HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
SKYRIZI safely and effectively. See full prescribing information for SKYRIZI.
SKYRIZI(risankizumab-rzaa)injection, for subcutaneous use
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
SKYRIZI is an interleukin-23 antagonist indicated for the treatment ofmoderate-to-severe plaque psoriasis in adults who are candidates for systemictherapy or phototherapy.
DOSAGE AND ADMINISTRATION
• 150 mg (two 75 mg injections) administered by subcutaneous injection atWeek 0, Week 4 and every 12 weeks thereafter. (2.1)
DOSAGE FORMS AND STRENGTHS
• Injection: 75 mg/0.83 mL in each single-dose prefilled syringe. (3)
CONTRAINDICATIONS
• None (4)
• Infections: SKYRIZI may increase the risk of infection. Instruct patients toseek medical advice if signs or symptoms of clinically important infectionoccur. If such an infection develops, do not administer SKYRIZI until theinfection resolves. (5.1)
• Tuberculosis (TB): eva luate for TB prior to initiating treatment with
SKYRIZI. (5.1)
ADVERSE REACTIONS
Most common adverse reactions (≥ 1%) are upper respiratory infections,headache, fatigue, injection site reactions, and tinea infections. (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.
DRUG INTERACTIONS
Avoid use of live vaccines in patients treated with SKYRIZI. (7.1)
See 17 for PATIENT COUNSELING INFORMATION and MedicationGuide.
Revised: 4/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
2.2 Tuberculosis Assessment Prior to Initiation of SKYRIZI
2.3 Important Administration Instructions
2.4 Preparation for Use of SKYRIZI Prefilled Syringes
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Infections
5.2 Pre-treatment eva luation for Tuberculosis
5.3 Immunizations
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
7 DRUG INTERACTIONS
7.1 Live Vaccinations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
SKYRIZI™ is indicated for the treatment of moderate-to-severe plaque psoriasis in adults whoare candidates for systemic therapy or phototherapy.
2 DOSAGE AND ADMINISTRATION
2.1 Dosage
The recommended dose is 150 mg (two 75 mg injections) administered by subcutaneousinjection at Week 0, Week 4, and every 12 weeks thereafter.
2.2 Tuberculosis Assessment Prior to Initiation of SKYRIZI
eva luate patients for tubercu