Skyrizi On-Body

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. Ask your health care professional how to prepare and use this medication. 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.

Inject this medication under the skin as directed by your doctor. The injection is given in the thighs or abdomen (at least 2 inches from your belly button). For the prefilled syringe or pen, it may also be given in the upper arms. If treating Crohn's disease or ulcerative colitis, 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.

Depending on your product, take the medication out of the refrigerator at least 15 to 90 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication any other way (for example, do not heat it in the microwave or place it in hot water). Do not shake the medication. The medication may contain a few clear or white particles. Before using, check this product for cloudiness, large particles, or discoloration. If you see any of these things, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is irritated, sore, bruised, red, hardened, or affected by psoriasis, or into scars or stretch marks. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, 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 or ulcerative colitis, 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 www.fda.gov/safety/medwatch-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.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you are using this medication to treat Crohn's disease or ulcerative colitis, 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 medication in the original carton to protect from light. 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.