Skyrizi On-Body

IMPORTANT: 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.

Before using risankizumab, 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).

Risankizumab can make you more likely to get infections (including fungal skin 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 risankizumab 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 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.

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.

Read the Medication Guide and the Instructions for Use leaflet provided by your pharmacist before you start using risankizumab 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.

This medication is given by injection under your skin as directed by your doctor. If treating Crohn's disease, the first 3 doses of this medication is given by injection into a vein by a healthcare professional. The dosage and treatment schedule are 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 instructions. Wash your hands before using this medication. Before use, take risankizumab out of the refrigerator and let it warm to room temperature. If you are using the prefilled syringe, remove it from the refrigerator 15 to 30 minutes before you inject it. If you are using the pen, remove it from the refrigerator 30 to 90 minutes before you inject it. If you are using the on-body injector, remove it from the refrigerator 45 to 90 minutes before you use it. Do not heat this medication any other way, such as by heating in the microwave or placing in hot water. Keep the medication in the carton until ready to use. Do not shake the medication. The medication should be clear or yellow and may contain a few clear or white particles. Before using, check this product visually for cloudiness, large particles, or discoloration. If you see any of these things, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. This medication can be injected into the thighs or abdomen (at least 2 inches from your belly button). The prefilled syringe or pen may also be injected into the upper arms. Do not inject the drug into areas of the skin with scars or stretch marks or into skin that is irritated, sore, bruised, red, hardened, or affected by psoriasis. If you are using the on-body injector, the medication is injected over 5 minutes. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely. Do not reuse syringes, on-body injectors, or cartridges.

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 does not get better or if it gets worse.

Headache or tiredness may occur. If either of these effects lasts or gets 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 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).

If you are using this medication to treat Crohn's disease, risankizumab may rarely cause serious liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, 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 MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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

Do not share this medication with others.

If you are using this medication to treat Crohn's disease, lab 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.

Store in the refrigerator. Do not freeze. Keep the product in the original carton to protect from light until the time of use. 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.