SAFETY HAS BEEN ASSESSED IN 3 LARGE CLINICAL TRIALS1-3
Safety was assessed in the 2 pivotal, registration trials, SAMURAI and SPARTAN. Safety also has been assessed in CENTURION, a multiple-attack study.
REYVOW has no contraindications.1
Safety results from the SAMURAI and SPARTAN clinical trials1,2
Click to scroll through complete data.
Image 1
Results of the SAMURAI and SPARTAN studies, showing the adverse reactions occurring in ≥2% of patients treated with REYVOW and at a higher percentage than placebo.
In the SAMURAI and SPARTAN studies, 1262 patients took placebo, 654 patients took 50 mg of REYVOW, 1265 patients took 100 mg of REYVOW, and 1258 patients took 200 mg of REYVOW. 3% of patients taking placebo, 9% of patients taking 50 mg, 15% of patients taking 100 mg, and 17% of patients taking 200 mg experienced dizziness. In general, dizziness was mild or moderate in severity. Approximately 1% of patients experienced severe dizziness: 50 mg, 0.3%; 100 mg, 0.8%; 200 mg, 1.4%. 1% of patients taking placebo, 4% of patients taking 50 mg, 5% of patients taking 100 mg, and 6% of patients taking 200 mg experienced fatigue. Fatigue includes the adverse reaction related terms asthenia and malaise. 2% of patients taking placebo, 3% of patients taking 50 mg, 7% of patients taking 100 mg, and 9% of patients taking 200 mg experienced paresthesia. Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral. 2% of patients taking placebo, 6% of patients taking 50 mg, 6% of patients taking 100 mg, and 7% of patients taking 200 mg experienced sedation. Sedation includes the adverse reaction related term somnolence. <1% experienced severe sedation: 50 mg, 0.2%; 100 mg, 0.3%; 200 mg, 0.4%. 2% of patients taking placebo, 3% of patients taking 50 mg, 4% of patients taking 100 mg, and 4% of patients taking 200 mg experienced nausea and/or vomiting. 0% of patients taking placebo, 1% of patients taking 50 mg, 1% of patients taking 100 mg, and 2% of patients taking 200 mg experienced muscle weakness.
Image 2
Results of the SAMURAI and SPARTAN studies, showing the summary of dizziness by severity: mild, moderate, or severe.
In the SAMURAI and SPARTAN studies, 1258 patients took 200 mg of REYVOW, 1265 patients took 100 mg of REYVOW, 654 patients took 50 mg of REYVOW, and 1262 patients took placebo. 9.6% of patients taking 200 mg, 9.3% of patients taking 100 mg, 6.1% of patients taking 50 mg, and 2.3% of patients taking placebo experienced mild dizziness. 6.2% of patients taking 200 mg, 5.2% of patients taking 100 mg, 2.1% of patients taking 50 mg, and 0.6% of patients taking placebo experienced moderate dizziness. 1.4% of patients taking 200 mg, 0.8% of patients taking 100 mg, 0.3% of patients taking 50 mg, and 0.1% of patients taking placebo experienced severe dizziness.
Image 3
Results of the SAMURAI and SPARTAN studies, showing the summary of sedation by severity: mild, moderate, or severe.
In the SAMURAI and SPARTAN studies, 1258 patients took 200 mg of REYVOW, 1265 patients took 100 mg of REYVOW, 654 patients took 50 mg of REYVOW, and 1262 patients took placebo. 4.1% of patients taking 200 mg, 3.1% of patients taking 100 mg, 3.8% of patients taking 50 mg, and 1.7% of patients taking placebo experienced mild sedation. 2.2% of patients taking 200 mg, 2.2% of patients taking 100 mg, 1.5% of patients taking 50 mg, and 0.5% of patients taking placebo experienced moderate sedation. 0.4% of patients taking 200 mg, 0.3% of patients taking 100 mg, 0.2% of patients taking 50 mg, and 0.1% of patients taking placebo experienced severe sedation.
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.
ADDITIONAL IMPORTANT INFORMATION
Driving Impairment:
Due to CNS adverse reactions, REYVOW was evaluated for its effect on driving ability based on updated FDA guidance released in 2017.1,4
- Advise patients not to drive or operate machinery for 8 hours after taking REYVOW1
- Patients who can't follow this advice should not take REYVOW1
- Patients may not be able to assess their own driving competence and degree of impairment1
Scheduling:
- REYVOW contains lasmiditan, a Schedule V controlled substance1
- REYVOW has abuse potential. Evaluate patients for risk of drug abuse and observe them for signs of REYVOW misuse or abuse.
- Schedule V represents the lowest abuse potential categorization from the Drug Enforcement Administration (DEA)
REYVOW is not a narcotic medication. REYVOW has low abuse potential and no evidence of physical withdrawal.1
SAFETY RESULTS FROM THE CENTURION MULTIPLE ATTACK CLINICAL TRIAL
REYVOW (100 mg and 200 mg) was evaluated in CENTURION, a multiple attack study. Safety findings observed in the CENTURION study were generally consistent with those seen in previous clinical trials for REYVOW.
Click to scroll through complete data.
Image 1
Results of the CENTURION study, showing the adverse reactions occurring in ≥2% of patients treated with REYVOW and at a frequency greater than placebo. The CENTURION study assessed adverse reactions for the first of 3 treated attacks.
In the CENTURION study, 500 patients took placebo, 485 patients took 100 mg of REYVOW, and 486 patients took 200 mg of REYVOW. 5% of patients taking placebo, 22% of patients taking 100 mg, and 27% of patients taking 200 mg experienced dizziness. 2% of patients taking placebo, 13% of patients taking 100 mg, and 15% of patients taking 200 mg experienced paresthesia. Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral. 2% of patients taking placebo, 11% of patients taking 100 mg, and 14% of patients taking 200 mg experienced fatigue. Fatigue includes the adverse reaction related terms asthenia and malaise. 5% of patients taking placebo, 7% of patients taking 100 mg, and 12% of patients taking 200 mg experienced nausea and/or vomiting. 1% of patients taking placebo, 5% of patients taking 100 mg, and 8% of patients taking 200 mg experienced sedation. Sedation includes the adverse reaction related term somnolence. 0% of patients taking placebo, 5% of patients taking 100 mg, and 7% of patients taking 200 mg experienced vertigo. 0% of patients taking placebo, 3% of patients taking 100 mg, and 5% of patients taking 200 mg experienced muscular weakness. 0% of patients taking placebo, 2% of patients taking 100 mg, and 3% of patients taking 200 mg experienced feeling abnormal. 0% of patients taking placebo, 1% of patients taking 100 mg, and 2% of patients taking 200 mg experienced balance disorder.
Image 2
Results from the CENTURION study representing the frequency of dizziness over time.
REYVOW (100 mg and 200 mg) was evaluated in CENTURION, a multiple-attack study.
During the treated first attack, 486 patients took 200 mg of REYVOW, 485 patients took 100 mg of REYVOW, and 500 patients took placebo. During the second treated attack, 396 patients took 200 mg of REYVOW, 413 patients took 100 mg of REYVOW, and 438 patients took placebo. During the third treated attack, 313 patients took 200 mg of REYVOW, 329 patients took 100 mg of REYVOW, and 317 patients took placebo.
During the first attack, 27% of patients taking 200 mg of REYVOW, 22% of patients taking 100 mg of REYVOW, and 5% of patients taking placebo experienced dizziness. During the second attack, 21% of patients taking 200 mg of REYVOW, 13% of patients taking 100 mg of REYVOW, and 2% of patients taking placebo experienced dizziness. During the third attack, 20% of patients taking 200 mg of REYVOW, 9% of patients taking 100 mg of REYVOW, and 3% of patients taking placebo experienced dizziness.
The dizziness data shown are from the CENTURION clinical trial. The data is not an illustration of what patients taking REYVOW will necessarily experience.
Image 3
Results from the CENTURION study representing the frequency of sedation* over time.
REYVOW (100 mg and 200 mg) was evaluated in CENTURION, a multiple-attack study.
During the treated first attack, 486 patients took 200 mg of REYVOW, 485 patients took 100 mg of REYVOW, and 500 patients took placebo. During the second treated attack, 396 patients took 200 mg of REYVOW, 413 patients took 100 mg of REYVOW, and 438 patients took placebo. During the third treated attack, 313 patients took 200 mg of REYVOW, 329 patients took 100 mg of REYVOW, and 317 patients took placebo.
During the first attack, 8% of patients taking 200 mg of REYVOW, 5% of patients taking 100 mg of REYVOW, and 1% of patients taking placebo experienced sedation. During the second attack, 6% of patients taking 200 mg of REYVOW, 4% of patients taking 100 mg of REYVOW, and 1% of patients taking placebo experienced sedation. During the third attack, 5% of patients taking 200 mg of REYVOW, 2% of patients taking 100 mg of REYVOW, and 0% of patients taking placebo experienced sedation. *Sedation also includes the treatment-emergent adverse event (TEAE) preferred term somnolence.
The sedation data shown are from the CENTURION clinical trial. The data is not an illustration of what patients taking REYVOW will necessarily experience.
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.
Discover dosing and prescribing guidance
SEE DOSING INFOReference:
- REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC.
- Krege JH, Rizzoli PB, Liffick E, et al. Safety findings from Phase 3 lasmiditan studies for acute treatment of migraine: Results from SAMURAI and SPARTAN. Cephalalgia. 2019;39:957-966.
- Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0033.
- Evaluating drug effects on the ability to operate a motor vehicle. Guidance for industry. U.S. Food and Drug Administration website. https://www.fda.gov/media/90670/download. Published November 2017. Accessed August 26, 2020.
- Data on File. Indianapolis, IN: Lilly USA, LLC. DOF-LM-US-0039.
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