Cluster Headache Dosing & Administration
Recommended dosing with no titration required1a
300 mg administered as 3 consecutive SC injections of 100 mg each, at the onset of the cluster period, and then monthly until the end of the cluster period.
- 300 mg dose; this comes in 3 x 100 mg prefilled syringes
- These 3 syringes are administered subcutaneously, one after another
- Patients begin treatment at the onset of a cluster period
- Patients take this 300 mg dose every month until their cluster period ends
Please review full Instructions for Use with your patients.
aThe Emgality prefilled syringe needle is 27 gauge x ½ inch.2
Consider having patients fill their prescription for their upcoming cluster cycle while they are in remission.
Advise patients to1,2:
- Store product refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect it from light until use
- Check expiration date on product prior to use
SELECT IMPORTANT SAFETY INFORMATION
Contraindications
Emgality is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
How to administer Emgality
Preparation3
- Inspect the prefilled syringe and the medicine. Do not use the prefilled syringe and dispose of it if it looks damaged; the expiration date printed on the label has passed; or the medicine is cloudy or discolored, has small particles, or is frozen
- Choose an area for injection: abdomen or thigh if self-injecting, and buttocks or back of upper arm if another person is injecting. Be sure to choose a different site (even within an area) for each injection
- Clean the site with an alcohol wipe and let it dry before injecting
3 key administration steps3
Please review the full Instructions for Use with your patients to ensure they understand how to properly administer Emgality.
1. Uncap the syringe
2. Insert the needle at a 45° angle into a gently pinched fold of skin
3. Inject slowly until the gray syringe plunger is pushed to the needle end of the syringe
SELECT IMPORTANT SAFETY INFORMATION
Adverse Reactions
The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in Emgality clinical studies were injection site reactions.
Telephonic injection training and an injection how-to video are available to help guide your patients through self-administration.
Questions? Call 1-800-LillyRx (1-800-545-5979).
Watch how to use the Emgality prefilled syringe*
*some video voiceover content created using AI
0:03-0:13
[Emgality logo with registered trademark symbol, generic version, galcanezumab gnlm, and brand bubbles on screen with the following captions]
Caption 1: INSTRUCTIONS FOR INJECTING. ONE DOSE OF EMGALITY (300 MG).
Caption 2: Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality. Please see Indication and Safety Summary at the end of this video.
Narrator: The following instructions are for one dose of Emgality, 300 mg, that is delivered via three prefilled syringes of 100 mg each.
00:13-00:21
[Emgality logo with registered trademark symbol, generic version, galcanezumab gnlm, and brand bubbles on screen with the following captions]
Caption 1: INSTRUCTIONS FOR INJECTING. ONE DOSE OF EMGALITY (300 MG). FOR THE TREATMENT OF EPISODIC CLUSTER HEADACHE
Caption 2: Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality. Do not inject yourself or someone else until you have been shown how to inject Emgality by a healthcare provider.
Narrator: For more information, please see the Instructions for Use that come in the Emgality box. Take Emgality as directed by your doctor.
00:21-00:27
[Emgality logo with registered trademark symbol, generic version, galcanezumab gnlm, and brand bubbles on screen with the following captions]
Caption 1: INSTRUCTIONS FOR INJECTING. ONE DOSE OF EMGALITY (300 MG). FOR THE TREATMENT OF EPISODIC CLUSTER HEADACHE
Caption 2: Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality. If you have vision problems, do not use the Emgality prefilled syringe without help from a caregiver.
Narrator: If you have vision problems, do not use the Emgality prefilled syringe without help from a caregiver.
00:28-00:32
[Frank, a fictional patient, leaves the living room and enters the kitchen]
Narrator: This video, in addition to the Instructions for Use, will help you get started.
00:36-00:38
[Red circle with teal, green and orange Emgality brand campaign bubbles scattered on the perimeter of the circle, flashed on the screen with white word in the middle]
Caption: GET READY
00:40-00:43
[Frank opens the refrigerator]
Narrator: Remove all three 100 milligram prefilled syringes...
00:44-00:47
[We see Frank taking the prefilled syringe box out of the refrigerator and placing it on the kitchen table.]
Narrator: ...from the refrigerator, and leave them at room temperature for 30 minutes.
Caption: Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
00:47-00:50
[A "1, 2, 3" graphic appears next to each syringe inside the box to clearly display that there are 3 syringes for injection.]
Narrator: One dose of Emgality is 300 mg.
00:52-00:59
[Upon mention of “microwave,” the foreground subtly blurs and the camera focuses on the microwave. An “X” moves on-screen. It stops on the microwave, indicating that the syringe cannot be microwaved.]
Narrator: Do not microwave the prefilled syringes, run hot water over them, or leave them in direct sunlight. Also, do not shake or freeze them.
01:00-01:04
[Camera shows Frank washing his hands with soap and water in the sink and drying them with a hand towel.]
Narrator: Wash your hands with soap and water before preparing the injection site.
01:10-01:15
[CUT TO: Frank looking at the prefilled syringe box and removing the first syringe.]
Narrator: Inspect each of the three prefilled syringes to ensure they do not look damaged.
01:15-01:33
[Frank's face is shown as he inspects the prefilled syringes. Camera zooms in on the prefilled syringes being inspected.]
Narrator: The medicine inside should be clear. Its color may 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.
01:33-01:37
[Close-up of Frank's hand placing the 3rd syringe on the counter to the left of the other 2.]
Narrator: Now you are ready to inject Emgality.
[Cut to red circle]
Caption 1: in circle: INJECT
01:39-01:51
[Body visual appears on the screen with recommended injection sites highlighted in coral.]
Narrator: You may inject in the abdomen, front of your thigh, or another person may give you Emgality and your buttocks or in the back of your upper arm. It's important not to inject in the same exact spot twice.
Caption: Abdomen: at least 2 inches from the belly button
Caption: Front of thigh: at least 2 inches above the knee and at least 2 inches below the groin.
01:51-02:03
[Frank exposes his stomach.]
Narrator: Choose an area for injection such as the abdomen that is at least 2" away from the belly button. The proper way to use Emgality is to inject each syringe one after the other.
Caption: Do not inject into areas where the skin is tender, bruised, red, or hard.
02:04-02:08
[Cut to Frank's face looking down as he prepares to inject. He then cleans the injection site.]
Narrator: Always clean the injection site with an alcohol wipe and let it dry before injecting.
02:10-02:29
[Frank pulls the needle cap off the prefilled syringe. He then pinches and holds his skin where he will inject.]
Narrator: Pull the needle cap off. Do not touch the needle or put the needle cap back on. Gently pinch and hold a fold of skin where you will inject.
02:19-02:29
[Frank holds the prefilled syringe against his skin and slowly pushes down on the thumb pad to push the plunger all the way in until the medicine is injected.]
Narrator: Be sure to insert the needle at a 45 degree angle. Slowly push down on the thumb pad to push the plunger all the way in until all the medicine is injected.
02:29-02:41
[We see the coral plunger rod through the syringe afterward and the gray plunger is pushed to the needle end of the syringe (meaning the injection is complete).]
Narrator: The gray syringe plunger should be pushed all the way to the needle end of the syringe. You should see the coral plunger rod through the syringe afterward. This means your injection is complete. Remove the needle from your skin and gently let go of your skin.
02:42-02:50
[We see Frank repeat the same process (cleaning and injecting) for the remaining 2 injections in the abdomen.]
Narrator: For the remaining two injections, repeat all instructions with new prefilled syringes to complete your dose.
02:50-02:55
[Red circle flashes on the screen again with the word FINISH in the middle.]
Caption: FINISH
02:55-03:13
[We see Frank throw all 3 prefilled syringes away.]
Caption: Do not put the needle cap back on the prefilled syringe.
Narrator: When you're done injecting, safely dispose off the syringes in a Sharps container. Do not throw syringes in the trash.
You've now completed your Emgality injections. For complete information on how to inject, please see the full instructions that came with your prefilled syringes.
03:13-03:17
[Frank leaving the kitchen and entering another room within his home.]
Narrator: Discover what Emgality can do for you.
03:17-06:49
[Scroll box with The Emgality Indication and Safety Summary appears on the screen]
Caption: Consumer Indication and safety summary.
Narrator: INDICATION AND SAFETY SUMMARY
Emgality® (em-GAL-it-e¯ ) is used in adults for the treatment of episodic cluster headache. The medicine comes in 3 [(100 mg)] prefilled syringes, which are taken one after the other at the start of a cluster period and then every month until the end of the cluster period.
Warnings - Do not use Emgality if you are allergic to galcanezumab-gnlm or any of the ingredients in Emgality.
Allergic reactions. 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.
High blood pressure. High blood pressure or worsening of high blood pressure can happen after receiving Emgality. Contact your healthcare provider if you have an increase in blood pressure.
Raynaud’s phenomenon. A type of circulation problem can worsen or happen after receiving Emgality. Raynaud’s phenomenon can lead to your fingers or toes feeling numb, cool, or painful, or changing color from pale, to blue, to red. Contact your healthcare provider if these symptoms occur.
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 have high blood pressure.
❑ Circulation problems in your fingers and toes.
❑ 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.pregnancyregistry.lilly.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, if your cluster period has not ended, inject Emgality one month after your last dose to get back on a monthly dosing schedule.
Learn more
Emgality is an injectable prescription medicine available as a pre-filled single-dose syringe with 100 mg/mL solution.
For more information, go to www.emgality.lilly.com or call 1-800-LillyRx (1-800-545-5979).
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. This information does not take the place of talking to your doctor. Be sure to talk to your doctor or other healthcare provider about Emgality and how to take it. Your doctor is the best person to help you decide if Emgality is right for you.
GZ CON ECH BS 04APR2025
Please see Instructions for Use that come with the device.
Voice over audio created using AI
Caption: Emgality® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. ©Lilly USA, LLC 2025. All rights reserved.
06:50-06:53
[Cut to: Emgality Logo in the center of the screen with Lilly logo on the bottom right of the frame. Soft music playing in the background]
Caption: Emgality® is a registered trademark of owned or licensed by Eli Lilly and Company, its subsidiaries, or affliliates. PP-GZ-US-2453 04/2025 ©Lilly USA, LLC 2025. All rights reserved.
Instructions for Use - 100 mg syringe for episodic cluster headache
If you or your patients have any questions about Emgality, call 1-800-LillyRx (1-800-545-5979) to talk to a healthcare provider.
SC=subcutaneous.
SELECT IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with Emgality in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of Emgality and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration and may be prolonged.
References
- Emgality. Prefilled Syringe Prescribing Information. Lilly USA, LLC.
- Data on File. Lilly USA, LLC. DOF-GZ-US-0071.
- Emgality. Prefilled Syringe Instructions for Use. Lilly USA, LLC.