Emgality (Galcanezumab): Uses, Side Effects and Dosage

• Your healthcare provider or nurse should show you how to prepare and inject EMGALITY using the Pen. 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 Pen is for one-time use only. Do not share or reuse your EMGALITY Pen. You may give or get an infection.

• The Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new Pen for your injection.

• Your healthcare provider 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 or hearing problems, do not use EMGALITY Pen without help from a caregiver.

• See “ Storing EMGALITY ” for important storage information.

Step 1a Take the Pen from the refrigerator

Check your prescription.

• EMGALITY comes as a single-dose prefilled Pen.
• You will need 2 Pens for your first dose (1-time loading dose). You will need 1 Pen for your monthly dose.

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

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

Leave the Pen at room temperature for 30 minutes before injecting.

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

Do not shake.

Step 1b 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.”

Step 1c Inspect the Pen and the medicine

Make sure you have the right medicine. The medicine inside should be clear. Its color may be colorless to slightly yellow to slightly brown.

Do not use the Pen, and throw away (dispose of) as directed by your healthcare provider or pharmacist if:

• it looks damaged
• the medicine is cloudy, is discolored, or has small particles
• the Expiration Date (Exp.) printed on the label has passed (see Figure A )
• the medicine is frozen

Figure A

Step 1d Prepare for injection

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

Step 1e Choose your injection site

Your healthcare provider can help you choose the injection site that is best for you.

Figure B

• You may inject the medicine into your stomach area (abdomen). Do not inject within 2 inches of the belly button (navel) (see Figure B ).

• You may inject the medicine into the front of your thighs. This area should be at least 2 inches above the knee and 2 inches below the groin.

• Another person may give you the injection in the back of your upper arm, or buttocks (see Figure B ).

• Do not inject in the exact same spot. For example, if you are giving 2 injections for your first dose (1-time loading dose) and want to use the same body site for the two separate injections, choose a different injection spot. If your first injection was in your abdomen, your next injection could be in another area of your abdomen.

• Do not inject into areas where the skin is tender, bruised, red, or hard.

• Clean your injection site with an alcohol wipe. Let the injection site dry before you inject.

Figure C

• Twist off the base cap (see Figure C ) and throw it away in your household trash.

• Do not put the base cap back on – this could damage the needle.

• Do not touch the needle.

Figure D

• Place and hold the clear base flat and firmly against your skin (see Figure D ).

Figure E

• Press and hold the teal injection button; you will hear a loud click (see Figure E ).

• Keep holding the clear base firmly against your skin. You will hear a second click in about 10 seconds after the first one. This second click tells you that your injection is complete.

• Remove the Pen from 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.

Figure F

• Put the used EMGALITY Pen in an FDA-cleared sharps disposal container right away after use (see Figure G ). Do not throw away (dispose of) the EMGALITY Pen in your household trash.

Figure G

• If you do not have an FDA-cleared 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 state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

• Store your Pen in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

• Your Pen may be stored out of the refrigerator in the original carton at temperatures up to 86°F (30°C) for up to 7 days. After storing out of the refrigerator, do not place EMGALITY back in the refrigerator.

• Do not freeze your Pen.

• Keep your Pen in the carton it comes in to protect it from light until time of use.

• Do not shake your Pen.

• Throw away your Pen if any of the above conditions are not followed.

• Keep your Pen and all medicines out of the reach of children.

Eli Lilly and Company

Indianapolis, IN 46285, USA

The Pen meets the current dose accuracy and functional requirements of ISO 11608-1 and 11608-5.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 11/2025

• 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.

• Your healthcare provider or nurse 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 provider 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.

• See “ Storing EMGALITY ” for important storage information.

Step 1a Take the Prefilled Syringe from the refrigerator

Check your prescription.

• EMGALITY comes as a single-dose prefilled syringe.
• You will need 2 prefilled syringes for your first dose (1-time loading dose). You will need 1 prefilled syringe for your monthly dose.

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

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

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.

Step 1b 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.”

Step 1c Inspect the Prefilled Syringe and the medicine

Make sure you have the right medicine. The medicine inside should be clear. Its color may be colorless to slightly yellow to slightly brown.

Do not use the prefilled syringe, and throw away (dispose of) as directed by your healthcare provider or pharmacist if:

• it looks damaged
• the medicine is cloudy, is discolored, or has small particles
• the Expiration Date (Exp.) printed on the label has passed (see Figure A )
• the medicine is frozen

Figure A

Step 1d Prepare for injection

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

Step 1e Choose your injection site

Your healthcare provider can help you choose the injection site that is best for you.

Figure B

• You may inject the medicine into your stomach area (abdomen). Do not inject within 2 inches of the belly button (navel) (see Figure B ).

• You may inject the medicine into the front of your thighs. This area should be at least 2 inches above the knee and 2 inches below the groin.

• Another person may give you the injection in the back of your upper arm, or buttocks (see Figure B ).

• Do not inject in the exact same spot. For example, if you are giving 2 injections for your first dose (1-time loading dose) and want to use the same body site for the two separate injections, choose a different injection spot. If your first injection was in your abdomen, your next injection could be in another area of your abdomen.

• Do not inject into areas where the skin is tender, bruised, red, or hard.

• Clean your injection site with an alcohol wipe. Let the injection site dry before you inject.

Figure C

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

• Pull the needle cap off (see Figure C ) 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.

Figure D

• Gently pinch and hold a fold of skin where you will inject (see Figure D ).

• Insert the needle at a 45-degree angle.

Figure E

• Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected (see Figure E ).

• The gray syringe plunger should be pushed all the way to the needle end of the syringe (see Figure F ).

• You should see the teal plunger rod show through the syringe body when the injection is complete as shown (see Figure F ).
• 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.
• Do not put the needle cap back on the prefilled syringe.

Figure F

Step 3 Disposing of EMGALITY

Step 3a Throw away the used prefilled syringe

• Put the used EMGALITY prefilled syringe in an FDA-cleared sharps disposal container right away after use (see Figure G ). Do not throw away (dispose of) the EMGALITY prefilled syringe in your household trash.

Figure G

• If you do not have an FDA-cleared 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 state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

• Store your prefilled syringe in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

• Your prefilled syringe may be stored out of the refrigerator in the original carton at temperatures up to 86°F (30°C) for up to 7 days. After storing out of the refrigerator, do not place EMGALITY back in the refrigerator.

• Do not freeze your prefilled syringe.

• Keep your prefilled syringe in the carton it comes in to protect it from light until time of use.

• Do not shake your prefilled syringe.

• Throw away your prefilled syringe if any of the above conditions are not followed.

• Keep your prefilled syringe and all medicines out of the reach of children.

• If you are using EMGALITY for preventive treatment of migraine, there is a different Instructions for Use because the dose and number of syringes needed is different.

• Your healthcare provider or nurse 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 provider 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.

• See “ Storing EMGALITY ” for important storage information.

Step 1a Take the Prefilled Syringes from the refrigerator

Take 3 EMGALITY prefilled syringes from the refrigerator.

Check your prescription.

• EMGALITY comes as a single-dose prefilled syringe.
• You will need 3 prefilled syringes for each dose.

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

Leave the prefilled syringes at room temperature for 30 minutes before injecting.

Do not microwave the prefilled syringes, run hot water over them, or leave them in direct sunlight.

Do not shake.

Step 1b 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.”

Step 1c Inspect the Prefilled Syringe and the medicine

Make sure you have the right medicine. The medicine inside should be clear. Its color may be colorless to slightly yellow to slightly brown.

Do not use the prefilled syringe, and throw away (dispose of) as directed by your healthcare provider or pharmacist if:

• it looks damaged
• the medicine is cloudy, is discolored, or has small particles
• the Expiration Date (Exp.) printed on the label has passed (see Figure A )
• the medicine is frozen

Expiration Date

Figure A

Step 1d Prepare for injection

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

Figure B

• You may inject the medicine into your stomach area (abdomen). Do not inject within 2 inches of the belly button (navel) (see Figure B ).

• You may inject the medicine into the front of your thighs. This area should be at least 2 inches above the knee and 2 inches below the groin.

• Another person may give you the injection in the back of your upper arm or buttocks (see Figure B ).

• 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.

• Do not inject into areas where the skin is tender, bruised, red, or hard.

• Clean your injection site with an alcohol wipe. Let the injection site dry before you inject.

Figure C

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

• Pull the needle cap off (see Figure C ) 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.

Figure D

• Gently pinch and hold a fold of skin where you will inject (see Figure D ).

• Insert the needle at a 45-degree angle.

Figure E

• Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected (see Figure E ).

• The gray syringe plunger should be pushed all the way to the needle end of the syringe (see Figure F ).

• You should see the coral plunger rod show through the syringe body when the injection is complete as shown (see Figure F ).
• 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.
• Do not put the needle cap back on the prefilled syringe.

Figure F

Step 3 Disposing of EMGALITY

Step 3a Throw away the used prefilled syringe

• Put the used EMGALITY prefilled syringe in an FDA-cleared sharps disposal container right away after use (see Figure G ). Do not throw away (dispose of) the EMGALITY prefilled syringe in your household trash.

Figure G

• If you do not have an FDA-cleared 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 state or local laws about how you should throw away needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• Do not recycle your used sharps disposal container.

• Store your prefilled syringes in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC).

• Your prefilled syringes may be stored out of the refrigerator in the original carton at temperatures up to 86ºF (30ºC) for up to 7 days. After storing out of the refrigerator, do not place EMGALITY back in the refrigerator.

• Do not freeze your prefilled syringes.

• Keep your prefilled syringes in the carton they come in to protect them from light until time of use.

• Do not shake your prefilled syringes.

• Throw away your prefilled syringes if any of the above conditions are not followed.

• Keep your prefilled syringes and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Revised: 11/2025