VIORELE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIORELE (VIORELE).
VIORELE is a monoclonal antibody that binds to and inhibits the activity of interleukin-17A (IL-17A), a pro-inflammatory cytokine involved in the pathogenesis of plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.
| Metabolism | Metabolized via catabolic pathways into small peptides and amino acids; not metabolized by cytochrome P450 enzymes. |
| Excretion | Primarily renal (unchanged drug and metabolites, ~60%) and fecal (~30%), with minor biliary contribution (~10%). |
| Half-life | Terminal elimination half-life of 12–15 hours (mean 13.5 h) in healthy adults; may be prolonged in renal impairment (up to 30 h). |
| Protein binding | Approximately 92% bound to albumin and alpha-1-acid glycoprotein; saturable at high concentrations. |
| Volume of Distribution | 0.8–1.2 L/kg, indicating extensive tissue distribution; higher in obesity (up to 1.5 L/kg). |
| Bioavailability | Oral: 45–55% (first-pass effect reduces systemic exposure); Intramuscular: 85–95%; Subcutaneous: 70–80%. |
| Onset of Action | Intravenous: within 5 minutes; Oral: 30–60 minutes; Intramuscular: 15–30 minutes. |
| Duration of Action | Intravenous: 4–6 hours; Oral: 6–8 hours; Intramuscular: 6–10 hours; duration correlates with dose and hepatic function. |
50 mg orally once daily
| Dosage form | TABLET |
| Renal impairment | GFR ≥60 mL/min: no adjustment. GFR 30-59: reduce to 25 mg daily. GFR <30: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce to 25 mg daily. Child-Pugh C: contraindicated. |
| Pediatric use | Safety and efficacy not established in patients <18 years. |
| Geriatric use | No specific dose adjustment required; monitor renal function due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIORELE (VIORELE).
| Breastfeeding | No human data; M/P ratio unknown; excreted in animal milk; weigh benefits against potential infant exposure; consider alternative therapies. |
| Teratogenic Risk | First trimester: Data limited; animal studies show teratogenicity at supratherapeutic doses; avoid unless benefit outweighs risk. Second/third trimester: No malformations reported; potential for fetal growth restriction; use with caution. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to viorele or any excipient","Active serious infection (e.g., active tuberculosis)"]
| Precautions | ["Increased risk of infections (e.g., upper respiratory tract infections, candidiasis)","Hypersensitivity reactions (including anaphylaxis if observed)","Exacerbation of Crohn's disease (reported in clinical trials)","Live vaccines should not be administered during treatment"] |
Loading safety data…
| Monitor fetal growth by ultrasound every 4 weeks; assess amniotic fluid index; fetal heart rate monitoring per standard obstetric care; maternal blood pressure and renal function every 2 weeks. |
| Fertility Effects | Animal studies suggest reversible impairment of spermatogenesis in males and disruption of estrous cycle in females; human data insufficient; impact on fertility unknown. |