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Omvoh

mirikizumab-mrkz
Used for Ulcerative Colitis
Used for Ulcerative Colitis

Omvoh (mirikizumab or mirikizumab-mrkz) is a biologic medication used to treat moderate-to-severe ulcerative colitis in adults. It helps reduce inflammation in the gut and colon. Typically, Omvoh (mirikizumab) is used when other options haven’t worked well. When you first start treatment, a healthcare professional will give you the first 3 doses as monthly intravenous (IV) infusions at a clinic, infusion center, or hospital. Then, you (or your caregiver) will get trained to inject the rest of your doses under the skin every month at home. Common side effects include joint pain and infections in the upper respiratory system (runny nose, sore throat).

Reviewed by:
reviewer
Ashlyn Clark, PharmD Candidate
reviewer
Cydnee Ng, PharmD
reviewer
Connie Zheng, PharmD
Last reviewed on March 3, 2024
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageCostAlternativesLatest newsImagesReferencesPricesMedicare
basics-icon

What is Omvoh (mirikizumab)?

What is Omvoh (mirikizumab) used for?

  • Moderate-to-severe active ulcerative colitis in adults

How Omvoh (mirikizumab) works

Ulcerative colitis is a condition that happens when your own immune system attacks your gut. This causes inflammation in the lining of the colon. In particular, proteins called interleukin-23 (IL-23) play a key role in causing gut inflammation in ulcerative colitis. This inflammation can lead to symptoms like stomach pain and cramping, bloody stools, and diarrhea.

Omvoh (mirikizumab) is a type of medication called an interleukin-23 antagonist. It blocks IL-23 from working. And when IL-23 can’t work like usual, it helps reduce inflammation. This helps lessen symptoms of ulcerative colitis.

Drug Facts

Common BrandsOmvoh
Drug ClassInterleukin-23 antagonist
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the 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:Maintenance with under-the-skin injections:
  • Upper respiratory tract infections (14%)
  • Injection site reaction (e.g., redness, pain; 9%)
  • Joint pain (7%)

Other Side Effects

  • Headache
  • Rash

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
  • Severe infection: fever, chills, sweating, weakness, flu-like symptoms, muscle pain or weakness, unexplained weight loss
  • Liver injury: unexplained rash, yellowing of skin or eyes, vomiting, abdominal pain

Source: DailyMed

The following 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):

pros-and-cons

Pros and cons of Omvoh (mirikizumab)

thumbs-up

Pros

Given once every month

Available as ready-to-inject prefilled pens after first three infusions are completed

Can inject maintenance doses at home with proper training

Can improve symptoms when standard treatments don’t work

thumbs-down

Cons

Injection only

Must get the first few doses as IV infusions from a healthcare professional, likely at an infusion center or medical office

Must give two under-the-skin injections each time for a full maintenance dose

May be difficult to self-inject for those with hearing or vision problems, or those who have a hard time using their hands

pharmacist-tips

Pharmacist tips for Omvoh (mirikizumab)

pharmacist

  • Talk to your pharmacist or primary care provider about getting up-to-date with your vaccinations before starting Omvoh (mirikizumab). There isn’t enough information to know how you’ll respond to live or non-live vaccines during treatment. Your healthcare team may want you to complete vaccinations before starting this medication.

    • For the best results with Omvoh (mirikizumab) treatment, it’s important to stay consistent and take each dose on time. Consider writing on your calendar or putting reminders in your phone for upcoming appointments and scheduled injection days.

      • Because Omvoh (mirikizumab) can increase the risk of infections, be sure to wash your hands often, wear masks in crowded areas that can’t be avoided, and clean common areas regularly.

        What to expect for Omvoh (mirikizumab) IV infusions:

        • Your first 3 doses will be given as IV infusions by a healthcare provider at a medical center or clinic. Getting Omvoh (mirikizumab) as an infusion into your vein at the start of treatment allows more medication to go straight into your bloodstream safely. This helps the medication work to treat UC the best it can.

          • Each Omvoh (mirikizumab) infusion takes at least 30 minutes, on top of traveling to the center and checking in. Be sure to give yourself enough time for the full infusion visit.

            • Drink lots of water before each infusion and wear comfortable clothing to your appointment as you’ll be sitting down for 30 minutes. You may want to bring something to do, such as music or a book, to entertain yourself during the visit.

              How to inject Omvoh (mirikizumab) maintenance doses at home:

              • Before your injections, be sure to take a set of prefilled pens out of the fridge. Keep them in the original carton until it’s time to use. Let the medication come to room temperature for 30 minutes so that it doesn’t sting when it’s injected. Don’t use other forms of heat to speed this up, as it could damage the medication. Don’t shake the pens.

                • For each maintenance dose, inject 2 prefilled pens of Omvoh (mirikizumab) under the skin in different fatty areas, such as the stomach (2 inches away from belly button), tops of both thighs (2 inches away from groin or knee), or back of both arms. Don’t inject both pens in the same area to lessen skin irritation and to let the area better heal from each injection.

                  • When you’re ready to inject, remove the gray cap and put the clear base against the skin. Turn the top of the pen towards the unlock symbol. Then, press and hold the blue button to inject the medication and keep the pen against your skin.

                    • You should hear two loud clicks during your injection — the first to let you know the injection has started and another, about 10 seconds later, when it’s done. Remove the pen from your skin after you hear the second click and after you see the gray plunger through the clear base. Repeat these steps with the second pen to get the full dose.

                      • Throw away each used Omvoh (mirikizumab) pen into a sharps container or a thick plastic container with a tight lid that’s labeled as “hazardous waste”. Discarding the pens in a safe manner is very important to make sure that anyone handling the garbage isn’t at risk for getting poked with the needle inside the pen. An accidental needle poke can cause infections and spread illness.

                        faqs

                        Frequently asked questions about Omvoh (mirikizumab)

                        How well does Omvoh (mirikizumab) work?
                        Clinical trials showed that almost 50% of adults with moderate-to-severe ulcerative colitis who took Omvoh (mirikizumab) were considered in remission after 1 year of therapy. In comparison, 25% of adults who were given placebo injections reached remission. Both groups included people who couldn’t take or had no improvement with other treatments. But they were able to continue with certain maintenance therapies, such as steroids, during the trials. Findings showed that 45% of people who took Omvoh (mirikizumab) could stop taking steroids before they reached remission. This meant that they were no longer at risk for steroid-related side effects and complications, such as weight gain and weak bones. What’s more, Omvoh (mirikizumab) helped improve symptoms, such as lessening urgent bathroom trips and healing damage to the lining of the colon.
                        Where can I inject Omvoh (mirikizumab)?
                        Starting in the third month of treatment, you’ll use a prefilled pen of Omvoh (mirikizumab) to inject the medication under the skin. Inject into a fatty area of the stomach, back of the upper arm, or front of the thigh. Make sure you choose an area that’s 2 inches away from your belly button, groin, and knee. Avoid any area of skin that’s injured, red, or hard. You’ll need to inject 2 pens back to back for a full dose. Pick a different area to inject each pen to prevent skin irritation and to allow the skin to heal more easily. For example, if you inject the first pen into the back of the arm, inject the second pen into another spot on the back of the arm, the back of the other arm, the stomach, or the thigh.
                        How do I store Omvoh (mirikizumab)?
                        Store Omvoh (mirikizumab) pens inside the original carton in the refrigerator between 36 and 46 degrees Fahrenheit. Don’t freeze or store them in the freezer. Before your injection, remove a set of pens from the fridge and let them reach room temperature for 30 minutes. Once you take the pens out of the fridge, they can also be stored inside the original carton at room temperature (up to 86 degrees Fahrenheit) for up to 2 weeks, if needed. Once the pens are at room temperature, don’t put them back in the refrigerator. Throw away any pens that were frozen, stored outside of the original carton, or outside of the fridge for longer than 2 weeks.
                        Is Omvoh (mirikizumab) a biologic?
                        Yes. Biologics are medications that are made from something that’s already living, like cells or proteins, in a lab. Omvoh (mirikizumab) is a monoclonal antibody, which is a lab-made group of proteins. The medication works by blocking interleukin-23 to reduce the amount of gut inflammation.
                        What should I do if I forget a dose of Omvoh (mirikizumab)?
                        If you miss an Omvoh (mirikizumab) infusion at the beginning of treatment, talk to your gastroenterologist right away about rescheduling. If you miss a maintenance dose (under-the-skin injection) of Omvoh (mirikizumab), you can give the dose as soon as you remember. After you take that dose, your next injection will be a month (or 4 weeks) from that day. Continue taking your doses every month (or every 4 weeks) with the new schedule.
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                        What are the 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.

                        risk-warning

                        Allergic reactions

                        Having an allergic reaction to Omvoh (mirikizumab) is possible. In clinical studies, allergic reactions happened during IV infusions in the induction phase of treatment. Seek medical help right away if you have symptoms of anaphylaxis, such as trouble breathing, swelling of the throat or face, itching, or hives. Your prescriber will stop the treatment and find another option for your symptoms if you have an allergic reaction to Omvoh (mirikizumab).

                        risk-warning

                        Infection risk

                        • Risk factors: Chronic or recurrent infections | Other conditions or medications that increase risk of infection

                          Omvoh (mirikizumab) can lower your body’s ability to fight off germs, which puts you at risk for getting an infection. The most commonly reported infections were upper respiratory tract infections and herpes viral infections.

                          Because of the risk for infections, your gastroenterologist may test you for tuberculosis (TB) or other infections before you start Omvoh (mirikizumab). Your body may have been able to protect you from infections before treatment. But once you start taking this medication, it may become harder to fight them and you could get seriously sick. Tell your gastroenterologist if you have a history of TB or other infection. You may need to take antibiotics before or during your treatment with Omvoh (mirikizumab).

                          Contact your prescriber if you have symptoms of an infection, including fever, weakness, cough, sweating, chills, or an unexplained rash. If your provider thinks you have an infection, you may need to stop your Omvoh (mirikizumab) treatment so your body can fight the infection.

                          risk-warning

                          Liver injury

                          • Risk factors: Liver cirrhosis | Elevated liver enzymes at baseline

                            There was a reported case of liver injury when a person received more than 3 induction doses of Omvoh (mirikizumab). But their liver function returned to normal once they stopped the medication.

                            Although liver injury is rare at recommended doses, it’s important to be aware of this risk. Many people with elevated liver labs don’t feel physical symptoms, so blood work helps check your liver function. You may need blood tests to check your liver before taking Omvoh (mirikizumab) to make sure it’s safe to start. You’ll also need routine blood work for at least 6 months while you're taking the medication.

                            Contact your prescriber and seek medical attention if you develop symptoms of liver injury, such as nausea, vomiting, yellowing of the skin or eyes, dark urine, or abdominal pain. You may need to stop this medication.

                            risk-warning

                            Avoid live vaccines

                            There isn't enough information to know how Omvoh (mirikizumab) affects vaccines. To be safe, make sure you’re up to date on all vaccines before starting treatment for the best protection.

                            In addition, avoid live vaccines right before you start Omvoh (mirikizumab), during treatment, and right after your last dose. Since Omvoh (mirikizumab) can lower your immune system’s ability to work, it may be harder for your body to fight off new germs. This puts you at risk of getting an infection from the live vaccine if Omvoh (mirikizumab) and the vaccine are given too close together.

                            Tell your pharmacist and primary care provider that you’re taking Omvoh (mirikizumab) before getting any vaccinations to make sure it’s safe.

                            dosage

                            Omvoh (mirikizumab) dosage forms

                            Typical dosing for Omvoh (mirikizumab)

                            Treatment with Omvoh (mirikizumab) has two phases: induction and maintenance.

                            • Induction phase (until month 2 of treatment): The typical induction dose is 300 mg given as an intravenous (IV) infusion every month for the first 3 doses. These infusions are administered by a healthcare professional at a medical center.

                            • Maintenance phase (month 3 and onwards): The typical maintenance dose is 200 mg (two 100 mg prefilled pens) injected under the skin every month.

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                            How much does Omvoh (mirikizumab) cost?

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                            alternatives

                            What are alternatives to Omvoh (mirikizumab)?

                            There are a number of medications that your doctor can prescribe in place of Omvoh (mirikizumab). Compare a few possible alternatives below.
                            Omvoh (mirikizumab)
                            Used for:

                            • Moderate-to-severe active ulcerative colitis in adults

                            $10712.04 Lowest GoodRx priceView Prices
                            Humira (adalimumab)
                            Used for:

                            • Rheumatoid arthritis (RA) - adults only

                            • Juvenile idiopathic arthritis (JIA) - people age 2 and older

                            • Psoriatic arthritis (PsA) - adults only

                            • Ankylosing spondylitis (AS) - adults only

                            • Crohn's disease (CD) - people age 6 and older

                            • Ulcerative colitis (UC) - people age 5 and older

                            • Plaque psoriasis - adults only

                            • Hidradenitis suppurativa (HS) - people age 12 and older

                            • Uveitis - people age 2 and older

                            $1335.32 Lowest GoodRx priceView Prices
                            Stelara (ustekinumab)
                            Used for:
                            $28386.60 Lowest GoodRx priceView Prices
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                            Omvoh (mirikizumab) images

                            brown - Omvoh 100mg / mL Prefilled Pen Solution for Injection
                            This medicine is Brown Carton.brown - Omvoh 100mg / mL Prefilled Pen Solution for Injection

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                            References

                            Best studies we found

                            American College of Gastroenterology. (n.d.). What is a gastroenterologist?

                            D’Haens, G., et al. (2023). Mirikizumab as induction and maintenance therapy for ulcerative colitis. New England Journal of Medicine.

                            Eli Lilly and Company. (n.d.). Get started on Omvoh.

                            View All References (4)

                            Eli Lilly and Company. (2024). Omvoh- mirkizumab-mrkz injection, solution [package insert]. DailyMed.

                            St Clair-Jones, A., et al. (2020). Understanding and minimising injection-site pain following subcutaneous administration of biologics: A narrative review. Rheumatology and Therapy.

                            Tang, C., et al. (2012). Interleukin-23: As a drug target for autoimmune inflammatory diseases. Immunology.

                            U.S. Food and Drug Administration. (2021). Safely using sharps (needles and syringes) at home, at work, and on travel.

                            GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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