ILUMYA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for ILUMYA (ILUMYA).
Humanized IgG1κ monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23), inhibiting its interaction with the IL-23 receptor, thereby blocking downstream signaling and production of pro-inflammatory cytokines such as IL-17 and IL-22.
| Metabolism | Degraded into small peptides and amino acids via general protein catabolism; not metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily eliminated via degradation into small peptides and amino acids; renal and biliary/fecal routes are negligible as intact molecule. |
| Half-life | Approximately 22-24 days (range 18-27 days), supporting quarterly (every 12 weeks) subcutaneous dosing in plaque psoriasis. |
| Protein binding | 93% bound to serum albumin; does not bind to IgG receptors. |
| Volume of Distribution | Approximately 10.7 L (0.15 L/kg for a 70 kg adult), indicating limited extravascular distribution. |
| Bioavailability | Subcutaneous bioavailability: 79% (range 60-100%) relative to intravenous administration. |
| Onset of Action | Clinical improvement as early as Week 4 with maximal response by Week 12 following 100 mg subcutaneous injection at Weeks 0 and 4 and every 12 weeks thereafter. |
| Duration of Action | Sustained efficacy over 12-week dosing interval; some patients maintain response up to 12 months with continued therapy. |
100 mg subcutaneously once every 12 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for renal impairment. Not studied in severe renal impairment (GFR <15 mL/min). |
| Liver impairment | No dosage adjustment required for mild or moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | Not approved for use in pediatric patients. |
| Geriatric use | No specific dosage adjustment recommended. Clinical studies included patients up to 65 years; 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 ILUMYA (ILUMYA).
| Breastfeeding | No data on presence in human milk, effects on breastfed infant, or milk production. Tildrakizumab is a large protein molecule; likely present in milk in low amounts but gastrointestinal breakdown limits absorption. M/P ratio unknown. Caution advised; consider benefits of breastfeeding and need for drug. |
| Teratogenic Risk | ILUMYA (tildrakizumab-asmn) is an IgG1/kappa monoclonal antibody. In pregnancy, IgG antibodies are actively transported across the placenta, increasing fetal exposure, especially in the third trimester. Limited human data; animal studies show no evidence of fetal harm at high doses. Risk cannot be excluded; benefits should outweigh risks. First trimester: unknown risk; second and third trimesters: increasing fetal exposure. Avoid use unless clearly needed. |
■ FDA Black Box Warning
None.
| Serious Effects |
["History of serious hypersensitivity reaction to tildrakizumab or any excipient"]
| Precautions | ["Serious hypersensitivity reactions including anaphylaxis","Potential increased risk of infections (avoid use in active infections)","May be associated with elevated liver enzymes (monitor LFTs)","Hypersensitivity to latex (needle cover contains natural rubber latex)"] |
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| Fetal Monitoring | No specific monitoring required beyond standard prenatal care. Monitor for maternal infections and hypersensitivity reactions. Fetal ultrasound as clinically indicated. |
| Fertility Effects | No human fertility data. Animal studies show no adverse effects on mating or fertility at doses up to 100 mg/kg. Potential impact on fertility unknown; unlikely to impair fertility. |