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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 hemisuccinate. It has the
empirical formula of C19H18F3N3O2•0.5[C4H6O4] and a molecular weight of 436.41 (hemisuccinate). Lasmiditan
hemisuccinate has the following structural formula:
Lasmiditan hemisuccinate is a white, crystalline powder that is sparingly soluble in water, slightly soluble in ethanol, and
soluble in methanol. A 1 mg/mL aqueous solution of lasmiditan hemisuccinate has a pH of 6.8 at ambient conditions.
REYVOW 50 mg tablets contain 50 mg lasmiditan (equivalent to 57.824 mg lasmiditan hemisuccinate) and the inactive
ingredients as follows:
Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, red ferric oxide, talc, titanium dioxide.
Indications & Dosage
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.
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 8 hours between
dosing and driving or operating machinery [see WARNINGS AND PRECAUTIONS].
A second dose of REYVOW has not been shown to be effective for the same migraine attack.
The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.
REYVOW may be taken with or without food.
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, film coated, tablets with “L-100” debossed on one side and “4491” on the other
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, tablets with “L-100” debossed on one side and
“4491” on the other.
Carton of 8
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
Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, USA. Revised: Oct 2019
The following clinically significant adverse reactions are described elsewhere in the labeling:
Driving Impairment [see WARNINGS AND PRECAUTIONS]
Central Nervous System Depression [see WARNINGS AND PRECAUTIONS]
Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
Medication Overuse Headache [see WARNINGS AND PRECAUTIONS]
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 another drug and may not reflect the rates
observed in practice.
The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW. In 2 placebocontrolled,
Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50,
100, or 200 mg [see Clinical Studies]. Of the REYVOW-treated patients in these 2 studies, approximately 84% were
female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity. The mean age at study entry
was 42.4 years (range 18 to 81).
Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12 months in a long-term safety study.
Of these, 728 patients were exposed to 100 mg or 200 mg for at least 3 months, 361 patients were exposed to these
doses for at least 6 months, and 180 patients were exposed to these doses for at least 12 months, all of whom treated at
least 2 migraine attacks per month on average. In that study, 14% (148 out of 1,039) in the 200 mg dose group, and 11%
(112 out of 991) in the 100 mg dose group withdrew from the trial because of an adverse event. The most common
adverse event resulting in discontinuation in the long-term safety study (greater than 2%) was dizziness.
Table 1 shows adverse reactions that occurred in at least 2% of patients treated with REYVOW and more frequently than
in patients who received placebo in Studies 1 and 2. The most common adverse reactions (at least 5%) were dizziness,
fatigue, paresthesia, and sedation.
Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2
REYVOW 50 mg
REYVOW 100 mg
REYVOW 200 mg
Nausea and/or Vomiting
a Fatigue includes the adverse reaction related terms asthenia and malaise.
b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral.
c Sedation includes the adverse reaction related term somnolence.
Less Common Adverse Reactions
The following adverse reactions occurred in less than 2% of REYVOW-treated patients but more frequently than in
patients receiving placebo: vertigo, incoordination, lethargy, visual impairment, feeling abnormal, palpitations, anxiety,
tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, muscle spasm, limb
discomfort, cognitive changes, confusion, euphoric mood, chest discomfort, speech abnormalities, dyspnea, and
Events of hypersensitivity, including angioedema, rash and photosensitivity reaction, occurred in patients treated with
REYVOW. In controlled trials, hypersensitivity was reported in 0.2% of patients treated with REYVOW compared to no
patients who received placebo. If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and
discontinue administration of REYVOW.
Vital Sign Changes
Heart Rate Decrease
REYVOW was associated with mean decreases in heart rate of 5 to 10 beats per minute (bpm) while placebo was
associated with mean decreases of 2 to 5 bpm. Consider evaluating heart rate after administration of REYVOW in
patients for whom these changes may not be tolerated, including patients taking other medications that lower heart rate
[see DRUG INTERACTIONS].
Blood Pressure Increase
REYVOW may increase blood pressure following a single dose. In non-elderly healthy volunteers there was a mean
increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after
administration of 200 mg REYVOW compared to a mean increase of up to 1 mm Hg for placebo. In healthy volunteers
over 65 years of age, there was a mean increase from baseline in ambulatory systolic blood pressure of 7 mm Hg
one hour after administration of 200 mg REYVOW compared to a mean increase of 4 mm Hg for placebo. By 2 hours,
there were no increases in mean blood pressure with REYVOW compared to placebo. REYVOW has not been well
studied in patients with ischemic heart disease. Consider evaluating blood pressure after administration of REYVOW in
patients for whom these changes may not be tolerated.
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 used with caution if used in combination with alcohol or other CNS depressants
[see WARNINGS AND PRECAUTIONS].
Concomitant administration of REYVOW and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the
counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John’s Wort) that increase serotonin may
increase the risk of serotonin syndrome [see WARNINGS AND PRECAUTIONS]. Use REYVOW with caution in patients
taking medications that increase serotonin.
Heart Rate Lowering Drugs
REYVOW has been associated with a lowering of heart rate [see ADVERSE REACTIONS]. In a drug interaction study,
addition of a single 200 mg dose of REYVOW to propranolol decreased heart rate by an additional 5 beats per minute
compared to propranolol alone, for a mean maximum of 19 beats per minute. Use REYVOW with caution in patients
taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern.
P-Gp And Breast Cancer Resistant Protein (BCRP)
REYVOW inhibits P-gp and BCRP in vitro. Concomitant use of REYVOW and drugs that are P-gp or BCRP substrates
should be avoided.
Drug Abuse And Dependence
REYVOW contains lasmiditan. (Controlled substance schedule to be determined after review by the Drug Enforcement
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), single oral therapeutic doses (100 and
200 mg) and a supratherapeutic dose (400 mg) of REYVOW were compared to alprazolam (2 mg) (C-IV) and placebo.
With all doses of REYVOW, subjects reported statistically significantly higher “drug liking” scores than placebo, indicating
that REYVOW has abuse potential. In comparison to alprazolam, subjects who received REYVOW reported statistically
significantly lower “drug liking” scores. In the HAP study, euphoric mood occurred to a similar extent with REYVOW
200 mg, REYVOW 400 mg, and alprazolam 2 mg (43-49%). A feeling of relaxation was noted in more subjects on
alprazolam (22.6%) than with any dose of REYVOW (7-11%).
Phase 2 and 3 studies indicate that, at therapeutic doses, REYVOW produced adverse events of euphoria and
hallucinations to a greater extent than placebo. However these events occur at a low frequency (about 1% of patients).
Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse.
Physical withdrawal was not observed in healthy subjects following abrupt cessation after 7 daily doses of lasmiditan
200 mg or 400 mg.
Warnings & Precautions
Included as part of the "PRECAUTIONS" Section
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 drive [see Clinical Studies]. Additionally, more
sleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not to
engage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle or
operating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should not
take REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own driving
competence and the degree of impairment caused by REYVOW.
Central Nervous System Depression
REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation [see ADVERSE REACTIONS].
Because of the potential for REYVOW to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and
driving impairment, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants
[see DRUG INTERACTIONS]. Patients should be warned against driving and other activities requiring complete mental
alertness for at least 8 hours after REYVOW is taken [see Driving Impairment].
In clinical trials, reactions consistent with serotonin syndrome were reported in patients treated with REYVOW who were
not taking any other drugs associated with serotonin syndrome. Serotonin syndrome may also occur with REYVOW
during coadministration with serotonergic drugs [e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin
norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors].
Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic
instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia,
incoordination), and/or gastrointestinal signs and symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms
usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication. Discontinue
REYVOW if serotonin syndrome is suspected.
Medication Overuse Headache
Overuse of acute migraine drugs (e.g., ergotamines, triptans, opioids, or a combination of these drugs for 10 or more days
per month) may lead to exacerbation of headache (i.e., medication overuse headache). Medication overuse headache
may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of
patients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a
transient worsening of headache) may be necessary.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients not to engage in potentially hazardous activities requiring complete mental alertness,
such as driving a motor vehicle or operating machinery for 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 [see WARNINGS AND PRECAUTIONS].
Inform patients that REYVOW may cause dizziness and sedation. Advise patients to use caution if
taking REYVOW in combination with alcohol or other CNS depressants [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Caution patients about the risk of serotonin syndrome with the use of REYVOW, particularly during
combined use with serotonergic medications such as SSRIs, SNRIs, TCAs, or MAO inhibitors [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS].
Medication Overuse Headache
Inform patients that use of drugs to treat migraine attacks for 10 or more days per month
may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by
keeping a headache diary) [see WARNINGS AND PRECAUTIONS].
Advise patients to seek immediate medical attention if they experience any symptoms of serious or
severe hypersensitivity reaction [see ADVERSE REACTIONS].
Abuse And Dependence
There is a pending DEA decision for control of REYVOW (lasmiditan) under the Controlled
Substances Act. A statement about abuse and dependence risks cannot be completed at this time.
Advise patients to notify their healthcare provider if they become pregnant during treatment or plan to
become pregnant [see Use In Specific Populations].
Inform patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use In Specific Populations].
Carcinogenesis, Mutagenesis, Impairment Of Fertility
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 of up to 75 mg/kg/day for 2 years. Plasma exposures
(AUC) at the highest dose tested in rats were approximately 15 times that in humans at the maximum recommended
human dose (MRHD) of 200 mg/day.
Lasmiditan was negative in in vitro (bacterial reverse mutation, chromosomal aberration in mammalian cells) and in vivo (mouse bone marrow micronucleus) assays.
Impairment Of Fertility
Oral administration of lasmiditan to male (0, 100, 175, or 200 mg/kg/day) or female (0, 100, 150, or 200 mg/kg/day) rats
prior to and during mating and continuing in females to Gestation Day 7 resulted in no adverse effects on fertility or
reproductive performance. Plasma exposures (AUC) at the highest dose tested (200 mg/kg/day) were approximately 26
times that in humans at the MRHD.
Use In Specific Populations
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, increased embryofetal and offspring
mortality, decreased fetal body weight) occurred at maternal exposures less than (rabbit) or greater than (rat) those
observed clinically (see Data).
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically
recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2% to
2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without
Published data have suggested that women with migraine may be at increased risk for preeclampsia and gestational
hypertension during pregnancy.
Oral administration of lasmiditan (0, 100, 175, or 250 mg/kg/day) to pregnant rats throughout organogenesis resulted in
increases in skeletal variations at the mid and high doses and reduced fetal body weight at the high dose. The high dose
was associated with maternal toxicity. At the no-effect dose (100 mg/kg/day) for adverse effects on embryofetal
development in rats, plasma exposure (AUC) was approximately 10 times that in humans at the MRHD.
Oral administration of lasmiditan (0, 50, 75, or 115 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in
malformations (skeletal and visceral), increases in skeletal variations and embryofetal mortality, and decreased fetal body
weight at the highest dose tested, which was associated with maternal toxicity. Plasma exposure (AUC) at the no-effect
dose (75 mg/kg/day) for adverse effects on embryofetal development in rabbits was less than that in humans at the
Oral administration of lasmiditan (0, 100, 150, or 225 mg/kg/day) to rats throughout pregnancy and lactation resulted in
increases in stillbirth and neonatal mortality at the highest dose tested, which was associated with maternal toxicity and
delayed parturition. Plasma exposure (AUC) at the no-effect dose (150 mg/kg/day) for adverse effects on pre- and
postnatal development was approximately 16 times that in humans at the MRHD.
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 metabolites into milk, at levels approximately 3
times those in maternal plasma, was observed in lactating rats following oral administration of lasmiditan.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for
REYVOW and any potential adverse effects on the breastfed infant from REYVOW or from the underlying maternal
Safety and effectiveness in pediatric patients have not been established.
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 (14% for REYVOW, 3% for
placebo). A larger increase in systolic blood pressure also occurred in patients 65 years of age and older compared to
patients who were less than 65 years of age [see ADVERSE REACTIONS]. Clinical studies of REYVOW did not include
sufficient numbers of subjects aged 65 and over to determine whether there is a difference in efficacy in these patients
compared to younger subjects. However, in clinical pharmacology studies, no clinically relevant effect on exposure to
REYVOW was observed in elderly subjects [see CLINICAL PHARMACOLOGY]. In general, dose selection for an elderly
patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of
decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
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 in these patients is not
Overdosage & Contraindications
No Information Provided
Mechanism Of Action
Lasmiditan binds with high affinity to the 5-HT1F receptor. Lasmiditan presumably exerts its therapeutic effects in the
treatment of migraine through agonist effects at the 5-HT1F receptor; however, the precise mechanism is unknown.
At a dose two times the maximum recommended daily dose, REYVOW does not prolong the QTc interval to any clinically
Following oral administration, lasmiditan is rapidly absorbed with a median tmax 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 Cmax and AUC values by 22% and
19%, respectively, and delayed the median tmax by 1 hour. This difference in exposure is not expected to be clinically
significant [see DOSAGE AND ADMINISTRATION]. Lasmiditan was administered without regard to food in clinical efficacy
The human plasma protein binding of lasmiditan is approximately 55% to 60% and independent of concentration between
15 and 500 ng/mL.
Lasmiditan was eliminated with a geometric mean t½ value of approximately 5.7 hours. No accumulation of lasmiditan was
observed with daily dosing. Lasmiditan is primarily eliminated via metabolism, with ketone reduction representing the
major pathway. Renal excretion is a minor route of lasmiditan clearance.
Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes. The following enzymes are
not involved in metabolism of lasmiditan: MAO-A, MAO-B, flavin monooxygenase 3, CYP450 reductase, xanthine oxidase,
alcohol dehydrogenase, aldehyde dehydrogenase, and aldo-keto reductases. Lasmiditan is also metabolized to M7
(oxidation on piperidine ring) and M18 (combination of M7 and M8 pathways). These metabolites are considered
Recovery of unchanged lasmiditan in urine was low and accounted for approximately 3% of the dose. Metabolite S-M8
represented approximately 66% of the dose in urine, with the majority of recovery within 48 hours postdose.
Age, Sex, Race/Ethnicity, And Body Weight
Based on a population pharmacokinetic (PK) analysis, age, sex, race/ethnicity, and body weight did not have a significant
effect on the PK (Cmax and AUC) of lasmiditan. Therefore, no dose adjustments are warranted based on age, sex,
race/ethnicity, or body weight.
In a clinical pharmacology study, administration of lasmiditan to subjects 65 years of age or older demonstrated 26%
greater exposure in AUC(0-∞) and 21% higher Cmax, compared to subjects 45 years of age or less. This difference in
exposure is not expected to be clinically significant [see Use In Specific Populations].
In a clinical pharmacology study, administration of lasmiditan to subjects with severe renal impairment (eGFR
<30 mL/min/1.73 m2) demonstrated 18% greater exposure in AUC(0-∞) and 13% higher Cmax, compared to subjects with
normal renal function. No dose adjustment is required based on renal function.
In a clinical pharmacology study, subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B,
respectively) demonstrated 11% and 35%, respectively, greater exposure [AUC(0-∞)] to lasmiditan, compared to subjects
with normal hepatic function. The Cmax were higher by 19% and 33%, respectively, for subjects with mild and moderate
hepatic impairment. This difference in exposure is not expected to be clinically significant. The use of lasmiditan has not
been studied in subjects with severe hepatic impairment [see Use In Specific Populations].
Drug Interaction Studies
Potential For Lasmiditan To Affect Other Drugs
Drug Metabolizing Enzymes
Lasmiditan is an in-vitro inhibitor of CYP2D6 but did not significantly inhibit the activity of other CYP450 enzymes.
Modeling and simulation of the impact of lasmiditan on the exposure of dextromethorphan, a recognized sensitive
CYP2D6 substrate, indicate that lasmiditan is unlikely to exert clinically significant inhibition of CYP2D6. Lasmiditan, M7,
S-M8, and [S,R]-M18 are not reversible or time-dependent inhibitors of monoamine oxidase A (MAO-A).
Daily dosing of lasmiditan did not alter the PK of midazolam, caffeine, or tolbutamide, which are substrates of CYP3A,
CYP1A2, and CYP2C9, respectively. Coadministration of lasmiditan with sumatriptan, propranolol, or topiramate resulted
in no clinically meaningful changes in exposure of these medicinal products.
Lasmiditan inhibits P-gp and BCRP in-vitro [see DRUG INTERACTIONS].
Lasmiditan inhibits OCT1 in-vitro. However, in a drug-drug interaction study with lasmiditan and sumatriptan (OCT1
substrate), no change in sumatriptan PK was observed. Lasmiditan inhibits renal efflux transporters, MATE1 and MATE2-
Potential For Other Drugs To Affect Lasmiditan
Drug Metabolizing Enzymes
Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes. Therefore, it is unlikely that
CYP inhibitors or inducers will affect lasmiditan pharmacokinetics. Clinical studies of lasmiditan with sumatriptan,
propranolol, or topiramate did not show any significant drug interaction potential.
Lasmiditan is a substrate for P-gp in-vitro.
The efficacy of REYVOW in the acute treatment of migraine was demonstrated in two randomized, double-blind, placebocontrolled
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). Twentytwo
percent of patients were taking preventive medication for migraine at baseline. Study 1 randomized patients to
REYVOW 100 mg (n=744), or 200 mg (n=745) or placebo (n=742) and Study 2 randomized patients to REYVOW 50 mg
(n=750), 100 mg (n=754), or 200 mg (n=750) or placebo (n=751). Patients were allowed to take a rescue medication
2 hours after taking study drug; however, opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of
study drug administration.
The primary efficacy analyses were conducted in patients that treated a migraine with moderate to severe pain within
4 hours of the onset of the attack. The efficacy of REYVOW was established by an effect on pain freedom at 2 hours and
Most Bothersome Symptom (MBS) freedom at 2 hours compared to placebo for Studies 1 and 2. Pain freedom was
defined as a reduction of moderate or severe headache pain to no pain, and MBS freedom was defined as the absence of
the self-identified MBS (photophobia, phonophobia, or nausea). Among patients who selected an MBS, the most
commonly selected MBS was photophobia (54%), followed by nausea (24%), and phonophobia (22%).
In both studies, the percentage of patients achieving pain freedom and MBS freedom 2 hours after treatment was
significantly greater among patients receiving REYVOW at all doses compared to those receiving placebo (see Table 2).
Table 2: Migraine Efficacy Endpoints after Treatment for Studies 1 and 2
Pain Free at 2 hours
Difference from placebo (%)
MBS Free at 2 hours
Difference from placebo (%)
Pain relief at 2 hours, defined as a reduction in migraine pain from moderate or severe to mild or none, was also
evaluated (see Table 3).
Table 3: Additional Migraine Efficacy Endpoint after Treatment for Studies 1 and 2
Pain Relief at 2 hoursa
Difference from placebo (%)
a The analysis of pain relief was descriptive and was not controlled for Type I error.
Figure 1 presents the percentage of patients achieving migraine pain freedom within 2 hours following treatment in
Studies 1 and 2.
Figure 1: Percentage of Patients Achieving Migraine Pain Freedom within 2 Hours in Pooled Studies 1 and 2
a The 50 mg arm was only included in Study 2.
Figure 2 presents the percentage of patients achieving MBS freedom within 2 hours in Studies 1 and 2.
Figure 2: Percentage of Patients Achieving MBS Freedom within 2 Hours in Pooled Studies 1 and 2
a The 50 mg arm was only included in Study 2.
Effects On Driving
Driving performance was assessed at 90 minutes after administration of REYVOW 50 mg, 100 mg, 200 mg, alprazolam
1 mg, and placebo in a randomized, double-blind, placebo- and active-controlled, five-period crossover study in 90 healthy
volunteers (mean age 34.9 years) using a computer-based driving simulation. Driving performance was evaluated using a
validated threshold established in a population with blood alcohol concentration of 0.05%. The primary outcome measure
was the difference from placebo in the Standard Deviation of Lateral Position (SDLP), a measure of driving performance.
A dose-dependent impairment of computer-based simulated driving performance was seen with all doses of REYVOW at
90 minutes after administration.
Driving performance was also assessed at 8, 12, and 24 hours after administration of REYVOW 100 mg or 200 mg, in a
separate randomized, double-blind, placebo- and active-controlled, four-period crossover study in 67 healthy volunteers
(mean age 32.8 years) evaluating computer-based simulated driving performance using SDLP as the primary endpoint.
Diphenhydramine 50 mg was used as a positive control. The mean SDLP did not reach the threshold for driving
impairment at 8 hours or later after administration of REYVOW 100 or 200 mg.
tablets, for oral use
What is the most important information I should know about REYVOW?
Do not drive or operate machinery for at least 8 hours after you take REYVOW, even if you feel well enough.
You should not take REYVOW if you cannot wait at least 8 hours between taking REYVOW and driving or operating machinery.
What is REYVOW?
REYVOW is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults.
REYVOW is not used as a preventive treatment of migraine.
It is not known if REYVOW is safe and effective in children.
[There is a pending DEA decision for control of REYVOW (lasmiditan) under the Controlled Substances Act. A
statement for patients about abuse and dependence risks cannot be completed at this time.]
Before you take REYVOW, tell your healthcare provider about all of your medical conditions, including if you:
have liver problems
have high blood pressure
have a low heart rate
are allergic to lasmiditan
are pregnant or plan to become pregnant. It is not known if REYVOW will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if REYVOW passes into your breastmilk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. Your healthcare provider will decide if you can take REYVOW with your
Especially, tell your healthcare provider if you take:
propranolol or other medicines that can lower your heart rate
any medicines that can increase your blood pressure
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of them and show it to your healthcare provider or pharmacist when you get a
How should I take REYVOW?
Take REYVOW exactly as your healthcare provider tells you to take it.
Your healthcare provider may change your dose. Do not change your dose without first talking to your healthcare
Take REYVOW tablets by mouth with or without food.
Do not take more than one dose in a 24-hour period.
If you take REYVOW 50 mg, 100 mg, or 200 mg, and your headache goes away but comes back, you should
not take a second dose within 24 hours.
Some people who take too many REYVOW tablets may have worse headaches (medication overuse headache). If
your headaches get worse, your healthcare provider may decide to stop your treatment with REYVOW.
You should write down when you have headaches and when you take REYVOW so you can talk to your
healthcare provider about how REYVOW is working for you.
What should I avoid while taking REYVOW?
Do not drive or operate machinery for at least 8 hours after taking REYVOW.
You should not drink alcohol or take other medicines that make you drowsy while taking REYVOW.
What are the possible side effects of REYVOW?
REYVOW can cause serious side effects including:
See “What is the most important information I should know about REYVOW?”
serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using
REYVOW, especially if REYVOW is used with anti-depressant medicines called SSRIs or SNRIs. Call your
healthcare provider right away if you have any of the following symptoms of serotonin syndrome:
mental changes such as seeing things that are not there (hallucinations), agitation, or coma
changes in blood pressure
high body temperature
nausea, vomiting, or diarrhea
medication overuse headache. Some people who take medicines like REYVOW for the acute treatment of
migraine attacks for 10 or more days each month may have worse headaches (medication overuse
headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with
The most common side effects of REYVOW include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of REYVOW. For more information ask your healthcare provider or
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Lilly at 1-800-LillyRx (1-800-545-5979).
How should I store REYVOW?
Store REYVOW at room temperature between 68°F to 77°F (20°C to 25°C).
Keep REYVOW and all medicines out of the reach of children.
General information about the safe and effective use of REYVOW.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REYVOW
for a condition for which it was not prescribed. Do not give REYVOW to other people, even if they have the same
symptoms you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about REYVOW that is written for health