Generic drug: lasmiditan
Brand name: Reyvow
What is Reyvow (lasmiditan), and how does it work?
Reyvow (lasmiditan) is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults.
- Reyvow is not used as a preventive treatment of migraine.
- It is not known if Reyvow is safe and effective in children.
What are the side effects of Reyvow?
Serious side effects of Reyvow include:
- serotonin syndrome. Serotonin syndrome is a rare but serious problem that can happen in people using
Reyvow, especially if Reyvow is used with anti-depressant medicines called SSRIs or SNRIs. Call your healthcare provider right away if you have any of the following symptoms of serotonin syndrome:- mental changes such as seeing things that are not there (hallucinations), agitation, or coma
- fast heartbeat
- changes in blood pressure
- high body temperature
- tight muscles
- trouble walking
- nausea, vomiting, or diarrhea
- medication overuse headache. Some people who take medicines like
Reyvow for the acute treatment of migraine attacks for 10 or more days each month may have worse headaches (medication overuse headache). If your headaches get worse, your healthcare provider may decide to stop your treatment with
Reyvow.
The most common side effects of Reyvow include:
- dizziness
- sleepiness
- numbness
- feeling tired
- tingling
Does Reyvow cause addiction or withdrawal symptoms?
Drug Abuse And Dependence
Controlled Substance
Reyvow contains lasmiditan, a Schedule V controlled substance (CV).
Abuse
- Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects.
- In a human abuse potential (HAP) study in recreational poly-drug users (n=58), single oral therapeutic doses (100 and 200 mg) and a supratherapeutic dose (400 mg) of
Reyvow were compared to alprazolam (2 mg) (C-IV) and placebo. - With all doses of Reyvow, subjects reported statistically significantly higher “drug liking” scores than placebo, indicating that
Reyvow has abuse potential. - In comparison to alprazolam, subjects who received Reyvow reported statistically significantly lower “drug liking” scores.
- In the HAP study, euphoric mood occurred to a similar extent with Reyvow 200 mg,
Reyvow 400 mg, and alprazolam 2 mg (43-49%). - A feeling of relaxation was noted in more subjects on alprazolam (22.6%) than with any dose of
Reyvow (7-11%). - Phase 2 and 3 studies indicate that, at therapeutic doses, Reyvow produced adverse events of euphoria and hallucinations to a greater extent than placebo. However these events occur at a low frequency (about 1% of patients).
- Evaluate patients for risk of drug abuse and observe them for signs of lasmiditan misuse or abuse.
Dependence
- Physical withdrawal was not observed in healthy subjects following abrupt cessation after 7 daily doses of lasmiditan 200 mg or 400 mg.
What is the dosage for 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. - 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.
What drugs interact with Reyvow?
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.
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. 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 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.
P-gp And Breast Cancer Resistant Protein (BCRP)
Reyvow inhibits P-gp and BCRP in vitro. Concomitant use of Reyvow and drugs that are P-gp or BCRP substrates should be avoided.
Is Reyvow safe to use while pregnant or breastfeeding?
- There are no adequate data on the developmental risk associated with the use of
Reyvow in pregnant women. - There are no data on the presence of lasmiditan in human milk, the effects of lasmiditan on the breastfed infant, or the effects of lasmiditan on milk production.
- 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.