DAYVIGO Film-coated tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Eisai Inc.
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
1. Indications and Usage
DAYVIGO is indicated for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance <em>[see Clinical Studies (14.1)]</em>.
2. Dosage and Administration
2.1 Dosing Information The recommended dosage of DAYVIGO is 5 mg taken no more than once per night, immediately before going to bed, with at least 7 hours remaining before the planned time of awakening. ...
3. Dosage Forms and Strengths
DAYVIGO (lemborexant) tablets are available as: 5 mg tablets: pale yellow, round, biconvex, film-coated tablets, and debossed with 5 on one side and LЄM on the other side. 10 mg tablets: orange, round, ...
4. Contraindications
DAYVIGO is contraindicated in patients with narcolepsy.
5. Warnings and Precautions
5.1 CNS Depressant Effects and Daytime Impairment DAYVIGO is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. CNS depressant effects may persist ...
6. Adverse Reactions
The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: CNS Depressant Effects and Daytime Impairment <em>[see Warnings and Precautions (5.1)] ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
7. Drug Interactions
<b>Table 2. Clinically Important Drug Interactions with DAYVIGO:</b> Effect of Other Drugs on DAYVIGO Strong, Moderate, and Weak CYP3A Inhibitors <em>Clinical Impact:</em> Concomitant use with a strong, ...
8. Use in Specific Populations
8.8 Patients with Compromised Respiratory Function In a study of patients with mild OSA (apnea-hypopnea index <15 events per hour of sleep), DAYVIGO did not increase the frequency of apneic events or cause ...
8.1. Pregnancy
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to DAYVIGO during pregnancy. Healthcare providers are encouraged to register ...
8.2. Lactation
Risk Summary There are no data on the presence of lemborexant in human milk, the effects on the breastfed infant, or the effects on milk production. Lemborexant and its metabolites are present in the milk ...
8.4. Pediatric Use
The safety and effectiveness of DAYVIGO have not been established in pediatric patients.
8.5. Geriatric Use
Of the total number of patients treated with DAYVIGO (n=1418) in controlled Phase 3 studies, 491 patients were 65 years and over, and 87 patients were 75 years and over. Overall, efficacy results for patients ...
8.6. Renal Impairment
No dose adjustment is required in patients with mild, moderate, or severe renal impairment. DAYVIGO exposure (AUC) was increased in patients with severe renal impairment. Patients with severe renal impairment ...
8.7. Hepatic Impairment
DAYVIGO has not been studied in patients with severe hepatic impairment. Use in this population is not recommended <em>[see Dosage and Administration (2.3), Clinical Pharmacology (12.3)]</em>. DAYVIGO ...
9.1. Controlled Substance
DAYVIGO contains lemborexant, a Schedule IV controlled substance.
9.2. Abuse
Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In a human abuse potential study conducted in recreational sedative abusers ...
9.3. Dependence
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant ...
10. Overdosage
There is limited clinical experience with DAYVIGO overdose. In clinical pharmacology studies, healthy patients who were administered multiple doses of up to 75 mg (7.5 times the maximum recommended dose) ...
11. Description
DAYVIGO contains lemborexant, an orexin receptor antagonist. The chemical name of lemborexant is (1R,2S)2{[(2,4-dimethylpyrimidin-5-yl)oxy]methyl}2(3-fluorophenyl)<em>N</em>(5-fluoropyridin-2-yl) cyclopropanecarboxamide. ...
12.1. Mechanism of Action
The mechanism of action of lemborexant in the treatment of insomnia is presumed to be through antagonism of orexin receptors. The orexin neuropeptide signaling system plays a role in wakefulness. Blocking ...
12.2. Pharmacodynamics
Lemborexant binds to orexin receptors OX1R and OX2R and acts as a competitive antagonist (IC<sub>50</sub> values of 6.1 nM and 2.6 nM, respectively). A major metabolite of lemborexant, M10, binds with ...
12.3. Pharmacokinetics
Following single doses of lemborexant 2.5 to 75 mg, geometric mean C<sub>max</sub> and AUC<sub>0-24h</sub> increased slightly less than in proportion to dose. The extent of accumulation of lemborexant ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Lemborexant did not increase the incidence of tumors in rats treated for 2 years at oral doses of 30, 100, and 300 mg/kg/day (males) and 10, 30, and 100 mg/kg/day (females), which are >80 ...
13.2. Animal Toxicology and/or Pharmacology
Lemborexant administered to mice at oral doses of 10 or 30 mg/kg resulted in behavior characteristic of cataplexy when presented with chocolate. Chocolate is a stimulus that has been demonstrated to increase ...
14. Clinical Studies
14.1 Controlled Clinical Studies DAYVIGO was evaluated in two clinical trials in patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance (Study 1, NCT02952820 and ...
16.1. How Supplied
DAYVIGO tablets are available as: 5 mg, pale yellow, round, biconvex, film-coated tablets, and debossed with 5 on one side and LЄM on the other side. NDC 62856-405-30, bottle of 30 with child-resistant ...
16.2. Storage and Handling
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].
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Administration Instructions Advise patients to take DAYVIGO only when preparing for or getting into bed and only if they ...