A DIFFERENT KIND OF MIGRAINE TREATMENT
REYVOW (lasmiditan) is the first and only FDA-approved ditan—a high-affinity 5-HT1F receptor agonist1
- REYVOW presumably exerts its therapeutic effects by activating the 5-HT1F receptor; however, the exact mechanism of action is unknown.1
5-HT1F receptors, involved in modulating pain signaling, are present on both the peripheral and central pain pathways.2,3 Based on the location of 5-HT1F receptors, REYVOW is believed to act both centrally and peripherally.3
In preclinical studies:
- Though not demonstrated in humans, REYVOW was shown to cross the blood-brain barrier in an animal model4
- REYVOW was shown to be lipophilic based on an in vitro assay4
REYVOW is a Selective 5-HT1F Receptor Agonist1
REYVOW is not a triptan. In preclinical studies, REYVOW was shown to have more than 440-fold greater selectivity for the 5-HT1F receptor than for the 5-HT1B and the 5-HT1D receptors.1,4
Activation of 5-HT1F receptors has been observed in preclinical studies to:2,5,6
Inhibit pain pathways, including the trigeminal nerve
Inhibit the release of neurotransmitters and neuropeptides
Not cause vasoconstriction of blood vessels
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.
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EXPLORE EFFICACY DATAReferences: 1. REYVOW [Prescribing Information]. Indianapolis, IN: Lilly USA, LLC. 2. Rubio-Beltran E, Labastida-Ramirez A, Villalon CM, MaassenVanDenBrink A. Is selective 5-HT1F receptor agonism an entity apart from that of the triptans in antimigraine therapy? Pharmacol Ther. 2018;186:88-97. 3. Vila-Pueyo M. Targeted 5-HT1F therapies for migraine. Neurotherapeutics. 2018;15:291-303. 4. Clemow DB, Johnson KW, Hochstetler HM, Ossipov MH, Hake AM, Blumenfeld AM. Lasmiditan mechanism of action-review of a selective 5-HT1F agonist. J Headache Pain. 2020;21:71. 5. Goadsby PJ, Holland PR, Martins-Oliveira M, Hoffmann J, Schankin C, Akerman S. Pathophysiology of migraine: a disorder of sensory processing. Physiol Rev. 2017;97:553-622. 6. Ahn SK, Khalmuratova R, Jeon SY, et al. Colocalization of 5-HT1F receptor and calcitonin gene-related peptide in rat vestibular nuclei. Neurosci Lett. 2009;465:151-156.
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