Why is this medicine prescribed?
Mirikizumab-mrkz injection is used to treat ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) and Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults. Mirikizumab-mrkz injection is in a class of medications called monoclonal antibodies. It works by stopping the action of certain cells in the body that cause the symptoms of ulcerative colitis.
Are there other uses for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
How should this medicine be used?
Mirikizumab-mrkz injection comes as a solution (liquid) to be slowly injected intravenously (into a vein) by a doctor or nurse in a medical office. It also comes as a solution in a prefilled pen or syringe to inject subcutaneously (under the skin) by yourself at home. It is given intravenously once every 4 weeks for the first 3 doses and then it is injected subcutaneously once every 4 weeks thereafter.
You will receive your first subcutaneous dose of mirikizumab-mrkz injection in your doctor's office. After that, you can inject mirikizumab-mrkz yourself or have a caregiver give the injections. Before you use mirikizumab-mrkz injection yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it. Do not inject more or less of it or inject it more often than prescribed by your doctor.
Use each pen or syringe only once and inject all the solution in the pen or syringe. Dispose of used pens or syringes in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
You can inject mirikizumab-mrkz injection anywhere on the front of your thighs (upper leg) or stomach except your navel (belly button) and the area 2 inches (5 centimeters) around it. If someone else is giving you the injection, that person can also inject the medication into your upper, outer arms. Each full dose requires 2 injections using 2 prefilled pens or syringes. Inject one prefilled pen or syringe and then inject a second dosing pen or syringe immediately. Use a different site for each injection to reduce the chances of soreness or redness. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
Remove the prefilled pen or syringe from the refrigerator and place it on a flat surface. Allow it to warm to room temperature for 30 minutes (prefilled pen) or 45 minutes (prefilled syringe) before injecting. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.
Do not remove the cap from the prefilled pen or syringe while the medication is warming. You should remove the cap right before you inject the medication. Do not replace the cap after you remove it. Do not use the device if you drop it on the floor.
Do not shake the prefilled dosing pen or syringe. This may damage the medication.
Always look at mirikizumab-mrkz solution before injecting it. Check that the expiration date has not passed. Check with the written instructions for use to find out what it should look like. Do not use a syringe or pen if it is expired or if the liquid does not look like it is described in the written instructions for use.
You will be given the Medication Guide when you begin treatment with mirikizumab-mrkz injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm to obtain the Medication Guide.
What special precautions should I follow?
Before using mirikizumab-mrkz injection,
- tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have vision or hearing problems or if you have or have ever had liver problems.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using mirikizumab-mrkz injection, call your doctor. If you used mirikizumab-mrkz injection while you were pregnant and have given birth, tell your baby's doctor that you used mirikizumab-mrkz injection. Mirikizumab-mrkz injection may interfere with your baby's immune response to infections.
- check with your doctor to see if you need to receive any vaccinations. It is important to have all vaccines appropriate for your age before beginning your treatment with mirikizumab-mrkz injection. Also tell your doctor if you have recently received any vaccinations. Do not have any vaccinations during your treatment without talking to your doctor.
- you should know that mirikizumab-mrkz injection may decrease your ability to fight infection and increase the risk that you will get a serious infection. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as herpes or cold sores), and chronic infections that do not go away. If you experience any of the following symptoms during or shortly after your treatment with mirikizumab-mrkz injection, call your doctor immediately: fever; headache; sore throat; cough; warm, red, or painful skin; mouth sores; frequent, urgent, or painful urination; muscle aches or pain; diarrhea, nausea, vomiting, or stomach pain; or other signs of infection.
- you should know that using mirikizumab-mrkz injection increases the risk that you will develop tuberculosis (TB; a serious lung infection), especially if you are already infected with tuberculosis but do not have any symptoms of the disease. Tell your doctor if you have or have ever had TB, if you have lived in a country where TB is common, or if you have been around someone who has TB. Your doctor may perform a skin test to see if you have an inactive TB infection. If necessary, your doctor will give you medication to treat this infection before you start using mirikizumab-mrkz injection. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, coughing up blood or mucus, weakness or tiredness, weight loss, loss of appetite, chills, fever, or night sweats.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do if I forget to take a dose?
Inject the missed dose as soon as you remember it and give the next injection 4 weeks later. Do not use a double dose to make up for a missed one.
What should I do in case of overdose?
In case of overdose, call the poison control helpline at 1-800-222-1222
. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What side effects can this medicine cause?
Mirikizumab-mrkz injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- injection site pain, bruising, bleeding, swelling, redness, warmth, or itching
- joint pain
Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:
- rash; hives; itching; sweating; difficulty breathing or swallowing; swelling of the eyes, face, mouth, lips, tongue or throat; dizziness; lightheadedness; fainting; rapid or pounding heartbeat; or chest pain
- nausea, vomiting, extreme tiredness, loss of appetite, pain in upper right side of your stomach, dark urine, or yellowing of the skin or eyes
Mirikizumab-mrkz injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone (
1-800-332-1088).What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and away from light. Do not freeze. Mirikizumab-mrkz injection may be stored at room temperature for up to 2 weeks but should be kept in the original carton to protect from light. Mirikizumab-mrkz injection should not be put back into the refrigerator after it has been stored at room temperature.
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach https://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to mirikizumab-mrkz injection.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies