Reyvow 100mg Tablets

Manufacturer LILLY Active Ingredient Lasmiditan(las MID i tan) Pronunciation Las-MID-i-tan
It is used to treat migraine headaches.
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Drug Class
Antimigraine agent
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Pharmacologic Class
Selective 5-hydroxytryptamine (5-HT)1F receptor agonist
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Pregnancy Category
Not available
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FDA Approved
Oct 2019
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Reyvow is a medication used to treat acute migraine headaches in adults. It works by targeting specific receptors in the brain to help stop a migraine attack once it has started. It is not used to prevent migraines.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take the medication as soon as possible after the attack has started. You can take it with or without food, but be sure to swallow the tablet whole - do not chew, break, or crush it.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Store it in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to keep the medication safe. Remember to keep all medications out of reach of pets.

Missing a Dose

Since this medication is taken as needed, do not take it more frequently than directed by your doctor. Do not take more than one dose of this medication within a 24-hour period.
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Lifestyle & Tips

  • Do not drive or operate machinery for at least 8 hours after taking Reyvow, even if you feel well, due to the risk of dizziness and sedation.
  • Avoid alcohol and other CNS depressants while taking Reyvow, as this can increase side effects like dizziness and drowsiness.
  • Take Reyvow as soon as migraine symptoms begin, but do not take more than one dose in 24 hours.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg orally once as needed for acute treatment of migraine. May also be dosed at 50 mg or 200 mg.
Dose Range: 50 - 200 mg

Condition-Specific Dosing:

max_dose_24h: Do not take more than one dose in 24 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific recommendations; Lasmiditan is not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Not studied; use with caution.

Pharmacology

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Mechanism of Action

Lasmiditan is a selective serotonin 5-HT1F receptor agonist. It is believed to exert its therapeutic effects in migraine by activating 5-HT1F receptors, which are located on trigeminal neurons and may inhibit pain signal transmission. Unlike triptans, lasmiditan does not cause vasoconstriction.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 10-20%
Tmax: 1.5 to 2 hours
FoodEffect: High-fat meal delays Tmax by approximately 1 hour and decreases Cmax by approximately 20%, but AUC is not significantly affected.

Distribution:

Vd: Approximately 223 L
ProteinBinding: Approximately 55-60%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 5-6 hours
Clearance: Approximately 30 L/hour
ExcretionRoute: Primarily renal (urine), with some fecal excretion.
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours
PeakEffect: Approximately 2 hours
DurationOfAction: Up to 24 hours (based on clinical effect, but patients are advised not to drive for at least 8 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
A burning, numbness, or tingling feeling that is not normal
A severe headache that does not improve after the first dose
Symptoms of serotonin syndrome, a potentially life-threatening condition, which may include:
+ Agitation
+ Change in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, upset stomach, or vomiting
+ A very bad headache

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:

* Feeling dizzy, sleepy, tired, or weak

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe dizziness or drowsiness
  • Confusion, agitation, or hallucinations (signs of serotonin syndrome)
  • Fast heart rate or changes in blood pressure (signs of serotonin syndrome)
  • Muscle stiffness or twitching (signs of serotonin syndrome)
  • Unusual tingling, numbness, or burning sensation (paresthesia)
  • Unexplained muscle weakness
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease, as this may affect how your body processes the medication.
If you are unable to wait at least 8 hours between taking this medication and engaging in activities that require alertness, such as driving.
If you are currently taking digoxin, as this may interact with the medication.

Please note that this is not an exhaustive list of potential interactions. It is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

After taking this drug, refrain from driving and engaging in other activities that require alertness for at least 8 hours, or until you feel fully awake and alert.

This medication is not intended to prevent or reduce the frequency of migraine headaches. If you experience a headache that is different from your typical migraine, consult your doctor before taking this drug.

Be cautious not to exceed the prescribed dose or frequency, as taking more of this medication than directed by your doctor may worsen your headaches. Additionally, avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness or impair your actions.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Exaggerated adverse effects such as severe dizziness, somnolence, fatigue, paresthesia, and nausea.

What to Do:

There is no specific antidote for lasmiditan overdose. Treatment should be symptomatic and supportive. Monitor vital signs and cardiac rhythm. Hemodialysis is unlikely to be effective due to high protein binding and large volume of distribution. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics): Increased risk of CNS depression (dizziness, sedation).
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, St. John's Wort): Increased risk of serotonin syndrome.
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Moderate Interactions

  • Drugs that lower heart rate (e.g., beta-blockers, digoxin): Potential for additive heart rate lowering effects (though clinical significance is low).

Monitoring

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Baseline Monitoring

Migraine frequency and severity

Rationale: To establish baseline and assess treatment efficacy.

Timing: Prior to initiation

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Routine Monitoring

CNS adverse effects (dizziness, somnolence, fatigue)

Frequency: With each dose

Target: N/A

Action Threshold: If severe or persistent, consider dose reduction or discontinuation.

Serotonin Syndrome symptoms

Frequency: Monitor closely, especially when co-administered with other serotonergic drugs

Target: N/A

Action Threshold: If symptoms occur, discontinue lasmiditan and initiate supportive treatment.

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Symptom Monitoring

  • Dizziness
  • Somnolence
  • Fatigue
  • Paresthesia
  • Nausea
  • Muscle weakness
  • Serotonin syndrome (agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

Limited human data on lasmiditan use in pregnant women. Animal studies have shown developmental toxicity (e.g., skeletal abnormalities, reduced fetal weight) at exposures higher than clinical. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity based on animal data.
Second Trimester: Potential for developmental toxicity based on animal data.
Third Trimester: Potential for developmental toxicity based on animal data.
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Lactation

Lasmiditan is present in human milk. There are no data on the effects of lasmiditan on the breastfed infant or on milk production. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Reyvow and any potential adverse effects on the breastfed infant from Reyvow or from the underlying maternal condition.

Infant Risk: Low to moderate risk. Monitor breastfed infants for sedation, poor feeding, or other adverse effects.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Not approved for use in patients younger than 18 years of age.

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Geriatric Use

No overall differences in effectiveness or safety were observed between elderly and younger patients. No dose adjustment is required based on age, but caution should be exercised due to the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in elderly patients.

Clinical Information

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Clinical Pearls

  • Reyvow is a non-triptan acute migraine treatment, making it an option for patients who have contraindications to triptans (e.g., cardiovascular disease, uncontrolled hypertension) or who do not respond to triptans.
  • Patients must be counseled on the 8-hour driving restriction after taking a dose due to the high incidence of CNS effects like dizziness and somnolence.
  • It is important to differentiate Reyvow from CGRP inhibitors; Reyvow is for acute treatment, while CGRP inhibitors (oral or injectable) are often for prevention.
  • Advise patients to take Reyvow as soon as migraine symptoms begin for optimal efficacy.
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Alternative Therapies

  • Triptans (e.g., sumatriptan, zolmitriptan, rizatriptan)
  • CGRP receptor antagonists (gepants) for acute treatment (e.g., ubrogepant, rimegepant)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Ergot alkaloids (e.g., dihydroergotamine)
  • Opioids (generally not recommended for migraine)
  • Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
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Cost & Coverage

Average Cost: $600 - $800 per 8 tablets (typical prescription)
Insurance Coverage: Often Tier 3 or Specialty, may require prior authorization
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.