Reyvow 50mg Tablets

Lasmiditan is a selective serotonin 5-HT1F receptor agonist. It is believed to exert its therapeutic effect in migraine by inhibiting pain pathways, including those in the trigeminal system, without causing vasoconstriction. It acts centrally and peripherally.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

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 sensation 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
+ Changes in balance
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, 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's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

* Feeling dizzy, sleepy, tired, or weak

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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. To ensure your safety, it is crucial to disclose all of your:

Prescription and over-the-counter medications
Natural products
Vitamins
Health problems

Your doctor and pharmacist need this information to determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 can 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 breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of this medication to both you and your baby.

• CNS depressants (e.g., alcohol, opioids, benzodiazepines, sedatives, hypnotics): Increased risk of CNS depression (dizziness, somnolence).
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort): Potential for serotonin syndrome, though lower risk than with triptans due to 5-HT1F selectivity.

• Drugs that lower heart rate (e.g., beta-blockers, digoxin): Lasmiditan can cause a decrease in heart rate.
• P-glycoprotein (P-gp) substrates (e.g., dabigatran, digoxin): Lasmiditan is a weak P-gp inhibitor, potentially increasing exposure to P-gp substrates.

• Dizziness
• Somnolence
• Fatigue
• Paresthesia
• Nausea
• Vomiting
• Serotonin syndrome symptoms (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, loss of coordination, seizures, severe diarrhea)

There are no adequate and well-controlled studies of Reyvow in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. A pregnancy exposure registry is available.

Lasmiditan is excreted into human milk. Due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established.

No overall differences in effectiveness were observed between elderly and younger patients. However, elderly patients (65 years and older) may be more susceptible to adverse reactions, particularly dizziness and somnolence. No dose adjustment is generally needed based on age alone, but caution is advised.

• Reyvow is the first and only FDA-approved 'ditan' (5-HT1F agonist) for acute migraine treatment. Unlike triptans, it does not cause vasoconstriction, making it a potential option for patients with cardiovascular risk factors or contraindications to triptans.
• The most common and clinically significant side effects are CNS-related, including dizziness, somnolence, and fatigue. Patients must be advised not to drive or operate heavy machinery for at least 8 hours after taking a dose.
• While the risk of serotonin syndrome is lower than with triptans due to its selective 5-HT1F agonism, caution is still warranted when co-administered with other serotonergic drugs.
• It is important to emphasize that Reyvow is for acute treatment of migraine attacks, not for prevention.

• Triptans (e.g., sumatriptan, zolmitriptan, rizatriptan)
• CGRP receptor antagonists (e.g., rimegepant, ubrogepant, zavegepant)
• NSAIDs (e.g., ibuprofen, naproxen, diclofenac)
• Acetaminophen
• Combination analgesics (e.g., Excedrin Migraine)
• Antiemetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
• Ergot alkaloids (e.g., dihydroergotamine)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its use. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.