MONO-LINYAH
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MONO-LINYAH (MONO-LINYAH).
Monoclonal antibody that binds to and inhibits the activity of interleukin-23 (IL-23), a pro-inflammatory cytokine involved in immune-mediated inflammatory diseases.
| Metabolism | Metabolized via general protein degradation pathways; not primarily metabolized by CYP450 enzymes. |
| Excretion | Predominantly renal as unchanged drug (≥90%); minor biliary/fecal (<5%). |
| Half-life | Terminal elimination half-life is 3–5 hours in adults; prolonged to 8–15 hours in renal impairment (CrCl <30 mL/min) and in neonates. |
| Protein binding | 20–30% bound to albumin. |
| Volume of Distribution | 0.5–0.8 L/kg, consistent with distribution into total body water; increased in edema or ascites. |
| Bioavailability | Oral bioavailability is 60–70% (first-pass metabolism ~30–40%); immediate-release tablets. |
| Onset of Action | Intravenous: 30–60 minutes; oral: 2–3 hours. |
| Duration of Action | Dosing interval-dependent; typically 6–12 hours after a single dose; reserve activity persists for 24–48 hours after discontinuing therapy. |
10 mg orally once daily
| Dosage form | TABLET |
| Renal impairment | GFR 30-89 mL/min: no adjustment; GFR 15-29 mL/min: 5 mg once daily; GFR <15 mL/min: not recommended |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 5 mg once daily; Child-Pugh C: not recommended |
| Pediatric use | Weight <20 kg: 2.5 mg once daily; 20-40 kg: 5 mg once daily; >40 kg: 10 mg once daily |
| Geriatric use | Start at 5 mg once daily; titrate based on response and tolerability |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MONO-LINYAH (MONO-LINYAH).
| Breastfeeding | Excreted in human milk. M/P ratio unknown. Due to potential for serious adverse reactions (e.g., renal toxicity), breast-feeding is contraindicated during therapy and for at least 30 days after last dose. |
| Teratogenic Risk | Pregnancy Category X. First trimester: High risk of major congenital malformations (e.g., craniofacial defects, neural tube defects). Second and third trimesters: Risk of oligohydramnios, fetal renal impairment, and neonatal anuria. Contraindicated in all trimesters. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to active substance or excipients","Clinically significant active infection"]
| Precautions | ["Increased risk of infections","Hypersensitivity reactions","Hepatotoxicity","Inflammatory bowel disease exacerbation"] |
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| Maternal: Renal function (serum creatinine, BUN, urinalysis), blood pressure, liver function tests, and complete blood count at baseline and monthly. Fetal: Ultrasound for fetal growth, amniotic fluid volume, and renal anatomy every 4 weeks if inadvertent exposure occurs. |
| Fertility Effects | Reversible impairment of spermatogenesis in males; may cause azoospermia or oligospermia. In females, can disrupt menstrual cycle and reduce fertility due to ovarian toxicity. Effects may persist for months after discontinuation. |