Lasmiditan
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kosar Doraghi, M.D.[2]
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Black Box Warning
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Warning
See full prescribing information for complete Boxed Warning.
Driving Impairment:
Do not use in combination with alcohol or other CNS depressants.
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Overview
Lasmiditan is a serotonin (5-HT) 1F receptor agonist that is FDA approved for the treatment of migraine with or without aura in adults. There is a Black Box Warning for this drug as shown here. Common adverse reactions include dizziness, fatigue, paresthesia, and sedation.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
The recommended dose is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours.
Off-Label Use and Dosage (Adult)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Lasmiditan FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Contraindications
None.
Warnings
|
Warning
See full prescribing information for complete Boxed Warning.
Driving Impairment:
Do not use in combination with alcohol or other CNS depressants.
|
can impair driving ability significantly, even after single doses. It may cause central nervous system depression and caution is advised when combined with alcohol or other depressants. Serotonin syndrome, characterized by various symptoms, may occur with REYVOW use. Prolonged use may lead to medication overuse headache, requiring detoxification.
Adverse Reactions
Clinical Trials Experience
- Driving Impairment
- Central Nervous System Depression
- Serotonin Syndrome [see Warnings and Precautions
- Medication Overuse Headache
The safety profile of REYVOW has been evaluated in clinical studies involving 4,878 subjects. In placebo-controlled Phase 3 trials, approximately 84% of the 3,177 patients who received REYVOW were female, with a mean age of 42.4 years. Long-term safety was assessed in 2,030 patients, with 14% withdrawing from the study due to adverse events, the most common being dizziness. Adverse reactions occurring in at least 2% of REYVOW-treated patients, and more frequently than in those receiving placebo, included dizziness, fatigue, paresthesia, and sedation. Less common adverse reactions included vertigo, visual impairment, palpitations, and hallucinations.
Hypersensitivity reactions, such as angioedema and rash, were reported in 0.2% of REYVOW-treated patients. REYVOW was associated with decreases in heart rate and increases in blood pressure following administration, particularly in older individuals and those with ischemic heart disease. These changes should be monitored, especially in patients taking medications that lower heart rate or in those who may not tolerate blood pressure fluctuations well.
Postmarketing Experience
There is limited information regarding Lasmiditan Postmarketing Experience in the drug label.
Drug Interactions
When REYVOW is taken alongside medications that lower heart rate, it may exacerbate the reduction in heart rate.
- Caution advised due to potential for sedation and cognitive/neuropsychiatric adverse reactions
- Use REYVOW cautiously with serotonergic drugs to prevent risk of serotonin syndrome
- REYVOW may lower heart rate; caution advised when used with heart rate-lowering medications.
- Not recommended to coadminister REYVOW with P-gp transporter substrates like digoxin due to potential for serious toxicities
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Patients should notify their healthcare provider if they become pregnant during treatment or plan to become pregnant. There's a pregnancy exposure registry monitoring outcomes in women exposed to REYVOW during pregnancy.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lasmiditan in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lasmiditan during labor and delivery.
Nursing Mothers
Patients should inform their healthcare provider if they are breastfeeding or plan to breastfeed.
Pediatric Use
There is no FDA guidance on the use of Lasmiditan in pediatric settings.
Geriatic Use
REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended.
Gender
There is no FDA guidance on the use of Lasmiditan with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lasmiditan with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lasmiditan in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Lasmiditan in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Lasmiditan in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Lasmiditan in patients who are immunocompromised.
Administration and Monitoring
Administration
- Recommended oral doses of REYVOW: 50 mg, 100 mg, or 200 mg, as needed for migraine relief.
- Do not exceed one dose within a 24-hour period.
- Avoid taking REYVOW if driving or operating machinery within 8 hours of dosing.
- Taking a second dose of REYVOW for the same migraine attack is not effective.
- Safety of treating more than 4 migraine attacks in a 30-day period has not been established.
- REYVOW can be taken with or without food
Monitoring
There is limited information regarding Lasmiditan Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Lasmiditan and IV administrations.
Overdosage
There is limited information regarding Lasmiditan overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Lasmiditan Pharmacology in the drug label.
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.
Structure
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-ylbenzamide hemisuccinate. It has the empirical formula of C19H18F3N3O2•0.5C4H6O4 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:
- Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.
Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.
- REYVOW 100 mg tablets contain 100 mg lasmiditan (equivalent to 115.65 mg lasmiditan hemisuccinate) and the inactive ingredients as follows:
Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.
Pharmacodynamics
There is limited information regarding Lasmiditan Pharmacodynamics in the drug label.
Pharmacokinetics
Absorption: Lasmiditan, taken orally, is rapidly absorbed with a median time to maximum concentration of 1.8 hours, and absorption remains consistent regardless of migraine attack or interictal period. Effect of Food: While a high-fat meal can slightly increase lasmiditan exposure, it's not clinically significant; efficacy studies were conducted irrespective of food intake. Distribution: Lasmiditan's plasma protein binding is approximately 55% to 60%, and it remains consistent within the therapeutic range. Elimination: Lasmiditan has a half-life of approximately 5.7 hours and is primarily metabolized in the liver, with minimal renal excretion. Metabolism: It undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes, producing pharmacologically inactive metabolites. Excretion: Urinary excretion of unchanged lasmiditan is low, with most excretion attributed to metabolite S-M8.
Nonclinical Toxicology
There is limited information regarding Lasmiditan Nonclinical Toxicology in the drug label.
Clinical Studies
REYVOW's efficacy in treating acute migraine was demonstrated in two double-blind, placebo-controlled trials (Study 1 and Study 2). These trials enrolled patients with a history of migraine, with or without aura, predominantly female (84%) and White (78%), with a mean age of 42 years. The primary efficacy analysis focused on patients treating migraines with moderate to severe pain within 4 hours of onset.
Results showed that REYVOW significantly increased pain freedom and relief at 2 hours compared to placebo in both studies, across all doses tested (50 mg, 100 mg, and 200 mg). Additionally, REYVOW significantly increased freedom from the most bothersome symptom (MBS) at 2 hours compared to placebo. The most commonly reported MBS was photophobia, followed by nausea and phonophobia.
Further analysis demonstrated that REYVOW did not impair driving performance at 8 hours or later after administration of doses up to 200 mg. However, a dose-dependent impairment in driving performance was observed at 90 minutes post-administration across all doses tested (50 mg, 100 mg, and 200 mg) in healthy volunteers.
How Supplied
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.
Storage
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)
Images
Drug Images
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Package and Label Display Panel
NDC 0002-4491-08
8 tablets (2 cards of 4 tablets)
REYVOW®
(lasmiditan) CV
tablets 100 mg
Each tablet contains 100 mg of lasmiditan.
Rx only
www.REYVOW.com
100 mg
Dispense enclosed Medication Guide to each patient.
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Patient Counseling Information
- Driving Impairment: Patients should refrain from engaging in activities requiring complete mental alertness, such as driving or operating machinery, for at least 8 hours after taking each dose of REYVOW. Patients unable to adhere to this should avoid taking REYVOW, as they may not accurately assess their own driving ability.
- CNS Depression: Patients should be aware that REYVOW may cause dizziness and sedation. Caution is advised when using REYVOW alongside alcohol or other CNS depressants.
- Serotonin Syndrome: Patients should be cautious about the risk of serotonin syndrome, particularly when using REYVOW alongside serotonergic medications such as SSRIs, SNRIs, TCAs, or MAO inhibitors.
- Medication Overuse Headache: Patients should be informed that using migraine medications for 10 or more days per month may worsen headaches. Keeping a headache diary to track frequency and medication use is encouraged.
- Hypersensitivity: Patients should seek immediate medical attention if they experience symptoms of a serious or severe hypersensitivity reaction.
- Abuse and Dependence: Patients should be informed that REYVOW is a federally controlled substance due to its potential for abuse. It's advised to keep the medication secure.
- Pregnancy: Patients should notify their healthcare provider if they become pregnant during treatment or plan to become pregnant. There's a pregnancy exposure registry monitoring outcomes in women exposed to REYVOW during pregnancy.
- Administration: Patients should swallow tablets whole and avoid splitting, crushing, or chewing them.
Precautions with Alcohol
Alcohol-Lasmiditan interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Lasmiditan Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Lasmiditan Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.