Patient Medication Information: uses, side effects, how to take - Omvoh (Eli Lilly Canada, 100 mg / 200 mg)

What is Omvoh 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 does Omvoh work?

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.

What are the ingredients in Omvoh?

Medicinal ingredients: mirikizumab

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

Non-medicinal ingredients (prefilled pen and syringe): L-histidine, L-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

The 200 mg / 2 mL prefilled pen and 200 mg / 2 mL prefilled syringe are only for treatment of Crohn’s disease.

Do not use Omvoh if:

You are allergic to mirikizumab or any of the other ingredients of this medicine. See What are the ingredients in Omvoh?
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.
For your full dose, you will need either 2 injections with the prefilled pen or 2 injections with the prefilled syringe. Inject 1 Omvoh pen or syringe followed right away by the other Omvoh pen or syringe.
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:

Treatment	Time of treatment	Dose and Route of administration
Treatment Start	Weeks 0, 4 and 8	300 mg intravenous infusion
If you do not have adequate therapeutic response after these 3 infusions, your healthcare professional might consider continuing intravenous infusions at weeks 12, 16 and 20.
Maintenance Treatment	4 weeks after Treatment Start and then every 4 weeks there after	200 mg subcutaneous injection Given either as: 2 injections of 100 mg prefilled pens, or
2 injections of 100 mg prefilled syringes

Usual dose for Crohn’s disease:

The recommended dosing schedule is as follows:

Treatment

Time of treatment

Dose and Route of administration

Treatment Start

Weeks 0, 4 and 8

900 mg intravenous infusion

Maintenance Treatment

Every 4 weeks starting at Week 12

300 mg subcutaneous injection

Given either as:

1 injection of 200 mg prefilled pen and 1 injection of 100 mg prefilled pen, or
1 injection of 200 mg prefilled syringe and 1 injection of 100 mg prefilled syringe

Overdose:

If you think you, or a person you are caring for, have taken too much Omvoh, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no 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.

What are 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

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
UNCOMMON
Infection Symptoms include: fever, chills, muscle aches, cough, shortness of breath, or pain during urination		x
RARE
Serious allergic reactions Symptoms include: fainting, dizziness, feeling lightheaded (low blood pressure); swelling of your face, eyelids, lips, mouth, tongue or throat; trouble breathing or throat tightening; chest tightness		x	x
Liver problems. Symptoms include tiredness, loss of appetite, pain on the right side of your stomach, dark urine, or yellowing of the skin and eyes (jaundice) or itching of the skin		x

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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

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

Storage:

Store 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 and 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 this Patient Medication Information by visiting the Health Canada 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

Last Revised Month DD, YYYY

A4.0-OMV-NL0001-CA-PM-YYYYMMDD

INSTRUCTIONS FOR USE

^PrOMVOH^TM(ahm-VOH)

mirikizumab injection

for subcutaneous use

100 mg Prefilled Syringe

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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.
If you have vision problems, do not use OMVOH prefilled syringe without help from a caregiver.
100 mg / mL
100 mg / mL
+
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

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Bottom

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

IMPORTANT:

2 OMVOH injections are required for a full dose.
Inject 1 OMVOH prefilled syringe followed right away by the other OMVOH prefilled syringe.
Thumb Pad
Finger Grips
Gray Syringe
Plunger
Syringe
Body with Medicine
Blue Plunger Rod
Needle
Needle Cap

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.

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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.

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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.

Expiration Date

Injecting OMVOH

1 Uncap

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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.

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2 Insert

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

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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.

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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

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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