Omvoh (Eli Lilly Canada, 100 mg, ..., 200 mL): Uses, Side Effects and Dosage

What OMVOH is used for:

• OMVOH contains the active substance ‘mirikizumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognise and bind specifically to certain proteins in the body.
• OMVOH works by stopping a protein in the body called ‘IL-23’, which causes inflammation.
• Ulcerative colitis is an inflammatory disease of the large bowel. If you have ulcerative colitis, you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given OMVOH to reduce signs and symptoms of ulcerative colitis such as diarrhea, rectal bleeding, and urgency.
• Crohn’s disease is a chronic inflammatory disease of the digestive tract. If you have Crohn’s disease, you will first be given other medicines. If you do not respond well enough or cannot tolerate these medicines, you may be given OMVOH to reduce signs and symptoms of Crohn’s disease such as diarrhea, abdominal pain, fatigue, and urgency.

How OMVOH works:

OMVOH contains the active substance ‘mirikizumab’, a monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind specifically to certain proteins in the body.

OMVOH works by stopping a protein in the body called ‘IL-23’, which causes inflammation.

The ingredients in OMVOH are:

Medicinal ingredients: mirikizumab

Non-medicinal ingredients (vial): citric acid anhydrous, histidine, histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection.

Non-medicinal ingredients (prefilled pen and syringe): histidine, histidine hydrochloride monohydrate, mannitol, polysorbate 80, sodium chloride, and water for injection.

OMVOH comes in the following dosage forms:

Intravenous Infusion:

• Single-use vial: 20 mg / mL (300 mg / 15 mL)

Subcutaneous Injection

• Prefilled syringe: 100 mg / mL
• Prefilled pen: 100 mg / mL
• Prefilled syringe: 200 mg / 2 mL
• Prefilled pen: 200 mg / 2 mL

Do not use OMVOH if:

• You are allergic to mirikizumab or any of the other ingredients of this medicine. See “The ingredients in OMVOH are:” section.
• If you have important active infections.

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

• currently have an infection or if you have an infection that keeps coming back. OMVOH may lower your ability to fight infections and may increase your risk of infections.
• have tuberculosis (TB) or have been in close contact with someone with TB.
• have recently received or plan to receive an immunization (vaccine). You should not be given certain types of vaccines (called ‘live vaccines’) while using OMVOH.
• have liver problems.
• experience signs of an allergic reaction or other reaction to an infusion such as wheezing, difficulty breathing, hives, itching, swelling or dizziness. These could occur during or several hours after the infusion.

Other warnings you should know about:

Your healthcare professional may check blood tests while taking OMVOH to help tell if your liver is functioning normally. If blood tests are abnormal, your healthcare professional might interrupt therapy with OMVOH and do additional tests on your liver to determine the cause.

OMVOH is not approved for children and adolescents under 18 years of age. This is because it has not been studied in this age group.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your healthcare professional for advice before using this medicine. This is because it is not known if OMVOH can harm your unborn baby. If you are a woman of childbearing potential, use adequate contraception while using OMVOH. Talk to your healthcare professional about your contraception options.

If you are breastfeeding or are planning to breastfeed, talk to your healthcare professional before using this medicine. It is not known if OMVOH passes into breast milk. You and your healthcare professional should decide if you will breastfeed while using OMVOH.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

OMVOH may change the way the body responds to live vaccines.

How to take OMVOH:

• You will first receive OMVOH through a vein in the arm (intravenous infusion or IV) given by a healthcare professional every 4 weeks for a total of 3 doses.
• Your healthcare professional may decide that you may benefit from an additional 3 doses of OMVOH by intravenous infusion.
• You will then continue to receive OMVOH as an injection under the skin (subcutaneous injection) every 4 weeks as described below.

Treatment Start: Intravenous Infusion

• OMVOH will be given to you by a healthcare professional in a healthcare setting.
• You will be given OMVOH through a needle placed in a vein (intravenous infusion or IV) in your arm over a period of about 30 minutes (ulcerative colitis) or 90 minutes (Crohn’s disease).
• Your healthcare professional will monitor you closely during the infusion.

Maintenance Treatment: Subcutaneous Injection by prefilled pen or prefilled syringe

• Use OMVOH exactly as your healthcare professional tells you to.

• OMVOH comes in 2 different types of devices:

  • a single-patient-use (1-time use only) prefilled pen
  • a single-patient-use (1-time use only) prefilled syringe
• Your healthcare professional will decide with you which type of device is best for you.
• Ulcerative colitis: A full maintenance dose for patients with ulcerative colitis is 200 mg given as two injections of 100 mg each or one injection of 200 mg. If administered as two injections (100 mg / mL + 100 mg / mL), 2 prefilled pens or 2 prefilled syringes should be given as two consecutive injections, in any order.
• Crohn’s disease: A full maintenance dose for patients with Crohn’s disease is 300 mg given as two consecutive injections of 100 mg and 200 mg (100 mg / mL + 200 mg / 2 mL) via two prefilled pens or two prefilled syringes, in any order.
• OMVOH is intended for use under the guidance and supervision of your healthcare professional. If your healthcare professional decides that you or a caregiver may give your injections of OMVOH at home, you should receive training on the correct way to prepare and inject OMVOH. Do not try to inject OMVOH yourself until you or your caregiver have been shown how to inject OMVOH.
• OMVOH can be injected by patients and/or caregivers under the skin in your stomach area (abdomen) or upper leg (thigh). OMVOH can be injected only by caregivers in the back of the upper arm.
• Use a different injection site each time you use OMVOH. For example, if the first injection was in the abdomen, the second injection - to complete a full dose - should be in another area of the abdomen, thigh, or back of upper arm. Rotate injection sites.
• Do not give an injection in an area that is tender, bruised, red, or hard.
• Do not use this medication if it looks cloudy or is leaking.
• Read the detailed Instructions for Use that come with OMVOH prefilled pen or prefilled syringe about how to use OMVOH the correct way.

Usual dose for Ulcerative colitis:

The recommended dosing schedule is as follows:

Usual dose for Crohn’s disease:

The recommended dosing schedule is as follows:

Overdose:

If you think you, or a person you are caring for, have taken too much OMVOH, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

Intravenous Infusion

• If you forget or miss an appointment to receive the OMVOH infusion, make another appointment as soon as possible.

Subcutaneous Injection

• If you miss a dose of OMVOH, inject the missed dose as soon as you remember. Then, take your next dose at your regularly scheduled time. If you have questions about your schedule, ask your healthcare professional.

Possible side effects from using OMVOH:

These are not all the possible side effects you may have when taking OMVOH. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects of OMVOH include:

• Injection site reactions
• Upper respiratory infections
• Headache
• Joint pain
• Rash

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell 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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

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

Storage:

• Store refrigerated at 2°C to 8°C.
• Do NOT freeze. Do not use OMVOH if it has been frozen.
• Do NOT shake.
• Keep OMVOH in the original carton to protect from light until the time of use.
• Throw away (dispose of) your prefilled pens or prefilled syringes, as described in the Instructions for Use, if any of the above conditions are not followed.
• If needed, your prefilled syringes or prefilled pens may be stored at room temperature up to 30°C for up to 2 weeks in the original carton to protect from light. Once OMVOH has been stored at room temperature, do not return it to the refrigerator. Discard any unused OMVOH after 2 weeks.

Keep OMVOH and all medicines out of the reach of children.

If you want more information about OMVOH:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (www.lilly.ca), or by calling 1-888-545-5972.
• Instructions for Use can be found on www.lilly.ca

Date of Authorization: 2026-06-16

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

B2.0-OMV-NL0003-CA-PM-YYYYMMDD

INSTRUCTIONS FOR USE

(Ulcerative Colitis)

^PrOMVOH^®

mirikizumab injection

for subcutaneous use

100 mg Prefilled Syringe

100 mg syringe + 100 mg syringe = full 200 mg dose

This Instructions for Use is for patients with ulcerative colitis. If you are using OMVOH for treatment of Crohn’s disease, there is a different Instructions for Use because the dose is different.

This Instructions for Use contains information on how to inject OMVOH.

For subcutaneous injection only.

Before you use OMVOH prefilled syringes, read and carefully follow all the step-by-step instructions. Two injections are required for a full dose.

Important information you need to know before injecting OMVOH

• Your healthcare provider should show you how to prepare and inject OMVOH using the prefilled syringe. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• 2 OMVOH injections are required for a full dose.
• Inject 1 OMVOH prefilled syringe followed right away by the other OMVOH prefilled syringe.
• Each OMVOH prefilled syringe is for one-time use only. Do not share or reuse your OMVOH 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.

  100 mg / mL

  100 mg / mL

  +

• If you have vision problems, do not use OMVOH prefilled syringe without help from a caregiver.

• See Storing OMVOH Prefilled Syringes for important storage information.

  INSTRUCTIONS FOR USE

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

Parts of the OMVOH Prefilled Syringe

Top

Bottom

100 mg/mL + 100 mg/mL = 1 Full Dose

Thumb Pad

Finger Grips

Gray Syringe

Plunger

Syringe

Body with Medicine

Blue Plunger Rod

Needle

Needle Cap

IMPORTANT:

• 2 OMVOH injections are required for a full dose.
• Inject 1 OMVOH prefilled syringe followed right away by the other OMVOH prefilled syringe.

Preparing to inject OMVOH

Take the Prefilled Syringes from the refrigerator

Take 2 OMVOH prefilled syringes from the refrigerator.

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, or run hot water over them, or leave them in direct sunlight.

Do not use the prefilled syringes if the medicine is frozen.

Do not shake the prefilled syringes.

Gather supplies

Supplies:

• 2 alcohol wipes
• 2 cotton balls or pieces of gauze
• 1 sharps container (see Disposing of OMVOH Prefilled Syringes)

Inspect the Prefilled Syringes and the medicine

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

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

• one or both prefilled syringes look damaged
• the medicine is cloudy, is discoloured, or has 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 OMVOH.

Choose your injection site

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

• You or another person may inject the medicine into your stomach area (abdomen). Do not inject within 5 centimeters of the belly button (navel).
• You or another person may inject the medicine in the front of your thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.

Expiration Date

• Another person may give you the injection in the back of your upper arm.
• Do not inject in the exact same spot every time. For example, if your first injection was in your abdomen, your second injection — to complete a full dose — could be in another spot in your abdomen.
• Do not inject into areas where the skin is tender, bruised, red, or hard.

Clean the injection sites with an alcohol wipe. Let the injection sites dry before you inject the medicine.

Injecting OMVOH

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

• Slowly push on the thumb pad to push the plunger all the way in until all the medicine is injected.
• The gray syringe plunger should be pushed all the way to the needle end of the syringe.

• You should see the blue 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, as this may cause bruising.

• Do not put the needle cap back on the prefilled syringe.

  Blue Plunger Rod

  Gray Syringe Plunger

2 injections are required for a full dose. Inject one prefilled syringe immediately followed by the other prefilled syringe.

Disposing of OMVOH Prefilled Syringes

Throw away the used prefilled syringes

• Put the used OMVOH prefilled syringes in a sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH prefilled syringes 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 local laws about how you should throw away needles and syringes.
• Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q.

What if I let my OMVOH prefilled syringe warm up for longer than 30 minutes before injecting?

A.

Your prefilled syringe can stay at room temperature up to 30°C for up to 2 weeks.

Q.

What if I see air bubbles in the OMVOH prefilled syringe?

A.

It is normal to have air bubbles in the prefilled syringe. They will not harm you or affect your dose.

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. This will not harm you or affect your dose.

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.

What if there is a drop of liquid or blood on my skin after my injection?

A.

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Q.

How can I tell if my injection is complete?

A.

When your injection is complete:

• The blue plunger rod should show through the body of the syringe.
• The gray 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 OMVOH prefilled syringe:

• Call your healthcare provider or
• Call Lilly at 1-888-545-5972
• Visit www.lilly.ca

Storing OMVOH Prefilled Syringes

• Store your prefilled syringes in the refrigerator between 2°C to 8°C.
• Your prefilled syringes may be stored at room temperature for up to 2 weeks. Do not store above 30°C. Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Do not freeze your prefilled syringes.
• Store your prefilled syringes in the original to protect from light until use.
• Do not microwave your prefilled syringes, or run hot water over them, or leave them in direct sunlight.
• Do not shake your prefilled syringes.
• Throw away (dispose of) your prefilled syringes if any of the above conditions are not followed.
• Keep your prefilled syringes and all medicines out of the sight and reach of children.

Read the Patient Medication Information for OMVOH inside this box to learn about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

OMVOH^® is a registered trademark of Eli Lilly and Company.

Copyright © 2023, 2026, Eli Lilly and Company. All rights reserved.

Document Revised: 2026-06-16

OMV-0003-CA-PFS-IFU-20260424

INSTRUCTIONS FOR USE

(Ulcerative Colitis)

^PrOMVOH^®

mirikizumab injection

for subcutaneous use

100 mg Prefilled Pen

100 mg prefilled pen + 100 mg prefilled pen = full 200 mg dose

This Instructions for Use is for patients with ulcerative colitis. If you are using OMVOH for treatment of Crohn’s disease, there is a different Instructions for Use because the dose is different.

This Instructions for Use contains information on how to inject OMVOH.

For subcutaneous injection only.

Before you use the OMVOH prefilled pens (Pens), read and carefully follow all the step-by-step instructions. Two injections are required for a full dose.

Important information you need to know before injecting OMVOH

• Your healthcare provider should show you how to prepare and inject OMVOH using the Pen. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• 2 OMVOH injections are required for a full dose.
• Inject 1 OMVOH Pen followed right away by the other OMVOH Pen.
• Each OMVOH Pen is for one-time use only.
• The OMVOH Pen contains glass parts. Handle it carefully. If you drop it on a hard surface do not use it. Use a new OMVOH 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 OMVOH Pen without help from a caregiver.

• See Storing OMVOH Pens for important storage information.

  100 mg / mL

  100 mg / mL

  +

  INSTRUCTIONS FOR USE

Before you use the OMVOH Pens, read and carefully follow all the step-by-step instructions.

Parts of the OMVOH Pen

100 mg/mL + 100 mg/mL = 1 Full Dose

IMPORTANT:

• 2 OMVOH injections are required for a full dose.

• Inject 1 OMVOH Pen followed right away by the other OMVOH Pen.

  Lock ring

  Lock/unlock symbols

Medicine

Needle

Clear base

Gray base cap

Bottom and Needle End

Top

Blue injection button

Preparing to inject OMVOH

Take the Pens from the refrigerator

Take 2 OMVOH Pens from the refrigerator.

Leave the gray base caps on until you are ready to inject.

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

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

Do not use the Pens if the medicine is frozen.

Do not shake the Pens.

Gather supplies

Supplies:

• 2 alcohol wipes
• 2 cotton balls or pieces of gauze
• 1 sharps container (see Disposing of OMVOH Pens)

Inspect the Pens and the medicine

Expiration date

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

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

• one or both Pens look damaged
• the medicine is cloudy, is discoloured, or has 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 OMVOH.

Choose your injection site

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

• You or another person may inject the medicine into your stomach area (abdomen). Do not inject within 5 centimeters of the belly button (navel).
• You or another person may inject the medicine in the front of your thighs. This area should be at least 5 centimeters above the knee and 5 centimeters below the groin.
• Another person may give you the injection in the back of your upper arm.
• Do not inject in the exact same spot every time. For example, if your first injection was in your abdomen, your second injection — to complete a full dose — could be in another spot in your abdomen.
• Do not inject into areas where the skin is tender, bruised, red, or hard.

Clean the injection sites with an alcohol wipe. Let the injection sites dry before you inject the medicine.

Injecting OMVOH

1

Uncap the Pen

Make sure the Pen is locked.

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

• Twist off the gray base cap and throw it away in your household trash.
• Do not put the gray base cap back on – this could damage the needle.
• Do not touch the needle.

2

Place and Unlock

• Place and hold the clear base flat and firmly against the skin.

  Keep the clear base on the skin, then turn the lock ring to the unlock position.

3

Press and Hold for up to 10 Seconds

• Press and hold the blue injection button. You will hear a loud click (injection started).

• Keep holding the clear base firmly against the skin. You will hear a second loud click in about 10 seconds after the first one (injection completed).
• You will know the injection is complete when the gray plunger is visible.

• Remove the Pen from the 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, as this may cause bruising.

  Gray Plunger

2 injections are required for a full dose. Inject one Pen immediately followed by the other Pen.

Disposing of OMVOH Pens

Throw away the used Pens

• Put the used OMVOH Pens in a sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH Pens 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 local laws about how you should throw away needles and syringes.
• Do not recycle your used sharps disposal container.

Commonly Asked Questions

Q.

What if I let my Pen warm up for longer than 30 minutes before injecting?

A.

Your Pen can stay at room temperature up to 30°C for up to 2 weeks.

Q.

What if I see bubbles in the Pen?

A.

It is normal to have air bubbles in the Pen. They will not harm you or affect your dose.

Q.

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

A.

It is okay to see a drop of liquid on the tip of the needle. This will not harm you or affect your dose.

Q.

What if I unlocked the Pen and pressed the blue injection button before I twisted off the gray base cap?

A.

Do not remove the gray base cap. Throw away (dispose of) the Pen and get a new one.

Q.

Do I need to hold the blue injection button down until the injection is complete?

A.

You do not need to hold the blue injection button down, but it may help you keep the Pen steady and firm against your skin.

Q.

What if the needle did not retract after my injection?

A.

Do not touch the needle or replace the gray base cap. Store the Pen in a safe place to avoid an accidental needlestick and contact 1-888-545-5972 for instructions on how to return the Pen.

Q.

What if there is a drop of liquid or blood on my skin after my injection?

A.

This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

Q.

What if I heard more than 2 clicks during my injection – 2 loud clicks and a soft one. Did I get my complete injection?

A.

Some patients may hear a soft click right before the second loud click. That is the normal operation of the Pen. Do not remove the Pen from your skin until you hear the second loud click.

Q.

How can I tell if my injection is complete?

A.

After you press the blue injection button, you will hear 2 loud clicks. The second loud click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base.

If you have more questions about how to use the OMVOH Pen:

• Call your healthcare provider or
• Call Lilly at 1-888-545-5972
• Visit www.lilly.ca

Storing OMVOH Pens

• Store your Pens in the refrigerator between 2°C to 8°C.
• Your Pens may be stored at room temperature for up to 2 weeks. Do not store above 30°C. Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Do not freeze your Pens.
• Store your Pens in the original carton to protect from light until use.
• Do not microwave your Pens, or run hot water over them, or leave them in direct sunlight.
• Do not shake your Pens.
• Throw away (dispose of) your Pens if any of the above conditions are not followed.
• Keep your Pens and all medicines out of the sight and reach of children.

Read the Patient Medication Information for OMVOH inside this box to learn more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

OMVOH^® is a registered trademark of Eli Lilly and Company.

Copyright © 2023, 2026, Eli Lilly and Company. All rights reserved.

Document Revised: 2026-06-16

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

OMV-0003-CA-AI-IFU-20260424

INSTRUCTIONS FOR USE

(Ulcerative Colitis)

^PrOMVOH^®

mirikizumab injection

for subcutaneous use

200 mg / 2 mL Prefilled Syringe

This Instructions for Use is for patients with ulcerative colitis. If you are using OMVOH for treatment of Crohn’s disease, there is a different Instructions for Use because the dose is different.

This Instructions for Use contains information on how to inject OMVOH.

Before you use the OMVOH Prefilled Syringe, read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• For injection under the skin (subcutaneous injection) only.
• Your healthcare provider should show you how to prepare and inject OMVOH using the Prefilled Syringe. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• The OMVOH Prefilled Syringe contains 1 dose of OMVOH. The Prefilled Syringe is for one-time use only.
• The OMVOH Prefilled Syringe contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new OMVOH Prefilled Syringe for your injection.
• Your healthcare provider may help you decide where on your body to inject your dose. You can also read the Choose and clean 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 OMVOH Prefilled Syringe without help from a caregiver.

• See Storing OMVOH Prefilled Syringe for important storage information.

  200 mg / 2 mL

  INSTRUCTIONS FOR USE

Before you use the OMVOH Prefilled Syringe, read and carefully follow all the step-by-step instructions.

Parts of the OMVOH Prefilled Syringe

Top

Bottom

Preparing to inject OMVOH

Gather supplies

• OMVOH Prefilled Syringe from the refrigerator.
• 1 alcohol wipe
• 1 cotton ball
• 1 sharps disposal container

Inspect the Prefilled Syringe and the medicine

Remove Prefilled Syringe from the carton.

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

Do not use the Prefilled Syringe (see Disposing of OMVOH Prefilled Syringe) if the:

• Prefilled Syringe looks damaged
• medicine is cloudy, discoloured, or has particles
• expiration date printed on the label has passed
• medicine has been frozen.

Wait 45 minutes

Do not warm up the Prefilled Syringe with a microwave, hot water, or direct sunlight.

With the needle cap on, allow the Prefilled Syringe to warm up to room temperature for 45 minutes before injecting.

Choose and clean your injection site

Your healthcare provider can help you choose the injection site that is best for you. Clean the injection site with an alcohol wipe and let dry.

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

• Stomach area (abdomen) At least 5 centimeters away from the belly button (navel).

• Front of thigh At least 5 centimeters above the knee and 5 centimeters below the groin.
• Back of upper arm Another person should inject into the back of your upper arm.

You or another person may inject into these areas

Another person should inject into this area

Expiration Date

Injecting OMVOH

1

Uncap the Prefilled Syringe

• Hold the middle of the Prefilled Syringe and pull off the needle cap when you are ready to inject. Throw away the needle cap in the household trash.
• Do not put the needle cap back, this could damage the needle.
• Do not touch the needle.

2

Pinch the injection site and insert the needle

• Gently pinch and hold a fold of skin where you will inject.
• Insert the needle at a 45-degree angle.
• Gently let go of the skin while keeping the needle in place.

3

Inject the Prefilled Syringe

• Slowly push on the thumb pad to push the plunger rod all the way in until all the medicine is injected.

• The gray syringe plunger should be pushed all the way to the needle end of the Prefilled Syringe.
• You should see the blue plunger rod show through the Prefilled Syringe body when the injection is complete as shown.
• Remove the needle from your skin.
• Do not put the needle cap back on the Prefilled Syringe.

If you have bleeding at the injection site, press a cotton ball over the injection site. Do not rub the injection site.

Disposing of OMVOH Prefilled Syringe

Throw away the used Prefilled Syringe

Put the used OMVOH Prefilled Syringe in a sharps disposal container right away after use.

Do not throw away (dispose of) the OMVOH Prefilled Syringe in the household trash.

For more information, see Used OMVOH Prefilled Syringe Disposal.

Storing OMVOH Prefilled Syringe

Refrigeration

In the original carton, store your Prefilled Syringe in the refrigerator between 2°C to 8°C until the expiration date.

Room Temperature

• If needed, your Prefilled Syringe may be stored at room temperature for up to 2 weeks in the carton. Do not store above 30°C.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your Prefilled Syringe from light until use.

Keep your Prefilled Syringe and all medicines out of sight and reach of children.

Blue plunger rod

Gray syringe plunger

Do not use the Prefilled Syringe and throw away (see Disposing of OMVOH Prefilled Syringe) if it has been

• frozen
• microwaved
• warmed with hot water
• left in direct sunlight
• shaken

Commonly Asked Questions

Q. What if I see air bubbles in the OMVOH Prefilled Syringe?

A. It is normal to have air bubbles in the Prefilled Syringe. They will not harm you or affect your dose.

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. This will not harm you or affect your dose.

Q. What if I cannot push in the plunger?

A. If the plunger is stuck or damaged:

• Do not continue to use the Prefilled Syringe
• Remove the needle from your skin
• Throw away (dispose of) the Prefilled Syringe and get a new one

Q. What if there is a drop of liquid or blood on my skin after my injection?

A. This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

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

A. When your injection is complete:

• The blue plunger rod should show through the body of the Prefilled Syringe
• The gray syringe plunger should be pushed all the way to the needle end of the Prefilled Syringe.

Q. How many syringes do I need to inject in order to get my full dose?

A. For this product, one 2 mL syringe equals a full dose. If your prescription previously required more injections and you would like to confirm your dose, or you have any questions about your dose, contact your healthcare provider.

Additional Information:

If you have more questions about how to use the OMVOH Prefilled Syringe:

• Call your healthcare provider
• Call Lilly at 1-888-545-5972
• Visit www.lilly.ca

Used OMVOH Prefilled Syringe Disposal

Put the used OMVOH Prefilled Syringe in a sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH Prefilled Syringe in the 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 local laws about how you should throw away needles and syringes.

Do not recycle your used sharps disposal container.

Read the Patient Medication Information for OMVOH inside this box to learn more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

OMVOH^® is a registered trademark of Eli Lilly and Company.

Copyright © 2026, Eli Lilly and Company. All rights reserved.

Document Issued: 2026-06-16

OMV-0001-200MG-PFS-CA-IFU-20260424

INSTRUCTIONS FOR USE

(Ulcerative Colitis)

^PrOMVOH^®

mirikizumab injection

for subcutaneous use

200 mg / 2 mL Prefilled Pen

This Instructions for Use is for patients with ulcerative colitis. If you are using OMVOH for treatment of Crohn’s disease, there is a different Instructions for Use because the dose is different.

This Instructions for Use contains information on how to inject OMVOH.

Before you use the OMVOH Prefilled Pen (Pen), read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• For injection under the skin (subcutaneous injection) only
• Your healthcare provider should show you how to prepare and inject OMVOH using the Pen. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• The OMVOH Pen contains 1 dose of OMVOH. The Pen is for one-time use only.
• The OMVOH Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new OMVOH 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 and clean 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 OMVOH Pen without help from a caregiver.

• See Storing OMVOH Pen for important storage information.

  200 mg / 2 mL

  INSTRUCTIONS FOR USE

Before you use the OMVOH Pen, read and carefully follow all the step-by-step instructions.

Parts of the OMVOH Pen

Bottom and Needle End

Preparing to inject OMVOH

Gather supplies

• OMVOH Pen from the refrigerator
• 1 alcohol wipe
• 1 cotton ball or piece of gauze
• 1 sharps disposal container

Inspect the Pen and the medicine

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

Do not use the Pen (see Disposing of OMVOH Pen) if the:

• Pen looks damaged
• medicine is cloudy, is discoloured, or has particles
• expiration date printed on the label has passed

Wait 45 minutes

With the gray base cap on, allow the Pen to warm up to room temperature for 45 minutes before injecting.

• Do not warm up the Pen with a microwave, hot water, or direct sunlight.
• Do not use the Pen if the medicine has been frozen.

Choose and clean your injection site

Your healthcare provider can help you choose the injection site that is best for you. Clean the injection site with an alcohol wipe and let dry.

You or another person may inject into these areas

• Do not inject into areas where the skin is tender, bruised, red, or hard.
• Stomach area (abdomen) At least 5 centimeters away from the belly button (navel).
• Front of thigh At least 5 centimeters above the knee and 5 centimeters below the groin.

• Back of upper arm Another person should inject into the back of your upper arm.

Another person should inject into this area

Expiration date

Injecting OMVOH

1

Uncap the Pen

Make sure the Pen is locked.

When you are ready to inject, twist off the gray base cap and throw the cap away in your household trash.

Do not put the gray base cap back on; this could damage the needle.

Do not touch the needle inside the clear base.

2

Place and unlock

Place and hold the clear base flat and firmly against the skin.

Keep the clear base on the skin, then turn the lock ring to the unlock position.

3

Press and Hold for 15 Seconds

Press and hold the blue injection button and listen for 2 loud clicks:

• First click: injection started
• Second click: injection completed

The injection may take up to 15 seconds.

You will know the injection is complete when the gray plunger is visible.

15 seconds

Gray Plunger

Clear base

Gray base cap

Needle

Disposing of OMVOH Pen

Throw away the used Pen

Put the used OMVOH Pen in a sharps disposal container right away after use.

Do not throw away (dispose of) the OMVOH Pen in the household trash.

For more information, see Used OMVOH Pen Disposal.

Storing OMVOH Pen

Refrigeration

• In the original carton, store your Pen in the refrigerator between 2°C to 8°C until the expiration date.

Room Temperature

• If needed, your Pen may be stored at room temperature for up to 2 weeks in the carton. Do not store above 30°C.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your Pen from light until use.

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

Do not use the Pen and throw away (see Disposing of OMVOH Pen) if it has been:

• frozen
• microwaved
• warmed with hot water
• left in direct sunlight
• shaken

Commonly Asked Questions

Q. What if I see bubbles in the Pen?

A. Air bubbles are normal. They will not harm you or affect your dose.

Q. What if I unlock the Pen and press the blue injection button before twisting off the gray base cap?

A. Do not remove the gray base cap. Throw away (dispose of) the prefilled Pen and use a new one.

Q. Do I need to hold the blue injection button down until the injection is complete?

A. You do not need to hold the blue injection button down, but it may help you keep the Pen steady and firm against your skin.

Q. What if the needle did not retract after my injection?

A. Do not touch the needle or replace the gray base cap. Store the Pen in a safe place to avoid an accidental needlestick and contact 1-888-545-5972 for instructions on how to return the Pen.

Q. What if there is a drop of liquid or blood on my skin after my injection?

A. This is normal. Press a cotton ball or gauze over the injection site. Do not rub the injection site.

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

A. After you press the blue injection button, you will hear 2 loud clicks. The second loud click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base. The injection may take up to 15 seconds.

Q. What if I remove the Pen before the second loud click or before the gray plunger stops moving?

A. You may not have received your full dose. Do not give another injection. Call your healthcare provider for help.

Q. What if I hear more than 2 clicks during my injection – 2 loud clicks and 1 soft one. Did I get my complete injection?

A. Some people may hear a soft click right before the second loud click. That is the normal operation of the prefilled Pen. Do not remove the Pen from your skin until you hear the second loud click.

Q. How many Pens do I need to inject in order to get my full dose?

A. For this product, one 2 mL Pen equals a full dose. If your prescription previously required more injections and you would like to confirm your dose, or you have any questions about your dose, contact your healthcare provider.

Additional Information:

If you have more questions about how to use the OMVOH Pen:

• Call your healthcare provider or
• Call Lilly at 1-888-545-5972
• Visit www.lilly.ca

Used OMVOH Pen Disposal

Put the used OMVOH Pen in a sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH Pen in the 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 local laws about how you should throw away needles and syringes.

Do not recycle your used sharps disposal container.

Read the Patient Medication Information for OMVOH inside this box to learn more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

OMVOH^® is a registered trademark of Eli Lilly and Company.

Copyright © 2026, Eli Lilly and Company. All rights reserved.

Document Issued: 2026-06-16

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

OMV-0001-200MG-AI-CA-IFU-20260424

INSTRUCTIONS FOR USE

(Crohn’s Disease)

^PrOMVOH^®

mirikizumab injection

for subcutaneous use

Prefilled Syringes

200 mg syringe + 100 mg syringe = full 300 mg dose

This Instructions for Use is for patients with Crohn’s disease. If you are using OMVOH for treatment of ulcerative colitis, there is a different Instructions for Use because the dose is different.

This Instructions for Use contains information on how to inject OMVOH.

Before you use the OMVOH prefilled syringes (Syringes), read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• 2 OMVOH injections, using the provided 1 mL and 2 mL Syringes, are required for a full 300 mg dose. The Syringes may be used in any order.
• Inject 1 OMVOH Syringe followed right away by the other OMVOH Syringe.
• Your healthcare provider should show you how to prepare and inject OMVOH using the Syringes. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• Each OMVOH Syringe is for one-time use only.
• Your healthcare provider can help you decide where on your body to inject your dose. Read the Choose and clean your injection sites section of these instructions to help you choose which area can work best for you.
• If you have vision problems, do not use OMVOH Syringes without help from a caregiver.
• See Storing OMVOH Syringes for important storage information.

INSTRUCTIONS FOR USE

Before you use the OMVOH Syringes, read and carefully follow all the step-by-step instructions.

2 Syringes = full 300 mg dose

After your first injection, choose a new injection site at least 5 centimeters away and clean it.

With your second Syringe, repeat steps 1-3 immediately after your first injection.

You must inject 2 Syringes to complete your full 300 mg dose.

Parts of the OMVOH Syringes

Inject both Syringes in any order for a full 300 mg dose.

The 200 mg Syringe is larger than the 100 mg Syringe.

Top

Bottom

Preparing to inject OMVOH

Gather supplies

• 2 OMVOH Syringes from the refrigerator

  • 2 cotton balls

• 2 alcohol wipes

  • sharps disposal container

Inspect the Syringes and the medicine

Remove both Syringes from the carton.

Make sure you have the right medicine.

The medicine inside should be clear. It may be colourless to slightly yellow.

Do not use the Syringes (see Disposing of OMVOH Syringes) if:

• one or both Syringes looks damaged

• the medicine is cloudy, discoloured, or has particles
• the expiration date printed on the label has passed
• the medicine is or has been frozen.

Wait 45 minutes

Do not warm up the Syringes with a microwave, hot water, or direct sunlight.

With the needle cap on, allow the Syringes to warm up to room temperature for 45 minutes before injecting.

Choose and clean your injection sites

Your healthcare provider can help you choose the injection sites that are best for you. Clean the injection sites with an alcohol wipe and let dry.

You or another person may inject into these areas.

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

• Stomach area (abdomen)

  At least 5 centimeters away from the belly button (navel).

• Front of thigh

  At least 5 centimeters above the knee and 5 centimeters below the groin.

Expiration Date

Another person should inject into this area.

• Back of upper arm

  Another person should inject into the back of your upper arm.

Injections should be at least 5 centimeters apart.

Injecting OMVOH

1. 1. Uncap the first Syringe (the Syringes may be used in any order)

Hold the middle of the Syringe and pull off the needle cap when you are ready to inject. Throw away the needle cap in the trash.

Do not put the needle cap back on —

this could damage the needle.

Do not touch the needle.

1. 2. Pinch the injection site and insert the needle

Gently pinch and hold a fold of skin where you will inject.

Insert the needle at a 45-degree angle.

Gently let go of the skin while keeping the needle in place.

1. 3. Inject the Syringe

Slowly push on the thumb pad to push the plunger rod all the way in until all the medicine is injected.

The gray Syringe plunger should be pushed all the way to the needle end of the Syringe.

Blue plunger rod

Gray Syringe plunger

You should see the blue plunger rod show through the Syringe body when the injection is complete as shown.

Remove the needle from your skin.

Do not put the needle cap back on the Syringe.

If you have bleeding at the injection site, press a cotton ball over the injection site. Do not rub the injection site.

1. 4. Inject the second Syringe

Choose a new injection site at least 5 centimeters away and clean it.

With your second Syringe, repeat steps 1-3 immediately after your first injection.

You must inject 2 Syringes to complete your full 300 mg dose.

Disposing of OMVOH Syringes

Throw away both used Syringes

Put the used OMVOH Syringes in a sharps disposal container right away after use.

Do not throw away (dispose of) the OMVOH Syringes in the trash.

Do not recycle your used sharps disposal container.

For more information, see Used OMVOH Syringe disposal.

Storing OMVOH Syringes

Refrigeration

• In the original carton, store your Syringes in the refrigerator between 2°C to 8°C until the expiration date.

Room Temperature

• If needed, your Syringes may be stored at room temperature for up to 2 weeks in the carton. Do not store above 30°C.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your Syringes from light until use.

Keep your Syringes and all medicines out of the sight and reach of children.

Do not use the Syringes and throw away (see Disposing of OMVOH Syringes) if they have been:

• frozen

  • left in direct sunlight

• microwaved

  • shaken
• warmed with hot water

Commonly asked questions

Q.

The Syringes are different sizes. Should I take one before the other?

A.

You can inject the Syringes in any order. Inject both Syringes for a full 300 mg dose.

Q.

What if I see air bubbles in the Syringes?

A.

Air bubbles are normal. They will not harm you or affect your dose.

Q.

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

A.

A drop of liquid on the tip of the needle is normal. This will not harm you or affect your dose. Do not touch 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 of the same dose, that is, either a new 2 mL Syringe or a new 1 mL Syringe, depending on which Syringe needs to be replaced.

Q.

What if there is a drop of liquid or blood on my skin after my injection?

A.

This is normal. Press a cotton ball over the injection site. Do not rub the injection site.

Q.

How can I tell if my injection is complete?

A.

When your injection is complete:

• The blue plunger rod should show through the body of the Syringe.
• The gray Syringe plunger should be pushed all the way to the needle end of the Syringe.

Additional Information:

If you have more questions about how to use the OMVOH Syringes:

• Call your healthcare provider or
• Call Lilly at 1-888-545-5972
• Visit www.lilly.ca

Used OMVOH Syringe disposal

Put the used OMVOH Syringes in a sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH Syringes in the 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
• 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 local laws about how you should throw away needles and syringes.

Do not recycle your used sharps disposal container.

Read the Patient Medication Information for OMVOH inside this box to learn more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

OMVOH^® is a registered trademark of Eli Lilly and Company.

Copyright © 2025, 2026, Eli Lilly and Company. All rights reserved.

Document Revised: 2026-06-16

OMV-0002-300MG-PFS-CA-IFU-20260424

INSTRUCTIONS FOR USE

(Crohn’s Disease)

^PrOMVOH^®

mirikizumab injection

for subcutaneous use

Prefilled Pens

200 mg prefilled pen + 100 mg prefilled pen = full 300 mg dose

This Instructions for Use is for patients with Crohn’s disease. If you are using OMVOH for treatment of ulcerative colitis, there is a different Instructions for Use because the dose is different.

This Instructions for Use contains information on how to inject OMVOH.

Before you use the OMVOH prefilled pens (Pens), read and carefully follow all the step-by-step instructions.

Important information you need to know before injecting OMVOH

• 2 OMVOH injections, using the provided 1 mL and 2 mL Pens, are required for a full 300 mg dose. The Pens may be used in any order.
• Inject 1 OMVOH Pen followed right away by the other OMVOH Pen.
• Your healthcare provider should show you how to prepare and inject OMVOH using the Pens. Do not inject yourself or someone else until you have been shown how to inject OMVOH.
• Keep this Instructions for Use and read it as needed.
• Each OMVOH Pen is for one-time use only.
• The OMVOH Pen contains glass parts. Handle it carefully. If you drop it on a hard surface, do not use it. Use a new OMVOH Pen for your injection.
• Your healthcare provider can help you decide where on your body to inject your dose. Read the Choose and clean your injection sites 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 OMVOH Pens without help from a caregiver.
• See Storing OMVOH Pens for important storage information

INSTRUCTIONS FOR USE

Before you use the OMVOH Pens, read and carefully follow all the step-by-step instructions.

2 Pens = full 300 mg dose

After your first injection, choose a new injection site at least 5 centimeters away and clean it.

With your second Pen, repeat steps 1-3 immediately after your first injection.

You must inject 2 Pens to complete your full 300 mg dose.

Parts of the OMVOH Pens

Inject both Pens in any order for a full 300 mg dose.

The 200 mg Pen is larger than the 100 mg Pen.

Preparing to inject OMVOH

Gather supplies

• 2 OMVOH Pens from the refrigerator

  • 2 cotton balls

• 2 alcohol wipes

  • sharps disposal container

Inspect the Pens and the medicine

Remove both Pens from the carton.

Make sure you have the right medicine.

The medicine inside should be clear. It may be colourless to slightly yellow.

Do not use the Pens (see Disposing of OMVOH Pens) if:

• one or both Pens looks damaged

• the medicine is cloudy, discoloured, or has particles
• the expiration date printed on the label has passed
• the medicine is or has been frozen.

Wait 45 minutes

Do not warm up the Pens with a microwave, hot water, or direct sunlight.

With the gray base cap on, allow the Pens to warm up to room temperature for 45 minutes before injecting.

Choose and clean your injection sites

Your healthcare provider can help you choose the injection sites that are best for you. Clean the injection sites with an alcohol wipe and let dry.

You or another person may inject into these areas.

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

• Stomach area (abdomen)

  At least 5 centimeters away from the belly button (navel).

• Front of thigh

  At least 5 centimeters above the knee and 5 centimeters below the groin.

Expiration date

Another person should inject into this area.

• Back of upper arm

  Another person should inject into the back of your upper arm.

Injections should be at least 5 centimeters apart.

Injecting OMVOH

1. 1. Uncap the first Pen (the Pens may be used in any order)

Make sure the Pen is locked.

Twist off the gray base cap and throw the cap away in the trash when you are ready to inject.

Do not put the gray base cap back on –

this could damage the needle.

Do not touch the needle inside the clear base.

1. 2. Place and unlock

Place and hold the clear base flat against the skin.

Keep the clear base on the skin, then turn the lock ring to the unlock position.

Needle

Gray base cap

Clear base

1. 3. Press and hold for 15 seconds

Press and Hold the blue injection button and listen for two loud clicks:

• first click = injection started
• second click = injection completed

The injection may take up to 15 seconds.

You will know the injection is complete when the gray plunger is visible.

If you have bleeding at the injection site, press a cotton ball over the injection site.

Do not rub the injection site.

1. 4. Inject the second Pen

Choose a new injection site at least 5 centimeters away and clean it.

With your second Pen, repeat steps 1-3 immediately after your first injection.

You must inject 2 Pens to complete your full 300 mg dose.

Disposing of OMVOH Pens

Throw away both used Pens

Put the used OMVOH Pens in a sharps disposal container right away after use.

Do not throw away (dispose of) the OMVOH Pens in the trash.

Do not recycle your sharps disposal container.

For more information, see Used OMVOH Pen disposal.

Storing OMVOH Pens

Refrigeration

• In the original carton, store your Pens in the refrigerator between 2°C to 8°C until the expiration date.

  15

  seconds

  Gray Plunger

Room Temperature

• If needed, your Pens may be stored at room temperature for up to 2 weeks in the carton. Do not store above 30°C.
• Throw away (dispose of) OMVOH if not used within 2 weeks at room temperature.
• Protect your Pens from light until use.

Keep your Pens and all medicines out of the sight and reach of children.

Do not use the Pens and throw away (see Disposing of OMVOH Pens) if they have been:

• frozen

  • left in direct sunlight

• microwaved

  • shaken
• warmed with hot water

Commonly asked questions

Q.

The Pens are different sizes. Should I take one before the other?

A.

You can inject the Pens in any order. Inject both Pens for a full 300 mg dose.

Q.

What if I see air bubbles in the Pens?

A.

Air bubbles are normal. They will not harm you or affect your dose.

Q.

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

A.

A drop of liquid on the tip of the needle is normal. This will not harm you or affect your dose. Do not touch the needle.

Q.

What if I unlock the Pen and press the blue injection button before twisting off the gray base cap?

A.

Do not remove the gray base cap. Throw away (dispose of) the Pen and get a new one.

Q.

Do I need to hold the blue injection button down until the injection is complete?

A.

You do not need to hold the blue injection button down, but it may help you keep the Pen steady against your skin.

Q.

What if the needle did not retract after my injection?

A.

Do not touch the needle or replace the gray base cap. Store the Pen in a safe place to avoid an accidental needlestick and contact 1-888-545-5972 for instructions on how to return the Pen.

Q.

What if there is a drop of liquid or blood on my skin after my injection?

A.

This is normal. Press a cotton ball over the injection site. Do not rub the injection site.

Q.

How can I tell if my injection is complete?

A.

After you press the blue injection button, you will hear 2 loud clicks. The second loud click tells you that your injection is complete. You will also see the gray plunger at the top of the clear base. The injection may take up to 15 seconds.

Q.

What if I remove the Pen before the second loud click or before the gray plunger stops moving?

A.

You may not have received your full dose. Do not give another injection. Call your healthcare provider for help.

Q.

What if I heard more than 2 clicks during my injection – 2 loud clicks and 1 soft one. Did I get my complete injection?

A.

Some people may hear a soft click right before the second loud click. That is the normal operation of the Pen. Do not remove the Pen from your skin until you hear the second loud click.

Additional Information:

If you have more questions about how to use the OMVOH Pens:

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

Used OMVOH Pen disposal

Put the used OMVOH Pens in a sharps disposal container right away after use. Do not throw away (dispose of) the OMVOH Pens in the 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
• 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 local laws about how you should throw away needles and syringes.

Do not recycle your used sharps disposal container.

Read the Patient Medication Information for OMVOH inside this box to learn more about your medicine.

Eli Lilly Canada Inc., P.O. Box 73, Toronto, Ontario, M5X 1B1

OMVOH^® is a registered trademark of Eli Lilly and Company.

Copyright © 2025, 2026 Eli Lilly and Company. All rights reserved.

Document Revised: 2026-06-16

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

OMV-0002-300MG-PEN-CA-IFU-20260424