Reyvow
Generic: LASMIDITAN
Basic Information
Manufacturer
Eli Lilly and Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
aea3358c-ff41-4490-9e6d-c7bf7b3de13f
Indications & Usage
1 INDICATIONS AND USAGE REYVOW ® is indicated for the acute treatment of migraine with or without aura in adults.
REYVOW ® is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.
( 1 ) Limitations of Use REYVOW is not indicated for the preventive treatment of migraine.
( 1 ) Limitations of Use REYVOW is not indicated for the preventive treatment of migraine.
REYVOW ® is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults.
( 1 ) Limitations of Use REYVOW is not indicated for the preventive treatment of migraine.
( 1 ) Limitations of Use REYVOW is not indicated for the preventive treatment of migraine.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Driving Impairment [see Warnings and Precautions ( 5.1 )] Central Nervous System Depression [see Warnings and Precautions ( 5.2 )] Serotonin Syndrome [see Warnings and Precautions ( 5.3 )] Medication Overuse Headache [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥5% and > placebo) were dizziness, fatigue, paresthesia, and sedation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW.
In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200 mg [see Clinical Studies ( 14.1 )] .
Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity.
The mean age at study entry was 42.4 years (range 18 to 81).
Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12 months in a long-term safety study.
Of these, 728 patients were exposed to 100 mg or 200 mg for at least 3 months, 361 patients were exposed to these doses for at least 6 months, and 180 patients were exposed to these doses for at least 12 months, all of whom treated at least 2 migraine attacks per month on average.
In that study, 14% (148 out of 1,039) in the 200 mg dose group, and 11% (112 out of 991) in the 100 mg dose group withdrew from the trial because of an adverse event.
The most common adverse event resulting in discontinuation in the long-term safety study (greater than 2%) was dizziness.
Table 1 shows adverse reactions that occurred in at least 2% of patients treated with REYVOW and more frequently than in patients who received placebo in Studies 1 and 2.
The most common adverse reactions (at least 5%) were dizziness, fatigue, paresthesia, and sedation.
Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2 a Fatigue includes the adverse reaction related terms asthenia and malaise.
b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral.
c Sedation includes the adverse reaction related term somnolence.
Adverse Reaction REYVOW 50 mg N=654 % REYVOW 100 mg N=1265 % REYVOW 200 mg N=1258 % Placebo N=1262 % Dizziness 9 15 17 3 Fatigue a 4 5 6 1 Paresthesia b 3 7 9 2 Sedation c 6 6 7 2 Nausea and/or Vomiting 3 4 4 2 Muscle Weakness 1 1 2 0 Less Common Adverse Reactions The following adverse reactions occurred in less than 2% of REYVOW-treated patients but more frequently than in patients receiving placebo: vertigo, incoordination, lethargy, visual impairment, feeling abnormal, feeling hot or feeling cold, palpitations, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, muscle spasm, limb discomfort, cognitive changes, confusion, euphoric mood, chest discomfort, speech abnormalities, dyspnea, and hallucinations.
Hypersensitivity Events of hypersensitivity, including angioedema, rash and photosensitivity reaction, occurred in patients treated with REYVOW.
In controlled trials, hypersensitivity was reported in 0.2% of patients treated with REYVOW compared to no patients who received placebo.
If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and discontinue administration of REYVOW.
Vital Sign Changes Heart Rate Decrease REYVOW was associated with mean decreases in heart rate of 5 to 10 beats per minute (bpm) while placebo was associated with mean decreases of 2 to 5 bpm.
Consider evaluating heart rate after administration of REYVOW in patients for whom these changes may not be tolerated, including patients taking other medications that lower heart rate [see Drug Interactions ( 7.3 )] .
Blood Pressure Increase REYVOW may increase blood pressure following a single dose.
In non-elderly healthy volunteers there was a mean increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of up to 1 mm Hg for placebo.
In healthy volunteers over 65 years of age, there was a mean increase from baseline in ambulatory systolic blood pressure of 7 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of 4 mm Hg for placebo.
By 2 hours, there were no increases in mean blood pressure with REYVOW compared to placebo.
REYVOW has not been well studied in patients with ischemic heart disease.
Consider evaluating blood pressure after administration of REYVOW in patients for whom these changes may not be tolerated.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The safety of REYVOW has been evaluated in 4,878 subjects who received at least one dose of REYVOW.
In 2 placebo-controlled, Phase 3 trials in adult patients with migraine (Studies 1 and 2), a total of 3,177 patients received REYVOW 50, 100, or 200 mg [see Clinical Studies ( 14.1 )] .
Of the REYVOW-treated patients in these 2 studies, approximately 84% were female, 78% were White, 18% were Black, and 18% were of Hispanic or Latino ethnicity.
The mean age at study entry was 42.4 years (range 18 to 81).
Long-term safety was assessed for 2,030 patients, dosing intermittently for up to 12 months in a long-term safety study.
Of these, 728 patients were exposed to 100 mg or 200 mg for at least 3 months, 361 patients were exposed to these doses for at least 6 months, and 180 patients were exposed to these doses for at least 12 months, all of whom treated at least 2 migraine attacks per month on average.
In that study, 14% (148 out of 1,039) in the 200 mg dose group, and 11% (112 out of 991) in the 100 mg dose group withdrew from the trial because of an adverse event.
The most common adverse event resulting in discontinuation in the long-term safety study (greater than 2%) was dizziness.
Table 1 shows adverse reactions that occurred in at least 2% of patients treated with REYVOW and more frequently than in patients who received placebo in Studies 1 and 2.
The most common adverse reactions (at least 5%) were dizziness, fatigue, paresthesia, and sedation.
Table 1: Adverse Reactions Occurring in ≥2% and at a Frequency Greater than Placebo in Studies 1 and 2 a Fatigue includes the adverse reaction related terms asthenia and malaise.
b Paresthesia includes the adverse reaction related terms paresthesia oral, hypoesthesia, and hypoesthesia oral.
c Sedation includes the adverse reaction related term somnolence.
Adverse Reaction REYVOW 50 mg N=654 % REYVOW 100 mg N=1265 % REYVOW 200 mg N=1258 % Placebo N=1262 % Dizziness 9 15 17 3 Fatigue a 4 5 6 1 Paresthesia b 3 7 9 2 Sedation c 6 6 7 2 Nausea and/or Vomiting 3 4 4 2 Muscle Weakness 1 1 2 0 Less Common Adverse Reactions The following adverse reactions occurred in less than 2% of REYVOW-treated patients but more frequently than in patients receiving placebo: vertigo, incoordination, lethargy, visual impairment, feeling abnormal, feeling hot or feeling cold, palpitations, anxiety, tremor, restlessness, sleep abnormalities including sleep disturbance and abnormal dreams, muscle spasm, limb discomfort, cognitive changes, confusion, euphoric mood, chest discomfort, speech abnormalities, dyspnea, and hallucinations.
Hypersensitivity Events of hypersensitivity, including angioedema, rash and photosensitivity reaction, occurred in patients treated with REYVOW.
In controlled trials, hypersensitivity was reported in 0.2% of patients treated with REYVOW compared to no patients who received placebo.
If a serious or severe hypersensitivity reaction occurs, initiate appropriate therapy and discontinue administration of REYVOW.
Vital Sign Changes Heart Rate Decrease REYVOW was associated with mean decreases in heart rate of 5 to 10 beats per minute (bpm) while placebo was associated with mean decreases of 2 to 5 bpm.
Consider evaluating heart rate after administration of REYVOW in patients for whom these changes may not be tolerated, including patients taking other medications that lower heart rate [see Drug Interactions ( 7.3 )] .
Blood Pressure Increase REYVOW may increase blood pressure following a single dose.
In non-elderly healthy volunteers there was a mean increase from baseline in ambulatory systolic and diastolic blood pressure of approximately 2 to 3 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of up to 1 mm Hg for placebo.
In healthy volunteers over 65 years of age, there was a mean increase from baseline in ambulatory systolic blood pressure of 7 mm Hg one hour after administration of 200 mg REYVOW compared to a mean increase of 4 mm Hg for placebo.
By 2 hours, there were no increases in mean blood pressure with REYVOW compared to placebo.
REYVOW has not been well studied in patients with ischemic heart disease.
Consider evaluating blood pressure after administration of REYVOW in patients for whom these changes may not be tolerated.