QELBREE- viloxazine hydrochloride capsule, extended release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

VILOXAZINE HYDROCHLORIDE (UNII: OQW30I1332) (VILOXAZINE - UNII:5I5Y2789ZF)

Доступно од:

Supernus Pharmaceuticals, Inc

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. 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)]. 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 . Risk Summary There are no data on the presence of viloxazine in human milk, the effects on the breastfed infant, or the effects on milk production. Viloxazine is likely present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. 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. 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 . 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. 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)].

Резиме производа:

How Supplied Qelbree (viloxazine extended-release capsules) are available in the following strengths and colors: 100mg (yellow capsule printed with "SPN" on capsule cap and "100" on capsule body with edible black ink). 150mg (lavender capsule printed with "SPN" on capsule cap and "150" on capsule body with edible black ink). 200mg (light green capsule printed with "SPN" on capsule cap and "200" on capsule body with edible black ink). Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Статус ауторизације:

New Drug Application

Информативни летак

Supernus Pharmaceuticals, Inc
----------
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Revised: 4/2022
MEDICATION GUIDE
QELBREE ® (Kel' bree)
(viloxazine extended-release capsules)
for oral use
What is the most important information I should know about QELBREE?
QELBREE can cause serious side effects, including:
•
Increased risk of suicidal thoughts or actions. QELBREE may increase
suicidal thoughts or
actions in children and adults with attention deficit hyperactivity
disorder (ADHD), especially
within the first few months of treatment or when the dose is changed.
How can I watch for and try to prevent suicidal thoughts and actions?
•
Pay close attention to any changes, especially sudden changes in mood,
behavior,
thoughts, or feelings or if you or your child develops suicidal
thoughts or actions. This is
very important when QELBREE treatment is started or when the dose is
changed.
•
Call your healthcare provider right away if you or your child has any
new or sudden
changes in mood, behavior, thoughts, or feelings, or if you or your
child develops suicidal
thoughts or actions.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency help right away if you
or your child has any of the
following symptoms, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
new or worse depression
•
feeling very agitated or restless
•
trouble sleeping (insomnia)
•
acting aggressive, being angry, or
violent
•
an extreme increase in activity and
talking (mania)
•
thoughts about suicide or dying
•
new or worse anxiety
•
panic attacks
•
new or worse irritability
•
acting on dangerous impulses
•
other unusual changes in behavior or mood
See " What are the possible side effects of QELBREE?" for more
information about side effects.
What is QELBREE?
QELBREE is a prescription medicin

Карактеристике производа

QELBREE- VILOXAZINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE
SUPERNUS PHARMACEUTICALS, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QELBREE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QELBREE
.
QELBREE (VILOXAZINE EXTENDED-RELEASE CAPSULES), FOR ORAL USE
INITIAL U.S. APPROVAL: 2021
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
IN CLINICAL TRIALS, HIGHER RATES OF SUICIDAL THOUGHTS AND BEHAVIOR
WERE REPORTED IN
PATIENTS TREATED WITH QELBREE THAN IN PATIENTS TREATED WITH PLACEBO.
CLOSELY MONITOR
FOR WORSENING AND EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS ( 5.1).
RECENT MAJOR CHANGES
Boxed Warning
4/2022
Indications and Usage ( 1)
4/2022
Dosage and Administration ( 2.2, 2.3)
4/2022
Warnings and Precautions ( 5.1, 5.2, 5.4)
4/2022
INDICATIONS AND USAGE
Qelbree is a selective norepinephrine reuptake inhibitor indicated for
the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years
and older ( 1)
DOSAGE AND ADMINISTRATION
_Pediatric patients 6 to 11 years of age_: Recommended starting dosage
is 100 mg once daily. May
titrate in increments of 100 mg weekly to the maximum recommended
dosage of 400 mg once daily (
2.2)
_Pediatric patients 12 to 17 years of age_: Recommended starting
dosage is 200 mg once daily. May
titrate after 1 week, by an increment of 200mg, to the maximum
recommended dosage of 400 mg
once daily ( 2.2)
_Adult patients_: Recommended starting dosage is 200 mg once daily.
May titrate in increments of 200
mg weekly, to maximum recommended dosage of 600 mg once daily ( 2.2)
Capsules may be swallowed whole or opened and the entire contents
sprinkled onto applesauce or
pudding ( 2.3)
Severe Renal Impairment _:_ Initial dosage is 100 mg once daily.
Titrate in weekly increments of 50 mg to
100 mg to a maximum recommended dosage of 200 mg once daily ( 2.4,
8.6)
DOSAGE FORMS AND STRENGTHS
Extended-release capsules: 100