended dosage of 200 mg once daily
  • Prior to initiating treatment, following increases in dosage, and periodically during therapy, measure heart rate and blood pressure
  • Qelbree is a strong CYP1A2 inhibitor. Coadministration with moderately sensitive CYP1A2 substrates (eg, clozapine and pirfenidone) is not recommended. If coadministered, dose reduction may be warranted
  • Qelbree is a weak inhibitor of CYP2D6 and CYP3A4, which increases exposure of those substrates (eg, dextromethorphan and alfentanil) when coadministered with Qelbree. Monitor patients for adverse reactions and adjust dosages of substrates as clinically indicated
    • For a more complete list of drug-to-drug interactions, including clinical effects and examples, please see table 2 in section 7 of the full Prescribing Information

PREGNANCY & LACTATION

  • Qelbree may cause maternal harm. It is not known if Qelbree passes into breastmilk or if Qelbree has an effect on the breastfed infant. Discontinue Qelbree if the risks of therapy during pregnancy outweigh the benefits

Please see full Prescribing Information, including Boxed Warning.

References:

1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.
2. Data on file, Supernus Pharmaceuticals.

IMPORTANT SAFETY INFORMATION

INDICATION

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric patients ages 6 to 17.

IMPORTANT SAFETY INFORMATION

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

In clinical studies, higher rates of suicidal thoughts and behaviors were reported in pediatric [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 pediatric 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.

IMPORTANT SAFETY INFORMATION (CONT’D)

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

  • 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) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.

DOSING SAFETY INFORMATION

  • Swallow Qelbree capsules whole or sprinkle entire contents on a teaspoonful of applesauce and consume all within 2 hours, without regard to meals. Do not cut, crush, or chew the capsules
  • Severe renal impairment: Initiate Qelbree at 100 mg once daily and increase by 50 mg to 100 mg at weekly intervals to a maximum recommended dosage of 200 mg once daily
  • Prior to initiating treatment, following increases in dosage, and periodically during therapy, measure heart rate and blood pressure
  • Qelbree is a strong CYP1A2 inhibitor. Coadministration with moderately sensitive CYP1A2 substrates (eg, clozapine and pirfenidone) is not recommended. If coadministered, dose reduction may be warranted
  • Qelbree is a weak inhibitor of CYP2D6 and CYP3A4, which increases exposure of those substrates (eg, dextromethorphan and alfentanil) when coadministered with Qelbree. Monitor patients for adverse reactions and adjust dosages of substrates as clinically indicated
    • For a more complete list of drug-to-drug interactions, including clinical effects and examples, please see table 2 in section 7 of the full Prescribing Information

PREGNANCY & LACTATION

  • Qelbree may cause maternal harm. It is not known if Qelbree passes into breastmilk or if Qelbree has an effect on the breastfed infant. Discontinue Qelbree if the risks of therapy during pregnancy outweigh the benefits

Please see full Prescribing Information, including Boxed Warning.