How can you help?
If you are or were recently pregnant and having migraines please enroll in this registry as early in your pregnancy as possible, even if you are not taking migraine medicines. We hope that the information we collect in this registry will help us better understand the benefits and risks of migraine treatment during pregnancy.
Whether you enroll in this registry or not is entirely your choice. Click here to learn more.
If you are or were recently pregnant and have migraines, please enroll today. You may receive a small payment for your participation.
THANK YOU FOR YOUR INTEREST IN THE MIGRAINE PREGNANCY REGISTRY.
PURPOSE AND SAFETY SUMMARY
Important Facts About Emgality® (em-GAL-it-e¯ ) 120 mg injection. Also known as galcanezumab-gnlm.
Emgality is a prescription medicine used for the preventive treatment of migraine in adults. The medicine comes in a prefilled pen or syringe and is taken once a month.
Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality.
Emgality may cause allergic reactions, such as itching, rash, hives, and trouble breathing. Allergic reactions can happen days after using Emgality. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms, which may be part of an allergic reaction: swelling of your face, mouth, tongue, or throat, or trouble breathing.
Common side effects
The most common side effects of Emgality are injection site reactions.
These are not all the possible side effects of Emgality. Tell your doctor if you have any side effects.
You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before you use Emgality, discuss these questions with your doctor:
- Do you have other medical conditions?
- Do you take other medicines? Tell your doctor about all the prescription and over-the-counter drugs, vitamins, and herbal supplements you take.
Tell your doctor if:
- You are pregnant or breastfeeding.
- Pregnancy Registry: There is a pregnancy registry for women who take Emgality. 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 healthcare provider about how you can take part in this registry.
- You are under age 18. It is not known if Emgality is safe and effective in children.
How to take
- Read the Instructions for Use that come with Emgality. There you will find information about how to store, prepare, and inject Emgality.
- Use Emgality exactly as your doctor says.
- If you miss a dose, inject it as soon as possible. Then continue to take it once a month from the date of your last dose.
For more information, go to www.emgality.com or call 1-833-EMGALITY (1-833-364-2548).
This summary provides basic information about Emgality, but it does not include all information known about this medicine. Read the information that comes with your prescription every time you have a prescription filled. Talk to your doctor or pharmacist about this information. Your doctor is the best person to help you decide if Emgality is right for you.
GZ CON MIG BS 11MAR2021
Please see Full Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the 120 mg Pen or 120 mg Syringe.
PURPOSE AND SAFETY SUMMARY
Important Facts About REYVOW® (RAY-vow) tablets. REYVOW is also known as lasmiditan.
- REYVOW is a prescription medicine for adults. It is used to treat migraine attacks with or without aura when they happen (acute treatment). It is a tablet that you take by mouth.
- REYVOW is not used to prevent migraine attacks.
- It is not known if REYVOW is safe and effective in children.
- REYVOW is a federally controlled substance (C-V) because it contains lasmiditan that can be abused. Protect REYVOW from being stolen, and never give it to others because it may harm them. Selling or giving away REYVOW is illegal. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
- 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:
- 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.
- 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.
For more information, go to REYVOW.com or call 1-833-REYVOW1 (1-833-739-8691).
This summary provides basic information about REYVOW, but it does not include all the information known about this medicine. Read the information that comes with your prescription every time you have a prescription filled. Talk to your doctor or pharmacist about this information. Your doctor is the best person to help you decide if REYVOW is right for you.
LM CON BS 09DEC2021
Please see Full Prescribing Information, including Medication Guide, for REYVOW.