Reyvow

— THERAPEUTIC CATEGORIES —
  • Migraine and headache
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Reyvow Generic Name & Formulations

    Legal Class

    CV

    General Description

    Lasmiditan 50mg, 100mg; tabs.

    Pharmacological Class

    Serotonin (5-HT) 1F receptor agonist.

    How Supplied

    Tabs—8

    How Supplied

    50mg tablet: light gray, oval, film coated, tablets with “L-50” debossed on one side and “4312” on the other.

    100mg tablet: 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).

    Manufacturer

    Eli Lilly and Company

    Generic Availability

    NO

    Reyvow Indications

    Indications

    Acute treatment of migraine with or without aura.

    Limitations of Use

    Not for preventive treatment of migraine.

    Reyvow Dosage and Administration

    Adult

    Swallow whole. 50–200mg once as needed; max 1 dose/24hrs. Do not administer unless patient can wait ≥8hrs between dosing and driving/operating machinery. The safety of treating an average of >4 migraine attacks in a 30-day period: not established.

    Children

    Not established.

    Reyvow Contraindications

    Not Applicable

    Reyvow Boxed Warnings

    Not Applicable

    Reyvow Warnings/Precautions

    Warnings/Precautions

    Driving impairment (see Adults). CNS depression. Discontinue if serotonin syndrome is suspected. Medication overuse headache; may need detoxification. Severe hepatic impairment (Child-Pugh C): not recommended. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Driving Impairment

    • Single doses (50mg, 100mg, or 200mg) of Reyvow significantly impaired an individual’s ability to drive in a driving study.
    • Compared with placebo, more sleepiness was reported at 8 hours following a dose of Reyvow.
    • Patients should avoid driving or operating machinery for at least 8 hours after each dose of Reyvow; if they are unable to do so, then they should not take Reyvow.
    • Patients may not be able to assess their own driving competence and the degree of impairment caused by Reyvow.

    CNS Depression

    • Dizziness and sedation are possible with Reyvow.
    • Use with caution if used in combination with alcohol or other CNS depressants.

    Serotonin Syndrome

    • Reactions consistent with serotonin syndrome have been reported with Reyvow.
    • Serotonin syndrome may also occur with Reyvow when coadministered with serotonergic drugs (eg, SSRIs, SNRIs, tricyclic antidepressants, MAOIs).
    • Serotonin syndrome symptoms include mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia, incoordination), and/or gastrointestinal signs and symptoms (eg, nausea, vomiting, diarrhea).
    • Onset may occur minutes to hours of receiving a new or greater dose of serotonergic medication.
    • Discontinue Reyvow if serotonin syndrome is suspected.

    Medication Overuse Headache

    • Overuse of acute migraine drugs may lead to exacerbation of headache.
    • May present as migraine-like daily headaches or as a marked increase in migraine attack frequency.
    • Withdrawal of overused medication and treatment of withdrawal symptoms may be necessary.

    Pregnancy Considerations

    Pregnancy exposure registry: (833) 464-4724 or visit www.migraine pregnancy registry.com.

    No adequate data on the developmental risk associated with the use of lasmiditan in pregnant women.

    Nursing Mother Considerations

    No data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production. Evaluate the benefits of use for the mother vs the potential risks for the infant.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Geriatric Considerations

    Dizziness occurred more frequently in patients 65 years of age and older compared with younger patients in clinical trials.

    Larger increases in blood pressure were also observed in study participants 65 years of age and older.

    No clinically relevant effect on exposure to Reyvow was observed in elderly patients in clinical pharmacology studies; however, clinical trials did not include a sufficient number of patients aged 65 years and over to determine whether there is a difference in efficacy.

    Hepatic Impairment Considerations

    Not studied in patients with severe hepatic impairment (Child-Pugh C); use in these patients is not recommended.

    Other Considerations for Specific Populations

    Lasmiditan is a Schedule V controlled substance. Evaluate patients for risk of drug abuse and observe for signs of misuse and abuse. 

    Reyvow Pharmacokinetics

    Absorption

    Lasmiditan is rapidly absorbed with a median tmax of 1.8 hours.

    Distribution

    Human plasma protein binding of lasmiditan is approximately 55% to 60%.

    Metabolism

    Lasmiditan undergoes hepatic and extrahepatic metabolism primarily by non-CYP enzymes.

    Elimination

    Mean half-life is approximately 5.7 hours. Ketone reduction is the major pathway of elimination. Renal excretion is a minor route.

    Reyvow Interactions

    Interactions

    Avoid concomitant P-gp or BCRP substrates. May potentiate CNS depression with alcohol or other CNS depressants. May increase risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, TCAs, MAOIs, trazodone, dextromethorphan, St. John's Wort). Caution with drugs that lower heart rate (eg, propranolol).

    Reyvow Adverse Reactions

    Adverse Reactions

    Dizziness, fatigue, paresthesia, sedation.

    Reyvow Clinical Trials

    Clinical Trials

    The approval of Reyvow was based on data from two phase 3 trials, SAMURAI (ClinicalTrials.gov Identifier: NCT02439320) and SPARTAN (ClinicalTrials.gov Identifier: NCT02605174). Patients enrolled in these studies had a history of migraine with and without aura, were predominantly female (84%) and White (78%); the mean age was 42 years. Patients were allowed to take rescue medication 2 hours after taking study drug; opioids, barbiturates, triptans, and ergots were not allowed within 24 hours of study drug administration.

    The primary endpoint of both studies was the effect on pain freedom (defined as a reduction of moderate to severe headache pain to no pain) at 2 hours and most bothersome symptom (MBS) freedom (defined as the absence of the self-identified MBS [photophobia, phonophobia, or nausea]) at 2 hours compared with placebo.

    In the SAMURAI study, patients were randomly assigned to receive Reyvow 100mg (n=744) or 200mg (n=745) or placebo (n=742). The percentage of responders in the Reyvow 100mg, Reyvow 200mg, and placebo groups were:

    • Pain free at 2 hours: 28.3% (difference from placebo, 13; P <.001), 31.8%, (difference from placebo, 16.5; P <.001) and 15.3%.
    • MBS free at 2 hours: 41.2% (difference from placebo, 11.6, P <.001), 40.7% (difference from placebo, 11.1; P <.001), and 29.6%.
    • Pain relief (defined as a reduction in migraine pain from moderate to severe to mild or none) at 2 hours: 54.0%, 55.3%, and 40.0%.

    In the SPARTAN trial, patients were randomly assigned to receive Reyvow 50mg (n=750), Reyvow 100mg (n=754), Reyvow 200mg (n=750) or placebo (n=751). The percentage of responders in the Reyvow 50mg, 100mg, 200mg, and placebo groups were:

    • Pain free at 2 hours: 28.3% (difference from placebo, 7.3; P =.006), 31.4%, (difference from placebo, 10.4; P <.001), 38.8% (difference from placebo, 17.8; P <.001) and 21.0%.
    • MBS free at 2 hours: 40.8% (difference from placebo, 7.6, P =.014), 44.0% (difference from placebo, 10.8; P <.001), 48.7% (difference from placebo, 15.5; P <.001), and 33.2%.
    • Pain relief at 2 hours: 55.9%, 61.4%, 61.0%, and 45.1%.

    Effects on Driving

    A randomized, double-blind, placebo- and active-controlled, 5-period crossover study was conducted in 90 healthy volunteers to determine driving performance (using a computer-based simulation) at 90 minutes after administration of Reyvow 50mg, 100mg, 200mg, alprazolam 1mg, and placebo. The primary endpoint was the difference from placebo in the Standard Deviation of Lateral Position (SDLP), a measure of driving performance. Results showed a dose-dependent impairment in driving performance at all doses of Reyvow.

    In a separate randomized, double-blind, placebo- and active-controlled, 4-period crossover study, driving performance (using a computer-based simulation) was assessed in 67 healthy volunteers at 8, 12, and 24 hours after administration of Reyvow 100mg or 200mg. Diphenhydramine 50mg was used as a positive control. Results showed the mean SDLP did not reach the threshold for driving impairment at 8 hours or later after Reyvow administration.

    Reyvow Note

    Not Applicable

    Reyvow Patient Counseling

    Patient Counseling

    Advise patients not to engage in potentially hazardous activities requiring complete mental alertness (eg, driving or operating machinery) for at least 8 hours after each dose of Reyvow.

    Dizziness and sedation with Reyvow may be exacerbated by alcohol or other CNS depressants.

    Be mindful of the potential for serotonin syndrome, hypersensitivity, and abuse and dependence potential.

    Drugs to treat migraine attacks for 10 or more days per month may lead to an exacerbation of headache. Record headache frequency and drug use with a headache diary.

    Pregnant, lactating women: notify health care provider.

    Reyvow tablets should be swallowed whole.

    Cost Savings Program

    Reyvow Savings Card

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