Skyrizi Risankizumab Injection

1. Indications and Usage
Plaque Psoriasis: Treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Psoriatic Arthritis (PsA): Treatment of adult patients with active PsA, as monotherapy or in combination with methotrexate (MTX).
Crohn’s Disease (CD): Treatment of adult patients with moderately to severely active CD.
Ulcerative Colitis (UC): Treatment of adult patients with moderately to severely active UC.
2. Dosage and Administration
Route of Administration:
Plaque Psoriasis & PsA: For Subcutaneous Injection ONLY.
Crohn’s Disease & Ulcerative Colitis: For Intravenous (IV) Induction, followed by Subcutaneous Maintenance.
Recommended Dosage:
Plaque Psoriasis: 150 mg administered subcutaneously at Weeks 0 and 4, and then every 12 weeks thereafter.
Psoriatic Arthritis: 150 mg administered subcutaneously at Weeks 0 and 4, and then every 12 weeks thereafter.
Crohn’s Disease (Induction): 600 mg administered as an intravenous infusion at Weeks 0, 4, and 8.
Crohn’s Disease (Maintenance): 180 mg or 360 mg administered subcutaneously starting at Week 12 and then every 8 weeks thereafter.
Ulcerative Colitis (Induction): 1200 mg administered as an intravenous infusion at Weeks 0, 4, and 8.
Ulcerative Colitis (Maintenance): 180 mg or 360 mg administered subcutaneously starting at Week 12 and then every 8 weeks thereafter.
3. Mechanism of Action
IL-23 Inhibition:
Risankizumab is a humanized IgG1 monoclonal antibody that binds specifically to the p19 subunit of interleukin-23 (IL-23).
Blocking the Pathway:
IL-23 is a naturally occurring cytokine involved in inflammatory and immune responses. By inhibiting IL-23, risankizumab blocks its interaction with the IL-23 receptor on the cell surface.
Downstream Effect:
This inhibition reduces the release of proinflammatory cytokines and chemokines, thereby modulating the inflammatory cascade responsible for psoriasis, psoriatic arthritis, and inflammatory bowel diseases.
4. Safety and Warnings
Infections:
Risankizumab may increase the risk of infections. Patients should be evaluated for tuberculosis (TB) infection prior to initiating therapy.
Hypersensitivity:
Hypersensitivity reactions (e.g., angioedema, urticaria) have been reported.
Vaccinations:
Avoid administration of live vaccines during treatment.
5.Adverse Reactions
Most Common (Incidence ≥3% and greater than placebo):
Upper respiratory tract infections, headache, fatigue, injection site reactions, arthralgia, and candidiasis.
6.Drug Interactions
CYP450 Substrates:
Chronic inflammation can normalize CYP450 enzyme activity. Caution is advised when co-administering with CYP1A2 substrates (e.g., theophylline, clozapine) as their metabolism may decrease.
Immunosuppressants:
Safety and efficacy in combination with other immunosuppressants have not been established.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Risankizumab.
Available Strength: 75 mg/0.83 mL, 150 mg/mL (prefilled syringes/pens); IV infusion vials (60 mg/mL).
Appearance: Clear to slightly opalescent, colorless to pale yellow liquid.
Storage: Store at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.