Risankizumab (Skyrizi) Laboratory Monitoring
Skyrizi prescribing information requires tuberculosis (TB) evaluation before initiation. [1] Skyrizi prescribing information requires baseline and early follow-up liver enzymes and bilirubin monitoring for Crohn’s disease and ulcerative colitis. [1]
Tuberculosis Evaluation Before Starting Therapy
Skyrizi should not be initiated until TB infection is evaluated prior to treatment initiation. [1] TB evaluation is typically performed with a blood-based interferon gamma release assay (IGRA) or a tuberculin skin test (TST), depending on clinical context. [2]
Hepatotoxicity Monitoring for Crohn’s Disease and Ulcerative Colitis
For Crohn’s disease and ulcerative colitis, liver enzymes and bilirubin should be obtained at baseline prior to initiating therapy. [1] During induction, liver enzymes and bilirubin should be monitored for at least up to 12 weeks of treatment. [1] After induction, liver tests should be monitored thereafter according to routine patient management. [1]
Laboratory Tests Commonly Not Required as “Routine Bloodwork”
Skyrizi prescribing information does not specify routine periodic complete blood count (CBC) monitoring for all indications. [1] Skyrizi prescribing information does not specify routine periodic hepatitis serology monitoring for all indications. [1]
Practical Monitoring Schedule
Baseline TB evaluation is performed prior to initiation. [1] Baseline liver enzymes and bilirubin are performed prior to initiation for Crohn’s disease and ulcerative colitis. [1] Liver enzymes and bilirubin are repeated during induction through at least 12 weeks. [1]
When Additional Testing Is Indicated
Prompt evaluation is recommended for suspected drug-induced liver injury if symptoms or laboratory abnormalities suggest hepatic dysfunction during treatment. [1]
Medication Label Wording for Ongoing Monitoring
Hepatotoxicity monitoring is explicitly described for Crohn’s disease and ulcerative colitis with baseline testing and monitoring through at least 12 weeks during induction, followed by routine patient management. [1]