REYVOW

AbsorptionFollowing oral administration, lasmiditan is rapidly absorbed with a median t max of 1.8 hours. In patients with migraine, the absorption or pharmacokinetics of lasmiditan was not different during a migraine attack versus during the interictal period. Effect of Food Coadministration of lasmiditan with a high-fat meal increased the mean lasmiditan C max and AUC values by 22% and 19%, respectively, and delayed the median t max by 1 hour. This difference in exposure is not expected to be...

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 studies enrolled patients with a history of migraine with and without aura according to the International Classification of Headache Disorders (ICHD-II) diagnostic criteria. Patients were predominantly female (84%), and White (78%), with a mean age of 42 years (range 18-81). Twenty-two percent of patients were taking preventive medication for migraine at baseline. Study 1 randomized patients ...

The following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment [see Warnings and Precautions ( 5.1 )] Central Nervous System Depression [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Medication Overuse Headache [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,...

None. None. ( 4 )

Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. ( 5.1 ) Central Nervous System (CNS) Depression: REYVOW may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants. ( 5.2 , 7.1 ) Serotonin ...

7 DRUG INTERACTIONS REYVOW may further lower heart rate when administered with heart rate lowering drugs. ( 7.3 ) 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 as other cognitive and/or neuropsychiatric adverse reactions, REYVOW should be us...