Skyrizi
Risankizumab-rzaa · KIT · AbbVie Inc.
Skyrizi is a kit containing risankizumab-rzaa, taken intravenous. Manufactured by AbbVie Inc..
Key Facts
- Brand Name
- Skyrizi
- Generic Name
- Risankizumab-rzaa
- NDC Code (Product)
0074-1065- Manufacturer
- AbbVie Inc.
- Dosage Form
- KIT
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761105
- Drug Class
- Interleukin-23 Antagonist [EPC]
- Marketing Start
- 09/23/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SKYRIZI is an interleukin-23 antagonist indicated for the treatment of: moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis in adults. ( 1.2 ) moderately to severely active Crohn's disease in adults. ( 1.3 ) moderately to severely active ulcerative colitis in adults. ( 1.4 ) 1.1 Plaque Psoriasis SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. 1.3 Crohn’s Disease SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults. 1.4 Ulcerative Colitis SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For the treatment of Crohn’s disease and ulcerative colitis: Obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI. ( 2.1 , 5.4 ) Complete all age-appropriate vaccinations as recommended by current immunization guidelines ( 2.1 , 5.5 ) Recommended Dosage Moderate-to-Severe Plaque Psoriasis: Adults : 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Pediatric P atients 6 Years of Age and Older : Patients weighing less than 40 kg: 55 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Patients weighing 40 kg or greater: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.3 ) Psoriatic Arthritis: 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter. ( 2.4 ) In patients with psoriatic arthritis SKYRIZI can be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs). ( 2.4 ) Crohn’s Disease: The recommended induction dosage is 600 mg administered by intravenous infusion over at least one hour at …
Contraindications
4 CONTRAINDICATIONS SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )] . SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Plaque Psoriasis and Psoriatic Arthritis (≥ 1%): upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections. ( 6.1 ) Crohn’s Disease (>3%): ◦ Induction : upper respiratory infections, headache, and arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, abdominal pain, injection site reactions, anemia, pyrexia, back pain, arthropathy, and urinary tract infection. ( 6.1 ) Ulcerative Colitis (≥3%): ◦ Induction : arthralgia. ( 6.1 ) ◦ Maintenance : arthralgia, pyrexia, injection site reactions, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug can…
Frequently Asked Questions
What is Skyrizi used for?
Skyrizi contains Risankizumab-rzaa. It is a kit taken intravenous. Consult your doctor for specific uses.
Is Skyrizi a controlled substance?
Skyrizi is not classified as a controlled substance by the DEA.
What is the generic name for Skyrizi?
The generic name for Skyrizi is Risankizumab-rzaa. There are no other listed brand versions of Risankizumab-rzaa.
What is the NDC code for Skyrizi ?
The NDC (National Drug Code) for Skyrizi is 0074-1065, listed by AbbVie Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)