Risankizumab-rzaa Injection

WHY is this medicine prescribed?

Risankizumab-rzaa injection is used to treat moderate to severe plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults whose psoriasis is too severe to be treated by topical medications alone. It is also used to treat active psoriatic arthritis (condition that causes joint pain and swelling and scales on the skin) in adults. Risankizumab-rzaa injection is also used to treat 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. Risankizumab-rzaa 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 psoriasis.

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?

Risankizumab-rzaa comes as a solution (liquid) in a prefilled syringe, in a prefilled pen, as an on-body injector with a prefilled cartridge to inject subcutaneously (just under the skin), and as a solution to inject intravenously (into a vein). For the treatment of plaque psoriasis and psoriatic arthritis, it is usually given subcutaneously, using a prefilled syringe or prefilled pen as two injections for the first dose, followed by two injections 4 weeks after the first dose, and then two injections every 12 weeks. For the treatment of Crohn's disease, risankizumab-rzaa is initially given intravenously over at least 60 minutes once every 4 weeks for the first 3 doses (at week 0, week 4, and week 8) by a doctor or nurse in a healthcare facility. After the first 3 doses, it is usually given subcutaneously using the on-body injector with a prefilled cartridge once every 8 weeks. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use risankizumab-rzaa injection exactly as directed. Do not inject more or less of it or inject it more often than prescribed by your doctor.

You may receive your first subcutaneous dose of risankizumab-rzaa injection in your doctor's office. After your first dose, your doctor may allow you or a caregiver to perform the injections at home. Carefully read the manufacturer's instructions for use that comes with the medication. These instructions describe how to inject a dose of risankizumab-rzaa injection. Be sure to ask your doctor or pharmacist if you have any questions about how to inject the medication.

You can inject risankizumab-rzaa 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 using the syringe or pen, that person can also inject the medication into your upper, outer arms. 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.

Do not shake a syringe, pen, on-body injector, or prefilled cartridge that contains risankizumab-rzaa.

Remove the carton containing the medication from the refrigerator and place it on a flat surface; do not remove the prefilled syringe, prefilled pen, or on-body injector with prefilled cartridge from the carton. Allow it to warm to room temperature (15 to 30 minutes for the prefilled syringe, 30 to 90 minutes for the prefilled pen, and 45 to 90 minutes for the prefilled automatic injection device) before you are ready to inject the medication. Do not remove the needle cover from the syringe or the needle cap from the prefilled pen until you are ready to inject the medication.

Always look at risankizumab-rzaa solution before injecting it. Check that the expiration date has not passed and that the liquid is colorless to slightly yellow and clear. The liquid should not contain visible particles. Do not use a syringe, pen, or prefilled cartridge if it is cracked or broken, if it has been dropped, if it is expired, or if the liquid is cloudy or contains large or colored particles.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with risankizumab-rzaa injection. Read the information carefully and ask your doctor or pharmacist if you have any questions.

What SPECIAL PRECAUTIONS should I follow?

Before using risankizumab-rzaa injection,

• tell your doctor and pharmacist if you are allergic to risankizumab-rzaa, any other medications, or any of the ingredients in risankizumab-rzaa. 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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or have ever had liver disease, including cirrhosis, or any other medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using risankizumab-rzaa injection, call your doctor.

• do not have any vaccinations during your treatment with risankizumab-rzaa injection without talking to your doctor. Talk to your doctor about all vaccines appropriate for your age before beginning risankizumab-rzaa injection.

• you should know that risankizumab-rzaa injection may decrease your ability to fight infection from bacteria, viruses, and fungi and increase the risk that you will get a serious or life-threatening 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 risankizumab-rzaa injection, call your doctor immediately: fever, sweats, or chills; muscle aches; shortness of breath; warm, red, or painful skin or sores on your body; weight loss; diarrhea; stomach pain; frequent, urgent, or painful urination; or other signs of infection.

• you should know that using risankizumab-rzaa 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 will 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 risankizumab-rzaa 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, chest pain, 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?

If a dose is missed, inject the dose as soon as possible and give the next injection at the regular scheduled time. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Risankizumab-rzaa injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• runny nose, sore throat, sneezing, or nasal congestion
• extreme tiredness
• injection site bruising, pain, redness, swelling, irritation, pain, itching, and warmth
• joint or back pain

Some side effects can be serious. If you experience any of these symptoms or those mentioned in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• swelling of the face, throat, or around the mouth or eyes; hives; rash; itching; trouble swallowing or breathing; dizziness; rapid heartbeat; or sweating
• nausea, vomiting, loss of appetite, pain in the upper right part of the stomach, unexplained rash, flu-like symptoms, dark urine, yellowing of the skin or eyes, or lack of energy

Risankizumab-rzaa injection may cause other side effects. Call your doctor if you have any unusual problems while using 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).

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 risankizumab-rzaa injection in the refrigerator but do not freeze.

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.

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 OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to risankizumab-rzaa 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.