What are the contraindications for Qelbree (viloxazine extended‑release)?

Contraindications for Qelbree (Viloxazine Extended-Release)

Qelbree is absolutely contraindicated in two specific situations: concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation, and concurrent use with sensitive CYP1A2 substrates or those with narrow therapeutic ranges. 1

Absolute Contraindications

1. MAOI Use (Current or Recent)

• Do not prescribe Qelbree to patients taking MAOIs or within 14 days of stopping an MAOI 1
• Reason: Risk of potentially life-threatening hypertensive crisis 1
• MAOIs include: phenelzine, isocarboxazid, moclobemide, isoniazid, and linezolid 2
• Clinical action: Wait at least 14 days after MAOI discontinuation before initiating Qelbree

2. Concurrent CYP1A2 Substrate Use

• Do not prescribe Qelbree with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic ranges 1
• Reason: Viloxazine is a strong CYP1A2 inhibitor that significantly increases exposure to these medications, raising risk of adverse reactions 1
• Clinical action: Review all current medications for CYP1A2 metabolism before prescribing

Critical Warnings (Not Absolute Contraindications, But Require Extreme Caution)

Pregnancy

• Discontinue Qelbree when pregnancy is recognized unless benefits clearly outweigh maternal risks 1
• Animal studies show fetal toxicities and maternal harm at doses equivalent to maximum human dosing 1
• No adequate human data exists 3
• Alternative agents are strongly preferred in pregnancy 3

Breastfeeding

• Exercise extreme caution - no published studies exist on viloxazine transfer into breast milk 3
• Alternative agents are strongly preferred during lactation 3

Pre-Treatment Screening Requirements

Before prescribing Qelbree, you must screen for:

1. Cardiac history (personal and family):

   • Heart rate and blood pressure measurement required 1
   • Screen for family history of sudden death, cardiovascular symptoms, Wolff-Parkinson-White syndrome, hypertrophic cardiomyopathy, long QT syndrome 4

2. Psychiatric history (personal and family):

   • History of suicide attempts or ideation 1
   • Bipolar disorder 1
   • Depression 1
   • Rationale: Qelbree carries increased risk of suicidal thoughts/behaviors (0.9% in pediatrics vs 0.4% placebo; 1.6% in adults vs 0% placebo) 1

Common Pitfalls to Avoid

• Don't overlook drug interactions: Always check for CYP1A2 substrates, CYP2D6 substrates (weak inhibition), and CYP3A4 substrates (weak inhibition) 1
• Don't forget the MAOI washout period: Must wait full 14 days after MAOI discontinuation 1
• Don't ignore serotonin syndrome risk: While viloxazine has serotonergic activity, avoid combining with multiple serotonergic agents 2, 5
• Don't prescribe without baseline vitals: Blood pressure and heart rate must be documented before initiation 1