REYVOW Tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Eli Lilly and Company
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1. Indications and Usage
REYVOW is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use REYVOW is not indicated for the preventive treatment of migraine.
2. Dosage and Administration
The recommended dose of REYVOW is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and REYVOW should not be taken unless the patient can wait at least ...
3. Dosage Forms and Strengths
REYVOW (lasmiditan) tablets are available in two strengths: 50 mg tablet: light gray, oval, film coated, tablets with L-50 debossed on one side and 4312 on the other 100 mg tablet: light purple, oval, ...
4. Contraindications
None.
5. Warnings and Precautions
5.1 Driving Impairment REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mg doses of REYVOW significantly impaired subjects' ability to ...
6. Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment <em>[see Warnings and Precautions (5.1)]</em> Central Nervous System Depression <em>[see ...
6.1. Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...
7. Drug Interactions
7.1 CNS Depressants Concomitant administration of REYVOW and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of REYVOW to cause sedation, as well ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risk associated with the use of REYVOW in pregnant women. In animal studies, adverse effects on development (increased incidences of fetal abnormalities, ...
8.2. Lactation
Risk Summary There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production. Excretion of lasmiditan and/or ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
In controlled clinical trials, dizziness occurred more frequently in patients who were at least 65 years of age (19% for REYVOW, 2% for placebo) compared to patients who were less than 65 years of age ...
8.6. Hepatic Impairment
No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use ...
9.1. Controlled Substance
REYVOW contains lasmiditan, a Schedule V 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 (HAP) study in recreational poly-drug users (n=58), ...
9.3. Dependence
Physical withdrawal was not observed in healthy subjects following abrupt cessation after 7 daily doses of lasmiditan 200 mg or 400 mg.
11. Description
REYVOW (lasmiditan) is a serotonin (5-HT) 1F receptor agonist for oral administration. The chemical name of lasmiditan hemisuccinate is 2,4,6-trifluoro-N-[6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl]benzamide ...
12.1. Mechanism of Action
Lasmiditan binds with high affinity to the 5-HT<sub>1F</sub> receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT<sub>1F</sub> ...
12.2. Pharmacodynamics
Cardiac Electrophysiology At a dose two times the maximum recommended daily dose, REYVOW does not prolong the QTc interval to any clinically relevant extent.
12.3. Pharmacokinetics
Absorption Following oral administration, lasmiditan is rapidly absorbed with a median t<sub>max</sub> of 1.8 hours. In patients with migraine, the absorption or pharmacokinetics of lasmiditan was not ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis No drug-related tumors were observed following oral administration of lasmiditan to TgRasH2 mice at doses of up to 150 (males) or 250 (females) mg/kg/day for 26 weeks or to rats at doses ...
14. Clinical Studies
14.1 Migraine The efficacy of REYVOW in the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials [Study 1 (NCT02439320) and Study 2 (NCT02605174)]. These ...
16.1. How Supplied
REYVOW (lasmiditan) 50 mg tablets are light gray, oval, film coated, tablets with L-50 debossed on one side and 4312 on the other. REYVOW (lasmiditan) 100 mg tablets are light purple, oval, film coated, ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
17. Patient Counseling Information
<em>Advise the patient to read the FDA-approved patient labeling (Medication Guide).</em> Driving Impairment Advise patients not to engage in potentially hazardous activities requiring complete mental ...