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LASMIDITAN TAB,ORAL

Clinical Criteria Summary

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Exclusion Criteria

  • Concurrent therapy with a P-glycoprotein substrates sensitive to minor changes in plasma concentration (e.g., digoxin)
  • Concurrent therapy with ubrogepant or rimegepant
  • Concurrent therapy with a triptan agent once lasmiditan is initiated
  • Pregnancy
  • Patient unable to comply with not engaging in activities requiring mental alertness (e.g. driving) for at least 8 hours after taking lasmiditan

Inclusion Criteria

  • Treatment initiated by a VA/VA Community Care neurologist or locally designated headache expert
  • Diagnosis of migraine, with or without aura, per the International Classification of Headache Disorders (ICHD-3)
  • Moderate to severe migraine intensity
  • Contraindication, intolerance, or lack of response to trial of two different triptans

Triptan Contraindications & Interactions

  • Vascular contraindications: ischemic coronary artery disease, previous stroke or transient ischemic attack, peripheral vascular disease, ischemic bowel disease, or uncontrolled hypertension
  • Drug interaction-related contraindications: concurrent use of a MAO inhibitor

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Indication

  • Acute treatment of migraine with or without aura in adults.

Patient Population & Clinical Context

  • Adults with a history of 3–8 migraine attacks and less than 15 headache days per month.
  • Patients with cardiovascular risk factors or disease for whom triptan use is contraindicated.
  • Triptan-experienced population, including patients who did not demonstrate an acceptable response to triptans.

Dosing & Administration

  • Doses of 50 mg, 100 mg, and 200 mg demonstrated efficacy for pain freedom at 2 hours.
  • Administer as the first treatment for each new migraine attack within 4 hours of pain onset.
  • Do not repeat a dose until more than 48 hours after treatment of an attack.

Safety Monitoring & Precautions

  • Monitor closely for CNS depression, dizziness, balance disorders, somnolence, fatigue, sedation, and paresthesia (occurring >2% greater than placebo).
  • Monitor closely for cardiovascular effects, including potential decrease in heart rate and/or increase in blood pressure, particularly in patients who may not tolerate these changes.
  • Monitor closely for signs of serotonin syndrome (mental status changes, autonomic instability, neuromuscular changes, GI symptoms, seizures) when used alone or with other serotonergic agents; discontinue immediately if signs/symptoms arise.
  • Patients must be able to abstain from activities requiring mental alertness for at least 8 hours after administration due to driving impairment risks.

Contraindications & Restrictions

  • Not recommended in patients with severe hepatic impairment.
  • Should not be taken with alcohol or other sedating medications.
  • Classified as a controlled substance monitored by the DEA; associated with euphoria and hallucinations.

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