Qelbree
- Generic Name: viloxazine extended-release capsules
- Brand Name: Qelbree
- Drug Class: Norepinephrine Reuptake Inhibitors, Selective
Qelbree (Viloxazine Extended-release Capsules) side effects drug center
Qelbree Side Effects Center
What Is Qelbree?
Qelbree (viloxazine extended-release capsules) is a selective norepinephrine reuptake inhibitor (SNRI) used to treat Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.
What Are Side Effects of Qelbree?
Side effects of Qelbree include:
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• drowsiness,
• decreased appetite,
• fatigue,
• nausea,
• vomiting,
• insomnia,
• irritability,
• headache,
• upper respiratory tract infection,
• abdominal pain, and
• fever
Dosage for Qelbree
The recommended starting dosage of Qelbree for pediatric patients 6 to 11 years of age is 100 mg once daily. The dose may be adjusted in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily.
The recommended starting dosage of Qelbree for pediatric patients 12 to 17 years of age is 200 mg once daily. The dose may be adjusted after 1 week, by an increment of 200 mg, to the maximum recommended dosage of 400 mg once daily.
Qelbree In Children
The safety and effectiveness of Qelbree in pediatric patients 6 to 17 years of age with ADHD have been established based on randomized, placebo-controlled studies in pediatric patients.
The safety and effectiveness of Qelbree have not been established in pediatric patients younger than 6 years old.
Patients treated with Qelbree should be monitored for suicidal thoughts and behavior, and for changes in weight.
What Drugs, Substances, or Supplements Interact with Qelbree?
Qelbree may interact with other medicines such as:
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• monoamine oxidase inhibitors (MAOIs),
• sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (such as alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, and theophylline),
• moderate sensitive CYP1A2 substrates (such as clozapine and pirfenidone),
• CYP2D6 substrates (such as atomoxetine, desipramine, dextromethorphan, nortriptyline, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, and risperidone), and
• CYP3A4 substrates (such as alfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, and lurasidone)
Tell your doctor all medications and supplements you use.
Qelbree During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Qelbree; it may harm the mother. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed Qelbree during pregnancy. It is unknown if Qelbree passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Qelbree (viloxazine extended-release capsules), for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Qelbree Professional Information
SIDE EFFECTS
The following serious adverse reactions are described in other sections of the labeling:
- Suicidal Thoughts and Behaviors [see WARNINGS AND PRECAUTIONS]
- Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
- Activation of Mania or Hypomania [see WARNINGS AND PRECAUTIONS]
- Somnolence and Fatigue [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction 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 practice.
The safety of Qelbree has been evaluated in 1118 patients (6 to 17 years of age) with ADHD exposed to one or more doses in short-term (6 to 8 week), randomized, double-blind, placebo-controlled trials.
A total of 682 pediatric patients were treated for at least 6 months, and 347 pediatric patients for at least 12 months with Qelbree.
The data described below reflect exposure to Qelbree in 826 patients who participated in randomized, doubleblind, placebo-controlled trials with doses ranging from 100 mg to 400 mg. The population (N=826) was 65% male, 35% female, 54% White, 41% Black, 4% multiracial, and 1% other races.
Adverse Reactions Leading To Discontinuation Of Qelbree Treatment
Approximately 3% of the 826 patients receiving Qelbree in clinical studies discontinued treatment due to an adverse reaction. The adverse reactions most commonly associated with discontinuation of Qelbree were somnolence, nausea, headache, irritability, tachycardia, fatigue, and decreased appetite.
Most Common Adverse Reactions (Occurring At ≥5% And At Least Twice The Placebo Rate For Any Dose)
somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, and irritability.
Table 1 lists adverse reactions that occurred in at least 2% of patients treated with Qelbree and more frequently in Qelbree-treated patients than in placebo-treated patients. Table 1 data represents pooled data from pediatric patients 6 to 17 years of age who were enrolled in randomized, placebo-controlled trials of Qelbree.
Table 1. Adverse Reactions Reported in ≥2% of Pediatric Patients (6 to 17 Years of Age) Treated with Qelbree and at a Rate Greater than Placebo-Treated Patients in Placebo-Controlled ADHD Studies
| Body System Adverse Reaction | Placebo N=463 (%) |
Qelbree | |||
| 100mg N=154 (%) |
200mg N=367 (%) |
400mg N=305 (%) |
All Qelbree N=826 (%) |
||
| Nervous system disorders | |||||
| Somnolence* | 4 | 12 | 16 | 19 | 16 |
| Headache* | 7 | 10 | 11 | 11 | 11 |
| Metabolic and nutritional disorders | |||||
| Decreased appetite | 0.4 | 5 | 8 | 8 | 7 |
| Infections and infestations | |||||
| Upper respiratory tract infection* | 6 | 5 | 7 | 8 | 7 |
| Body as a Whole - General disorders | |||||
| Fatigue | 2 | 4 | 5 | 9 | 6 |
| Pyrexia | 0.2 | 3 | 2 | 1 | 2 |
| Gastrointestinal system disorders | |||||
| Abdominal Pain* | 4 | 3 | 6 | 7 | 5 |
| Nausea | 3 | 1 | 4 | 7 | 5 |
| Vomiting | 2 | 5 | 3 | 6 | 4 |
| Psychiatric disorders | |||||
| Insomnia* | 1 | 2 | 5 | 5 | 4 |
| Irritability | 1 | 3 | 2 | 5 | 3 |
| *The following terms were combined: Somnolence: somnolence, lethargy, sedation Headache: headache, migraine, migraine with aura, tension headache Upper respiratory tract infection: nasopharyngitis, pharyngitis, sinusitis, upper respiratory tract infection, viral sinusitis, viral upper respiratory tract infection Abdominal pain: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper Insomnia: initial insomnia, insomnia, middle insomnia, poor quality sleep, sleep disorder, terminal insomnia |
|||||
Effects on Weight:
In short–term, controlled studies (6 to 8 weeks), Qelbree-treated patients 6 to 11 years of age gained an average of 0.2 kg, compared to a gain of 1 kg in same-aged patients who received placebo. Qelbreetreated patients 12 to 17 years of age lost an average of 0.2 kg, compared to a weight gain of 1.5 kg in same-aged patients who received placebo. In a long-term open-label extension safety trial, 1097 patients received at least 1 dose of Qelbree. Among the 338 patients evaluated at 12 months, the mean change from baseline in weight-forage z-score was -0.2 (standard deviation of 0.5). In the absence of a control group, it is unclear whether the weight change observed in the long-term open-label extension was attributable to the effect of Qelbree.
DRUG INTERACTIONS
Drugs Having Clinically Important Interactions With Qelbree
Table 2: Clinically Important Drug Interactions with Qelbree
| Monoamine Oxidase Inhibitors (MAOI) | |
| Clinical Impact | Concomitant use of Qelbree with an MAOI may lead to a potentially life-threatening hypertensive crisis. |
| Intervention | Concomitant use of Qelbree with an MAOI or within 2 weeks after discontinuing an MAOI is contraindicated [see CONTRAINDICATIONS]. |
| Examples | Selegiline, isocarboxazid, phenelzine, tranylcypromine, safinamide, rasagiline |
| Sensitive CYP1A2 Substrates or CYP1A2 Substrates with a Narrow Therapeutic Range | |
| Clinical Impact | Viloxazine is a strong CYP1A2 inhibitor. Concomitant use of viloxazine significantly increases the total exposure, but not peak exposure, of sensitive CYP1A2 substrates [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions associated with these CYP1A2 substrates. |
| Intervention | Coadministration with Qelbree is contraindicated [see CONTRAINDICATIONS]. |
| Examples | Alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline |
| Moderate Sensitive CYP1A2 Substrate | |
| Clinical Impact | Viloxazine is a strong CYP1A2 inhibitor. Concomitant use of viloxazine significantly increases the total, but not peak, exposure of sensitive CYP1A2 substrates [see CLINICAL PHARMACOLOGY], which may increase the risk of adverse reactions associated with these CYP1A2 substrates. |
| Intervention | Not recommended for coadministration with Qelbree. Dose reduction may be warranted if coadministered. |
| Examples | Clozapine, pirfenidone |
| CYP2D6 Substrates | |
| Clinical Impact | Viloxazine is a weak inhibitor of CYP2D6, and increases the exposure of CYP2D6 substrates when coadministered [see CLINICAL PHARMACOLOGY]. |
| Intervention | Monitor patients for adverse reactions and adjust dosages of CYP2D6 substrates, as clinically indicated. |
| Examples | Atomoxetine, desipramine, dextromethorphan, nortriptyline, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, and risperidone |
| CYP3A4 Substrates | |
| Clinical Impact | Viloxazine is a weak inhibitor of CYP3A4 which increases the exposure of CYP3A4 substrates when coadministered [see CLINICAL PHARMACOLOGY]. |
| Intervention | Monitor patients for adverse reactions and adjust dosages of CYP3A4 substrates, as clinically indicated. |
| Examples | Alfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, and lurasidone |
Read the entire FDA prescribing information for Qelbree (Viloxazine Extended-release Capsules)
&Copy; Qelbree Patient Information is supplied by Cerner Multum, Inc. and Qelbree Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.