Drug - Reyvow™ (lasmiditan) [Eli Lilly and Company]
Therapeutic area - Antimigraine Agents, Other
Initial approval criteria:
- Patient must be ≥ 18 years of age; AND
- Patient must have a diagnosis of migraine, with or without aura; AND
- Patient must not have headache frequency ≥ 15 headache days per month; AND
- Patient must not have hypersensitivity to any component of the product; AND
- Patient must not have severe hepatic impairment (Child-Pugh C); AND
- Patient must have tried and failed to at least one of the following: NSAID, non-opioid analgesic, acetaminophen OR caffeinated analgesic combination; AND
- Patient must have tried and failed, or have contraindication to, ≥ 2 preferred triptans; AND
- Prescriber must attest to all of the following:
- Patient has been cautioned about potential of Reyvow to cause sedation, alone or in combination of other CNS depressants or alcohol; AND
- Patient has been educated about need to refrain from driving or operating machinery for ≥ 8 hours after dose; AND
- Patient has been advised about the increased risk of serotonin syndrome when Reyvow is used in combination with other drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.); AND
- If applicable, provider has completed a review of patient’s adherence of any medication used to prevent migraine and address any patient’s adherence issue.
- Patient must continue to meet the above criteria; AND
- Patient has not had any treatment-limiting adverse effects (e.g., central nervous system depression, sedation, serotonin syndrome, medication overuse headache); AND
- Patient must demonstrate resolution in headache pain or reduction in headache severity, as assessed by prescriber.
- 4 doses per 30 days
- Any request for quantities exceeding those recommended by the FDA will not be approved
Reyvow FDA-approved label states:
- No more than one dose should be taken in 24 hours
- 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.
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