Reyvow

• Generic Name: lasmiditan tablets
• Brand Name: Reyvow

Reyvow (Lasmiditan Tablets) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Reyvow Side Effects Center

What Is Reyvow?

Reyvow (lasmiditan) is a serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults. Reyvow is not indicated for the preventive treatment of migraine.

What Are Side Effects of Reyvow?

Common side effects of Reyvow include:

• dizziness,
• fatigue,
• numbness and tingling,
• sedation,
• nausea, and
• vomiting

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 of Reyvow should be taken in 24 hours.

What Drugs, Substances, or Supplements Interact with Reyvow?

Reyvow may interact with alcohol or other CNS depressants, antidepressants, MAO inhibitors, trazodone, dextromethorphan, St. John's wort, medications that lower heart rate, and P-gp or BCRP substrates. Tell your doctor all medications and supplements you use.

Reyvow During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Reyvow; it may harm a fetus. It is unknown if Reyvow passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Reyvow (lasmiditan) Tablets, for Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Reyvow Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

• dizziness, drowsiness;
• feeling tired; or
• numbness or tingling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Reyvow (Lasmiditan Tablets)

 

Reyvow Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Driving Impairment [see WARNINGS AND PRECAUTIONS]
• Central Nervous System Depression [see WARNINGS AND PRECAUTIONS]
• Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
• Medication Overuse Headache [see WARNINGS AND PRECAUTIONS]

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]. 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

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
Fatiguea	4	5	6	1
Paresthesiab	3	7	9	2
Sedationc	6	6	7	2
Nausea and/or Vomiting	3	4	4	2
Muscle Weakness	1	1	2	0
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.

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].

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.

DRUG INTERACTIONS

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].

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]. 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 [see ADVERSE REACTIONS]. 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.

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.

Read the entire FDA prescribing information for Reyvow (Lasmiditan Tablets)

&Copy; Reyvow Patient Information is supplied by Cerner Multum, Inc. and Reyvow Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.