Reyvow

Approved Uses

Reyvow is specifically indicated for the acute treatment of migraine attacks in adults. It is used for migraines that occur both with and without aura, which are sensory disturbances like flashes of light or blind spots that sometimes happen before or during a headache.

How It Is Used

This medication is taken at the onset of migraine symptoms to help reduce or eliminate common migraine effects, including:

• Severe headache pain
• Nausea
• Sensitivity to light
• Sensitivity to sound

Important Limitations

Reyvow is intended only for the treatment of active migraine attacks and has specific limitations on its use:

• Not for prevention: It is not used to reduce the frequency of future migraine attacks or to prevent them from occurring.
• Specific headache types: It has not been established as a safe or effective treatment for cluster headaches.
• Acute treatment only: It should only be used when a migraine is currently occurring and is not meant for daily use to manage chronic pain.

Mechanism of Action

Reyvow belongs to a class of drugs known as serotonin (5-HT) 1F receptor agonists, or "ditans." It is designed to treat the acute symptoms of a migraine headache by acting on the central nervous system.

How It Affects the Brain

During a migraine, the trigeminal nerve pathway—a major pain signaling system in the brain—becomes overactive. Reyvow works by binding to 5-HT1F receptors located on these nerves. When the medication attaches to these receptors, it helps to:

• Reduce the release of certain proteins and chemicals that cause inflammation and pain.
• Interrupt the transmission of pain signals along the nerve pathways.

Difference From Other Migraine Drugs

Many older migraine treatments, such as triptans, work by narrowing blood vessels (vasoconstriction) to relieve pain. Reyvow is different because it targets the pain pathway directly without constricting blood vessels. This makes it a unique option for treating migraine pain and associated symptoms like nausea and sensitivity to light or sound.

Reyvow is intended only to treat a migraine that has already started; it is not used to prevent migraines from occurring in the future.

Common Side Effects

Many people taking Reyvow experience mild to moderate side effects. These often include:

• Dizziness
• Drowsiness or fatigue
• Numbness or tingling sensations (paresthesia)
• Nausea or vomiting
• Muscle weakness

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious issues:

• Central Nervous System Depression: Reyvow causes significant sleepiness and decreased mental alertness. You must not drive or operate heavy machinery for at least 8 hours after taking a dose.
• Serotonin Syndrome: This is a serious reaction that may occur if Reyvow is taken with certain other medications. Symptoms include agitation, hallucinations, rapid heart rate, fever, shivering, or muscle twitching.
• Allergic Reactions: Seek emergency help for signs of a severe allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, or throat.

This is not a complete list of side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Driving and Impairment

Reyvow causes significant central nervous system (CNS) depression. Individuals are instructed not to drive or operate machinery for at least 8 hours after taking a dose, even if they feel fully awake. Because the drug's effects on driving may not be easily self-assessed, this 8-hour restriction is necessary for every dose taken.

Central Nervous System Effects

The medication can cause dizziness, sedation, and extreme sleepiness. These effects may be increased if Reyvow is taken with alcohol or other substances that cause drowsiness, such as benzodiazepines or opioids.

Serotonin Syndrome

There is a risk of serotonin syndrome, a potentially life-threatening condition, especially when Reyvow is used with other drugs that increase serotonin levels. These include:

• Selective serotonin reuptake inhibitors (SSRIs)
• Serotonin-norepinephrine reuptake inhibitors (SNRIs)
• Tricyclic antidepressants (TCAs)
• Monoamine oxidase inhibitors (MAOIs)
• Triptans

Symptoms of serotonin syndrome may include agitation, hallucinations, rapid heart rate, fever, muscle stiffness, or nausea.

Medication Overuse Headache

Using acute migraine medications like Reyvow for 10 or more days per month may lead to more frequent or worse headaches, known as medication overuse headaches. If headaches become more frequent, evaluation by a healthcare professional is recommended.

Abuse and Dependence

Reyvow is a Schedule V controlled substance because it has the potential for abuse. It may cause feelings of relaxation or euphoria in some individuals.

Pregnancy

It is not known if Reyvow will harm an unborn baby. There are no adequate studies in pregnant women to determine the risks of birth defects, miscarriage, or other adverse outcomes. In animal studies, high doses of the medication were associated with decreased fetal weight and skeletal variations. A pregnancy exposure registry exists to monitor the health of individuals who take this medication while pregnant. If you are pregnant or planning to become pregnant, consult your healthcare provider to discuss the potential risks and benefits of using this medication.

Breastfeeding

It is unknown whether Reyvow passes into human breast milk or how it might affect a nursing infant or milk production. Animal studies have shown that the drug is excreted in the milk of lactating animals. Because the effects on a human infant are not known, you should consult your healthcare provider to decide whether to breastfeed or use this medication.

Available Forms

Reyvow is supplied as film-coated tablets intended for oral administration. The tablets are designed to be swallowed whole and should not be split, crushed, or chewed.

• Oral tablet

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Reyvow in October 2019. It is indicated for the acute treatment of migraine with or without aura in adult patients. It is not intended for the preventive treatment of migraines.

Regulatory Classification

Reyvow is classified by the Drug Enforcement Administration (DEA) as a Schedule V controlled substance. This classification is based on clinical studies showing that the medication has a potential for abuse and may cause psychic dependence in some individuals.

Safety Requirements and Driving Warning

While Reyvow does not have a boxed warning, the FDA-approved labeling includes a significant warning regarding driving impairment. Because the medication can cause central nervous system depression, patients are advised not to drive or operate heavy machinery for at least 8 hours after taking each dose. Patients who cannot follow this requirement are advised not to take the medication.

Factors Influencing Price

The amount you pay for Reyvow can vary based on several conditions:

• Insurance Coverage: Your specific health insurance plan determines your out-of-pocket costs, such as copays or coinsurance. Some plans may require prior authorization before they agree to cover the medication.
• Pharmacy Selection: Prices for prescription drugs can differ between retail pharmacies and mail-order services.
• Generic Availability: Reyvow is a brand-name drug. There is currently no generic version of lasmiditan available, and brand-name medications typically cost more than generics.

Financial Assistance Programs

The manufacturer may offer savings cards or patient assistance programs to help reduce the cost for eligible individuals. These programs are often available to patients with commercial insurance or those who meet specific income requirements. It is recommended to check with the manufacturer or your pharmacist for current assistance options.