Talking to Your Patients About Their ADHD Medication

Qelbree (viloxazine extended-release capsules) is the first nonstimulant treatment option approved for adult ADHD patients in 20 years.^1-3 You can offer Qelbree to your patients 6 years and older as a novel nonstimulant approach to help them manage their ADHD.

INDICATION

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

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

Please see full Important Safety Information to the top left.

Qelbree Features the First 2-bead Microtrol™ Technology Delivery of Nonstimulant Viloxazine for 24-hour Patient Exposure^1,2

Share with your patients the different features of Qelbree as a once-daily medication. Inform them of its extended-release delivery system that utilizes a 2-bead Microtrol™ technology, which allows for once-daily dosing that provides full 24-hour exposure for your patients.^1,2,4

IMPORTANT SAFETY INFORMATION

• 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

Please see full Important Safety Information to the top left.

Qelbree offers flexibility to your patients with a variety of administration choices. Patients should know that these capsules can be swallowed whole, or the entire contents can be sprinkled onto a spoonful of soft foods (applesauce or pudding).¹ However, the entire contents of the pudding mixture should be consumed within 15 minutes, without chewing. The entire contents of the applesauce mixture should be consumed within 2 hours, without chewing. Lastly, these mixtures should not be stored for future use.^1,2

• Capsules and their contents should not be cut, crushed, or chewed
• Can be taken with or without food
• Dose will depend on patient age and response to medication

IMPORTANT SAFETY INFORMATION

• 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

Please see full Important Safety Information to the top left.

How to Take Qelbree

You can also show your patients the 3 different strengths in which the Qelbree capsules are available: 100 mg, 150 mg, and 200 mg capsules.

The recommended dosage and administration for Qelbree differs with age.

IMPORTANT SAFETY INFORMATION

• 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

Please see full Important Safety Information to the top left.

It is important to communicate the important dosing guidelines to your patients for their safety.

For your pediatric patients (ages 6 to 11 years), inform them and their care takers that the recommended starting dose is 100 mg once daily.¹ This dose can be titrated weekly as needed up to the maximum daily dose as shown below.¹

For your adolescent patients (ages 12 to 17 years), inform them and their care takers that the recommended starting dose is 200 mg once daily.¹ After one week, this dose can be titrated weekly as needed up to the maximum daily dose as shown below.¹

For your adult patients (18 years and older), inform them that the recommended starting dose is 200 mg once daily.¹ The dose can be titrated incrementally each week as needed up to the maximum daily dose as shown below.¹

IMPORTANT SAFETY INFORMATION

• 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

Please see full Important Safety Information to the top left.

Possible Side Effects 

Educate your patients on the possible side effects while taking Qelbree. Talk to them about the clinical trials that showed the most common adverse reactions (≥5% and at least twice the rate of placebo for any dose) in patients 6 to 17 years were noted to be somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability. In adults 18 to 60 years of age, the most common adverse reactions (greater than or equal to 5% and at least twice the placebo rate of Qelbree) were insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, and constipation.¹ Negative side effects can be reported to the US Food and Drug Administration at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

IMPORTANT SAFETY INFORMATION

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

Please see full Important Safety Information to the top left.

Helping Patients Understand Important Safety Information 

It is critical that patients taking Qelbree are well-informed of its boxed warning and understand the signs or symptoms to watch for as well as when it is important to call a physician or seek professional help for them or their child. Let your patients know that Qelbree may increase suicidal thoughts and actions in children and adults with ADHD who are 6 years of age and older, especially within the first few months of treatment or when the dose is changed. Advise your patients to tell their doctor if they have (or if there is a family history of) suicidal thoughts or actions before starting Qelbree. Patient moods, behaviors, thoughts, and feelings should be monitored during treatment with Qelbree. Any new or sudden changes in these symptoms should be reported to the physician right away. Qelbree can also increase blood pressure and heart rate, so these vital signs should be monitored closely throughout treatment. 

Let your patients know that they should not take Qelbree if they also take a monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past 14 days. Your patients should also avoid alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline.

Warn your patients with bipolar disorder that taking Qelbree may cause manic or mixed episodes. Patients should be informed to tell their doctor if they show any signs of mania or hypomania.

Lastly, be sure to advise your patients not to drive or operate heavy machinery until they determine how Qelbree will affect them because Qelbree may cause patients to feel somnolent or fatigued.

Please see full Prescribing Information, including Boxed Warning.

Learn more about Qelbree, an extended-release, nonstimulant medication for ADHD: https://www.QelbreeHCP.com/

QBE.2022-0366