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.