mirikizumab-mrkz 100 mg/mL subcutaneous pen injector

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Medication name

Generic name:
Mirikizumab - injection

Pronunciation
(MIR-i-KIZ-ue-mab)

Brand name(s)
Omvoh

Uses

This medication is used to treat a certain bowel condition called ulcerative colitis. Mirikizumab belongs to a class of drugs known as monoclonal antibodies. It works by blocking a certain natural protein in your body (interleukin-23) that may cause inflammation and swelling.

How to use

Read the Medication Guide and the Instructions for Use leaflet provided by your pharmacist before you start using mirikizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before treatment with this medication, your doctor will test you for tuberculosis (TB). Your doctor should also monitor you for symptoms of TB during and after treatment with this drug. If needed, treatment for TB or other infections should be given before using this medication.

The first 3 doses of this medication are given by a slow injection into a vein, usually over 30 minutes each time, by a healthcare provider. All other doses will be given by injection under your skin as directed by your doctor, usually every 4 weeks. Each dose given under the skin requires 2 injections, one after the other. The dosage is based on your medical condition and response to treatment. Follow your doctor's directions carefully.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Wash your hands before using this medication. Take mirikizumab out of the refrigerator 30 minutes before use and let it warm to room temperature. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Do not shake the medication. The medication should be clear or slightly yellow or brown in color. Before using, check this product visually for cloudiness, particles, or discoloration. If you see any of these things, do not use the liquid.

Before injecting each prefilled pen or syringe, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. This medication should be injected in either the thighs, the abdomen (at least 2 inches from your belly button), or the back of the upper arms. Do not inject the drug into skin that is tender, sore, bruised, red, or hardened. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely. Do not reuse the prefilled pens or syringes.

Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder.

Tell your doctor if your condition lasts or gets worse.

Side effects

Redness, pain, or swelling may occur at the injection site. Headache or joint pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

Get medical help right away if you have any very serious side effects, including:

  • signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, yellowing eyes/skin, dark urine)

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using mirikizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • current/recent/returning infection (such as tuberculosis, herpes)

Mirikizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using mirikizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light until the time of use. If the prefilled pen or syringe is taken out of the refrigerator and stored at room temperature, discard any unused medication after 2 weeks. Do not put room-temperature product back in the refrigerator. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised January 2024.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.