REYVOW (lasmiditan) tablets

REYVOW (lasmiditan) tablets

REYVOW (lasmiditan) tablets

REYVOW (lasmiditan) is a serotonin (5-HT) 1F receptor agonist for oral administration. The chemical name of lasmiditan hemisuccinate is 2,4,6-trifluoro-N-[6-(1-methylpiperidine-4-carbonyl)pyridine-2-yl]benzamide hemisuccinate. It has the empirical formula of C19H18F3N3O2•0.5[C4H6O4] and a molecular weight of 436.41 (hemisuccinate).

Lasmiditan hemisuccinate is a white, crystalline powder that is sparingly soluble in water, slightly soluble in ethanol, and soluble in methanol. A 1 mg/mL aqueous solution of lasmiditan hemisuccinate has a pH of 6.8 at ambient conditions.

REYVOW 50 mg tablets contain 50 mg lasmiditan (equivalent to 57.824 mg lasmiditan hemisuccinate) and the inactive ingredients as follows:

Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.

Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

REYVOW 100 mg tablets contain 100 mg lasmiditan (equivalent to 115.65 mg lasmiditan hemisuccinate) and the inactive ingredients as follows:

Excipients – croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium lauryl sulfate.

Color mixture ingredients – black ferric oxide, polyethylene glycol, polyvinyl alcohol, red ferric oxide, talc, titanium dioxide.

INDICATIONS AND USAGE

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

Limitations of Use: REYVOW is not indicated for the preventive treatment of migraine.

Mechanism of Action

Lasmiditan binds with high affinity to the 5-HT1F receptor. Lasmiditan presumably exerts its therapeutic effects in the treatment of migraine through agonist effects at the 5-HT1F receptor; however, the precise mechanism is unknown.

DOSAGE AND ADMINISTRATION

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.

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A second dose of REYVOW has not been shown to be effective for the same migraine attack.

The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.

REYVOW may be taken with or without food.

Administer tablets whole; do not split, crush, or chew.

CONTRAINDICATIONS

None.

WARNINGS AND PRECAUTIONS

Driving Impairment: REYVOW may cause significant driving impairment. In a driving study, administration of single 50 mg, 100 mg, or 200 mgdoses of REYVOW significantly impaired subjects’ ability to drive. Additionally, moresleepiness was reported at 8 hours following a single dose of REYVOW compared to placebo. Advise patients not toengage in potentially hazardous activities requiring complete mental alertness, such as driving a motor vehicle oroperating machinery, for at least 8 hours after each dose of REYVOW. Patients who cannot follow this advice should nottake REYVOW. Prescribers and patients should be aware that patients may not be able to assess their own drivingcompetence and the degree of impairment caused by REYVOW.

Central Nervous System Depression: REYVOW may cause central nervous system (CNS) depression, including dizziness and sedation.Because of the potential for REYVOW to cause sedation, other cognitive and/or neuropsychiatric adverse reactions, and driving impairment, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants. Patients should be warned against driving and other activities requiring complete mental alertness for at least 8 hours after REYVOW is taken.

Serotonin Syndrome: In clinical trials, reactions consistent with serotonin syndrome were reported in patients treated with REYVOW who werenot taking any other drugs associated with serotonin syndrome. Serotonin syndrome may also occur with REYVOWduring coadministration with serotonergic drugs [e.g., selective serotonin reuptake inhibitors (SSRIs), serotoninnorepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and monoamine oxidase (MAO) inhibitors].

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular signs (e.g., hyperreflexia, incoordination), and/or gastrointestinal signs and symptoms (e.g., nausea, vomiting, diarrhea). The onset of symptoms usually occurs within minutes to hours of receiving a new or a greater dose of a serotonergic medication.

Discontinue REYVOW if serotonin syndrome is suspected.

Medication Overuse Headache: Overuse of acute migraine drugs (e.g., ergotamines, triptans, opioids, or a combination of these drugs for 10 or more daysper month) may lead to exacerbation of headache (i.e., medication overuse headache). Medication overuse headachemay present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification ofpatients including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes atransient worsening of headache) may be necessary.

DRUG INTERACTIONS

CNS Depressants: Concomitant administration of REYVOW and alcohol or other CNS depressant drugs has not been evaluated in clinicalstudies. Because of the potential of REYVOW to cause sedation, as well as other cognitive and/or neuropsychiatricadverse reactions, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants.

Serotonergic Drugs: Concomitant administration of REYVOW and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-thecounter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John’s Wort) that increase serotonin mayincrease the risk of serotonin syndrome. Use REYVOW with caution in patients taking medications that increase serotonin.

Heart Rate Lowering Drugs: REYVOW has been associated with a lowering of heart rate. In a drug interaction study,addition of a single 200 mg dose of REYVOW to propranolol decreased heart rate by an additional 5 beats per minutecompared to propranolol alone, for a mean maximum of 19 beats per minute. Use REYVOW with caution in patientstaking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern.

P-glycoprotein (P-gp) Transporter Substrates: Coadministration of REYVOW with P-gp substrates where a small change in substrate plasma concentration may lead toserious toxicities (e.g., digoxin) is not recommended.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are 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 embryofetal and offspring mortality, decreased fetal body weight) occurred at maternal exposures less than (rabbit) or greater than (rat) those observed clinically.

Lactation: There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or theeffects of lasmiditan on milk production. Excretion of lasmiditan and/or metabolites into milk, at levels approximately 3times those in maternal plasma, was observed in lactating rats following oral administration of lasmiditan.

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The developmental and health benefits of breastfeeding should be considered 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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Hepatic Impairment: No dosage adjustment is needed for patients with mild or moderate hepatic impairment (Child-Pugh A or B). REYVOWhas not been studied in patients with severe hepatic impairment (Child-Pugh C) and its use in these patients is notrecommended.

DRUG ABUSE AND DEPENDENCE

Controlled Substance: REYVOW contains lasmiditan, a Schedule V controlled substance (CV).

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