reyvow

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 [see Warnings and Precautions ( 5.1 )] . 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. The recommended dose is 50 mg, 100 mg, or 200 mg taken orally, as needed. ( 2 ) No more than one dose should be taken in 24 hours. ( 2 , 5.1 ) Administer tablets whole. ( 2 )

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…

None. None. ( 4 )

REYVOW may further lower heart rate when administered with heart rate lowering drugs. ( 7.3 ) 7.1 CNS Depressants Concomitant administration of REYVOW and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of REYVOW to cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions, REYVOW should be used with caution if used in combination with alcohol or other CNS depressants [see Warnings and Precautions ( 5.2 )] . 7.2 Serotonergic Drugs Concomitant administration of REYVOW and drugs (e.g., SSRIs, SNRIs, TCAs, MAO inhibitors, trazodone, etc.), over-the counter medications (e.g., dextromethorphan), or herbal supplements (e.g., St. John's Wort) that increase serotonin may increase the risk of serotonin syndrome [see Warnings and Precautions ( 5.3 )] . Use REYVOW with caution in patients taking medications that increase serotonin. 7.3 Heart Rate Lowering Drugs REYVOW has been associated with a lowering of heart rate [see Adverse Reactions ( 6.1 )] . 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 minute compared to propranolol alone, for a mean maximum of 19 beats per minute. Use REYVOW with caution in patients taking concomitant medications that lower heart rate if this magnitude of heart rate decrease may pose a concern. 7.4 P-glycoprotein (P-gp) Transporter Substrates Coadministration of REYVOW with P-gp substrates where a small change in substrate plasma concentration may lead to serious toxicities (e.g., digoxin) is not recommended [see Clinical Pharmacology ( 12.3 )] .