SKYRIZI (risankizumab-rzaa) injection is supplied in the following strengths:
|150 mg/mL single-dose pen||Carton of 1||0074-2100-01|
|150 mg/mL single-dose prefilled syringe||Carton of 1||0074-1050-01|
|75 mg/0.83 mL single-dose prefilled syringe||Carton of 2||0074-2042-02|
|360 mg/2.4 mL (150 mg/mL) single-dose prefilled cartridge with on-body injector||Kit||0074-1070-01|
|600 mg/10 mL (60 mg/mL) single-dose vial||Carton of 1||0074-5015-01|
SKYRIZI 150 mg/mL prefilled syringe or prefilled pen contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each prefilled syringe or prefilled pen consists of a 1 mL glass syringe with a fixed 27-gauge ½ inch needle with needle guard.
SKYRIZI 75 mg/0.83 mL prefilled syringe is a sterile, preservative-free, colorless to slightly yellow and clear to slightly opalescent solution. Each prefilled syringe consists of a 1 mL glass syringe with a fixed 29-gauge ½ inch needle with needle guard.
SKYRIZI 360 mg/2.4 mL (150 mg/mL) cyclic olefin polymer prefilled cartridge with a septum and cap contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution for use with supplied on-body injector administration device.
SKYRIZI 600 mg/10 mL (60 mg/mL) vial contains a sterile and preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each glass vial is closed with a stopper and blue flip cap.
Storage and Handling
- Store in a refrigerator at 36°F to 46° F (2°C to 8°C).
- Do not freeze.
- Do not shake.
- Keep in the original cartons to protect from light.
- Not made with natural rubber latex.
Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.1)].
Inform patients that SKYRIZI may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions ( 5.2)].
Hepatotoxicity in Treatment of Crohn’s Disease
Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks of treatment. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction. (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions ( 5.4)] .
Administration of Vaccines
Advise patients that vaccination with live vaccines is not recommended during SKYRIZI treatment and immediately prior to or after SKYRIZI treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform the healthcare practitioner that they are taking SKYRIZI prior to a potential vaccination [see Warnings and Precautions ( 5.5) ].
Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous injection technique [see Instructions for Use].
If using SKYRIZI 75 mg/0.83 mL, instruct patients or caregivers to administer two 75 mg single-dose syringes to achieve the full 150 mg dose of SKYRIZI [see Instructions for Use].
Instruct patients or caregivers in the technique of pen or syringe disposal [see Instructions for Use].
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SKYRIZI during pregnancy and patients can call 1-877-302-2161 [see Use in Specific Populations ( 8.1) ].
North Chicago, IL 60064, USA
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
© 2019-2022 AbbVie Inc.20070464 06/2022
|Medication Guide SKYRIZI ® (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous or intravenous use|
|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:|
|● fainting, dizziness, feeling lightheaded (low blood pressure)||● chest tightness|
|● 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: |
|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.|
|Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: |
|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 . |
| What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects including: |
| || || || |
|The most common side effect s of S KYRIZI in people treated for Crohn’s disease include:|
| || || |
|The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include:|
| || || |
|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.|
| How should I store SKYRIZI? |
|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.|
|What are the ingredients in SKYRIZI? Active ingredient: risankizumab-rzaa.SKYRIZI 150 mg/mL , 360 mg/2.4 mL, and 600 mg/ 10 mL inactive ingredient s: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP.SKYRIZI 75 mg/0.83 mL i nactive ingredients: sodium succinate, polysorbate 20, sorbitol, succinic acid, and Water for Injection, USP. Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.US License Number 1889SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.© 2019-2022 AbbVie Inc.For more information, call 1-866-SKYRIZI (1-866-759-7494) or go to www.SKYRIZI.com.|
|This Medication Guide has been approved by the U.S. Food and Drug Administration20070464||Revised: 06/2022|
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