SKYRIZI- risankizumab-rzaa
SKYRIZI- risankizumab-rzaa injection
AbbVie Inc.
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Medication Guide
SKYRIZI® (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous or intravenous use |
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What is the most important information I should know about SKYRIZI?
SKYRIZI may cause serious side effects, including: Serious allergic reactions. Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: |
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● fainting, dizziness, feeling lightheaded (low blood pressure) | ● chest tightness |
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● swelling of your face, eyelids, lips, mouth, tongue, or throat | ● skin rash, hives | ||||||
● trouble breathing or throat tightness | ● itching | ||||||
Infections. SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: | |||||||
● fever, sweats, or chills | ● muscle aches | ● weight loss | |||||
● cough | ● warm, red, or painful skin or sores on your body different from your psoriasis | ● diarrhea or stomach pain | |||||
● shortness of breath | ● burning when you urinate or urinating more often than normal | ||||||
● blood in your mucus (phlegm) | |||||||
See “What are the possible side effects of SKYRIZI?” for more information about side effects. | |||||||
What is SKYRIZI?
SKYRIZI is a prescription medicine used to treat:
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Who should not use SKYRIZI?
Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the end of this Medication Guide for a complete list of ingredients in SKYRIZI. |
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Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:
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How should I use SKYRIZI?
See the detailed “Instructions for Use” that comes with SKYRIZI for information on how to prepare and inject a dose of SKYRIZI, and how to properly throw away (dispose of) a used SKYRIZI prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector.
Adults with Crohn’s disease will receive their starter doses with SKYRIZI through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive SKYRIZI as an injection under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector. |
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What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects including:
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The most common side effects of SKYRIZI in people treated for Crohn’s disease include: | |||||||
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The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: | |||||||
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These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store SKYRIZI?
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General information about the safe and effective use of SKYRIZI.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SKYRIZI for a condition for which it was not prescribed. Do not give SKYRIZI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SKYRIZI that is written for health professionals. |
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What are the ingredients in SKYRIZI?
Active ingredient: risankizumab-rzaa. SKYRIZI 75 mg/0.83 mL and 90 mg/mL inactive ingredients: sodium succinate, polysorbate 20, sorbitol, succinic acid, and Water for Injection, USP. SKYRIZI 150 mg/mL, 180 mg/1.2 mL, 360 mg/2.4 mL, and 600 mg/ 10 mL inactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP. Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A. US License Number 1889 SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd. © 2019-2023 AbbVie Inc. For more information, call 1-866-SKYRIZI (1-866-759-7494) or go to www.SKYRIZI.com. |
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This Medication Guide has been approved by the U.S. Food and Drug Administration 20071775 R1 | Revised: 03/2023 |