Abbreviated steps for injecting the Emgality Pen

Leave the pen at room temperature for 30 minutes before injecting. Wash your hands, select an injection site, clean it with an alcohol wipe, and let it dry before you inject. Inspect the pen and the medicine. Make sure the pen is locked and the base cap is on until you inject.

1. Uncap the pen

Step 1 Graphic

Twist off base cap and throw it away. Do not put the base cap back on, as this could damage the needle. Do not touch the needle.

2. Place and unlock

Step 2 Graphic

Place the clear base flat and firmly at the injection site and unlock the pen.

3. Press, hold, and listen

Step 3 Graphic

Press and hold the teal button. Listen for a loud click. Keep holding the pen against your skin. After about 10 seconds, you will hear a second click. That means the full dose has been delivered.


IMPORTANT: These are abbreviated instructions for using the pen. When injecting Emgality, please refer to the Instructions for Use that come with your pen or with the prefilled syringe.

Do not inject Emgality until your healthcare provider has shown you how to prepare and inject.

Prefilled syringes are also available. Talk to your doctor about which type of device is right for you.

The most common side effects of Emgality were injection site reactions such as pain, redness, and itching.

Indications and Important Safety Information
Indication

Emgality is indicated for the preventive treatment of migraine in adults.

Important Safety Information about Emgality (galcanezumab-gnlm)

Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality.


Emgality may cause serious side effects, including: 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
  • trouble breathing

Before you use Emgality, tell your healthcare provider if you are:

  • pregnant or plan to become pregnant. It is not known if Emgality will harm your unborn baby
  • breastfeeding or plan to breastfeed. It is not known if Emgality passes into breast milk
  • taking any prescription or over-the-counter medicines, vitamins, or herbal supplements

The most common side effects of Emgality include: Injection site reactions


Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Emgality. For more information, ask your healthcare provider or pharmacist.


You can report side effects to the Food and Drug Administration (FDA) at www.fda.gov/medwatch or by calling 1-800-FDA-1088.


Emgality is available by prescription only.


Please see Prescribing Information, including Patient Information, for Emgality. See Instructions for Use included with the pen and prefilled syringe.


GZ CON ISI 27SEP2018