Lasmiditan

Lasmiditan Structure

What is Lasmiditan?

Lasmiditan (REYVOW™) is a new FDA approved medication for the acute treatment of migraine, with or without aura, in adults.

What are the uses of this medicine?

REYVOW^® is indicated for the acute treatment of migraine with or without aura in adults.

How does this medicine work?

Lasmiditan works by stopping pain signals from being sent to the brain and stopping inflammation of the nerves that cause symptoms of migraine.

What studies were done to prove safety and effectiveness of Lasmiditan?

• The effectiveness of Reyvow for the acute treatment of migraine was demonstrated in two randomized, double-blind, placebo-controlled trials.
• A total of 3,177 adult patients with a history of migraine with and without aura treated a migraine attack with Reyvow in these studies.
• In both studies, the percentages of patients whose pain resolved and whose most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved two hours after treatment were significantly greater among patients receiving Reyvow at all doses compared to those receiving placebo.
• Although patients were allowed to take a rescue medication two hours after taking Reyvow, opioids, barbiturates, triptans and ergots were not allowed within 24 hours of the study drug’s administration.
• Twenty-two percent of patients were taking a preventive medication for migraine.

Who Should Not Use this medicine?

• People who are not experiencing a migraine should not take this medication

Is this medicine FDA approved?

Lasmiditan has been approved by the FDA [1]

How should this medicine be used?

REYVOW may be taken with or without food. Administer tablets whole; do not split, crush, or chew. [2]

What are the dosage forms and brand names of this medicine?

The recommended dose of REYVOW is 50 mg, 100 mg, or 200 mg taken orally, as needed. No more than one dose should be taken in 24 hours, and REYVOW should not be taken unless the patient can wait at least 8 hours between dosing and driving or operating machinery. REYVOW may be taken with or without food. Administer tablets whole; do not split, crush, or chew.[3] Lasmiditan is sold under the company name of REYVOW.

What side effects can this medication cause?

Dizziness, fatigue and nausea are all common side effects of the lasmiditan drug. Serotonin Syndrome – Be aware of risk of serotonin syndrome with the use of REYVOW, particularly during combined use with serotonergic medications such as SSRIs, SNRIs, TCAs, or MAO inhibitors

Medication Overuse Headache – Use of drugs to treat migraine attacks for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary).

Hypersensitivity – Seek immediate medical attention if they experience any symptoms of serious or severe hypersensitivity reaction.

Abuse and Dependence – REYVOW is a federally controlled substance because it has the potential to be abused. Keep their medication secure.

What special precautions should I follow?

• There is a risk of driving impairment while taking Reyvow.
• Patients are advised not to drive or operate machinery for at least eight hours after taking Reyvow, even if they feel well enough to do so.
• Patients who cannot follow this advice are advised not to take Reyvow.
• The drug causes central nervous system (CNS) depression, including dizziness and sedation.
• It should be used with caution if taken in combination with alcohol or other CNS depressants.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There is no adequate data on the developmental risk associated with the use of REYVOW in pregnant women. In animal studies, adverse effects on development (increased incidences of fetal abnormalities, increased embryo fetal and offspring mortality, decreased fetal body weight) occurred at maternal exposures less than (rabbit) or greater than (rat) those observed clinically (see Data).

• In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated rates of major birth defects (2.2% to 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine.

Can this medicine be used in children?

It is not studied in children.

What should I know about storage and disposal of this medication?

• 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) [see USP Controlled Room Temperature].

What are the active and inactive ingredients in Lasmiditan?

Active ingredients

• Lasmiditan

Inactive ingredients

• Microcrystalline cellulose
• Starch, corn
• Croscarmellose sodium
• Sodium lauryl sulfate
• Magnesium stearate
• Polyvinyl alcohol, unspecified
• Titanium dioxide
• Polyethylene glycol 3350
• Talc
• Ferrosoferric oxide

Who manufactures and distributes Lasmiditan?

• Eli Lilly and Company.

• Dailymed label info on Lasmiditan
• FDA Lasmiditan

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