The following instructions are for the Emgality Pen. For information about the prefilled syringe
and for additional information about the pen, please see the Instructions for Use that come
in the Emgality box.
If you have vision or hearing problems, do not use the Emgality Pen without help from
a caregiver.
This video, in addition to the Instructions for Use, will help you get started.
Take the pen from the refrigerator and leave it at room temperature for at least 30 minutes.
Do not microwave the pen, run hot water over it, or leave it in direct sunlight. Also,
do not shake it or freeze it.
Wash your hands before preparing the injection site.
If this is your first dose of Emgality, you will be injecting a loading dose of 240 milligrams,
or 2 pens. Your first dose may be administered at your doctor’s office. After that, you
can inject 1 dose, or pen, on your own each month.
Inspect the pen to ensure it does not look damaged. The medicine inside should be colorless
to slightly yellow to slightly brown. Do not use if it is frozen, cloudy or discolored,
or contains any particles. Be sure to check the expiration date before administering.
Choose an injection site, such as the abdomen, that is at least 2 inches away from the belly
button. You may also inject in the front of your thighs, at least 2 inches above the knee
and 2 inches below the groin. Another person may administer Emgality in the back of your
upper arm or buttocks. Make sure that you clean the injection site with an alcohol wipe
and let it dry before administering Emgality. Do not inject in the exact same spot twice.
Now that your pen is ready, here are the 3 basic steps to administer your injection.
First, make sure the pen is in the locked position, then uncap the pen by twisting off
the base cap and throw it in the trash.
Second, place and hold the clear base flat and firmly against your skin. Turn the lock
ring to the unlock position.
The third step is to press and hold the teal injection button. You will hear a loud click.
Keep holding the clear base firmly against your skin. About 10 seconds after the first
click, you will hear a second click, and the gray plunger will be visible. This means your
injection is complete.
After the injection, put the used pen in a sharps container.
Now that you’ve viewed the basic steps, remember to read and follow the Instructions
for Use when you use Emgality each month.
PURPOSE AND SAFETY SUMMARY Important Facts About Emgality® (em-GAL-it-ē) 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.
WARNINGS: 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 USING: 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.
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.
LEARN MORE: For more information, go to
www.emgality.com or call 1-833-EMGALITY (1-833-364-2548) Monday – Friday,
9 AM – 8 PM EST.
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.
Please see Instructions for Use that come with the device.