Pronunciation:

las-MID-i-tan

Brand Names:

• Reyvow

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antimigraine

Uses of This Medicine:

Lasmiditan is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches. Lasmiditan works in the brain to relieve the pain from migraine headaches.

Lasmiditan is not an ordinary pain reliever. It will not help with any kind of pain other than migraine headaches. This medicine is usually used in people whose headaches are not helped or relieved by acetaminophen (Tylenol®), aspirin, or other pain relievers.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lasmiditan in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of lasmiditan have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of lasmiditan in the elderly. However, elderly patients are more likely to have dizziness, and age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving lasmiditan.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Anileridine
• Benzhydrocodone
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorpheniramine
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Colchicine
• Cyclobenzaprine
• Cyclosporine
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Difenoxin
• Digoxin
• Dihydrocodeine
• Diphenoxylate
• Dolasetron
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Ethylmorphine
• Everolimus
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Furazolidone
• Gepirone
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Iproniazid
• Isocarboxazid
• Ketobemidone
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lorcaserin
• Melitracen
• Meperidine
• Methadone
• Methamphetamine
• Methylene Blue
• Milnacipran
• Mirtazapine
• Moclobemide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nialamide
• Nicomorphine
• Nortriptyline
• Oliceridine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Phenelzine
• Piritramide
• Procarbazine
• Protriptyline
• Rasagiline
• Remifentanil
• Rizatriptan
• Safinamide
• Selegiline
• Sertraline
• Sibutramine
• Sirolimus
• St John's Wort
• Sufentanil
• Sumatriptan
• Tacrolimus
• Tapentadol
• Tianeptine
• Tilidine
• Tolvaptan
• Tramadol
• Tranylcypromine
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone
• Zolmitriptan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (low heart rate) or
• Heart disease or
• Hypertension (high blood pressure)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Using too much lasmiditan may increase the chance of side effects.

Do not use this medicine for a headache that is not a migraine headache. Talk to your doctor about what to do for regular headaches.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it. You may take it with or without food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For migraine headaches:
    • Adults—50 milligrams (mg), 100 mg, or 200 mg per day, as needed. Do not take more than one dose within 24 hours.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Check with your doctor if you used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often.

Lasmiditan may cause drowsiness or dizziness. Wait at least 8 hours after taking lasmiditan before you drive, use machines, or do anything else that requires you to be alert.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with lasmiditan may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

Using lasmiditan alone or in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record your headache frequency and drug use.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Dizziness

drowsiness

relaxed and calm

sleepiness

Less common

Irregular heartbeat

trouble breathing

Rare

Fast heartbeat

fever

hives, itching, rash

hoarseness

irritation

joint pain, stiffness or swelling

redness of the skin

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

troubled swallowing

Incidence not known

Anxiety

confusion

diarrhea

difficulty sleeping

disorientation

drowsiness to profound coma

dry mouth

fever

headache

hyperventilation

irritability

lightheadedness

nervousness

overactive reflexes

poor coordination

restlessness

seeing, hearing, or feeling things that are not there

shivering

sweating

talking or acting with excitement you cannot control

trembling or shaking

twitching

unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

Less common

False or unusual sense of well-being

feeling of constant movement of self or surroundings

muscle spasm

sensation of spinning

trouble seeing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.