EXPLORE MORE REYVOW DATA
Clinical Study Design: CENTURION
REYVOW (lasmiditan) was evaluated in CENTURION, a multiple attack consistency study. In the study, consistency was defined as achieving pain freedom in 2 out of the first 3 treated attacks.1
In CENTURION, patients (N=1471; REYVOW: 971, Placebo: 500) were required to be age 18 and older, have a history of migraine for at least 1 year, have 3-8 migraine attacks/month, and have at least moderate migraine disability (MIDAS score ≥11)1
PAIN FREEDOM1
Complete elimination of moderate to severe headache pain at 2 hours during the first treated attack
PAIN FREEDOM ACROSS MULTIPLE ATTACKS1
Complete elimination of moderate to severe headache pain at 2 hours in 2 out of the first 3 treated attacks
Patients were instructed to take the study drug to treat 4 attacks within 4 hours of headache onset when the pain was moderate to severe1
Doses evaluated: 100 mg, 200 mg 1
SELECT IMPORTANT SAFETY INFORMATION
Medication Overuse Headache
Overuse of acute migraine drugs 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.
For the acute treatment of migraine with or without aura in adults2
REYVOW CAN DELIVER FAST MIGRAINE PAIN RELIEF IN 60 MINUTES WITH A SINGLE DOSE3
Pain relief, a secondary endpoint, was defined as reduction of migraine pain from moderate or severe to mild or none at 2 hours post-dose during the first attack.
Results for pain relief at 30 minutes are descriptive and not controlled for Type 1 error.
See pain relief data for pivotal trials SPARTAN/SAMURAI
See CENTURION study design
SELECT IMPORTANT SAFETY INFORMATION
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.
For the acute treatment of migraine with or without aura in adults2
FAST AND COMPLETE ELIMINATION OF PAIN IS POSSIBLE AT 2 HOURS WITH A SINGLE DOSE OF REYVOW4
Some patients achieved pain freedom at 1 hour (200 mg)4
Results for pain freedom at 1 hour for 100 mg and less than 1 hour for all doses are descriptive and not controlled for Type 1 error. Effect of pain freedom at these time points cannot be regarded as statistically significant.
See pain freedom data for pivotal trials SPARTAN/SAMURAI
See CENTURION study design
SELECT IMPORTANT SAFETY INFORMATION
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 REYVOW misuse or abuse.
For the acute treatment of migraine with or without aura in adults2
REYVOW EFFICACY WAS CONSISTENT OVER MULTIPLE ATTACKS5
Patients who achieved complete elimination of pain at 2 hours reported similar effects in 2 out of 3 attacks when treated with REYVOW5
See CENTURION study design
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.
SAFETY WAS ASSESSED FOR THE FIRST ATTACK IN THE CENTURION STUDY6
Observed safety findings in the CENTURION study were generally consistent with those seen in previous REYVOW clinical trials.
See CENTURION study design
Discover dosing and prescribing information
LEARN MOREReferences: 1. Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0026. 2. REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 3. Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0029. 4. Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0028. 5. Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0027. 6. Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0033.
INDICATION 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.
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. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular signs, and/or gastrointestinal signs and symptoms. 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 may lead to exacerbation of 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 Full Prescribing Information and Medication Guide.
LM HCP ISI 28SEP2020