Patient Medication Information: uses, side effects, how to take - Emgality

What is EMGALITY used for?

EMGALITY is a medicine used in adults:

to prevent migraine in patients who have at least 4 migraine days per month
to reduce the number of attacks throughout a cluster period in patients with episodic cluster headache

How does EMGALITY work?

EMGALITY contains the active substance galcanezumab, which belongs to a group of substances called monoclonal antibodies. Galcanezumab binds to a protein called calcitonin gene-related peptide (CGRP). Increased CGRP levels in the blood have been linked to migraine and episodic cluster headache.

What are the ingredients in EMGALITY?

Medicinal ingredients: galcanezumab

Non-medicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sodium chloride, water for injection

EMGALITY comes in the following dosage forms:

120 mg solution for injection in a 1 mL prefilled syringe for migraine
120 mg solution for injection in a 1 mL prefilled pen for migraine
100 mg solution for injection in a 1 mL prefilled syringe for episodic cluster headache

Do not use EMGALITY if:

You have an allergy to galcanezumab or any of the other ingredients of this medicine
(see What are the ingredients in EMGALITY? above).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take EMGALITY. Talk about any health conditions or problems you may have, including if you:

have had an allergic reaction to EMGALITY.
have any chronic medical disease or need to take medication regularly.

Other warnings you should know about:

Allergic reactions with EMGALITY are usually mild to moderate (such as rash or itching).
Rarely patients taking EMGALITY have experienced a serious allergic reaction and the signs
may include:
- Difficulty breathing or swallowing,
- Low blood pressure, which can cause dizziness or light-headedness,
- Swelling of the neck, face, mouth, lips, tongue or throat, which may develop rapidly,
- Severe itching of the skin with a red rash or raised bumps.

If you experience any of the signs of a serious allergic reaction, stop taking EMGALITY immediately and contact your healthcare professional immediately.

Reactions may occur within minutes but may occur up to one month after taking EMGALITY.

Tell your healthcare professional if you are pregnant, think you are pregnant, or are planning to have a baby while receiving this medicine.
Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known whether EMGALITY passes into breast milk.
EMGALITY should not be given to patients under the age of 18 years.

How to take EMGALITY:

See the detailed Instructions for Use that comes with this Patient Medication
Information for instructions about the right way to give yourself EMGALITY injections
EMGALITY is given as an injection under the skin (subcutaneous injection).
EMGALITY comes as a single-use (1 time) prefilled syringe or pen.
If your healthcare professional decides that you or your caregiver can give the injections of
EMGALITY, you or your caregiver should receive training on the right way to inject EMGALITY. Do not try to inject EMGALITY until you have been shown the right way to give the injections by a healthcare professional.
Your healthcare professional may help you decide where on your body to inject your dose.
You can also read the “Choose your injection site” section of the Instructions for Use to help you choose which area can work best for you.
If you have vision problems, do not use EMGALITY prefilled syringe or pen without help from a caregiver.

Usual dose:

For migraine: The recommended dose of EMGALITY is a first dose of 240 mg (2 injections of the 120 mg/mL strength) followed by 120 mg (1 injection of the 120 mg/mL strength) every month thereafter.

EMGALITY is not intended for the acute treatment of migraine; patients should not exceed the monthly dose prescribed by the healthcare professional.

For episodic cluster headache: The recommended dose of EMGALITY is 300 mg (3 injections of the 100 mg/mL strength) at the start of a cluster period. After 3 weeks your healthcare provider will decide if you should continue treatment. If you continue treatment, EMGALITY 300 mg should not be administered more than once every month during a cluster period.

EMGALITY is not intended for the acute treatment of individual cluster headache attacks; patients should not exceed the monthly dose prescribed by the healthcare professional.

EMGALITY should not be used after the end of a cluster period and during the remission time.

Overdose:

If you think you have taken too much EMGALITY, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

For migraine: If you miss a dose take your dose as soon as you can. Thereafter resume monthly dosing.

For episodic cluster headache: If you take a partial dose (only 1 or 2 of the three prefilled syringes), take the missed injection(s) as soon as you can. If your healthcare provider determines that you should continue treatment, take the next complete dose one month from the date you took the missed injection(s).

What are possible side effects from using EMGALITY?

These are not all the possible side effects you may feel when taking EMGALITY. If you experience any side effects not listed here, contact your healthcare professional.

Very Common (≥ 1 in 10):

injection site itching, redness, or swelling
injection site pain
injection site bruising
injection site hardness

Common (≥ 1 in 100 and < 1 in 10)

constipation
dizziness
itching
rash

Uncommon (≥ 1 in 1000 and < 1 in 100):

hives

Rare (≥ 1 in 10,000 and < 1 in 1000)

serious allergic reaction

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (http://www.hc-sc.gc.ca/dhp-mps/medeff/report-declaration/index-eng.php) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store EMGALITY in a refrigerator at 2°C to 8°C until time of use. Keep the syringe or pen in the carton in order to protect from light.

If needed, EMGALITY may be left out of the refrigerator at a temperature up to 30°C for up to 7 days. EMGALITY should be discarded if not used within this 7-day period.

Do not freeze or shake the syringe or pen.

Keep out of reach and sight of children.

If you want more information about EMGALITY:

Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.lilly.ca, or by calling 1-888-545-5972.
Instructions for Use can be found on www.lilly.ca

The information in this document is current as of the last revision date shown below. For the most current information please visit our website or contact us directly.

EMGALITY is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries or affiliates.

You may need to read this package insert again.

Please do not throw it away until you have finished your medicine.

Last Revised September 11, 2020

A3.0-EMG-NL0002-CA-PM-YYYYMMDD

INSTRUCTIONS FOR USE

^PrEMGALITY^®(em-GAL-it-ē)

galcanezumab injection

120 mg/mL solution for subcutaneous use

prefilled syringe

www.lilly.ca

This Instructions for Use is for patients with migraine.

If you are using EMGALITY for episodic cluster headache, there is a different Instructions for Use because the dose and number of syringes needed is different.

For subcutaneous injection only.

Before you use the EMGALITY prefilled syringe, read and carefully follow all the step-by-step instructions.

Important Information

Your healthcare professional should show you how to prepare and inject
EMGALITY using the prefilled syringe. Do not inject yourself or someone else until you have been shown how to inject EMGALITY.
Keep this Instructions for Use and refer to it as needed.
Each EMGALITY prefilled syringe is for one-time use only. Do not share or reuse your EMGALITY prefilled syringe. You may give or get an infection.
Your healthcare professional may help you decide where on your body to inject your dose. You can also read the “Choose your injection site” section of these instructions to help you choose which area can work best for you.
If you have vision problems, do not use EMGALITY prefilled syringe without help from a caregiver.
INSTRUCTIONS FOR USE

Before you use the EMGALITY prefilled syringe, read and carefully follow all the step-by-step instructions.

Parts of the EMGALITY Prefilled Syringe

Thumb Pad

Teal Plunger Rod

Finger

Grips

Syringe

Body with Medicine

Grey Syringe Plunger

Needle Cap Needle

Before You Get Started

Take the Prefilled Syringe from the refrigerator

Put the original package with any unused syringes back in the refrigerator.

Leave the needle cap on until you are ready to inject.

For a more comfortable injection, leave the prefilled syringe at room temperature for 30 minutes before injecting.

Do not microwave the prefilled syringe, run hot water over it, or leave it in direct sunlight. Do not shake.

Gather Supplies For each injection you will need:

1 alcohol wipe
1 cotton ball or piece of gauze
1 sharps disposal container. See “After
You Inject Your Medicine.”

Inspect the Prefilled Syringe and the medicine

Make sure you have the right medicine. The medicine inside should be clear. Its colour may be colourless to slightly yellow.

Do not use the prefilled syringe, and dispose of as directed by your healthcare professional or pharmacist if:

it looks damaged
the medicine is cloudy, is discoloured, or has small particles
the Expiration Date printed on the label has passed
the medicine is frozen

Prepare for injection Wash your hands with soap and water before you inject your EMGALITY. Make sure a sharps disposal container is close by.

Choose your injection site Your healthcare professional can help you choose the injection site that is best for you.

Expiration Date

1 Uncap

Leave the needle cap on until you are ready to inject.
Pull the needle cap off and
throw it away in your household trash.
Do not put the needle cap
back on – you could
damage the needle or stick yourself by accident.
Do not touch the needle.

2 Insert

Gently pinch and hold a fold
of skin where you will inject.
Insert the needle at a 45-
degree angle.

3 Inject

You may inject the medicine into your stomach area (abdomen) or thigh. Do not inject within 2 inches of the belly button (navel).
Another person may give you the
injection in the back of your upper arm or buttocks.
Do not inject in the exact same spot. For example, if your first injection was in your abdomen, your next injection could be in another area of your abdomen.
Clean the injection site with an alcohol wipe. Let the injection site dry before you inject.

Back of arm

Abdomen

Buttock

Thigh

Slowly push on the thumb
pad to push the plunger all the way in until all the medicine is injected.
The grey syringe plunger
should be pushed all the way to the needle end of the syringe.
You should see the teal
plunger rod show through the syringe body when the injection is complete as shown.
Remove the needle from
your skin and gently let go of your skin.
If you have bleeding at the
injection site, press a cotton ball or gauze over the injection site. Do not rub the injection site.
Teal plunger rod
Grey syringe plunger
- Do not put the

needle cap back on the prefilled syringe.

After You Inject Your Medicine

Throw away the used prefilled syringe

Put the used EMGALITY prefilled
syringe in a sharps disposal
container right away after use. Do
not throw away (dispose of) the
EMGALITY prefilled syringe in
your household trash.
If you do not have a sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be provincial or local laws about how you should throw away needles and syringes. For more information about the proper way to dispose of the container contact your healthcare professional.
Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q. What if I see air bubbles in my EMGALITY prefilled syringe?

A. It is normal to have air bubbles in the prefilled syringe. EMGALITY is injected under your skin (subcutaneous injection).

Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?

A. It is okay to see a drop of liquid on the tip of the needle.

Q. What if I cannot push in the plunger?

A. If the plunger is stuck or damaged:

Do not continue to use the syringe
Remove the needle from your skin
Dispose of the syringe and get a new one

Q. How can I tell if my injection is complete?

A. When your injection is complete:

The teal plunger rod should show through the body of the syringe.
The grey syringe plunger should be pushed all the way to the needle end of the syringe.

If you have more questions about how to use the EMGALITY prefilled syringe:

Call your healthcare professional
Call 1-888-545-5972
Visit www.lilly.ca