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Omvoh Results for Ulcerative Colitis

For adults with moderate to severe ulcerative colitis

Rapid Relief Is Possible

at Week 3

Some people taking Omvoh experienced less rectal bleeding and fewer bowel movements.

SELECT SAFETY INFORMATION
You should avoid receiving live vaccines right before, during, or right after treatment with Omvoh. Tell your healthcare provider that you are taking Omvoh before receiving a vaccine.

Remission That Lasts

Among people who achieved clinical remission at Week 12,

66% maintained remission at 1 year of continuous treatment.

At 12 weeks, 24% of people taking Omvoh achieved clinical remission.

Among people who saw improvement at Week 12, 51% achieved clinical remission at 1 year.

Even if you’ve tried other UC medications, you can still get lasting remission with Omvoh.

Among people whose past UC biologic medication didn't work or stopped working and who achieved clinical remission at Week 12, 65% maintained remission at 1 year.

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Improved Bowel Urgency

No to minimal bowel urgency is possible.

Some patients saw improvement at Week 12, defined as a weekly average urgency score of 0 to 1. Urgency was rated from 0 (no urgency) to 10 (worst possible urgency).

Select Safety Information
The most common side effects of Omvoh in people treated for ulcerative colitis include upper respiratory infections, injection site reactions, joint pain, rash, headache, and herpes viral infection. The most common side effects of Omvoh in people treated for Crohn’s disease include upper respiratory infections, injection site reactions, headache, joint pain, and elevated liver blood tests. These are not all of the possible side effects of Omvoh. Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Continue to Heal Your Gut

Omvoh works within your gut to help repair your colon lining at 1 year.

Among people that saw improvement at Week 12, 58% had visible healing of their colon lining and 22% had no inflammation in their rectum and colon.

Ready to Start on Omvoh?

Learn how to take Omvoh for ulcerative colitis.

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SAFETY SUMMARY

Warning:

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 pounding 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.

Before starting treatment with Omvoh, your healthcare provider should assess 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.
Before starting Omvoh, tell your healthcare provider if you think you have an infection or 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 (phlegm)
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

After starting Omvoh, tell your healthcare provider right away if you have any symptoms of an infection.

Liver Problems: Omvoh may cause liver problems. Your healthcare provider should do blood tests to check your liver enzyme and bilirubin levels before treatment, during, and 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
stomach-area (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 in people treated for ulcerative colitis include:

upper respiratory infections
injection site reactions
joint pain
rash
headache
herpes viral infections

The most common side effects of Omvoh in people treated for Crohn’s disease include:

upper respiratory infections
injection site reactions
headache
joint pain
elevated liver blood tests

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 should avoid receiving live vaccines right before, during or right after treatment with Omvoh. Tell your healthcare provider that you are taking Omvoh before receiving a vaccine.
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

Follow your healthcare provider’s instructions for using Omvoh. You will receive your first 3 doses of Omvoh through a vein in your arm (intravenous infusion) in a healthcare facility by a healthcare provider every 4 weeks. Each infusion will last about 30 minutes (for ulcerative colitis) or about 90 minutes (for Crohn’s disease). After induction, you will continue to receive Omvoh maintenance doses as self- injections under the skin (subcutaneous injection) every 4 weeks. For these injections, Omvoh is available as prefilled pens or prefilled syringes. For a full dose you will need two injections with either two prefilled pens or two prefilled syringes. Inject 1 Omvoh prefilled pen or prefilled syringe followed right away by the other Omvoh prefilled pen or prefilled syringe. If you give injections at home, you should be trained 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. Read the detailed Instructions for Use about how to use and dispose of Omvoh the correct way.

Learn more

Omvoh is a prescription medicine. During induction, Omvoh is available as a single-dose vial for intravenous infusion containing 300 mg/15 mL that is administered in a healthcare facility. During maintenance, Omvoh is available as:

For ulcerative colitis: two 100 mg/mL prefilled pens or prefilled syringes.
For Crohn’s disease: one 100 mg/mL prefilled pen or prefilled syringe and one 200 mg/2 mL prefilled pen or prefilled syringe.

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.

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Omvoh^® and its delivery device base are trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATIONS

Omvoh^® (ahm-VOH) is a medicine used to treat

adults with moderately to severely active ulcerative colitis
adults with moderately to severely active Crohn’s disease

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