SAFETY SUMMARY
Warnings -
Do not drive or operate machinery for at least 8 hours after you take REYVOW, even if you feel well enough. You should not take REYVOW if you cannot wait at least 8 hours between taking REYVOW and driving or operating machinery.
- You should not drink alcohol or take other medicines that make you drowsy while taking REYVOW.
REYVOW can cause serious side effects, including:
- Medication overuse headache: People who take medicines to treat a migraine when it happens (acute treatments such as REYVOW) for 10 or more days each month can sometimes get worse headaches. If your headaches get worse, your doctor may stop your treatment.
- Serotonin syndrome is a rare but serious problem that can happen to people who take REYVOW. This is more likely to happen if you take it with antidepressant medicines called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors). Call your doctor right away if you have any of these symptoms:
- mental changes, such as seeing things that are not there (hallucinations), agitation, or coma
- fast heartbeat or changes in blood pressure
- high body temperature
- tight muscles
- trouble walking
- nausea, vomiting, or diarrhea
Common side effects
The most common side effects of REYVOW include dizziness, sleepiness, numbness, feeling tired, and tingling. These are not all the possible side effects of REYVOW. Tell your doctor if you have any side effects.
You can report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before You Take REYVOW:
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Tell your doctor about all your medical conditions, including these:
❑ liver problems
❑ high blood pressure❑ a low heart rate
❑ allergy to lasmiditan -
Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor if you are breastfeeding or plan to breastfeed.
❑ There is a pregnancy registry for women who take REYVOW. The purpose of this registry is to collect information about the health of you and your baby. You may enroll yourself by calling 1-833-464-4724 or by visiting www.migrainepregnancyregistry.com. Or you may talk to your doctor about how you can take part in this registry.
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Tell your doctor about all prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Especially tell your doctor if you take any of these:
❑ propranolol or other medicines that can lower your heart rate
❑ medicines that can increase blood pressure
❑ medicines that make you sleepy
❑ antidepressant medicines of these types:- SSRIs or SNRIs
- TCAs (tricyclic antidepressants)
- MAOIs (monoamine oxidase inhibitors)
How to take
Take REYVOW exactly as your doctor tells you to, and do not change your dose without talking to your doctor. REYVOW should only be used during a migraine attack. It should not be used to try to prevent migraine attacks.
- Take REYVOW tablets by mouth, with or without food.
- Swallow REYVOW tablets whole. Do not split, crush, or chew them.
- Do not take REYVOW more than one time within a 24-hour period. This means you must wait 24 hours between doses of REYVOW, even if your headache does not go away or goes away and comes back.
Learn more
REYVOW is a prescription medicine. For more information, call 1-833-REYVOW1 (1-833-739-8691).
This summary provides basic information about REYVOW but does not include all information known about this medicine. Read the information that comes with your prescription every time you have a prescription filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about REYVOW and how to take it. Your doctor is the best person to help you decide if REYVOW is right for you.
LM CON BS 14SEP2022