SKYRIZI
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SKYRIZI (SKYRIZI).
Risankizumab is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor. This blocks IL-23-mediated signaling, reducing the production of pro-inflammatory cytokines such as IL-17 and IL-22, which are involved in the pathogenesis of psoriasis, psoriatic arthritis, and inflammatory bowel disease.
| Metabolism | Risankizumab is a monoclonal antibody, expected to be degraded into small peptides and amino acids via general protein catabolic pathways. No specific metabolic enzymes involved. |
| Excretion | Primarily eliminated via intracellular catabolism; no significant renal or biliary excretion. Fecal excretion is minimal (<1%), and renal excretion of intact drug is negligible. |
| Half-life | Terminal elimination half-life is approximately 20–30 days, supporting an every-12-week subcutaneous dosing interval for maintenance therapy. |
| Protein binding | Bound to plasma proteins, primarily albumin; approximately 95% protein bound. |
| Volume of Distribution | Volume of distribution is approximately 0.06–0.09 L/kg, indicating limited extravascular distribution, consistent with a monoclonal antibody confined primarily to the vascular and interstitial spaces. |
| Bioavailability | Subcutaneous: Absolute bioavailability is approximately 90% after subcutaneous injection. |
| Onset of Action | Subcutaneous: Clinical response (e.g., reduction in Psoriasis Area and Severity Index) observed as early as Week 4, with maximal effect by Week 16–24. |
| Duration of Action | Duration of clinical effect persists for at least 12 weeks after a single subcutaneous dose, aligning with the maintenance dosing interval. |
150 mg subcutaneously at week 0, week 4, and every 12 weeks thereafter for plaque psoriasis; 600 mg intravenously at week 0, week 4, and every 8 weeks thereafter for Crohn's disease.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for any degree of renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment; not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Safety and efficacy in pediatric patients (<18 years) have not been established; no approved dosing. |
| Geriatric use | No specific dose adjustment recommended; use with caution due to limited data in patients ≥65 years. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SKYRIZI (SKYRIZI).
| Breastfeeding | No human data; risankizumab is a large monoclonal antibody likely excreted in milk in low amounts. M/P ratio unknown. Consider developmental risks of breastfeeding vs drug need. |
| Teratogenic Risk | No adequate human data; animal studies show no fetal harm at exposures up to 49x MRHD. Risk cannot be ruled out; avoid in pregnancy unless benefit outweighs risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["History of serious hypersensitivity reaction to risankizumab or any excipients","Clinically significant active infection (e.g., active tuberculosis)"]
| Precautions | ["Risk of serious infections","Hypersensitivity reactions including angioedema and urticaria","Pre-treatment evaluation for tuberculosis infection required","Avoid live vaccines during treatment","Potential risk of hepatotoxicity (elevated liver enzymes)"] |
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| No specific monitoring required; standard prenatal care. Monitor for infections in newborn if used near term. |
| Fertility Effects | No human data; animal studies show no impairment of fertility. Based on mechanism, unlikely to affect fertility. |