LEADERS IN MIGRAINE DISCUSS THE ROLE OF REYVOW AS AN ACUTE TREATMENT¹

REYVOW Connect: Patient Profile

Dr Sara Sacco describes the type of patient who may benefit from REYVOW

(Doctor appears on screen with title card bottom right: “SARA SACCO, MD; Director, Carolinas Headache Clinic in North Carolina”)

Doctor Voiceover: Hi. I'm Dr. Sara Sacco. I'm a headache specialist and a neurologist. And I have been certified by the UCNS to treat headaches.

(Video topic appears in middle with REYVOW logo at top and doctor’s name at bottom: “HOW CAN I HELP ENSURE MY PATIENTS HAVE THE APPROPRIATE TREATMENT OPTIONS TO MANAGE THEIR ATTACKS? With SARA SACCO, MD”)

(Doctor appears on screen with REYVOW logo and text, “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. Please see additional safety information at the end of this video. Click the links below for access to the Full Prescribing Information and Medication Guide.”)

Doctor Voiceover: REYVOW is indicated for the acute treatment of migraine with or without aura in adults. REYVOW is not indicated for the preventive treatment of migraine.

(Doctor appears on screen)

Doctor Voiceover: I have been treating patients with migraine in my own clinic, now, for 20 years. When a patient comes in, I like to try to see what I can do to help make things better. And it turns out patients are really looking for complete relief for their migraines. They want it to be gone. And they want it to be gone quickly. We can't always accomplish that with just a single medication or a single treatment. Frequently, we have to have a full toolbox, because migraines are different. And you need to be able to treat differently, depending on the type of migraine attack. We do have patients who are using triptans, and supplements, other prescription nonsteroidals, and even over-the-counter medications. Sometimes they work, and then—sometimes they don't. And having REYVOW, it can serve as another or a different treatment option for them. People have lived with migraines for so many years, and they've gotten used to the fact that there's times when they're not going to be able to do things. When my patient comes in, and they have been treated, I'm always asking them how well their treatment is working for them. And they might say fine. But I think it's important for us to ask, “Is it getting rid of the headache completely?” And a lot of times they'll say, “No. It makes it better.” We're looking for pain freedom. Not only do they want the headache to be gone completely, but I want to ask them, “How long does it take?” “Oh, six to seven hours.” Well, that's not good enough either. We want the headache to be gone completely. But we also want it to be gone quickly. And I think, when you ask those questions, if they feel like the medicine isn't working the way they should, or if you feel like the medicine isn't working optimally for them, then we need to discuss a different treatment plan with them. You know, just the other day, I had this patient that came in. And I thought I was doing a really good job treating her headaches. So, I asked her about her migraines, and how well she was responding. And she said, “You know, most of the time it works really—pretty well. But every so often—maybe a couple times a month—I get this headache that doesn't go away with the treatments you've given me.” And I said, “You know, I think we need to think about a different treatment for you, for those particular attacks.” What we want from these treatments is something that's going to help us with that migraine attack, to get rid of the pain, to get them to pain freedom. When I'm thinking about REYVOW, and which patient might be appropriate for it, I think about those patients who are having disabling attacks, a couple of disabling attacks a month. I'm also thinking about the patient whose particular treatment isn't working quickly enough, or isn't getting rid of the pain completely. I think about those patients who are taking their current medications and are adding additional things to their current medications, such as nonsteroidals or over-the-counters. And that's still not working to get rid of their pain completely. That's someone I would think about trying REYVOW for.

(Text appears on screen: “SELECT IMPORTANT SAFETY INFORMATION Driving Impairment: REYVOW may cause significant driving impairment. 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. Please see additional safety information at the end of this video.”)

Professional Voiceover: REYVOW does carry a driving restriction. In studies, more sleepiness was reported at 8 hours compared to placebo. So, patients should be advised not to engage in activities requiring complete mental alertness for at least 8 hours after each dose. If they're unable to do this, they should not be prescribed REYVOW.

(Dr appears on screen with text: “The primary endpoint was pain freedom, defined as a reduction of moderate or severe migraine pain to no pain at 2 hours.¹”)

(Text appears on the left side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.^1-3”)

(Icon: Bubble with two figures within)

(Text:

4439 PATIENTS AGE 18 AND OLDER WERE DOSED (REYVOW=3177; PLACEBO=1262), INCLUDING THOSE WITH

≥2 cardiovascular risk factors (41%)⁴
Concomitant use of migraine preventive drugs (22%)¹
Concomitant use of serotonergic medication (22%)⁵
Prior triptan exposure within the past 3 months (37%)⁶

ALL PATIENTS HAD

History of migraine for at least 1 year^2,3
3-8 migraine attacks/month^2,3
MIDAS* score ≥11 (pooled median was 25)⁷

*Migraine Disability Assessment)

Doctor Voiceover: There were two pivotal trials that demonstrated that REYVOW was effective in treating migraine, the SPARTAN and the SAMURAI trials. These studies evaluated more than 4,400 patients with migraines, with or without aura. These patients were instructed to take their dose within four hours of the headache onset, and when the pain was moderate to severe.

(New text appears on left side of screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.^1-3”)

(Icon: Bubble with medicine bottle within)

(Text: “Patients were allowed to take a rescue medication 2 hours after taking study drug; however, opiods, barbituates, triptans, and ergots were not allowed within 24 hours of study drug administration¹ DOSING: 100 mg, 200 mg (SAMURAI); 50 mg, 100 mg, 200 mg (SPARTAN)¹”)

Doctor Voiceover: They were allowed to take a rescue medicine two hours after taking the REYVOW.

(Data appears on screen)

(Text: “FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 2 HOURS WITH A SINGLE DOSE OF REYVOW^1,8; UP TO 39% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 2 HOURS COMPARED TO UP TO 21% WITH PLACEBO ACROSS 2 STUDIES^1,8”)

(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 2 hours with REYVOW vs placebo^1,8)

Doctor Voiceover: As you can see from these charts, REYVOW provided fast and complete elimination of migraine pain at all doses, compared with the placebo at two hours. In the SPARTAN study, up to 39% of the patients achieved pain freedom at two hours, compared to 21% of the patients on placebo. And in SAMURAI, up to 32% of the patients achieved pain freedom at two hours, compared to 15% of the patients on placebo.

(Text appears on screen: “Safety Summary: REYVOW may cause significant driving impairment. Advise patients not to engage in activities requiring complete mental alertness, such as driving or operating machinery, for at least 8 hours after taking REYVOW. Patients who cannot do this should not take REYVOW. Be aware that patients may not be able to assess their degree of impairment. REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. Use caution if REYVOW is used in combination with alcohol or other CNS depressants. Reactions consistent with serotonin syndrome have occurred in patients taking REYVOW who were not taking other drugs associated with serotonin syndrome. Discontinue REYVOW if you suspect serotonin syndrome. Overuse of acute migraine drugs may cause medication overuse headache, which may present as migraine-like daily headaches or a marked increase in attack frequency. Detoxification, including withdrawal of overused drugs and treatment of symptoms, may be necessary. Common side effects include dizziness, fatigue, paresthesia, sedation, nausea, vomiting, and muscle weakness. REYVOW contains lasmiditan, a Schedule V controlled substance, which has abuse potential. Evaluate patients for risk of drug abuse and watch for signs of REYVOW misuse or abuse. This is not the complete safety information for REYVOW. Please see the full Important Safety Information below. Click the links below for access to the full Prescribing Information and Medication Guide. LM HCP MSR 30JUN2021”)

Professional Voiceover: Safety Summary; REYVOW may cause significant driving impairment. Advise patients not to engage in activities requiring complete mental alertness, such as driving or operating machinery, for at least 8 hours after taking REYVOW. Patients who cannot do this should not take REYVOW. Be aware that patients may not be able to assess their degree of impairment. REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. Use caution if REYVOW is used in combination with alcohol or other CNS depressants. Reactions consistent with serotonin syndrome have occurred in patients taking REYVOW who were not taking other drugs associated with serotonin syndrome. Discontinue REYVOW if you suspect serotonin syndrome. Overuse of acute migraine drugs may cause medication overuse headache, which may present as migraine-like daily headaches or a marked increase in attack frequency. Detoxification, including withdrawal of overused drugs and treatment of symptoms, may be necessary. Common side effects include dizziness, fatigue, paresthesia, sedation, nausea, vomiting, and muscle weakness. REYVOW contains lasmiditan, a Schedule V controlled substance, which has abuse potential. Evaluate patients for risk of drug abuse and watch for signs of REYVOW misuse or abuse. This is not the complete safety information for REYVOW. Please see the full Important Safety Information below. Click the links below for access to the full Prescribing Information and Medication Guide.

(Text appears on screen with REYVOW logo, Lilly logo, trademark statement, copyright info, and video number and date)

(Text:

References

REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
Kuca B, Silberstein SB, Wietecha L, Berg PH, Dozier G, Lipton RB. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018;91:e2222-e2232.
Goadsby PJ, Weitecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019;142:1894-1904.
Shapiro RE, Hochstetler HM, Dennehy EB, et al. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019;20:90.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0018.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0005.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0012.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0004.

REYVOW Connect: Efficacy

Dr Carrie Dougherty examines the data behind REYVOW and reflects on what it could mean for your patients with migraine

(Doctor appears on screen with title card bottom right: “CARRIE DOUGHERTY, MD; Associate Professor of Neurology, MedStar Georgetown University Hospital; Paid Spokesperson”)

Doctor Voiceover: I'm Carrie Dougherty. I am a headache specialist and neurologist. I'm associate professor of neurology at MedStar Georgetown University Hospital. And I work as a part of the MedStar Georgetown Headache Center.

(Video topic appears in middle with REYVOW logo at top and doctor’s name at bottom: “WHAT ROLE DOES PAIN FREEDOM PLAY WHEN EVALUATING AN ACUTE MIGRAINE TREATMENT? With CARRIE DOUGHERTY, MD”)

Doctor Voiceover: REYVOW is indicated for the acute treatment of migraine with or without aura in adults. REYVOW is not indicated for the preventive treatment of migraine.

(Doctor appears on screen)

Doctor Voiceover: I have to say in my clinic, when it comes to patient expectations, I often find that my patients are settling when it comes to acute treatment, that they may have over time learned to be complacent and satisfied with a medication that just provides pain relief but that doesn't provide pain freedom. And oftentimes when we talk about what the acute medications that they're using are providing, they describe it, that it helps, or that it prevents the pain from worsening. I have found over the past year that if I reflect on how I take a patient history, I wasn't asking the right questions. Oftentimes, I was satisfied when a patient was telling me, "My acute medication works, yeah, I'm happy with it." But when I ask, "Well, what does it do for you?” The descriptions that they give aren't what I would consider success.

(Doctor appears on screen)

(Text appears on the right side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.^1-3”)

(Icon: Bubble with two figures within)

(Text:

4439 PATIENTS AGE 18 AND OLDER WERE DOSED (REYVOW=3177; PLACEBO=1262), INCLUDING THOSE WITH:

≥2 cardiovascular risk factors (41%)⁴
Concomitant use of migraine preventive drugs (22%)¹
Concomitant use of serotonergic medication (22%)⁵
Prior triptan exposure within the past 3 months (37%)⁶

ALL PATIENTS HAD:

History of migraine for at least 1 year^2,3
3-8 migraine attacks/month^2,3
MIDAS* score ≥11 (pooled median was 25)⁷

*Migraine Disability Assessment)

Doctor Voiceover: REYVOW was evaluated in two randomized double-blind, placebo-controlled, single-attack trials. They were labeled SPARTAN and SAMURAI. These studies evaluated more than 4,400 patients with migraine, with or without aura. Patients were instructed to take their dose of study medication within four hours of headache onset and when the pain was moderate to severe.

(New text appears on the right side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.^1-3”)

(Icon: Bubble with medicine bottle within)

Doctor Voiceover: Patients were allowed to take a rescue medicine two hours after taking REYVOW, but they were not allowed to take opioids, barbiturates, triptans or ergots within 24 hours of taking REYVOW.

(New text appears on the right side of the screen: “CLINICAL STUDY DESIGN: SAMURAI AND SPARTAN; REYVOW WAS EVALUATED IN 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE-ATTACK TRIALS.^1-3”)

(Icon: Bubble containing head within)

(Text: “Primary endpoint PAIN FREEDOM¹; Complete elimination of moderate to severe headache pain at 2 hours; Patients were instructed to take the study drug within 4 hours of headache onset when the pain was moderate to severe¹”)

Doctor Voiceover: In both SPARTAN and SAMURAI, the primary endpoint was pain freedom at two hours. It's important to understand the distinction between pain freedom and pain relief. Patients have a priority for the pain to be gone with their acute migraine treatment, not for just pain reduction. Oftentimes, in clinic, we don't make this distinction and don't ask enough questions to really characterize what degree of pain relief or pain resolution patients are achieving with their acute treatments.

(Doctor appears on screen with text along the bottom)

(Text: “For the acute treatment of migraine in adults¹, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 2 HOURS WITH A SINGLE DOSE OF REYVOW^1,8. UP TO 39% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 2 HOURS COMPARED TO UP TO 21% WITH PLACEBO ACROSS 2 STUDIES^1,8”)

Doctor Voiceover: The effect of REYVOW on pain freedom is that it provided fast and complete elimination of migraine pain at all doses, compared with placebo, at two hours.

(Data appears on screen)

(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 2 hours with REYVOW vs placebo^1,8)

Doctor Voiceover: In SPARTAN, up to 39% of patients achieved pain freedom at two hours, compared to 21% of patients on placebo, and in SAMURAI, up to 32% of patients on REYVOW achieved pain freedom at two hours, compared to 15% of patients on placebo.

(Text appears on screen: “SELECT IMPORTANT SAFETY INFORMATION Central Nervous System Depression: REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. 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. Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken. Please see additional safety information at the end of the video.”)

Professional Voiceover: REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation. 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.

(Doctor appears onscreen with text: “For the acute treatment of migraine in adults¹, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 90 MINUTES WITH A SINGLE DOSE OF REYVOW^1,8. UP TO 28% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 90 MINUTES COMPARED TO UP TO 13% WITH PLACEBO ACROSS 2 STUDIES^1,8. The results for pain freedom at timepoints before 2 hours are descriptive and the analyses were not controlled for Type I error. Effect of REYVOW on pain freedom at these earlier timepoints cannot be regarded as statistically significant.”)

Doctor Voiceover: Some patients achieved pain freedom even earlier than two hours. Pain freedom in 90 minutes was possible. The results for pain freedom at time points before two hours are descriptive, and the analyses were not controlled for Type I error; thus, the effect of REYVOW on pain freedom at these earlier time points cannot be regarded as statistically significant.

(Data appears onscreen)

(Text: “For the acute treatment of migraine in adults¹, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 90 MINUTES WITH A SINGLE DOSE OF REYVOW^1,8. UP TO 28% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 90 MINUTES COMPARED TO UP TO 13% WITH PLACEBO ACROSS 2 STUDIES^1,8.”)

(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 90 minutes with REYVOW vs placebo^1,8)

Doctor Voiceover: In SPARTAN, up to 28% of patients achieved pain freedom at 90 minutes, compared to 13% of patients on placebo. In SAMURAI, up to 25% of patients achieved pain freedom in 90 minutes, compared to 10% of patients on placebo.

(Doctor appears onscreen with text: “For the acute treatment of migraine in adults¹, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 60 MINUTES WITH A SINGLE DOSE OF REYVOW (200 mg)^1,8. UP TO 17% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 60 MINUTES COMPARED TO UP TO 7% WITH PLACEBO^1,8. The results for pain freedom at timepoints before 2 hours are descriptive and the analyses were not controlled for Type I error. Effect of REYVOW on pain freedom at these earlier timepoints cannot be regarded as statistically significant.”)

Doctor Voiceover: REYVOW provided pain freedom in 60 minutes for some patients taking 200 milligrams.

(Data appears onscreen)

(Text: “For the acute treatment of migraine in adults¹, FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 60 MINUTES WITH A SINGLE DOSE OF REYVOW (200 mg)^1,8. UP TO 17% OF PATIENTS ACHIEVED COMPLETE ELIMINATION OF MIGRAINE PAIN AT 60 MINUTES COMPARED TO UP TO 7% WITH PLACEBO^1,8.”)

(Graphs displayed side-by-side: Results from the SPARTAN and SAMURAI trials showing the percent of patients who achieved pain freedom at 60 minutes with REYVOW vs placebo^1,8)

Doctor Voiceover: In SPARTAN, up to 17% of patients taking 200 milligrams of REYVOW achieved pain freedom at 60 minutes, compared to 7% on placebo. In SAMURAI, up to 14% of patients taking 200 milligrams of REYVOW achieved pain freedom at 60 minutes, compared to 7% on placebo.

(Doctor appears onscreen)

Doctor Voiceover: The results of these clinical trials align with what patients are looking for when it comes to acute treatment for migraine. Fast elimination of pain by acute migraine medication is a priority for patients. They don't have time to wait around for their medication to be effective. Many patients in my practice are looking for acute treatment for their migraine that's fast and effective at providing pain freedom. And it's nice to have options that really reflect what their priorities are. Thank you for watching this video. If you're interested in watching other videos in the REYVOW Connect series, please reach out to your Lilly representative.

(Text appears on screen with REYVOW logo, Lilly logo, trademark statement, copyright info, and video number and date)

(Text:

References

REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
Kuca B, Silberstein SB, Wietecha L, Berg PH, Dozier G, Lipton RB. Lasmiditan is an effective acute treatment for migraine: a phase 3 randomized study. Neurology. 2018;91:e2222-e2232.
Goadsby PJ, Weitecha LA, Dennehy EB, et al. Phase 3 randomized, placebo-controlled, double-blind study of lasmiditan for acute treatment of migraine. Brain. 2019;142:1894-1904.
Shapiro RE, Hochstetler HM, Dennehy EB, et al. Lasmiditan for acute treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials. J Headache Pain. 2019;20:90.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0018.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0005.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0012.
Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0004.

Hear more experts discuss REYVOW and treating migraine

WATCH MORE VIDEOS

Reference:

REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

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 drive. 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. 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. Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken.

Serotonin Syndrome - 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 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.

ADVERSE REACTIONS

The most common adverse reactions associated with REYVOW (≥2% and greater than placebo in clinical studies) were dizziness, fatigue, paresthesia, sedation, nausea and/or vomiting, and muscle weakness.

ABUSE

REYVOW contains lasmiditan, a Schedule V controlled substance (C-V).
REYVOW has abuse potential. Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse.

See Prescribing Information and Medication Guide.
LM HCP ISI 28SEP2020

INDICATIONS

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.

LEADERS IN MIGRAINE DISCUSS THE ROLE OF REYVOW AS AN ACUTE TREATMENT1

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

ABUSE

INDICATIONS

LEADERS IN MIGRAINE DISCUSS THE ROLE OF REYVOW AS AN ACUTE TREATMENT¹