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Skyrizi

Generic Name: Risankizumab-Rzaa Injection
Drug Category: Interleukin-23 Antagonist
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of year old and under the age of 18 years old for a maximum duration of 1 year.

Approved Uses

Indicated for:

Plaque Psoriasis:

• The treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Psoriatic Arthritis:

• The treatment of active psoriatic arthritis in adults.

SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI.

Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in 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. 

Complete all age-appropriate vaccinations as recommended by current immunization guidelines.

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.

Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. 

SKYRIZI may increase the risk of infections. Upper respiratory tract infections and tinea infections occurred more frequently in the SKYRIZI group than in the placebo group.

Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.

Limited available data with SKYRIZI use in pregnant women are insufficient to evaluate a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcome. Human IgG is known to cross the placental barrier; therefore, SKYRIZI may be transmitted from the mother to the developing fetus.

Maternal IgG is known to be present in human milk.

GoToSource

Off-label Uses

• Use in patients under the age of 18. GoToSource

• Psoriatic arthritis, erythrodermic psoriasis and generalized pustular psoriasis. GoToSource 

• Crohn’s disease. GoToSource

Adverse Events

Upper respiratory infections, cellulitis (deep infection of the skin) and infections. GoToSource

Osteomyelitis (bone infection), sepsis (life-threatening response to infection) and herpes zoster. GoToSource

Litigation

No major injury lawsuits reported.

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

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Site Last Updated May 18, 2024