Dosage & Administration
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Qelbree Prescribing Information
In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] .
Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Important Considerations Prior to Initiating Treatment
- Assess heart rate and blood pressure prior to initiating treatment with Qelbree, following increases in dosage, and periodically while on therapy [see Warnings and Precautions (5.2)] .
- Prior to initiating treatment with Qelbree, screen patients for a personal or family history of suicide, bipolar disorder, and depression [see Warnings and Precautions (5.3)].
Recommended Dosage
Pediatric patients
The recommended starting dosage for pediatric patients 6 to 11 years of age is 100 mg orally once daily. Dosage may be titrated in increments of 100 mg at weekly intervals to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.
The recommended starting dosage for pediatric patients 12 to 17 years of age is 200 mg orally once daily. After 1 week, dosage may be titrated by an increment of 200 mg to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.
Adult patients
The recommended starting dosage for adults is 200 mg orally once daily. Dosage may be titrated in increments of 200 mg weekly to the maximum recommended dosage of 600 mg once daily, depending on response and tolerability.
Pharmacological treatment of ADHD may be needed for extended periods. Periodically reevaluate the long-term use of Qelbree and adjust dosage as needed.
Administration Information
Administer Qelbree orally with or without food [see Clinical Pharmacology (12.3)] . Do not cut, crush, or chew the capsules.
Swallow Qelbree capsules whole, or open the capsule and sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce. Consume the food mixture in its entirety, without chewing, within 15 minutes for pudding, or within 2 hours for applesauce; do not store for future use.
Dosage Recommendations in Patients with Renal Impairment
In patients with severe renal impairment (eGFR < 30 mL/min/1.73m 2), the recommended starting dosage is 100 mg once daily. Dosage may be titrated in weekly increments of 50 to 100 mg once daily, to a maximum recommended dosage of 200 mg once daily.
No dosage adjustment is recommended in patients with mild to moderate (eGFR of 30 to 89 mL/min/1.73m 2) renal impairment [see Use in Specific Populations (8.6)] .
Qelbree (viloxazine extended-release capsules) are available as:
100 mg: yellow opaque body and cap (printed "SPN" on the cap, "100" on the body)
150 mg: lavender opaque body and cap (printed "SPN" on the cap, "150" on the body)
200 mg: light green opaque body and cap (printed "SPN" on the cap, "200" on the body)
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed Qelbree during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/preg.
Risk Summary
Based on findings from animal reproduction studies, viloxazine may cause maternal harm when used during pregnancy. Discontinue Qelbree when pregnancy is recognized unless the benefits of therapy outweigh the potential risk to the mother. Available data from case series with viloxazine use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal outcomes.
In animal reproduction studies, oral administration of viloxazine during the period of organogenesis caused fetal toxicities and delayed fetal development in the rat and maternal toxicities in the rabbit at doses approximately equal to the maximum recommended human dose (MRHD) of 600 mg in adults, based on mg/m 2.Oral administration of viloxazine to pregnant rats and mice during pregnancy and lactation caused maternal toxicities and deaths and fetal toxicities at doses equal to or less than the MRHD of 600 mg in adults, based on mg/m 2, respectively (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data
Animal Data
Viloxazine was administered orally to pregnant rats during the period of organogenesis at doses of 13, 33, and 82 mg/kg/day. The high dose is approximately equal to the MRHD of 600 mg in adults, based on mg/m 2. Viloxazine did not cause maternal toxicity up to the high dose. Viloxazine at the high dose increased early and late resorption, delayed fetal development, and possibly caused low incidences of fetal malformations or anomalies (craniorachischisis, missing cervical vertebrae, and morphological changes associated with hydranencephaly). The NOAEL for fetal toxicity and malformation is 33 mg/kg/day, which is less than the MRHD of 600 mg in adults, based on mg/m 2.
Viloxazine was administered orally to pregnant rabbits during the period of organogenesis at doses of 43, 87, and 130 mg/kg/day, which are approximately 1, 3, and 4 times the MRHD of 600 mg in adults, based on mg/m 2, respectively. Viloxazine decreased maternal body weight, weight gain, or food consumption at doses ≥ 87 mg/kg/day but did not cause fetal toxicity at doses up to 130 mg/kg/day. The NOAELs for maternal and fetal toxicity is 43 and 130 mg/kg/day, respectively, which is approximately 1 and 4 times the MRHD, based on mg/m 2, respectively.
Viloxazine was administered orally to pregnant rats during gestation and lactation at doses of 43, 87, and 217 mg/kg/day, which are less than, equal to , and 4 times the MRHD of 600 mg in adults, based on mg/m 2, respectively. Viloxazine caused maternal toxicity of decreased body weight, weight gain, and food consumption at doses ≥ 87 mg/kg/day and maternal deaths near term at 217 mg/kg/day. At these maternally toxic doses, viloxazine caused lower live birth, decreased viability, and delayed growth and sexual maturation without affecting learning and memory in the offspring. The NOAEL for maternal and developmental toxicity is 43 mg/kg/day, which is less than the MRHD of 600 mg in adults, based on mg/m 2.
Viloxazine was administered orally to pregnant mice during gestation and lactation at doses of 13, 33, and 82 mg/kg/day, which are less than the MRHD of 600 mg in adults, based on mg/m 2,. Viloxazine treatment at 82 mg/kg/day during the gestation period caused maternal deaths and decreased body weight in the offspring. The NOAEL for both maternal and developmental toxicity is 33 mg/kg/day, which is less than the MRHD of 600 mg in adults, based on mg/m 2.
Lactation
Risk Summary
Available data from a lactation study in 15 women indicate that viloxazine and its metabolite, 5-HVLX-gluc, are present in breastmilk. The estimated daily infant dose of viloxazine and 5-HVLX-gluc is 0.085 mg/kg and 0.00595 mg/kg (using a nominal infant body weight of 6 kg), respectively, and the relative infant dose (RID) is approximately 1% and 0.07%, respectively, the weight-normalized maternal daily dose (8.58 mg/kg) of viloxazine. These data support that transfer of viloxazine into breastmilk is low (see Data) . There are no data on the effects of viloxazine on the breastfed infant or the effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Qelbree and any potential adverse effects on the breastfed child from Qelbree or from the underlying maternal condition.
Data
A multi-dose (600 mg daily for three days) milk and plasma lactation study was conducted in 15 healthy lactating women. The geometric mean of the total excreted amounts of viloxazine and 5-HVLX-gluc in breast milk over a period of 24 hours at steady-state were 0.511 mg and 0.0357 mg, respectively. The RID of viloxazine and 5-HVLX-gluc were approximately 1% and 0.07%, respectively, of the weight-normalized maternal daily dose (8.58 mg/kg) of viloxazine.
Pediatric Use
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 [see Adverse Reactions (6.1)and Clinical Studies (14)] .
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 [see Warnings and Precautions (5.1)] , and for changes in weight [see Adverse Reactions (6.1)].
Juvenile Animal Toxicity Data
Viloxazine was administered orally to juvenile rats from postnatal day (PND) 23 through PND 79 at doses of 43, 130, and 217 mg/kg/day, which are approximately 1, 2, and 3 times the MRHD of 400 mg in children, based on mg/m 2, respectively. Viloxazine decreased body weight, weight gain, and food consumption in both sexes at 217 mg/kg/day. Sexual maturation, reproductive capacity, and learning and memory were not affected. The NOAEL for juvenile toxicity is 130 mg/kg/day, which is approximately 2 times the MRHD of 400 mg in children, based on mg/m 2.
Geriatric Use
Clinical trials of Qelbree in the treatment of ADHD did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients.
Renal Impairment
Dosage reduction is recommended in patients with severe (eGFR of < 30 mL/min/1.73m 2[MDRD]) renal impairment [see Dosage and Administration (2.4)] .
No dosage adjustment of Qelbree is recommended in patients with mild to moderate (eGFR of 30 to 89 mL/min/1.73m 2[MDRD]) renal impairment.
The exposure of viloxazine increases in patients with renal impairment [see Clinical Pharmacology (12.3)].
Qelbree is contraindicated in patients:
- receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuing an MAOI, because of an increased risk of hypertensive crisis [see Drug Interactions (7.1)] .
- receiving concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range [see Drug Interactions (7.1)].