Reyvow 100 mg/1
lasmiditan · TABLET · Eli Lilly and Company
Reyvow is a tablet containing lasmiditan at 100 mg/1, taken oral. Manufactured by Eli Lilly and Company.
Key Facts
- Brand Name
- Reyvow
- Generic Name
- lasmiditan
- NDC Code (Product)
0002-4491- Manufacturer
- Eli Lilly and Company
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- NDA211280
- Marketing Start
- 10/11/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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.
Dosage & Administration
2 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 [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 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 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 min…
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 S…
Frequently Asked Questions
What is Reyvow used for?
Reyvow contains lasmiditan. It is a tablet taken oral. Consult your doctor for specific uses.
Is Reyvow a controlled substance?
Yes, Reyvow is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Reyvow?
The generic name for Reyvow is lasmiditan. There are no other listed brand versions of lasmiditan.
What is the NDC code for Reyvow 100 mg/1?
The NDC (National Drug Code) for Reyvow 100 mg/1 is 0002-4491, listed by Eli Lilly and Company.
Other Reyvow Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)