pharmacopeia
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Mechanism of action

Sourced from openFDA

Lasmiditan binds with high affinity to the 5-HT 1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT 1F receptor; however, the precise mechanism is unknown.

Indications

Sourced from openFDA
  • REYVOW ® is indicated for the acute treatment of migraine with or without aura in adults. REYVOW ® is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.ICD-10: G43.909

Contraindications

Sourced from openFDA
  • None. None.contraindicated

Dosage & administration

Sourced from openFDA

The recommended dose of REYVOW is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and REYVOW should not be taken unless the patient can wait at least 8 hours between dosing and driving or operating machinery [see Warnings and Precautions ( 5.1 )] . A second dose of REYVOW has not been shown to be effective for the same migraine attack. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established. REYVOW may be taken with or without food. Administer tablets whole; do not split, crush, or chew. The recommended dose is 50 mg, 100 mg, or 200 mg taken orally, as needed. ( 2 ) No more than one dose should be taken in 24 hours. ( 2 , 5.1 ) Administer tablets whole. ( 2 )

Warnings & precautions

Sourced from openFDA

Driving Impairment: Advise patients not to drive or operate machinery until at least 8 hours after taking each dose of REYVOW. Patients who cannot follow this advice should not take REYVOW. Patients may not be able to assess their own driving competence and the degree of impairment caused by REYVOW. ( 5.1 ) Central Nervous System (CNS) Depression: REYVOW may cause CNS depression and should be used with caution if used in combination with alcohol or other CNS depressants. ( 5.2 , 7.1 ) Serotonin Syndrome: Reactions consistent with serotonin syndrome were reported in patients treated with REYVOW. Discontinue REYVOW if symptoms of serotonin syndrome occur. ( 5.3 ) Medication Overuse Headache: Detoxification may be necessary. ( 5.4 ) 5.1 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 [see Clinical Studies ( 14.2 )] . 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.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment [see Warnings and Precautions ( 5.1 )] Central Nervous System Depression [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Medication Overuse Headache [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW. In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200 mg [see Clinical Studies ( 14.1 )] . Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity. The mean age at study entry was 42.4 years (range 18 to 81). Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12 months in a long-term safety study.

Use in specific populations

Sourced from openFDA

Based on animal data, may cause fetal harm. ( 8.1 ) REYVOW has not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is not recommended. ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REYVOW during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724. To learn more please call or visit www.migrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of REYVOW in pregnant women. In animal studies, adverse effects on development (increased incidences of fetal abnormalities, increased embryofetal and offspring mortality, decreased fetal body weight) occurred at maternal exposures less than (rabbit) or greater than (rat) those observed clinically (see Data) . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Following oral administration, lasmiditan is rapidly absorbed with a median t max of 1.8 hours. In patients with migraine, the absorption or pharmacokinetics of lasmiditan was not different during a migraine attack versus during the interictal period.

Approval history

Sourced from openFDA
  • Oct 11, 2019NDANDA211280Eli Lilly And Co

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Reyvow, Tablet, 100 mg (NDC 0002-4491-08)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Reyvow, Tablet, 100 mg (NDC 0002-4491-61)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Reyvow, Tablet, 100 mg (NDC 0002-4491-62)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Reyvow, Tablet, 50 mg (NDC 0002-4312-08)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Reyvow, Tablet, 50 mg (NDC 0002-4312-61)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated
  • Reyvow, Tablet, 50 mg (NDC 0002-4312-62)To be discontinued
    Sponsor: Eli Lilly and Co.
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,126 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Dizziness20718%
  2. 2Drug Ineffective13612%
  3. 3Feeling Abnormal11710%
  4. 4Somnolence1079.5%
  5. 5Migraine827.3%
  6. 6Nausea817.2%
  7. 7Sedation797.0%
  8. 8Fatigue665.9%
  9. 9Headache645.7%
  10. 10Paraesthesia585.2%
  11. 11Hallucination443.9%
  12. 12Hypoaesthesia292.6%
  13. 13Insomnia282.5%
  14. 14Serotonin Syndrome282.5%
  15. 15Euphoric Mood262.3%

Clinical trials

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The 10 most recently updated of 35 ClinicalTrials.gov registrations naming Lasmiditan as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Lasmiditan work?
Lasmiditan binds with high affinity to the 5-HT 1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT 1F receptor; however, the precise mechanism is unknown.
What is Lasmiditan used for?
According to FDA labeling, Lasmiditan carries indications including: REYVOW ® is indicated for the acute treatment of migraine with or without aura in adults. REYVOW ® is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lasmiditan?
Lasmiditan is classified as Selective serotonin (5HT1) agonists, Unknown Cellular or Molecular Interaction.
What are the brand names for Lasmiditan?
Lasmiditan is marketed under brand names including Reyvow.
What are the contraindications for Lasmiditan?
Lasmiditan labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.
Note. Data for lasmiditan is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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