GET STARTED ON OMVOH

Taking Omvoh for ulcerative colitis (UC)

Treatment starts with infusions and transitions to self-injections

The starter dose of Omvoh is 300 mg and will be given to you as 3 intravenous (IV) infusions by your healthcare provider (HCP) at Weeks 0, 4, and 8. IV infusions are given through a vein in your arm
Afterwards, at Week 12 you will continue to take 200 mg of Omvoh as 2 self-injections, every 4 weeks. Self-injections are given subcutaneously, or under the skin

Omvoh dosing schedule with infusions and self-injections — Start with 3 infusions at week 0, week 4 and week 8. At week 12, continue with 2 self-injections every 4 weeks.

Omvoh is intended for use under the guidance and supervision of your healthcare provider.

Read the detailed Instructions for Use that come with your Omvoh device about how to use Omvoh the correct way.

SELECT SAFETY INFORMATION
Before you use Omvoh, make sure you tell your healthcare provider if you are being treated for an infection, have an infection that does not go away or keeps coming back or have symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination; if you have tuberculosis (TB) or have been in close contact with someone with TB.

After completing IV infusions (induction), transitioning to self-injections (maintenance) gives you the flexibility to manage your ulcerative colitis within your hands. Below you'll find the steps to prepare, inject, store and dispose of Omvoh.

Omvoh injection sites — Injection sites of a pen: abdomen, front of thigh, or back of upper arm.

IMPORTANT: These are not the complete instructions for how to inject Omvoh. Please see the instructions for use that come with the devices.

Preparing to Inject Omvoh

Take your devices out of the refrigerator and leave them (with the cap on) at room temperature for 30 minutes before injecting.

Do not microwave the devices, run them under hot water, shake them, freeze them, or leave them in direct sunlight.

Choose your injection sites next. You can inject in your stomach (abdomen) or in the front of your thighs. If you choose your stomach, do not inject within 2 inches of your belly button. Another person can inject in the back of your upper arm.

Be sure not to inject in the exact same spot each time or where the skin is tender, bruised, red, or hard.

Before you or your caregiver inject for the first time, your healthcare provider should show you or your caregiver how to prepare and inject Omvoh.

How do I inject Omvoh?

Abbreviated steps to inject Omvoh

See How to Use the Omvoh Pen

Please see the Instructions for Use that come with your Omvoh devices.

Omvoh is intended for use under the guidance and supervision of your healthcare provider.

Read the detailed Instructions for Use that come with the Omvoh device about how to use Omvoh the correct way.

Injection site reactions (ISR) were a common side effect reported by patients who took Omvoh, including redness and pain. Patients should reference the full Medication Guide and Instructions for Use when preparing to inject. If you believe to be experiencing an ISR, talk to your doctor about using the following tips.

Tips to help you inject Omvoh

Talk to your doctor about whether the tips below may help with the injection of biologics.^*

Placing something cold (such as an ice gel pack or cold water bottle) on the injection site before and after the injection may help reduce pain
Allow Omvoh to reach room temperature before injecting
Acetaminophen or local numbing medications such as lidocaine/prilocaine may help relieve pain
Antihistamines or topical corticosteroids may help with itching or swelling caused by the injection
Choose different injection sites each time you inject

^*These tips have not been developed or studied specifically for Omvoh.

SELECT SAFETY INFORMATION
Omvoh may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Stop using Omvoh and get emergency medical help right away if you develop symptoms of a serious allergic reaction such as: fainting, dizziness, feeling lightheaded, swelling of your face, throat, or trouble swallowing, trouble breathing, throat tightening or wheezing, chest tightness, fast heartbeat, severe itching, hives, or redness all over your body, or sweating.

How should I store and dispose of Omvoh?

Storage

Omvoh is a biologic medicine, which requires refrigeration. If required storage conditions aren't met, dispose of Omvoh devices.

Store Omvoh devices in your refrigerator at 36 °F to 46 °F (2 °C to 8 °C) until you’re ready to inject
If needed, Omvoh may be stored at room temperature for up to 2 weeks. After storing Omvoh at room temperature, do not return it to the refrigerator. Dispose of Omvoh if not used within 2 weeks at room temperature
Keep Omvoh in its original carton to protect it from light
Do not freeze, shake, or microwave Omvoh

Disposal

Dispose of Omvoh devices in a sharps disposal container right away after use.

Do not reuse Omvoh devices
Do not throw away Omvoh devices in your household trash
If you do not have a sharps disposal container, 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

If you do not have a puncture-resistant container with a secure lid, you can request a free sharps container through our support program.

When your sharps disposal container is almost full, follow your community guidelines for the right way to dispose of your container.

There may be local laws about how you should throw away needles
Do not recycle your used sharps disposal container

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: https://www.fda.gov/safesharpsdisposal.

Please see the Instructions for Use that come with your Omvoh devices.

SELECT SAFETY INFORMATION
Omvoh may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for tuberculosis (TB) and other infections and treat them before you start Omvoh. Tell your healthcare provider if you have symptoms of an infection such as: fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination.

SAFETY SUMMARY

Warnings – Omvoh can cause serious side effects including:

Serious allergic reactions: Omvoh may cause serious allergic reactions that may need to be treated in a hospital and may be life-threatening. Do not use Omvoh if you have had a serious allergic reaction to mirikizumab-mrkz or any of the ingredients in Omvoh. See the Medication Guide that comes with Omvoh for a list of ingredients. Stop using Omvoh and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction:

fainting, dizziness, feeling lightheaded
swelling of your face, eyelids, lips, mouth, tongue, throat, or trouble swallowing
trouble breathing, throat tightening, or wheezing
chest tightness
fast heartbeat or tightening in your chest
severe itching, hives, or redness all over your body
sweating

Infections: Omvoh may lower the ability of your immune system to fight infections and may increase your risk of infections. If you have an infection, your healthcare provider should not start treatment with Omvoh until your infection is gone. After starting Omvoh, tell your healthcare provider right away if you have any symptoms of an infection, such as:

fever, sweating, or chills
muscle aches and pain
cough or shortness of breath
blood in your mucus
flu-like symptoms
headache
warm, red, or painful skin or sores on your body
diarrhea or stomach pain
weight loss
nausea or vomiting
pain during urination

Before starting treatment with Omvoh, your healthcare provider should test you for tuberculosis (TB). If you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Omvoh. Your healthcare provider should watch you closely for signs and symptoms of TB while you are being treated with Omvoh and after treatment.

Liver Problems: Omvoh may cause liver problems. Your healthcare provider will do blood tests to check your liver enzyme and bilirubin levels before treatment, for at least 24 weeks during treatment, and possibly after treatment with Omvoh. Your healthcare provider may hold or stop treatment if needed. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:

unexplained rash
nausea
vomiting
abdominal pain
feeling tired
loss of appetite
yellowing of the skin or the whites of your eyes
dark urine

Common side effects

The most common side effects of Omvoh include:

Upper respiratory infections
Joint pain
Injection site reaction
Headache
Rash
Herpes viral infections

These are not all the possible side effects of Omvoh.
Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before you use Omvoh, review these questions with your doctor:

Are you being treated for an infection?
Do you have an infection that does not go away or keeps coming back?
Do you have TB or have you been in close contact with someone with TB?
Do you have any possible symptoms of an infection such as fever, chills, muscle aches, cough, shortness of breath, runny nose, sore throat, or pain during urination?

Tell your doctor about all your medical conditions, including if:

You have a history of serious allergic reaction to Omvoh, any infections or liver problems.
You need any vaccines or have had one recently. Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines.
You are pregnant, or plan to become pregnant. It is not known if Omvoh will harm your unborn baby. There will be a pregnancy registry to collect information about women who are exposed to Omvoh during pregnancy. If you become pregnant while taking Omvoh, you are encouraged to report your pregnancy to Eli Lilly and Company at 1-800-545-5979.
You are breastfeeding or plan to breastfeed. It is not known if Omvoh passes into your breastmilk.
You take prescription or over-the-counter medicines, vitamins, and herbal supplements.

How to take

Use Omvoh exactly as your healthcare provider tells you to. You will receive your first 3 doses of Omvoh through a vein in the arm (intravenous infusion) given by a healthcare provider. After the first 3 doses, Omvoh is injected under the skin (subcutaneous injection).

Omvoh is intended for use under the guidance and supervision of your doctor. If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the correct way to prepare and inject Omvoh. Read the detailed Instructions for Use that come with Omvoh devices for information about how to use Omvoh the correct way.

Learn more

Omvoh is a prescription medicine. For more information, call 1-800-545-5979.

This summary provides basic information about Omvoh but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Omvoh and how to take it. Your doctor is the best person to help you decide if Omvoh is right for you.

MR CON BS 07FEB2024

Omvoh^™ and its delivery device base, Omvoh Together^™, Lilly Together^™, and Companion in Care^™ are trademarks owned by Eli Lilly and Company.

INDICATION

Omvoh^™ (ahm-VOH) is a medicine used to treat adults with moderately to severely active ulcerative colitis.

It is not known if Omvoh is safe and effective in children under 18 years of age.