Omvoh
Omvoh (mirikizumab or mirikizumab-mrkz) helps treat ulcerative colitis and Crohn's disease in adults. It's a biologic known as an interleukin-23 antagonist. It works to help lower inflammation in the gut. When you first start, you'll get your first three doses as an infusion through the vein (IV) once a month at a clinic. After that, you (or your caregiver) can inject the rest of your doses under the skin every month at home. Side effects include joint pain and upper respiratory tract infections. Omvoh (mirikizumab) is available as a brand-name medication only.
What is Omvoh (mirikizumab)?
What is Omvoh (mirikizumab) used for?
- Moderate-to-severe ulcerative colitis in adults
- Moderate-to-severe Crohn's disease in adults
How Omvoh (mirikizumab) works
Omvoh (mirikizumab) is a type of medication called an interleukin-23 antagonist. It blocks proteins called interleukin-23 (IL-23). These proteins play a key role in causing gut inflammation in people with ulcerative colitis and Crohn's disease.
By blocking IL-23, Omvoh (mirikizumab) helps lower inflammation in the gut. This can help improve symptoms like stomach pain, bloody stools, and diarrhea.
Drug facts
More on Omvoh (mirikizumab) essentials
Side effects of Omvoh (mirikizumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Induction with IV infusions
- Upper respiratory tract infections (8%)
- Joint pain (2%)
Maintenance with under-the-skin injections
- Upper respiratory tract infections (14%)
- Injection site reaction (e.g., redness, pain; 9%)
- Joint pain (7%)
Less Common Side Effects
- Headache
- Rash
Note: Side effects listed were reported by people with ulcerative colitis. They might slightly differ for people with Crohn's disease.
Omvoh (mirikizumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Allergic reaction: swelling of face or throat, trouble breathing, hives, itching
- Serious infection: fever, chills, sweating, weakness, flu-like symptoms, muscle pain or weakness, unexplained weight loss
- Liver injury: yellowing of skin or eyes, vomiting, stomach pain
The following Omvoh (mirikizumab) side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Cough
- Headache
- Joint pain
- Pain, redness, or irritation at injection site
- Runny or stuffy nose
- Sore throat
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Pros and cons of Omvoh (mirikizumab)
Pros
- Given once a month
- Available as ready-to-inject prefilled pens after the first three infusions
- Can inject maintenance doses at home with proper training
- Can improve symptoms when other treatments haven't worked well
Cons
- Injection only
- Must get the first few doses as IV infusions from a healthcare professional
- Must give two under-the-skin injections each time for a full maintenance dose
- Risk of getting sick more easily
Pharmacist tips for Omvoh (mirikizumab)
- Your first 3 doses of Omvoh (mirikizumab) will be given as an IV infusion once every month at a clinic. After 3 months, you'll switch to injections under the skin once a month. You can give these under-the-skin injections at home after getting trained.
- For the best results, it’s important to take Omvoh (mirikizumab) on time. You can write reminders on your calendar or put them on your phone to help you remember your appointments and injection days.
- If you miss your dose of Omvoh (mirikizumab), take the medication as soon as you remember. For infusions, call your care team to reschedule your infusion appointment. For injections under the skin, inject the medication at the usual dose as soon as you can. Your next dose will be a month later.
- Be sure to wash your hands often, wear masks in crowded areas, and clean common areas regularly. Omvoh (mirikizumab) can raise your risk of infections. These tips can help protect you from getting sick.
- Before getting any vaccines, let the healthcare professional know you're taking Omvoh (mirikizumab). They can help check that the vaccine is safe for you. It's best to avoid live vaccines right before, during, and after treatment. There's a risk that this medication can make it more likely for you to get sick from the live vaccine itself.
What to expect for Omvoh (mirikizumab) IV infusions
- Be sure to give yourself enough time for the full infusion visit. Each Omvoh (mirikizumab) infusion takes at least 30 minutes for ulcerative colitis and at least 90 minutes for Crohn's disease. Also account for the time it takes to get to the clinic, check in, and get situated.
- To help prepare for your Omvoh (mirikizumab) infusion, drink lots of water to stay hydrated. It's also a good idea to wear comfortable clothes to your appointment. It's helpful to bring something to do, like music to listeb to music or a book to read, to entertain yourself during the visit.
How to use Omvoh (mirikizumab) at home
- Your care team will show you how to inject Omvoh (mirikizumab). They'll make sure you can do it on your own before you can inject by yourself. Omvoh (mirikizumab) comes as prefilled pens or prefilled syringes. Carefully review the instructions for use or watch the instructional videos. Ask your pharmacist or prescriber if you have more questions on how to inject the medication.
- How to store Omvoh (mirikizumab): Store the prefilled pens and syringes in the refrigerator, but don't let them freeze. If needed, you can keep them at room temperature (up to 86ºF) for up to 2 weeks. Once at room temperature, don't put the medication back in the fridge. Keep pens and syringes in the original carton to protect them from light.
- For ulcerative colitis: Use two 100 mg prefilled pens or syringes for each maintenance dose. Inject them right after one another.
- For Crohn's disease: Use one 100 mg and one 200 mg prefilled pen or syringe for each maintenance dose. Inject each one after the other (the order doesn't matter).
- Before each Omvoh (mirikizumab) injection: Take a set of the medication out of the fridge. Let the medication come to room temperature for 45 minutes in the original carton. This helps the injection not sting as much. Don’t use any other way to warm it up; this could damage the medication. Don’t shake the pen or syringe.
- Where to inject Omvoh (mirikizumab): Inject the medication under the skin of your stomach (2 inches away from your belly button) or the top of your thigh (2 inches away from your groin or knee). Someone can also help give the injection into the back of your upper arm. Use a different spot for each injection. And don't inject into skin that's tender, bruised, red, or hard. This helps prevent skin irritation and damage.
- How to inject using the Omvoh (mirikizumab) pens: Take off the gray cap, press the clear base to your skin, and unlock the pen. Push and hold the blue button for up to 10 seconds to inject the medication. Keep the pen against your skin the whole time. You'll hear two loud clicks — one when the injection starts and another when it’s done. Lift the pen after you see the gray plunger through the clear base. Do these steps again with the second pen to get the full dose.
- How to inject using the Omvoh (mirikizumab) syringes: Pull the needle cap off when you're ready. Gently pinch your skin and insert the needle at a 45-degree angle. While still pinching, slowly push the blue plunger all the way in to inject the medication. When you see the blue rod inside the syringe body, your injection is done. Remove the needle and and let go of your skin. Repeat with the second syringe to get the full dose.
- How to throw away Omvoh (mirikizumab): Throw away each used pen or syringe into a sharps container or a strong plastic container with a tight lid labeled “hazardous waste”. Don't throw them away in the regular trash. This keeps you and others safe from getting poked by the needle by accident. A needle poke can hurt, spread germs, and cause infections.
Common questions about Omvoh
Yes, Omvoh is a biologic medication. Biologics are made from living things, like cells or proteins, in a lab. Omvoh is a type of monoclonal antibody, a protein that's made in cells in a lab setting. More specifically, it works by blocking interleukin-23. This helps lessen gut inflammation.
Omvoh is administered as an injection. For the first 3 doses, you'll get it through an infusion into the vein, also called an intravenous (IV) infusion. It's given by a healthcare professional at a clinic. After that, you switch to injections given under the skin of your stomach, thigh, or the back of your upper arm. Once your care team shows you how, you can give these injections at home by yourself.
Yes. The FDA first approved Omvoh for adults with ulcerative colitis in October 2023. Later in January 2025, the FDA approved the medication for adults with Crohn's disease . For both, Omvoh is a helpful option when other treatments haven't work well enough.
In studies, adults with ulcerative colitis who took Omvoh had fewer symptoms as early as 2 weeks. They had less rectal bleeding and less bathroom trips. But it could take a few months to see the full benefits of the medication. This timeline was similar for people with Crohn's disease. Keep in mind that everyone's experience with the medication is different. Be sure to keep taking Omvoh even if you don't feel better right away. Talk to your prescriber about how long it's taking for medication to help with your symptoms.
For ulcerative colitis, an Omvoh infusion takes at least 30 minutes. And for Crohn's disease, an infusion takes at least 90 minutes. Be sure to plan ahead for your infusion appointments. You can bring something to do to help pass the time. Examples include a book to read or an electronic device to watch your favorite show.
Omvoh and Skyrizi (risankizumab) are both injections that treat ulcerative colitis and Crohn's disease in adults. They work in similar ways and can both raise the risk of infections. Both start with 3 monthly doses given as an infusion through the vein once a month at a clinic. Then, you switch to under-the-skin injections at home. For Omvoh, these injections are given every month. But for Skyrizi, they're given every 2 months. Another difference is that Skyrizi is also approved for plaque psoriasis and psoriatic arthritis. Ask your prescriber to help compare to see which is best for you.
Omvoh and Stelara (ustekinumab) are both injections for adults with ulcerative colitis and Crohn's disease. But they have different dosing schedules. Omvoh starts with 3 monthly infusions given through the vein at a clinic. Then, you switch to monthly under-the-skin injections at home. For Stelara, it starts with just 1 infusion through the vein. Then 2 months later, you inject it under the skin at home every 2 months. Another difference is that Stelara can also help with plaque psoriasis and psoriatic arthritis in people 6 years and older. Ask your prescriber to compare the medications and help decide which is best for you.
If you're pregnant or thinking of getting pregnant, talk to your prescriber or obstetrician-gynecologist (OB-GYN) about taking Omvoh. There isn't enough information to know for sure how safe it is for you and your baby. But we know that having inflammatory bowel disease that isn't controlled during pregnancy can be harmful. Your care team can help you weight the risks and benefits. If you take Omvoh while pregnant, you can join the manufacturer's pregnancy registry. This program helps researchers learn more about how safe the medication is during pregnancy. Ask your prescriber or call Eli Lilly and Company at 1-800-545-5979 to find out more.
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Risks and warnings for Omvoh (mirikizumab)
Omvoh (mirikizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Allergic reactions
It's possible to have an allergic reaction to Omvoh (mirikizumab). In studies, this sometimes happened during the IV infusions at the beginning of treatment.
The care team will watch for allergic reactions during your infusions. But call your care team or get medical help right away if you notice signs of anaphylaxis at any time. These include itching, skin redness, hives, trouble breathing, or swelling of the throat or face.
Risk of infection
- Risk factors: Chronic or recurrent infections | Other conditions or medications that raise the risk of infection
Omvoh (mirikizumab) can lower your body’s ability to fight off germs. This can put you at risk of getting an infection more easily. In studies, some people had upper respiratory tract infections or herpes viral infections.
Before starting Omvoh (mirikizumab), tell your prescriber about your medical history, including if you've had tuberculosis (TB). Your prescriber will weigh the risks and benefits to see if this medication is safe for you. If you have an infection, you'll need to wait until you're better to start Omvoh (mirikizumab). Your prescriber will also test you for TB before you begin. You might need treatment for any infections you already have.
Talk to a healthcare professional or call your prescriber if you have signs of an infection. Look out for fever, weakness, cough, sweating, chills, or an unexplained rash. If your care team thinks you have an infection, you might need to take a break from Omvoh (mirikizumab). You also might need to take antibiotics or other medications to treat the infection. This will help your body fight the infection better.
Liver injury
- Risk factors: Liver cirrhosis | High liver enzyme levels before starting treatment
In studies, one person had liver injury after getting more than 3 induction doses of Omvoh (mirikizumab). After stopping the medication, their liver function went back to normal.
Although liver injury is rare at recommended doses, it’s important to be aware of this risk. Many people with high liver labs don’t feel physical symptoms, so blood work helps check that your liver is okay. Your prescriber will check your liver before you start Omvoh (mirikizumab). You’ll also need routine blood work for at least 6 months while taking the medication.
Call your care team and get medical help if you have signs of liver injury. Watch for signs like nausea, vomiting, stomach pain, yellowing of the skin or eyes, or dark urine. You might need to stop taking Omvoh (mirikizumab).
Avoid live vaccines
There isn't enough information to know how Omvoh (mirikizumab) affects how your body reacts to vaccines. To be safe, it's best to be up to date on all your vaccines before starting this medication.
Avoid live vaccines right before starting Omvoh (mirikizumab), during treatment, and right after your last injection. This medication can affect how well your immune system works. This can raise your risk of getting sick from a live vaccine itself. Examples include Varivax (chickenpox vaccine) and MMR (measles, mumps, and rubella vaccine).
Before getting any vaccines, tell your healthcare professional you’re taking Omvoh (mirikizumab). They can help make sure the vaccine is safe for you.
Omvoh (mirikizumab) dosage
Carton| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 2 pens of 100mg/ml | 1 carton | $5.00 | $5.00 |
| 1 1ml pen and 1 2ml pen of 200mg/2ml and 100mg/ml | 1 carton | $5.00 | $5.00 |
| 2 syringes of 100mg/ml | 2 cartons | $5.00 | $2.50 |
| 1 1ml syringe and 1 2ml syringe of 200mg/2ml and 100mg/ml | 1 carton | $5.00 | $5.00 |
| 1 pen of 200mg/2ml | 1 carton | $5.00 | $5.00 |
| 1 syringe of 200mg/2ml | 1 carton | $5.00 | $5.00 |
Vial| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 15ml of 300mg/15ml | 1 vial | $5.00 | $5.00 |
Typical dosage for Omvoh (mirikizumab)
There are two phases of treatment: induction and maintenance. Omvoh (mirikizumab) has different dosing and administration for each phase.
-
Ulcerative colitis
- Induction: The typical induction dose is 300 mg given as an intravenous (IV) infusion every month for the first 3 doses. These infusions are given by a healthcare professional at a medical center.
- Maintenance (starting month 3 and onwards): The typical maintenance dose is 200 mg injected under the skin every month. You'll need to use two 100 mg prefilled pens or syringes for each full dose.
-
Crohn's disease
- Induction: The typical induction dose is 900 mg given as an intravenous (IV) infusion every month for the first 3 doses. These infusions are given by a healthcare professional at a medical center.
- Maintenance (starting month 3 and onwards): The typical maintenance dose is 300 mg injected under the skin every month. You'll need to use one 100 mg and one 200 mg prefilled pen or syringe for each full dose.
How much does Omvoh (mirikizumab) cost?
$5.00
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