HOW should this medicine be used?
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.