QUVIVIQ- daridorexant tablet, film coated

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

daridorexant (UNII: LMQ24G57E9) (daridorexant - UNII:LMQ24G57E9)

Disponibbli minn:

Idorsia Pharmaceuticals Ltd

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

QUVIVIQ is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance [see Clinical Studies (14.1)] . QUVIVIQ is contraindicated: - in patients with narcolepsy. - in patients with a history of hypersensitivity to daridorexant or any components of QUVIVIQ. Angioedema with pharyngeal involvement has been reported [see Adverse Reactions (6.2)] . Pregnancy Exposure Registry There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to QUVIVIQ during pregnancy. Pregnant women exposed to QUVIVIQ and healthcare providers are encouraged to call Idorsia Pharmaceuticals Ltd at 1-833-400-9611. Risk Summary There are no available data on QUVIVIQ use in pregnant women to evaluate for drug-associated risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of daridorexant to pregnant rats and rabbits during the period of organogenesi

Sommarju tal-prodott:

QUVIVIQ tablets are available as: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

L-istatus ta 'awtorizzazzjoni:

New Drug Application

Fuljett ta 'informazzjoni

Idorsia Pharmaceuticals Ltd
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MEDICATION GUIDE
QUVIVIQ® (CUE-VIH-VICK)
(DARIDOREXANT)
TABLETS, FOR ORAL USE, CIV
This Medication Guide has been approved by the U.S. Food
and Drug Administration.
Issued: 10/2023
What is the most important information I should know about QUVIVIQ?
QUVIVIQ may cause serious side effects, including:
•
Decreased awareness and alertness. The morning after you take QUVIVIQ,
your ability to drive
safely and think clearly may be decreased. You may also have
sleepiness during the day.
•
Do not take more QUVIVIQ than prescribed.
•
Do not take QUVIVIQ unless you are able to stay in bed for a full
night (at least 7 hours)
before you must be active again.
•
Take QUVIVIQ in the evening within 30 minutes before going to bed.
See "What are the possible side effects of QUVIVIQ?" for more
information about side effects.
What is QUVIVIQ?
•
QUVIVIQ is a prescription medicine for adults who have trouble falling
asleep or staying asleep
(insomnia).
•
It is not known if QUVIVIQ is safe and effective for use in children.
QUVIVIQ is a federally controlled substance (CIV) because it can be
abused or lead to dependence.
Keep QUVIVIQ in a safe place to prevent misuse and abuse. Selling or
giving away QUVIVIQ may
harm others and is against the law.
Who should not take QUVIVIQ?
•
If you fall asleep often at unexpected times (narcolepsy).
•
If you are allergic to daridorexant, or any ingredients in QUVIVIQ.
See the end of this
Medication Guide for a complete list of ingredients in QUVIVIQ.
Before taking QUVIVIQ, tell your healthcare provider about all of your
medical conditions, including if
you:
•
have a history of depression, mental illness, or suicidal thoughts or
actions
•
have a history of drug or alcohol abuse or addiction
•
have a history of a sudden onset of muscle weakness (cataplexy)
•
have a history of daytime sleepiness
•
have lung or breathing problems, including sleep apnea
•
have liver problems
•
are pregnant or plan to become pregnant. It is not known if QU

Karatteristiċi tal-prodott

QUVIVIQ- DARIDOREXANT TABLET, FILM COATED
IDORSIA PHARMACEUTICALS LTD
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
QUVIVIQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUVIVIQ.
QUVIVIQ (DARIDOREXANT) TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 2022
RECENT MAJOR CHANGES
Contraindications (4)
10/2023
INDICATIONS AND USAGE
QUVIVIQ is an orexin receptor antagonist indicated for the treatment
of adult patients with insomnia,
characterized by difficulties with sleep onset and/or sleep
maintenance. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is 25 mg to 50 mg once per night, taken orally
within 30 minutes before
going to bed, with at least 7 hours remaining prior to planned
awakening. (2.1)
Time to sleep onset may be delayed if taken with or soon after a meal.
(2.1)
Hepatic Impairment: (2.3)
Moderate hepatic impairment: Maximum recommended dosage is 25 mg no
more than once per
night.
Severe hepatic impairment: Not recommended.
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg. (3)
CONTRAINDICATIONS
Narcolepsy. (4)
Known hypersensitivity to daridorexant or other components of QUVIVIQ.
(4)
WARNINGS AND PRECAUTIONS
CNS-Depressant Effects and Daytime Impairment: Impairs alertness and
motor coordination including
morning impairment. Risk increases when used with other central
nervous system (CNS) depressants.
For patients taking QUVIVIQ, caution against next-day driving and
other activities requiring complete
mental alertness. (5.1)
Worsening of Depression/Suicidal Ideation: Worsening of depression or
suicidal thinking may occur. (5.2)
Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, and
Cataplexy-like Symptoms: May occur
with use of QUVIVIQ. (5.3)
Complex Sleep Behaviors: Behaviors including sleepwalking, sleep
driving, and engaging in other
activities while not fully awake may occur. Discontinue immediately if
complex sleep behavior occurs.
(5.4)
Compromised Respiratory Function: Effect on respiratory function
should