Labeling for ADHD Med Qelbree Updated With Lactation, Pharmacodynamic Data

The prescribing information for Qelbree^® (viloxazine extended-release capsules) has been updated with new pharmacodynamic and lactation data. 

Qelbree is a selective norepinephrine reuptake inhibitor indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients aged 6 years and older. The nonstimulant therapy was approved based on results from multiple adult and pediatric studies demonstrating improvements in ADHD symptoms.

The updated labeling for Qelbree provides additional information on the pharmacodynamic profile of the drug. Findings show that viloxazine binds to and exhibits partial agonist activity at the serotonin 5-HT2C receptor, in addition to binding to and inhibiting the norepinephrine transporter. 

Regarding the new lactation data, a study from 15 women who received viloxazine 600mg daily for 3 days demonstrated that viloxazine and its metabolite, 5-HVLX-gluc, were present in breastmilk, though the transfer of the drug into breastmilk was low. 

Results showed the estimated daily infant dose of viloxazine and 5-HVLX-gluc (using a nominal infant body weight of 6kg) was 0.085mg/kg and 0.00595mg/kg, respectively. The relative infant dose was approximately 1% and 0.07%, respectively, of the weight-normalized maternal daily dose (8.58mg/kg) of viloxazine. 

There are currently no data available on the effect of viloxazine on breastfed infants or the effect on milk production. 

Commenting on the new labeling, Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals, said, “By expanding Qelbree’s label to include new data on the pharmacodynamics and use in breastfeeding mothers, Supernus continues to empower health care providers and patients to make informed treatment decisions.” 

Before initiating treatment with Qelbree, patients should be screened for a personal or family history of suicide, bipolar disorder, and depression, as higher rates of suicidal thoughts and behavior were reported in patients treated with Qelbree vs placebo in clinical trials.

Additionally, Qelbree may cause increases in heart rate and diastolic blood pressure. It is recommended that prior to starting treatment, following increases in dosage, and periodically while on therapy, heart rate and blood pressure should be assessed.

This article originally appeared on MPR