Pregnancy & Lactation: Risk data not available
What is Mirikizumab?
Mirikizumab is used in adults to treat moderate to severe ulcerative colitis.
Mirikizumab may also be used for purposes not listed in this medication guide.
Warnings
You should not use mirikizumab if you are allergic to it.
Before you start using mirikizumab, tell your doctor if you have any signs of infection such as fever, chills, cough, body aches, tiredness, open sores or skin wounds, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.
Tell your doctor if you have or have ever had:
- an active, chronic, or recent infection;
- tuberculosis, been exposed to tuberculosis, or if you recently traveled;
- if you have recently received or are scheduled to receive a vaccine; or
- liver disease.
Make sure you are current on all vaccines before you start using mirikizumab.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of mirikizumab on the baby.
Tell your doctor if you are pregnant or breastfeeding.
How should I use Mirikizumab
Use Mirikizumab (Intravenous,Subcutaneous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Before you use mirikizumab, your doctor may test you for tuberculosis or other infections.
For the first 3 doses, mirikizumab is injected into a vein by a healthcare provider every 4 weeks.
Later doses are then injected under the skin every 4 weeks. A healthcare provider may give you this injection or teach you how to properly use this medicine by yourself.
Your dose should be given as 2 injections under the skin to receive the full dose. Your healthcare provider will show you where to inject mirikizumab. Do not inject into the same place two times in a row. Do not give an injection into skin that is hard, red, bruised, or tender.
Do not shake the injection pen.
Ask your doctor or pharmacist if you don't understand how to use an injection pen.
Prepare an injection pen only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Each injection pen is for one use only. Throw away after one use, even if there is still medicine left inside. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
You will need frequent blood tests to check your liver function.
Store the medicine in the original container in the refrigerator. Protect from light and do not freeze.
Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.
Mirikizumab may also be stored in the original container at room temperature away from moisture, heat and light. Do not return the medicine to the refrigerator. Throw the medicine away after 2 weeks if stored at room temperature.
Use the medicine as soon as you remember, and then go back to your regular schedule. Do not use two doses at one time.
Mirikizumab side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
- fever, chills, sore throat;
- mouth sores, red or swollen gums;
- pale skin, easy bruising, unusual bleeding; or
- chest discomfort, wheezing, dry cough or hack, rapid weight loss.
Call your doctor at once if you have:
- liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Your treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- cold symptoms such as stuffy nose, sneezing, sore throat;
- herpes virus infections;
- rash;
- pain, bruising, swelling, or irritation where the medicine was injected;
- joint pain; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Mirikizumab?
Never share an injection pen even if you changed the needle. Sharing these devices can pass infections from person to person.
Avoid receiving a "live" vaccine while using mirikizumab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).