SKYRIZI (risankizumab-rzaa) by AbbVie Inc.



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Indications and Usage

INDICATIONS and USAGE

 

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults. 

 

 

Please see full Prescribing Information.

Dosage and Administration

DOSAGE AND ADMINISTRATION

 

150mg/mL administered by subcutaneous injection at Week 0, Week 4 and every 12 weeks thereafter.

 

Please see full Prescribing Information.

Contraindications

CONTRAINDICATIONS

SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients.

 

Please see full Prescribing Information.

Warnings and Precautions

WARNINGS AND PRECAUTIONS

 

  • Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur.
  • Infections: SKYRIZI may increase the risk of infection. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur.  If such an infection develops do not administer SKYRIZI until the infection resolves.
  • Tuberculosis (TB): Evaluate for TB prior to initiating treatment with SKYRIZI.
  • Administration of Vaccines: Avoid use of live vaccines 

 

 

Please see full Prescribing Information.

Adverse Reactions

ADVERSE REACTIONS

 

Most common adverse reactions (≥ 1%) are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

 

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.

 

 

Please see full Prescribing Information.

US-SKZD-220076

© 2022 AbbVie. All rights reserved. 
SKYRIZI® and its design are registered trademarks of AbbVie Biotechnology Ltd.

Please see Full Prescribing Information.

Indications and Important Safety Information


INDICATIONS

Plaque Psoriasis: SKYRIZI is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis: SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults.

Important Safety Information

Hypersensitivity Reactions

SKYRIZI® (risankizumab-rzaa) is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients. Serious hypersensitivity reactions, including anaphylaxis, have been reported with the use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately.

Infection

SKYRIZI may increase the risk of infection. Do not initiate treatment with SKYRIZI in patients with a clinically important active infection until it resolves or is adequately treated.

In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, closely monitor and discontinue SKYRIZI until the infection resolves.

Tuberculosis (TB)

Prior to initiating treatment with SKYRIZI, evaluate for TB infection and consider treatment in patients with latent or active TB for whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.

Administration of Vaccines

Avoid use of live vaccines in patients treated with SKYRIZI. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating SKYRIZI, complete all age appropriate vaccinations according to current immunization guidelines.

Adverse Reactions

Most common (≥1%) adverse reactions associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.

In psoriatic arthritis phase 3 trials, the incidence of hepatic events was higher with SKYRIZI compared to placebo.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen.