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An ADHD Treatment with Flexible Dosing and Administration

03/01/2023

 

 

Qelbree (Viloxazine Extended-Release Capsules) Dosing and Administration

Qelbree is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older and is available in three dosage strengths: 100 mg, 150 mg, and 200 mg.1 (Figure 1) A single daily dose of Qelbree provides full-day exposure to medication.

figuer 1
Figure 1

 IMPORTANT SAFETY INFORMATION

black box warning

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. 

 

 

Dosing Information

Dosing of Qelbree differs depending on age. Once-daily Qelbree offers straightforward, convenient dosing with easy administration and titration.1

Pediatric Patients

For pediatric patients ages 6 to 11 years, the recommended starting dose is 100 mg taken once daily.1 Patients can increase this starting dose by 100 mg a week over 1 to 3 weeks as needed to reach an effective dose. The maximum dose for children is 400 mg daily.1 (Figure 2)

 

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. 

 

Adolescent Patients

For adolescent patients ages 12 to 17 years, the recommended starting dose is 200 mg taken once daily.1 Patients can increase this starting dose by 200 mg a week over 1 week as needed to reach an effective dose. The maximum dose for adolescents is 400 mg daily.(Figure 2)

 

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. 

 

Adult Patients

For adult patients ages 18 and above, the recommended starting dose is 200 mg taken once daily.1 Patients can increase this starting dose by 200 mg a week over 1 to 2 weeks as needed to reach an effective dose. The maximum dose for adults is 600 mg daily.1 (Figure 2)

 

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. 

 

figure 2
Figure 2

 

IMPORTANT SAFETY INFORMATION

  • 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

 

  Please see full Important Safety Information to the top left. 

 

Administration Information

Qelbree (viloxazine extended-release capsules) offers a few methods of administration. First, capsules may be consumed whole, with or without food.Alternatively, the capsule may be opened, and the entire contents can be sprinkled onto a spoonful of applesauce or pudding.1

The food mixture should be consumed in its entirety, without chewing, within 15 minutes for pudding or within two hours for applesauce; do not store for future use.1 It is important to not cut, crush, or chew the capsules or their contents.1 (Figure 3)

 

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. 

 

figure 3
Figure 3

 

Adjustments for Renal Impairment

Dosage adjustments are not recommended for patients with mild to moderate renal impairment (eGFR of 30 to 89 mL/min/1.73m2).1 However, dosage reduction is recommended for patients with severe renal impairment (eGFR < 30 mL/min/1.73m2).1

For such patients, the recommended starting dose is 100 mg taken once daily.1 This starting dose may be titrated weekly in increments of 50 to 100 mg up to a maximum daily dose of 200 mg.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
  • 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.

Please see full Prescribing Information, including Boxed Warning.

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

 

References

  1. Qelbree [package insert]. Rockville, MD: Supernus Pharmaceuticals, Inc.

 

QBE.2022-0332

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