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Qelbree and
ADHD FAQs

Qelbree is a once-daily sprinkable capsule that treats ADHD in patients ages 6 and older.1

See how it works 

The most common adverse reactions for children and adolescents (occurring at ≥5% and at least twice the placebo rate for any dose) were somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. And in adults, insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation.1,2

Adverse reactions 

Ask your patients about their medical conditions, including if they:

  • Have or their family has a history of suicide, bipolar disorder, depression, mania, or hypomania
  • Have blood pressure or heart rate problems
  • Have severe kidney disease or dysfunction. Their dose of Qelbree and/or other medicines may need to be reduced3
  • Are pregnant or plan on becoming pregnant
  • Are breastfeeding or plan to breastfeed

Ask your patients about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Taking Qelbree with certain other medicines may cause side effects or affect how well they work.

Especially ask if your patients take:

  • Asthma medicines including theophylline
  • Anti-depression medicines including MAOIs (monoamine oxidase inhibitors)
  • Medicines metabolized by liver enzymes CYP1A2

Do not administer Qelbree if patients are allergic to viloxazine or any of the other ingredients in Qelbree. You can direct your patients to the Medication Guide for a complete list of ingredients in Qelbree.

Do not administer Qelbree if patients also take a medicine called a monoamine oxidase inhibitor (e.g., isocarboxazid, phenelzine, selegiline, tranylcypromine).

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Store Qelbree capsules at room temperature 68-77°F (excursions permitted between 59-86°F) and 20-25°C (excursions permitted between 15-30°C). Keep Qelbree and all medicines out of reach of children.1

Once-daily Qelbree shows no evidence of abuse potential or dependence across several phase III clinical trials – minimizing the risk of misuse and diversion.2

Adverse reactions 

Qelbree can be taken with or without food, whole, or the entire contents can be sprinkled over a spoonful (teaspoon or tablespoon) of soft food (pudding or applesauce). Consume the entire pudding mixture within 15 minutes or the applesauce mixture within 2 hours, without chewing. Do not store for future use. Capsules and their contents should not be cut, crushed, or chewed.1,2

See more on dosing 

Qelbree™ (viloxazine extended-release capsules) 100-mg capsule

100 mg: yellow, opaque body and cap (printed “SPN” on the cap, “100” on the body)1

Qelbree™ (viloxazine extended-release capsules) 150-mg capsule

150 mg: lavender, opaque body and cap (printed “SPN” on the cap, “150” on the body)1

Qelbree™ (viloxazine extended-release capsules) 200-mg capsule

200 mg: light green, opaque body and cap (printed “SPN” on the cap, “200” on the body)1

See inside the novel, non-stimulant approach to ADHD 

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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. Qelbree Medication Guide. Supernus Pharmaceuticals, Inc.; 2021.

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.