Mirikizumab-mrkz Injection

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) 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.

Mirikizumab-mrkz injection comes as a solution (liquid) to be injected intravenously (into a vein) over at least 30 minutes by a doctor or nurse in a medical office and as a prefilled dosing pen to inject subcutaneously (under the skin) by yourself at home. It is usually given intravenously once every 4 weeks for the first 3 doses (at week 0, week, 4, and week 8) and then it is injected subcutaneously once every 4 weeks thereafter (maintenance dose). If you are injecting mirikizumab-mrkz injection yourself, follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mirikizumab-mrkz injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You will receive your first subcutaneous dose of mirikizumab-mrkz injection in your doctor's office. After that, your doctor may allow you to inject mirikizumab-mrkz yourself or have a friend or relative perform 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.

Use each dosing pen only once and inject all the solution in the dosing pen. Dispose of used dosing pens 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 abdomen (stomach) except your navel 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 dosing pens. Inject one prefilled dosing pen and then inject a second dosing pen 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 dosing pen from the refrigerator and allow it to warm to room temperature for 30 minutes before using it. Take it out of its carton, and allow it to rest on a flat surface so that it can warm to room temperature. 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 dosing pen 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.

Never shake the prefilled dosing pen. This may damage the medication.

Always look at mirikizumab-mrkz solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless or slightly yellow or brown. The liquid should not contain visible particles. Do not use a dosing pen if it is expired, appears damaged, or if the liquid is cloudy, discolored, or contains particles.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (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 the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using mirikizumab-mrkz injection,

• tell your doctor and pharmacist if you are allergic to mirikizumab-mrkz, any other medications, or any of the ingredients in mirikizumab-mrkz injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• 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.
• 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 from bacteria, viruses, and fungi 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.

Unless your doctor tells you otherwise, continue your normal diet.

Inject the missed dose as soon as you remember it and give the next injection 4 weeks later. Do not take a double dose to make up for a missed one.

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:

• dizziness, fainting, or feeling lightheaded
• rapid or pounding heartbeat
• rash
• hives or itching
• difficulty breathing or swallowing; swelling of the eyes, face, mouth, lips, tongue or throat; dizziness; lightheadedness; fainting; 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

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.

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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Omvoh^®